#Penicillin G Sodium News

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Penicillin G Sodium Prices | Pricing | Trend | News | Database | Chart | Forecast

 Penicillin G Sodium Prices is an essential antibiotic used to treat a broad range of bacterial infections, and the market for this medication is influenced by several factors. The pricing of Penicillin G Sodium has fluctuated over the years due to varying dynamics in supply chains, manufacturing costs, and global demand. Price movements in this market are often closely monitored by hospitals, pharmacies, and procurement managers in both private and public sectors, as Penicillin G Sodium is a critical drug for many health conditions. One of the leading factors influencing its price is the cost of raw materials required for the production process. Penicillin G Sodium is derived from penicillin, which is cultivated in a fermentation process. Any disruptions in the availability of high-quality raw materials, such as the feedstocks used to cultivate penicillin, can lead to price hikes.

Moreover, geopolitical issues and environmental regulations have an impact on the pricing structure of Penicillin G Sodium. For instance, stricter environmental laws in countries that are major producers of antibiotics have at times led to a reduction in output. These regulations often impose limits on factory emