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hl12supplementblog-blog · 8 years ago

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pharmacyinpractice · 5 years ago

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Class 4 Medicines Defect Information: Sodium Benzoate (Amzoate) 2g in 10 mL Sterile Solution for injection

Torbay Pharmaceuticals has informed the MHRA that the carton label on Sodium Benzoate (Amzoate) 2g in 10 mL Sterile Solution for injection incorrectly states the concentration of disodium edetate (excipient) as 0.1% w/v (10mg in 1mL) instead of 0.1% w/v (10mg in 10mL).

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chemanalystdata · 2 months ago

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Sodium benzoate is a widely used food preservative and antimicrobial agent, especially popular in the food and beverage industry. The chemical compound, known for its effectiveness in inhibiting the growth of bacteria, mold, and yeast, is often included in acidic foods like sodas, jams, sauces, and dressings. Due to its extensive usage, the demand for sodium benzoate remains steady, making its pricing a point of concern for manufacturers, suppliers, and even consumers. In recent years, sodium benzoate export prices have become a critical factor in the global food and beverage industry, largely due to the volatility in raw material costs, transportation, and evolving regulatory policies.

Sodium benzoate prices are influenced by several factors, with the primary driver being the cost of raw materials. Sodium benzoate is derived from benzoic acid, which is produced through the partial oxidation of toluene, a petrochemical derivative. Any fluctuation in crude oil prices, which directly affect toluene production, has a significant impact on sodium benzoate pricing. In periods where crude oil prices rise, the cost of toluene increases, causing manufacturers to hike sodium benzoate prices. Conversely, a dip in oil prices often results in lower production costs, potentially leading to reduced sodium benzoate prices. However, the correlation between crude oil prices and sodium benzoate is not always direct, as there are other operational and logistical factors at play.

Get Real Time Prices for Sodium Benzoate Excipient: https://www.chemanalyst.com/Pricing-data/sodium-benzoate-excipient-1515

Regulatory factors also contribute significantly to fluctuations in sodium benzoate export prices. Many countries have stringent regulations governing food additives, including sodium benzoate. Changes in regulations, particularly in major markets like the United States and the European Union, can influence production costs. For instance, stricter guidelines regarding the acceptable levels of sodium benzoate in food products may require manufacturers to modify production processes or invest in compliance technologies, thus raising operational costs. Furthermore, any regulatory changes that affect import and export tariffs also impact pricing. Countries imposing higher tariffs on sodium benzoate or its raw materials can lead to increased costs for international buyers, causing a ripple effect across the global market.

Geopolitical dynamics and trade policies further complicate the sodium benzoate pricing environment. Trade disputes, particularly between large economies like the US and China, can have significant ramifications for sodium benzoate export prices. China is a major producer and exporter of sodium benzoate, and any disruptions in its trade with other countries can create a supply shortfall, pushing up prices. Additionally, when geopolitical tensions cause fluctuations in currency exchange rates, exporters and importers may face added uncertainty in pricing. A weakened currency in an exporting country may lead to lower prices for international buyers, while a stronger currency could make sodium benzoate more expensive.

On the demand side, the growing consumer awareness of food safety and preservatives has also had an impact on sodium benzoate export prices. Consumers are increasingly seeking out products that are free from artificial preservatives, including sodium benzoate, which has spurred some food manufacturers to reformulate their products. As a result, there has been a slight dip in demand for sodium benzoate in certain markets, particularly in developed countries where clean label trends are more pronounced. However, in other parts of the world, especially in developing countries, the demand for sodium benzoate remains robust due to the need for effective food preservation solutions. This divergence in demand trends across different regions contributes to price variability in the global market.

Sodium benzoate prices are also subject to seasonal fluctuations. Since it is widely used in the food and beverage industry, particularly in products that experience peak demand during certain times of the year, such as soft drinks in the summer, the pricing of sodium benzoate can see seasonal shifts. Manufacturers often stockpile sodium benzoate in advance of these peak demand periods, which can lead to temporary price increases due to heightened demand for the preservative. On the other hand, during off-peak seasons, sodium benzoate prices may stabilize or even decline as demand tapers off.

In addition to these factors, technological advancements in the production of sodium benzoate could play a role in future pricing trends. Manufacturers are continuously seeking more efficient production processes to reduce costs and improve yields. Innovations in chemical synthesis and improvements in production technology may eventually help stabilize sodium benzoate prices by making production more cost-effective. However, these advancements are often met with significant upfront investment costs, which can keep prices elevated in the short term.

Finally, environmental and sustainability considerations are increasingly affecting the sodium benzoate market. As consumers and regulators place more emphasis on sustainability, the environmental impact of chemical production, including sodium benzoate, is coming under scrutiny. Companies are now exploring greener production methods that reduce the carbon footprint of their operations. While these initiatives are commendable, they may result in higher production costs in the short term, which could drive up sodium benzoate prices. Over time, however, sustainable practices could lead to more stable and potentially lower prices, as companies optimize their processes and consumers become more accepting of the costs associated with environmentally friendly production.

In conclusion, sodium benzoate export prices are influenced by a complex interplay of factors, including raw material costs, global supply chains, regulatory changes, geopolitical dynamics, consumer demand, and technological advancements. As the global economy continues to evolve and new challenges emerge, the pricing of sodium benzoate will likely remain fluid, with periodic fluctuations driven by both external and internal market forces. For manufacturers, suppliers, and buyers, staying informed about these factors is essential to navigating the ever-changing landscape of sodium benzoate pricing.

Get Real Time Prices for Sodium Benzoate Excipient: https://www.chemanalyst.com/Pricing-data/sodium-benzoate-excipient-1515

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#Sodium Benzoate Excipient #Sodium Benzoate Excipient Price #Sodium Benzoate Excipient Prices #Sodium Benzoate Excipient Pricing #Sodium Benzoate Excipient News

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callitlouisa-blog · 6 years ago

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Extemporaneously Compounded Preparations

http://www.fshealth.gov.za/subsites/DWoods/index.html

The formulation of an oral liquid for paediatric use requires careful consideration of many factors to ensure that the product is of optimum quality and efficacy. Compounding an oral liquid from crushed tablets should only be considered if there are adequate stability data and it should be recognised that there are often simpler or more reliable methods of preparing the dose. Before discussing the formulation of oral liquids it is important to briefly consider these alternatives some of which are perhaps under utilised.

Alternatives to formulation of oral liquids

An alternative drug which is available commercially in liquid form could be selected. For example, it is usually preferable to use captopril oral solution rather than prepare enalapril solution from tablets.

Tablet dispersion - The practice of crushing tablets or opening capsules and adding the powder to a palatable drink or sprinkling onto solid food is a time-honoured alternative, but there are few circumstances when this method is appropriate or necessary.

It is difficult to ensure that a complete dose has been taken and the practice of nurses or carers handling powdered drug may present health concerns.

Tablet dispersion is a simpler, more reliable and potentially safer method. If the tablet disperses in water, it can be dispersed in a small volume and the dose given when a suspension is formed, mixed with a flavoured vehicle if required.

Not all tablets disperse readily but some form a suspension in seconds. If the tablet disperses readily and the drug is soluble, dispersing the tablet in a known volume of water allows a fractional dose to be accurately measured with a syringe as in the case of captopril.

As extraction of soluble drug from the tablet excipients may be incomplete the suspension should be shaken or stirred prior to measuring the dose and not filtered unless it has been established that active drug is not removed.

In the case of an insoluble drug, the measurement of a fractional dose by taking an aliquot from a suspension formed in this way cannot be recommended due to probable rapid sedimentation of insoluble drug and resultant dosage inaccuracy. Tablet dispersion may not always be practical for infants when the doses required are the equivalent of small tablet fractions.

Oral administration of the injection

If the injectable form of the drug is the same as the oral form (for example labetalol hydrochloride, ondansetron hydrochloride) it can be assumed that the drug will be absorbed from the injectable formulation. However, as the drug is in solution more rapid absorption and higher peak levels may occur compared to slower absorption from a solid dose form.

Some injectable drug forms are produced by reaction of the insoluble oral form with sodium hydroxide to give a soluble salt (for example acetazolamide sodium, sodium folate). In the acidic conditions of the stomach the oral form (acetazolamide, folic acid) will be generated.

The injectable form of drugs which are chemically degraded by gastric acid (for example omeprazole) are unsuitable for oral administration.

The oral use of the injectable form of a drug which is subjected to extensive first-pass metabolism, resulting in poor oral bioavailability, may be impractical due to the large volume required. For example, a volume of 15 mL (15 ampoules) of 1 mg per mL is required if propranolol injection is used to give an oral dose of 15 mg.

Drugs such as cefuroxime and enalaprilat which are administered orally as pro-drugs (cefuroxime axetil and enalapril maleate) have relatively poor bioavailability and are not suitable for oral administration.

Injections may contain excipients and adjuvants that are undesirable in some patients. For example proplylene glycol and ethanol.

The cost of using the injectable form orally may be prohibitive. For example, the cost of giving dantrolene injection orally is approximately 60 times the cost (per mg of drug) of using the oral form.

Powder Papers or Repacked Capsules

Fractional doses can be prepared by repacking dosage aliquots of powdered tablets or capsule contents, or mixing with a diluent such as starch or lactose prior to repacking into powder papers or empty capsules. This method can be used for drugs which are unstable in aqueous solution and was used to prepare paediatric doses of captopril before a stabilised solution was made commercially available.

Preparation of Oral Liquids: Practices and Problems

If alternatives are not possible or the convenience and flexibility of a ready prepared product is preferred an extemporaneously compounded oral liquid might be considered.

The most frequently used method is to grind the required number of tablets to a fine powder in a mortar and form a slurry by adding a small volume of water.

Excipients such as antimicrobial preservatives, suspending agents and flavouring agents are added to make the final product.

Frequently used base is a mixture of glycerol or syrup

Frequently used suspending agent is methylcellulose

Frequently used preservative is para-hydroxybenzoates (parabens)

Other agents sometimes added include alternative solvents such ethanol, particularly when the drug is poorly soluble in water, and buffer systems to provide the optimum pH for drug stability or activity of the antimicrobial preservative.

If the drug is water soluble there is a temptation to filter out the insoluble tablet excipients to leave a clear solution but filtration can remove significant amounts of drug if extraction from tablets is incomplete.

Insoluble tablet excipients are in suspension and may compromise product appearance whereas soluble excipients may reduce drug stability, for example, by altering the pH of the preparation.

The expiry date of an extemporaneously prepared oral liquid is assigned empirically or based on published information on a particular formulation. A conservative approach must be adopted when assigning an expiry date because of lack of information on drug stability. Most studies base their expiry date recommendation on chemical stability but do not address possible physical or microbiological spoilage which may be significant during actual use of the product.

For these reasons it is the author's opinion that extemporaneously prepared oral liquids should only be used for a maximum of one month from the date of preparation to minimise any unrecognised product deterioration. Longer expiry dates may be applied if more extensive testing is performed.

Side effects of excipients

Sucrose (in syrup) can promote the formation of dental caries

Ethanol can cause hypoglycaemia .

Para-hydroxybenzoates can cause hypersensitivity reactions and exacerbate the symptoms of asthma. It has also been suggested that benzoates and para-hydroxybenzoates can aggravate neonatal hyperbilirubinaemia by displacing bilirubin which is bound to plasma proteins but the amounts present in oral formulations are unlikely to pose any risk.

Limits for the inclusion of ethanol in paediatric formulations have been proposed by the American Academy of Paediatrics

Chemical instability

Drugs in extemporaneously prepared liquids may be susceptible to chemical reactions leading to degradation. The most common reactions are hydrolysis, oxidation and reduction. Usually the reaction rate or type is influenced by pH

Azathioprine is rapidly hydrolysed to 6-mercaptopurine at alkaline pH but is relatively stable in acidic or neutral conditions

Presence of trace metals catalyse the oxidation of captopril, methyldopa

Exposure to light catalyses the oxidative degradation of 6-mercaptopurine

The rate of chemical degradation usually increases with temperature

Preparations made from tablets contain excipients such as binders and disintegrating agents in addition to the active drug may reduce chemical stability by changing the pH so more rapid degradation occurs

Amiloride solution prepared from pure drug is more stable than an oral liquid prepared from tablet

Drug in preparation may be totally or partially in solution or predominantly in the solid state as a suspension.

Drugs in solution are more susceptible to chemical degradation than drugs in the solid state (ie. suspensions), thus suspensions of acetazolamide and chlorothiazide are more stable than solutions

However it cannot be assumed in all cases that an extemporaneously prepared suspension is more stable than a solution. Frusemide undergoes hydrolysis in acidic conditions where the solid state is predominant, but is much more stable at alkaline pH where it is totally in solution.

Microbiological Instability

Microbial growth in an oral liquid may cause foul odour and turbidity and adversely effect palatability and appearance. High titres of micro-organisms may be hazardous to health especially in very young or immunocompromised patients.

By-products of microbial metabolism may cause a change in the pH of the preparation and reduce the chemical stability or solubility of the drug.

Microbial contamination during preparation must be minimised by using clean equipment, sterile water (Water for Irrigation BP) and avoiding contaminated raw materials and containers.

If sodium benzoate or benzoic acid are used as antimicrobial preservatives the final pH must be less than 5 so that the active unionised form is predominant.Consequently the drug must also be stable at this pH

Many factors can reduce the effectiveness of the preservative including use of contaminated materials, chemical degradation, binding of preservative to suspending agents or tablet excipients, incorrect storage or unhygienic use of the final product.

Physical Instability

Extemporaneously prepared oral suspensions may be susceptible to sedimentation of insoluble drug causing caking. Difficulty in re-suspending the drug or rapid sedimentation following shaking can lead to erratic dosage measurement

Spironolactone suspensions have been reported to be excessively thick and almost un-pourable.

Refrigeration, whilst usually desirable to maximise chemical stability and reduce microbial growth, can also increase the viscosity of a suspension making re-suspension more difficult or cause the precipitation of active drug or preservatives

It is important to consider the effect on pH of all components of the formulation and the possible impact on stability. Syrup, for example, is relatively acidic and if used in phenobarbitone sodium oral solution it will cause the precipitation of unionised phenobarbitone.

Preparation of a Paediatric Oral Liquid - A Guide

Consider an alternative drug.

Consider an alternative method, for example, tablet dispersion or oral administration of the injection.

Consult the latest information data-bases and publications. Prepare a formulation according to a published study and follow the conditions of this study as closely as possible. Modifications to published formulations are only appropriate if there are no detrimental effects on stability. A maximum expiry date of one month from preparation is recommended and liquids without an antimicrobial preservative should be given a shorter expiry date.

If there are no data from a published study consult pharmaceutical manufacturers, other paediatric hospitals and research centres.

It may be possible to adapt existing information from drug stability texts (e.g. solubility, pH stability profile) or from the formulation details of the injection or oral liquid available elsewhere.

Monitor use of the product and observe for any signs of physical instability such as colour change or difficulty in re-suspension.

Provide information to carers to ensure correct use of the product (e.g. storage conditions, use of an oral syringe, shaking before administration).

Ensure that formulations details are available to all practitioners involved in the patients care to ensure that the product is consistent in appearance and quality. Prescriptions could contain full details of the formula and hospital pharmacists could provide details to their community colleagues.

Compounding Of Oral Liquid Cytotoxic Drugs

The compounding of oral liquid dosage forms of cytotoxic drugs can pose problems due to the hazardous nature of the product and the lack of stability data

Patients also require special instructions on the safe use and handling of such preparations

Some injectable preparations can be given orally, e.g. methotrexate, cyclophosphamide. The manufacturers information on the stability of reconstituted or diluted solutions should be consulted

All procedures must be carried out under conditions which protect the operator from exposure to the drug and prevent contamination of the product. Standard procedures relating to the compounding of parenteral cytotoxic drugs should be followed.

Crushing tablets and grinding powders in the dry state with a mortar and pestle is very hazardous and must be avoided. Cytotoxic drug safety cabinets are not designed to contain large particles such as those which may be released when tablets are crushed with a mortar and pestle. If crushing or grinding tablets is unavoidable, a glass mortar and pestle should be used and the tablets allowed to wet or disperse before trituration.

After completion of the operation the equipment should be thoroughly cleaned with hot water and alkaline detergent.

If tablets are readily dispersible in water, oral suspensions of cytotoxic drugs may be prepared by dispersing tablets in water in pre-calibrated bottles, and then making up to final volume with suspending base. This has the advantage of minimising the risk of exposure to cytotoxic drugs while also reducing the time involved in preparing extemporaneous mixtures.

The following procedure may be used for the preparation of these suspensions:

Calculate the quantity of whole tablets required and the final volume.

Calibrate the final volume on the outside of the final container (e.g. with a marker pen).

Place the required number of tablets in the bottle.

Add enough water to cover the tablets and allow dispersion. Shake gently to allow dispersion.

After the tablets are dispersed, make up to volume with suspending base or water.

Tablets which can be dispersed in this way include those containing:

Mercaptopurine (Purinethol)

Busulphan (Myleran)

Methotrexate (Ledertrexate) (Methoblastin)

Administration of medications through enteral feeding tubes

Drugs are commonly administered via feeding tubes. Tablet fragments or viscous oral liquids may block or adhere to the tubing causing blockage or incomplete dose delivery

Prior dilution of viscous oral liquids by about 50% with water may decrease adherence to the tubing and increase dose delivery

Tablets should be completely dispersed or finely crushed as fragments may block the tubing.

Enteric coated or modified release forms should not be crushed

Use about 10 - 15mL of water to prepare the dose.

Flush the tubing with 20 - 30mL of water before drug administration.

Administer each drug separately and rinse the tube with 5mL of water between each drug.

Flush the tube with water when drug administration is complete.

Medications should not be mixed with enteral feeding formulas as interactions can occur

Medications in enteral feedings:

Amlodipine - Tablets disperse very readily in water and can be administered via tubing. Useful if a long-acting dihydropyridine calcium antagonist is required

Carbamazepine - Prior dilution of viscous liquids may decrease adhesion to the tubing and improve dose delivery. Carbamazepine suspension should be well shaken and diluted with water before administration.

Sorbitol in large dose volume containing suspensions may cause diarrhoea

Ciprofloxacin - well absorbed orally. Bioavailability is much lower and extremely variable when crushed tablets are administered via nasogastric tube to critically ill patients receiving continuous enteral feeds. It is probable that ciprofloxacin forms insoluble chelates with constituents of the enteral feed. Continued IV administration is preferred in such patients unless facilities to monitor ciprofloxacin plasma concentrations are available

Clarithromycin - Clarithromycin is well absorbed when administered via nasogastric tube to critically ill patients.

Diazepam - Some commercially available suspensions are very viscous. Dilute before administration. Most tablet brands disperse readily and such a preparation may be easier to administer than the suspension

Itraconazole - Extemporaneously prepared oral liquids using capsule contents for tube administration have been described. However, the bioavailability of itraconazole from these preparations is lower than with commercially available capsules and suspension

Lansoprazole - See oral liquid (See Emixt)

Nifedipine - Not recommended as nifedipine is very light sensitive and it is difficult to remove the required dose from the capsule. The capsule contents are not miscible with water and may stick to tubing. Refer to oral liquid (See Emixt). Consider using amlodipine as an alternative

Omeprazole - See oral liquid (See Emixt)

Phenytoin - Enteral feeds can reduce the absorption of phenytoin. The drug suspension can also stick to the sides of feeding tubes preventing administration of the full dose. The extent of these interactions is unpredictable due to the many variables. A consistent method of administration will assist in providing dose uniformity. It is not necessary to stop the enteral feeds for extended periods (e.g. 2 hours) either side of phenytoin dose administration. It is important to monitor phenytoin plasma concentrations regularly and to anticipate a possible dose reduction when the enteral feed is discontinued

Give phenytoin IV if an initial loading dose is required or if the patient is having seizures

Oral phenytoin can be given once daily if tolerated

Stop the enteral feed and flush the tube with 20mL of Normal Saline*

Use Dilantin Forte Suspension (100mg Phenytoin per 5mL)

SHAKE WELL before measuring the dose

Dilute the phenytoin dose with Normal Saline* to a total volume of 30mL

Shake or mix, and administer via the tube

Flush the tube with a further 30 mL of Normal Saline*

Restart the feed

Ophthalmic Preparations http://www.fshealth.gov.za/subsites/DWoods/index.html

Rectal administration of oral dose forms and injectable preparations

Rectal suppository formulations are not always available and the rectal administration of tablets, injections or retention enemas is often considered

Generally, manufacturers do not endorse the use of their products by unlicensed routes of administration.

General Considerations

Adequate hydration of the dose form is important. If tablets or capsules are being inserted and the rectum is very dry, insert 10 - 15mL of warm water to assist the dissolution or dispersion of the dosage form. A water miscible lubricant such as KY jelly is useful if tablets or capsules are inserted.

Partial avoidance of hepatic first-pass metabolism. The superior rectal vein, which perfuses the upper part of the rectum, passes directly into the portal circulation. The middle and inferior rectal veins perfuse the lower part of the rectum, and venous blood avoids first pass through the liver. Thus, the positioning of the dose form in the rectum will influence the bioavailability of drugs that are subjected to extensive first-pass metabolism.

Large dose volumes are difficult to retain in the rectum and hypertonic solutions have a laxative effect.

Some vehicles used for parenteral solutions, such as ethanol and propylene glycol, may be irritant to the rectal mucosa, especially if used chronically

Medications in rectal form:

Baclofen - Not absorbed rectally from an aqueous vehicle when compared to oral administration. Rectal administration of baclofen does not appear to be a therapeutic option

Carbamazepine - Bioavailability of carbamazepine from rectally administered suspension is similar to that following oral administration

Clonazepam - Well absorbed rectally but that absorption may be erratic with considerable variability between individuals

Diazepam - parenteral solution is rapidly absorbed when administered rectally. Local burning sensation is often reported following rectal administration of diazepam solution but this is not associated with pathological changes

Doxepin - Rectal absorption of doxepin administered as 25mg capsules has been demonstrated in cancer patients with severe pain. Low doses of doxepin (25mg daily) gave serum doxepin and N-desmethyldoxepin concentrations of < 25mcg/mL but increasing the dose to 50mg (as two 25mg capsules) three times daily gave concentrations ranging from 204 - 573mcg/mL.

Droperidol injection - administered rectally but the extent of absorption is unknown. The duration of antiemetic activity of rectally administered droperidol is only about 2 - 4 hours which may limit its use by this route

Gabapentin - rectal administration of gabapentin is not satisfactory when oral dosing is interrupted

Lamotrigine - Lamotrigine is absorbed rectally. The relative bioavailability of lamotrigine administered as a crushed tablet suspended in 10mL of water was about 0.63 compared with oral administration

Levodopa - poorly absorbed when given rectally

Methadone - well absorbed when administered rectally. Suppositories can be prepared using methadone powder and a hydrogenated oil base. A simpler method is to administer the methadone as a microenema. Six opioid-naive patients with pain due to cancer received a 1mL microenema of 10mg methadone administered with an insulin syringe. Methadone was well absorbed and provided significant analgesia.The details of the enema preparation were not provided but a simple aqueous solution of methadone or the injection can be used. If only the tablets are available disperse in the smallest volume of water possible

Midazolam - administered rectally, usually as the parenteral solution diluted with normal saline. Data on the extent of rectal absorption are conflicting and may be due to variable absorption amplified by partial avoidance of hepatic first-pass metabolism. Midazolam is absorbed rectally but the clinical response may be variable and the site of rectal absorption influences the bioavailability

Ondansetron - Ondansetron is absorbed rectally as formulated suppositories or administered as the parenteral solution. Ondansetron tablets administered rectally with a water based lubricant were successful in alleviating post chemotherapy induced emesis

Phenobarbitone Sodium - The sodium salt, dissolved in a vehicle containing 10% ethanol, 75% propylene glycol and water, resulted in a rectal bioavailability of 90% relative to intramuscular administration. Absorption may be too slow for the treatment of status epilepticus

Phenytoin - Therapeutic serum concentrations of phenytoin have not been achieved by rectal administration in humans. The injectable preparation would be unsuitable for rectal administration due the irritant nature of the vehicle and the alkaline pH. Rectal administration of phenytoin is not recommended

Propylthiouracil - The rectal administration of propylthiouracil for the treatment of thyroid storm has been described Retention enemas were prepared by dispersing eight 50mg tablets (400mg) in Fleets mineral oil for the first dose and Fleets phospho soda. Plasma propylthiouracil concentrations confirmed rectal absorption and a therapeutic response was obtained. The extent of rectal absorption and optimal vehicle for administration have not been determined

Valproic acid - Valproic acid (Depakene syrup) can be administered rectally, and the bioavailability is comparable to that following oral administration. A 1:1 dilution with water was used to minimise the laxative effect of the hypertonic formulation. Sodium valproate syrup has also been administered rectally by mixing 5mL of sodium valproate syrup (250mg/5mL) with 30mL of water and given as a retention enema.Clinical response and plasma concentrations should be monitored

Sucralfate - The enema can be prepared by dispersing tablets in 20mL of water or by administering 20mL of the commercially available 10% w/v sucralfate suspension (Carafate)

Preparations For Topical Application

The practice of extemporaneously compounding creams, ointments and pastes for dermatological use is common but there have been few published studies on the stability or appropriateness

Useful reference texts include Martindale, and Remington's Pharmaceutical Sciences.

The following general points are emphasised:

Proprietary alternatives are often available

The compounding procedure should be carried out in conditions which minimise microbial contamination and cross contamination from other medications or excipients.

The principles of GMP should be observed

Oil in water emulsions (i.e. creams) are very susceptible to microbial contamination and require the inclusion of a compatible antimicrobial preservative

If a proprietary product is diluted (e.g. a corticosteroid ointment) a recommended diluent should be used. Manufacturers can often provide advice and the compounding and dilution of topical steroids has been reviewed in the literature. The National Pharmaceutical Association (NPA), UK, also publishes a diluent directory.

The dilution of topical proprietary corticosteroids may be avoided when a suitable, less potent preparation is available. Tables of the approximate relative potencies of topical corticosteroids are included in publications such as MIMS and New Ethicals Compendium (New Zealand ). It should also be noted that the dilution of some products does not necessarily result in a corresponding dilution in potency

A diluted product may be more susceptible to microbial contamination

It is illogical to mix proprietary preparations (e.g. a corticosteroid with an antifungal) when combination products are available. Such practices may lead to sub-therapeutic drug concentrations and reduce the effectiveness of preservatives.

For most preparations there is little information on stability and assigned expiry dates should be conservative.

The regular preparation of small quantities is more desirable than large bulk supplies.

Preservatives

High concentrations of syrup, glycerol and ethanol may have a preservative effect.

The preservative content of additives such as preserved syrup should be taken into account when the total concentration of preservative in the formulation is calculated

Parabens

Parabens (p-hydroxybenzoates) are effective over a wide pH range but are more active in acidic conditions.

Maximum chemical stability is at pH 4 - 5

Various combinations of Methyl Hydroxybenzoate and Propyl Hydroxybenzoate are used to give a total concentration of about 0.1% w/v

Published formulations have included many different combinations and for simplicity the use of 0.1% total parabens has been standardised in most of the formulations in the monographs.

Compound Hydroxybenzoate Solution APF provides a convenient stock solution of parabens

The effectiveness of parabens may be reduced by binding interactions with macromolecules (e.g. suspending agents or some tablet excipients)

Methyl Hydroxybenzoate is very slightly soluble in water (1 in 400) and freely soluble in alcohol

Propyl Hydroxybenzoate is soluble 1 in 2500 of water and 1 in 1.5 of alcohol

The solubility of both compounds is increased in hot water

A combination of agents provides a more effective antimicrobial preservative system and propylene glycol also increases the activity.

If Propyl Hydroxybenzoate is not available, Methyl Hydroxybenzoate 0.1% can be used alone and is sufficiently soluble in hot water (about 100mg in 5mL at 80°C) to allow easy preparation when required

A variety of preparations and formulas are available. Stock solutions can be prepared and stored for 3 - 6 months

Methyl Hydroxybenzoate is also known as Methyl Parahydroxybenzoate or Methylparaben

Propyl Hydroxybenzoate is also known as Propyl Parahydroxybenzoate or Propylparaben

The term parabens used in the monographs refers to the use of the preparations described above or any other suitable combination of Methyl Hydroxybenzoate BP and Propyl Hydroxybenzoate BP to give a total concentration of 0.1% w/v.

Benzoic Acid/Sodium Benzoate

Benzoic acid is a colourless crystalline powder that has antibacterial and antifungal properties

It is used in concentrations of 0.05 - 0.1%. It is active at a pH of 4 or under. The salt form, sodium benzoate is more soluble in water.

BP Solubility

Sweetening agents

Sweetening agents are often added to formulations in an attempt to mask the bitter taste of a drug

As well as being sweetening agents, these compounds may contribute to the stability of the formulation and in the appropriate concentration provide antimicrobial activity

If sugar containing medicines must be given to children, methods to minimise the contact of the preparation with the teeth should be employed.

Syrups have frequently been included in published formulations and official preparations vary slightly

Sweetening agents or other flavouring agents may be omitted from a formulation if unnecessary, as when patients are receiving medications via a nasogastric tube

The sweetness of sucrose will change with time due to inversion

Sweet taste depends on the concentration of the sweetener, temperature, pH, solvent system and sensitivity of the taster.

Some sweeteners are unstable in solution, at elevated temperatures and in fluctuating pH, e.g. aspartame.

Syrups

More information should be obtained about these syrups and other syrups from the various official publications

Citric acid, sodium benzoate or parabens are often added as preservatives

Syrups should not be exposed to widely fluctuating temperatures and should be discarded one month after preparation unless preserved

Syrup BP

Sucrose 667g, purified water sufficient to produce 1000g

One or more suitable antimicrobial preservatives may be added

Syrup NF (Simple Syrup NF)

Sucrose 850g, purified water sufficient to produce 1000ml

Cherry Syrup NF

Cherry juice 475ml, Sucrose 800g, Alcohol 20ml, purified water sufficient to produce 1000ml

Extemporaneous preparation

Dissolve the sucrose in the cherry juice by heating on a steam bath, cool and remove the foam and floating solids. Add the alcohol and sufficient water to make 1000ml and mix.

Vehicles

Suspending and Thickening Agents

In some formulations suspending agents may not be required, for example, when it is known that the drug is completely dissolved in the vehicle

The use of syrup or glycerol as a simple suspending agent may be adequate in some circumstances

The effectiveness of antimicrobial preservatives may be reduced by chemical degradation and binding interactions with macromolecules.

Mixture bases should not be stored for prolonged periods without appropriate testing to justify the shelf life. The pH of the base must be compatible with the pH stability profile of the drug and the activity of the preservative system

Carboxymethylcellulose (CMC)

This is usually available as the sodium salt.

CMC is used in concentrations of 1-2% w/v to give good suspending properties.

It has been reported that sodium carboxymethylcellulose solution has a pH of about 10 which may be incompatible with some acidic drugs. However, to comply with the BP and USP a 1% solution is required to have a pH of 6.0 - 8.0 or 6.5 - 8.5 respectively.

Sodium carboxymethylcellulose is easily dispersed in water forming a colloidal solution

CMC exhibits maximum viscosity at pH 7 - 9, and viscosity is markedly reduced below pH 4 and above pH 10.

Methylcellulose

The viscosity of methylcellulose solutions depends on the grade of methylcellulose used

A 1% concentration is the most frequently employed

Large amounts of electrolytes can cause precipitation of methylcellulose causing physical instability

Methylcellulose hydrates and swells in hot water. The usual method of preparation is to tritutrate at high shear with about 1/3 of the required amount of water at 80 - 90°C. When dispersed, the rest of the water (as cold water or iced-water) is added with stirring.

Ora-Plus, Ora-Sweet and Ora-Sweet SF (Paddock Laboratories)

Ora-Plus

Contains: purified water, microcrystalline cellulose, carboxymethylcellulose sodium, xanthan gum, flavouring, citric acid, sodium phosphate, simethicone, methylparaben, and potassium sorbate. pH 4.2.

Ora-Sweet

Contains: purified water, sucrose, glycerin, sorbitol, flavouring, citric acid, sodium phosphate, methylparaben and potassium sorbate. pH 4.2

Ora-Sweet SF

Contains: purified water, glycerin, sorbitol, sodium saccharin, xanthan gum, flavouring, citric acid, sodium citrate, methylparaben, propylparaben, potassium sorbate. pH 4.2.

Xanthan Gum

This preparation is used in some countries to prepare suspensions of crushed tablets.

As the preparation takes a while to dissolve, a 1% solution containing parabens can be prepared in advance and diluted to 0.5% with water when required.

Xanthan Gum has been successfully used in suspensions of many drugs including acetazolamide, allopurinol, diazepam and spironolactone.

However a small number of drugs (including tamoxifen, verapamil and amitriptyline) have been found to be incompatible.

Tragacanth

Tragacanth in the form of tragacanth mucilage or compound tragacanth powder has been widely used as a suspending agent.

Many commercial sources are heavily contaminated with microorganisms and tragacanth should never be used in preparations which do not contain an antimicrobial preservative.

Other agents are now considered to be superior to tragacanth.

Reference list:

Resource list for all medicine issues: http://www.nzhpa.org.nz/media/23434/recommended%20resources%20list%202017.pdf

#june

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finarchemical · 2 years ago

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Why The Industry of Food Additives Manufacturers is a never dying industry? Let’s Find Out!

One of the first things that come to mind while considering COVID-19 is its effect on the globe. Whether it be our working methods or the many businesses we work in, everything has got to adapt. Numerous firms were compelled to shut down or scale back operations due to the unexpected decline in demand.

However, if you were to choose one sector that will continue to grow regardless of the passing of time, it would be the food sector. Even during the pandemic, agriculture, packaging, and food additives manufacturers in India kept up with the output.

It follows that the anticipated growth of the food additive manufacturers in India between 2020 and 2030 is not surprising.

There is a sizable market for milk drinks, juice-based drinks, energy drinks, and preservatives like sodium benzoate food preservatives. They are extensively utilised in a variety of products, including dairy, meat, soft drinks, beverages, baked goods, and others.

In addition, their use in foods including cheese, ice cream, yoghurt, dips, and spreads are expanding. The production, use, and distribution of common additives, including paprika oleoresin, chlorophyll, carmine, spirulina extract, and carotenoids, occurs all over the world.

Recently, market research was carried out to identify and evaluate global growth, decrease, and future prospects of global food colour additives. The final report extensively details the prospects, dangers, volume, and income mechanisms related to food additives.

The main drivers of the industry's anticipated growth, target markets for manufacturers, growth opportunities, and other factors were uncovered.

A number of factors affect the use of food additives.

The fact that people all around the world are gradually switching to healthy lifestyles and favouring safe products over chemical ones is one of the main causes. This is due to the fact that health problems are now more common, and these solutions have proven to be attractive, providing noteworthy advantages.

Manufacturers like Finar are aiming to develop certified food additives of the highest calibre for their consumers. They take advantage of the chance, enhance the quality of their existing products, and create new ones that can appeal to expanding markets and end customers. Entering new markets and boosting revenue growth is essential.

The technological boom has made it possible to produce more with less work and money while increasing overall efficiency, supporting their goal. Although there are markets for food additives all around the world, East and South Asia are crucial because of their booming food and beverage sectors.

Given all the reasons propelling the market for food additives in that direction, there is no doubt that the business will boom. Unprecedented changes in how it functions, where it is going, and the opportunities it offers are all expected by 2030.

Finar is one of the finest chemical manufacturers in India. It is known for its quality and expertise, enabling the end products to be of top quality too. They offer not only food additives but also Lab chemicals for pharmaceutical excipients.

Trust the best for your food manufacturing business! Trust Finar Limited!

#food additives manufacturers in india #sodium benzoate food preservative #finar

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chemanalystdata · 3 months ago

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Sodium Benzoate Excipient Prices a widely used preservative in the pharmaceutical and food industries, has seen fluctuations in excipient prices over recent years, driven by various global factors. The price dynamics of sodium benzoate as an excipient are influenced by several elements, including raw material availability, production costs, regulatory changes, and market demand. As a key preservative, sodium benzoate plays a crucial role in extending the shelf life of various products, which is why its pricing is closely monitored by manufacturers and buyers alike.

The global market for sodium benzoate excipients has experienced significant changes, primarily due to shifts in the supply chain. The availability of raw materials, particularly benzoic acid, is one of the most critical factors affecting sodium benzoate prices. Benzoic acid, which is derived from toluene, is subject to the volatility of the petrochemical market. Any disruptions in the supply of toluene or changes in crude oil prices can directly impact the cost of benzoic acid and, consequently, sodium benzoate. Furthermore, the competition for benzoic acid between different industries, such as plastics and coatings, can lead to price increases in the pharmaceutical and food sectors where sodium benzoate is used as an excipient.

Get Real Time Prices for Sodium Benzoate Excipient: https://www.chemanalyst.com/Pricing-data/sodium-benzoate-excipient-1515

Another factor contributing to the pricing of sodium benzoate is the cost of production, which includes energy costs, labor, and manufacturing processes. The production of sodium benzoate involves the neutralization of benzoic acid with sodium hydroxide, a process that requires significant energy input. Fluctuations in energy prices, particularly in regions where production is concentrated, can cause variations in the cost of sodium benzoate. Additionally, labor costs in countries where sodium benzoate is manufactured can also influence its price. Countries with lower labor costs might offer more competitive prices, but this advantage can be offset by higher transportation costs or tariffs in international trade.

Regulatory changes also play a significant role in determining sodium benzoate excipient prices. Different countries have varying regulations regarding the use of preservatives in pharmaceuticals and food products. Changes in these regulations, such as stricter limits on the allowable concentration of sodium benzoate in products, can affect demand and, therefore, pricing. For example, if a major market like the European Union or the United States imposes stricter regulations on sodium benzoate use, manufacturers might need to seek alternative preservatives or reformulate their products, leading to a decrease in demand and potentially lower prices. Conversely, relaxed regulations could increase demand, driving prices higher.

Market demand for sodium benzoate is another crucial factor influencing its price. The demand is driven by its use as a preservative in a wide range of products, including pharmaceuticals, food and beverages, and cosmetics. In the pharmaceutical industry, sodium benzoate is valued for its ability to prevent microbial growth in liquid formulations, ensuring the safety and efficacy of medicines. In the food industry, it is used to extend the shelf life of acidic products such as soft drinks, fruit juices, and pickles. The cosmetics industry also relies on sodium benzoate as a preservative in lotions, creams, and other personal care products. Any increase in demand from these industries can lead to higher prices for sodium benzoate excipients.

The global supply chain also affects sodium benzoate prices. China is one of the largest producers of sodium benzoate, and any disruptions in Chinese manufacturing, whether due to environmental regulations, energy shortages, or trade tensions, can lead to supply shortages and price increases. For example, if Chinese production is reduced due to stricter environmental controls, the global supply of sodium benzoate could decrease, driving up prices. Similarly, trade disputes between major economies could result in tariffs or other trade barriers, increasing the cost of imported sodium benzoate.

Moreover, transportation costs significantly impact sodium benzoate prices, especially in the context of global trade. The cost of shipping raw materials and finished products across international borders can fluctuate due to changes in fuel prices, shipping container availability, and global logistics disruptions. For instance, an increase in fuel prices or a shortage of shipping containers can lead to higher transportation costs, which manufacturers may pass on to buyers in the form of higher sodium benzoate prices.

In recent years, sustainability concerns have also started to influence sodium benzoate excipient prices. As consumers and regulatory bodies increasingly prioritize environmentally friendly products, there is a growing demand for sustainable preservatives. This shift has prompted some manufacturers to explore alternative preservation methods or to invest in greener production processes for sodium benzoate. While these initiatives may lead to higher initial costs, they can also position companies to meet the rising demand for sustainable excipients, potentially leading to long-term pricing stability.

Finally, currency exchange rates can impact the pricing of sodium benzoate excipients, particularly in international trade. Fluctuations in exchange rates between major currencies, such as the US dollar, Euro, and Chinese Yuan, can affect the cost of importing or exporting sodium benzoate. For example, if the value of the US dollar strengthens against other currencies, it might become more expensive for foreign buyers to purchase sodium benzoate from the United States, potentially leading to reduced demand and lower prices. Conversely, a weaker US dollar could make US-produced sodium benzoate more competitive in international markets, driving up demand and prices.

In conclusion, sodium benzoate excipient prices are influenced by a complex interplay of factors, including raw material availability, production costs, regulatory changes, market demand, supply chain dynamics, transportation costs, sustainability concerns, and currency exchange rates. Understanding these factors is crucial for manufacturers, buyers, and other stakeholders in the pharmaceutical, food, and cosmetics industries who rely on sodium benzoate as a key preservative. As global markets continue to evolve, staying informed about these influences will be essential for navigating the challenges and opportunities in the sodium benzoate excipient market.

Get Real Time Prices for Sodium Benzoate Excipient: https://www.chemanalyst.com/Pricing-data/sodium-benzoate-excipient-1515

ChemAnalyst

GmbH - S-01, 2.floor, Subbelrather Straße,

15a Cologne, 50823, Germany

Call: +49-221-6505-8833

Email: [email protected]

Website: https://www.chemanalyst.com

#Sodium Benzoate Excipient #Sodium Benzoate Excipient Price #Sodium Benzoate Excipient Prices #Sodium Benzoate Excipient Pricing

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chemanalystdata · 6 months ago

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Sodium Benzoate Excipient Prices Trend, Pricing, Database, Index, News, Chart, Forecast

Sodium Benzoate Excipient Prices, a widely used food preservative, has experienced significant price fluctuations in recent years, driven by various factors impacting its supply chain dynamics. This compound, chemically denoted as NaC7H5O2, plays a crucial role in extending the shelf life of many processed foods and beverages by inhibiting the growth of bacteria, yeast, and mold. The volatility in sodium benzoate prices can be attributed to several key influencers within the global market.

One of the primary drivers affecting sodium benzoate prices is the cost of raw materials. The production of sodium benzoate typically involves benzoic acid, which can be derived from various sources such as toluene or benzene. Fluctuations in crude oil prices directly impact the cost of these raw materials, thereby influencing the overall production costs of sodium benzoate. Furthermore, changes in global demand for crude oil and its derivatives can create ripple effects throughout the chemical supply chain, impacting the availability and cost of benzoic acid.

In addition to raw material costs, market demand for sodium benzoate plays a crucial role in price determination. The food and beverage industry, which represents the largest consumer of sodium benzoate, experiences seasonal variations and shifts in consumer preferences that directly influence demand patterns. During peak production seasons or when there is a surge in demand for processed foods and beverages, the need for sodium benzoate intensifies, leading to potential price increases due to supply constraints.

Get Real Time Prices of Sodium Benzoate Excipient: https://www.chemanalyst.com/Pricing-data/sodium-benzoate-excipient-1515

Moreover, regulatory factors and compliance requirements also contribute to price fluctuations in the sodium benzoate market. As governments around the world implement stricter regulations on food safety and additive usage, manufacturers may need to invest in upgrades to their production facilities or adopt more stringent quality control measures. These regulatory changes can increase operational costs for sodium benzoate producers, which in turn may be reflected in higher market prices to maintain profitability.

Furthermore, global economic conditions and currency exchange rates can impact the cost competitiveness of sodium benzoate on the international market. A strong local currency relative to major trading currencies can make exports more expensive, potentially reducing international demand and placing downward pressure on prices. Conversely, a weaker local currency may enhance export competitiveness, thereby stimulating demand and supporting higher prices depending on global supply dynamics.

Environmental factors also influence sodium benzoate prices, albeit indirectly. Concerns over sustainability and environmental impact are prompting manufacturers to explore alternative production methods or sources of raw materials that are more environmentally friendly. Investments in eco-friendly technologies or sourcing practices may initially increase production costs, contributing to short-term price volatility until economies of scale and efficiencies are realized.

In conclusion, sodium benzoate prices are subject to a complex interplay of factors ranging from raw material costs and market demand to regulatory compliance and environmental considerations. This multifaceted landscape underscores the importance of understanding the broader dynamics shaping the chemical industry and food sector. As stakeholders navigate these challenges, they must remain vigilant of market trends and regulatory developments that could impact pricing strategies and operational decisions in the sodium benzoate market. By fostering resilience and adaptability, businesses can mitigate risks and capitalize on emerging opportunities within this essential segment of the global economy.

Get Real Time Prices of Sodium Benzoate Excipient: https://www.chemanalyst.com/Pricing-data/sodium-benzoate-excipient-1515

ChemAnalyst

GmbH - S-01, 2.floor, Subbelrather Straße,

15a Cologne, 50823, Germany

Call: +49-221-6505-8833

Email: [email protected]

Website: https://www.chemanalyst.com

#Sodium Benzoate Excipient #Sodium Benzoate Excipient Price #Sodium Benzoate Excipient Prices #Sodium Benzoate Excipient Pricing

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chemanalystdata · 6 months ago

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Sodium Benzoate Excipient Prices: In the first quarter of 2024

Sodium Benzoate Excipient Prices, a common excipient in pharmaceuticals and food products, plays a crucial role in enhancing stability and extending shelf life. As demand for this versatile preservative continues to rise, understanding its pricing dynamics becomes imperative for manufacturers and suppliers alike. The cost of sodium benzoate excipient is subject to various factors, including raw material availability, production processes, market demand, and regulatory compliance.

Raw material availability significantly influences sodium benzoate prices. Benzoic acid, derived from benzene or toluene, serves as the primary precursor for sodium benzoate synthesis. Fluctuations in the prices of these raw materials due to factors like supply disruptions, geopolitical tensions, or changes in crude oil prices directly impact the overall cost of sodium benzoate. Moreover, any regulatory changes affecting the production or import of these raw materials can further influence pricing dynamics.

Production processes also play a pivotal role in determining sodium benzoate prices. Manufacturers employ different methods such as the Grignard reaction or the neutralization of benzoic acid with sodium hydroxide to produce sodium benzoate. Each method comes with its own set of advantages and challenges, affecting production costs. Energy expenses, labor costs, equipment maintenance, and technological advancements in production processes all contribute to the final pricing structure.

Get Real Time Prices of Sodium Benzoate Excipient Acid: https://www.chemanalyst.com/Pricing-data/sodium-benzoate-excipient-1515Market demand acts as a key driver in sodium benzoate pricing. With its widespread application in pharmaceuticals, food preservation, and personal care products, the demand for sodium benzoate remains robust. Factors such as population growth, dietary habits, and consumer preferences influence the demand for products containing sodium benzoate. Additionally, the emergence of new applications or formulations requiring sodium benzoate can create shifts in demand-supply dynamics, thereby impacting prices.

Regulatory compliance is another critical aspect affecting sodium benzoate pricing. As a food additive and pharmaceutical excipient, sodium benzoate is subject to stringent regulations and quality standards enforced by regulatory authorities worldwide. Compliance with these regulations necessitates adherence to specific manufacturing practices, purity criteria, and labeling requirements, all of which may entail additional costs for producers. Any changes in regulatory frameworks or stricter enforcement measures can influence production costs and, subsequently, product pricing.

Furthermore, market dynamics such as competition among suppliers, trade policies, and currency fluctuations contribute to the variability in sodium benzoate prices. Manufacturers operating in highly competitive markets may adjust their pricing strategies to gain a competitive edge or maintain market share. Additionally, fluctuations in exchange rates can impact the cost of imported raw materials or finished products, thereby influencing sodium benzoate prices in domestic markets.

In conclusion, the pricing of sodium benzoate excipient is a complex interplay of various factors, including raw material availability, production processes, market demand, regulatory compliance, and market dynamics. Manufacturers and suppliers need to closely monitor these factors and adapt their strategies to navigate the evolving landscape effectively. By understanding the underlying drivers of sodium benzoate pricing, stakeholders can make informed decisions to optimize costs, enhance competitiveness, and meet the needs of consumers and regulatory requirements effectively.

Get Real Time Prices of Sodium Benzoate Excipient Acid: https://www.chemanalyst.com/Pricing-data/sodium-benzoate-excipient-1515

ChemAnalyst

GmbH - S-01, 2.floor, Subbelrather Straße,

15a Cologne, 50823, Germany

Call: +49-221-6505-8833

Email: [email protected]

Website: https://www.chemanalyst.com

#Sodium Benzoate Excipient Prices

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greatestlcve · 4 years ago

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Meteospasmyl Capsules Uses, Dosage, Side Effects, Description

Drug Online

Meteospasmyl Capsules Generic drug of the Therapeutic class: Gastro-Entero – Hepatology active ingredients: Alverine , Simeticone

What is MeteoSpasmyl drug used for and indication?

Symptomatic treatment of intestinal functional manifestations, particularly with meteorism.

Meteospasmyl Capsules Dosage

Oral way.RESERVED FOR ADULTS1 capsule 2 to 3 times a day at the beginning of meals or at the time of pain.

Contraindications

Alverine hypersensitivity

Simeticone hypersensitivity

Pregnancy

Feeding with milk

Hypersensitivity to the active substances or to any of the excipients listed in the Composition section.

meteospasmyl mechanism of action

Pharmacotherapeutic group: ANTISPASMODIC MUSCULOTROPE / ANTIFLATULENT

ATC Code: A03AX08 – Other Medications for Gastrointestinal Functional Disorders

Alverine citrate is a musculotropic anti-spasmodic.

Simeticone is a physiologically inert substance and therefore has no pharmacological activity. It acts by modifying the surface tension of the gas bubbles thus causing their coalescence.

How To Store meteospasmyl ?

Keep this medication out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the package after EXP. The expiration date refers to the last day of that month.

PVC / Aluminum pads

Store at a temperature not exceeding 30 ° C.

PVC / PE / PVDC-Aluminum pads

No special storage conditions.

Do not throw away any medicines via a wastewater treatment plant or with household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.

Meteospasmyl Side Effects

Due to the presence of alverine:

rare cases of urticaria, sometimes with laryngeal edema, shock,

rare cases of regressive liver damage at the end of treatment.

Meteospasmyl Capsules Side Effects

Meteospasmyl drug Interactions

The data available to date do not suggest the existence of clinically significant interactions.

Warnings and Precautions

Liver function:

Increases in ALT (Alanine Aminotransferase) and ASAT (Aspartate Aminotransferase)> 2 times the upper limit of normal (ULN) have been reported in patients receiving alverine / simeticone therapy. These increases may be associated with a concomitant elevation of total serum bilirubin.

If hepatic aminotransferases increase by> 3 times the ULN, and even more so in cases dictere, treatment with alverine / simeticone should be discontinued.

Drive and use machines

Prevent drivers of vehicles and machinery users from the risk of drowsiness, amnesia or impaired muscle concentration or function.

The combination with other sedative drugs should be discouraged or taken into account when driving or using machines.

If sleep time is insufficient, the risk of impaired alertness is further increased.

Meteospasmyl Capsules and Pregnancy / Breastfeeding

meteospasmyl during pregnancy

Many data from cohort studies have not revealed the occurrence of malformative effects during benzodiazepine exposure during the course of 1

first trimester of pregnancy. However, in some case-control epidemiological studies, an increase in the occurrence of cleft lip and palate has been observed with benzodiazepines. According to these data, the incidence of cleft lip and palate in newborns would be less than 2/1000 after exposure to benzodiazepines during pregnancy while the expected rate in the general population is 1/1000.

If benzodiazepines are taken in high doses at 2 nd and / or 3 rd trimesters of pregnancy, a decrease in fetal active movements and a variability in fetal heart rate have been described.

Treatment with benzodiazepines at the end of pregnancy, even at low doses, may be responsible in the newborn for signs of impregnation such as axial hypotonia, sucking disorders resulting in low weight gain.

These signs are reversible, but can last 1-3 weeks depending on the half-life of the prescribed benzodiazepine. At high doses, respiratory depression or apnea, and hypothermia may occur in the newborn. In addition, a neonatal withdrawal syndrome is possible, even in the absence of signs of impregnation.

It is characterized in particular by hyperexcitability, agitation and tremulations of the newborn occurring at a distance from the delivery.

The time of onset depends on the elimination half-life of the drug and may be important when it is long.

Based on these data, as a precautionary measure, the use of alprazolam is not recommended during pregnancy, regardless of the term.

When prescribing alprazolam to a woman of childbearing potential, she should be advised of the need to contact her physician if pregnancy is planned or initiated to re-assess the benefit of the treatment.

At the end of pregnancy, if it is really necessary to start a treatment with alprazolam, avoid prescribing high doses and take into account, for surveillance of the newborn, effects previously described.

Breastfeeding

Alprazolam is excreted in breast milk at low concentrations. However, the use of this medicine during breastfeeding is not recommended.

What happens if I overdose from Meteospasmyl ?

Cases of vertigo have been reported when taken at a dosage higher than that recommended.

What should I do if I miss a dose?

Do not take a double dose to make up for the dose you forgot to take.

What happens if you stop taking meteospasmyl ?

If you stop taking METEOSPASMYL, soft capsule:

Not applicable.

If you have further questions on the use of this medicine, ask your doctor or pharmacist for more information.

What is Forms and Composition Meteospasmyl Capsules?

FORMS and PRESENTATIONS

0.25 mg scored tablet: Box of 30, in blister packs.

Hospital model: Box of 100. 0.50 mg scored tablet: Box of 30, in blister packs. Hospital model: Box of 100. Breakable tablet 1 mg: Box of 100, in blister packs.

COMPOSITION

p cpAlprazolam (DCI)0.25 mgor0.50 mgor1 mg

Excipients (common): lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, mixture of sodium docusate (85%) and sodium benzoate (15%), corn starch, magnesium stearate, aluminum erythrosine lake (cp 0 , 50 mg and 1 mg), indigo aluminum lake (cp 1 mg).

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

It treats possible side effects and drug interactions that require attention and its effect on continuous use.

The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

The post Meteospasmyl Capsules Uses, Dosage, Side Effects, Description appeared first on Drug Online.

from Drug Online https://bit.ly/3keXXFN via Edrug Online from Faculty of Medicine https://bit.ly/32sffsR via Internal Medicine

#medicines #including Allergy Medicines #Anemia #Antibiotic Medicines #Colds & Flu Medicines #Cough Me

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thesittingduck · 4 years ago

Text

Meteospasmyl Capsules Uses, Dosage, Side Effects, Description

Drug Online

Meteospasmyl Capsules Generic drug of the Therapeutic class: Gastro-Entero – Hepatology active ingredients: Alverine , Simeticone

What is MeteoSpasmyl drug used for and indication?

Symptomatic treatment of intestinal functional manifestations, particularly with meteorism.

Meteospasmyl Capsules Dosage

Oral way.RESERVED FOR ADULTS1 capsule 2 to 3 times a day at the beginning of meals or at the time of pain.

Contraindications

Alverine hypersensitivity

Simeticone hypersensitivity

Pregnancy

Feeding with milk

Hypersensitivity to the active substances or to any of the excipients listed in the Composition section.

meteospasmyl mechanism of action

Pharmacotherapeutic group: ANTISPASMODIC MUSCULOTROPE / ANTIFLATULENT

ATC Code: A03AX08 – Other Medications for Gastrointestinal Functional Disorders

Alverine citrate is a musculotropic anti-spasmodic.

Simeticone is a physiologically inert substance and therefore has no pharmacological activity. It acts by modifying the surface tension of the gas bubbles thus causing their coalescence.

How To Store meteospasmyl ?

Keep this medication out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the package after EXP. The expiration date refers to the last day of that month.

PVC / Aluminum pads

Store at a temperature not exceeding 30 ° C.

PVC / PE / PVDC-Aluminum pads

No special storage conditions.

Meteospasmyl Side Effects

Due to the presence of alverine:

rare cases of urticaria, sometimes with laryngeal edema, shock,

rare cases of regressive liver damage at the end of treatment.

Meteospasmyl Capsules Side Effects

Meteospasmyl drug Interactions

The data available to date do not suggest the existence of clinically significant interactions.

Warnings and Precautions

Liver function:

If hepatic aminotransferases increase by> 3 times the ULN, and even more so in cases dictere, treatment with alverine / simeticone should be discontinued.

Drive and use machines

Prevent drivers of vehicles and machinery users from the risk of drowsiness, amnesia or impaired muscle concentration or function.

The combination with other sedative drugs should be discouraged or taken into account when driving or using machines.

If sleep time is insufficient, the risk of impaired alertness is further increased.

Meteospasmyl Capsules and Pregnancy / Breastfeeding

meteospasmyl during pregnancy

Many data from cohort studies have not revealed the occurrence of malformative effects during benzodiazepine exposure during the course of 1

If benzodiazepines are taken in high doses at 2 nd and / or 3 rd trimesters of pregnancy, a decrease in fetal active movements and a variability in fetal heart rate have been described.

It is characterized in particular by hyperexcitability, agitation and tremulations of the newborn occurring at a distance from the delivery.

The time of onset depends on the elimination half-life of the drug and may be important when it is long.

Based on these data, as a precautionary measure, the use of alprazolam is not recommended during pregnancy, regardless of the term.

Breastfeeding

Alprazolam is excreted in breast milk at low concentrations. However, the use of this medicine during breastfeeding is not recommended.

What happens if I overdose from Meteospasmyl ?

Cases of vertigo have been reported when taken at a dosage higher than that recommended.

What should I do if I miss a dose?

Do not take a double dose to make up for the dose you forgot to take.

What happens if you stop taking meteospasmyl ?

If you stop taking METEOSPASMYL, soft capsule:

Not applicable.

If you have further questions on the use of this medicine, ask your doctor or pharmacist for more information.

What is Forms and Composition Meteospasmyl Capsules?

FORMS and PRESENTATIONS

0.25 mg scored tablet: Box of 30, in blister packs.

Hospital model: Box of 100. 0.50 mg scored tablet: Box of 30, in blister packs. Hospital model: Box of 100. Breakable tablet 1 mg: Box of 100, in blister packs.

COMPOSITION

p cp Alprazolam (DCI) 0.25 mg or 0.50 mg or 1 mg

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

Special warnings:

For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

It treats possible side effects and drug interactions that require attention and its effect on continuous use.

The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

The post Meteospasmyl Capsules Uses, Dosage, Side Effects, Description appeared first on Drug Online.

from Drug Online https://bit.ly/3keXXFN via Edrug Online from faculty of medicine https://bit.ly/3hvchbB via Faculty of Medicine

#medicines #including Allergy Medicines #Anemia #Antibiotic Medicines #Colds & Flu Medicines #Cough Me

0 notes

colinfitzpatrick · 4 years ago

Text

Meteospasmyl Capsules Uses, Dosage, Side Effects, Description

Drug Online

Meteospasmyl Capsules Generic drug of the Therapeutic class: Gastro-Entero – Hepatology active ingredients: Alverine , Simeticone

What is MeteoSpasmyl drug used for and indication?

Symptomatic treatment of intestinal functional manifestations, particularly with meteorism.

Meteospasmyl Capsules Dosage

Oral way.RESERVED FOR ADULTS1 capsule 2 to 3 times a day at the beginning of meals or at the time of pain.

Contraindications

Alverine hypersensitivity

Simeticone hypersensitivity

Pregnancy

Feeding with milk

Hypersensitivity to the active substances or to any of the excipients listed in the Composition section.

meteospasmyl mechanism of action

Pharmacotherapeutic group: ANTISPASMODIC MUSCULOTROPE / ANTIFLATULENT

ATC Code: A03AX08 – Other Medications for Gastrointestinal Functional Disorders

Alverine citrate is a musculotropic anti-spasmodic.

Simeticone is a physiologically inert substance and therefore has no pharmacological activity. It acts by modifying the surface tension of the gas bubbles thus causing their coalescence.

How To Store meteospasmyl ?

Keep this medication out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the package after EXP. The expiration date refers to the last day of that month.

PVC / Aluminum pads

Store at a temperature not exceeding 30 ° C.

PVC / PE / PVDC-Aluminum pads

No special storage conditions.

Meteospasmyl Side Effects

Due to the presence of alverine:

rare cases of urticaria, sometimes with laryngeal edema, shock,

rare cases of regressive liver damage at the end of treatment.

Meteospasmyl Capsules Side Effects

Meteospasmyl drug Interactions

The data available to date do not suggest the existence of clinically significant interactions.

Warnings and Precautions

Liver function:

If hepatic aminotransferases increase by> 3 times the ULN, and even more so in cases dictere, treatment with alverine / simeticone should be discontinued.

Drive and use machines

Prevent drivers of vehicles and machinery users from the risk of drowsiness, amnesia or impaired muscle concentration or function.

The combination with other sedative drugs should be discouraged or taken into account when driving or using machines.

If sleep time is insufficient, the risk of impaired alertness is further increased.

Meteospasmyl Capsules and Pregnancy / Breastfeeding

meteospasmyl during pregnancy

Many data from cohort studies have not revealed the occurrence of malformative effects during benzodiazepine exposure during the course of 1

If benzodiazepines are taken in high doses at 2 nd and / or 3 rd trimesters of pregnancy, a decrease in fetal active movements and a variability in fetal heart rate have been described.

It is characterized in particular by hyperexcitability, agitation and tremulations of the newborn occurring at a distance from the delivery.

The time of onset depends on the elimination half-life of the drug and may be important when it is long.

Based on these data, as a precautionary measure, the use of alprazolam is not recommended during pregnancy, regardless of the term.

Breastfeeding

Alprazolam is excreted in breast milk at low concentrations. However, the use of this medicine during breastfeeding is not recommended.

What happens if I overdose from Meteospasmyl ?

Cases of vertigo have been reported when taken at a dosage higher than that recommended.

What should I do if I miss a dose?

Do not take a double dose to make up for the dose you forgot to take.

What happens if you stop taking meteospasmyl ?

If you stop taking METEOSPASMYL, soft capsule:

Not applicable.

If you have further questions on the use of this medicine, ask your doctor or pharmacist for more information.

What is Forms and Composition Meteospasmyl Capsules?

FORMS and PRESENTATIONS

0.25 mg scored tablet: Box of 30, in blister packs.

Hospital model: Box of 100. 0.50 mg scored tablet: Box of 30, in blister packs. Hospital model: Box of 100. Breakable tablet 1 mg: Box of 100, in blister packs.

COMPOSITION

p cp Alprazolam (DCI) 0.25 mg or 0.50 mg or 1 mg

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

Special warnings:

For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

It treats possible side effects and drug interactions that require attention and its effect on continuous use.

The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

The post Meteospasmyl Capsules Uses, Dosage, Side Effects, Description appeared first on Drug Online.

from Drug Online https://bit.ly/3keXXFN via Edrug Online

#medicines #including Allergy Medicines #Anemia #Antibiotic Medicines #Colds & Flu Medicines #Cough Me

0 notes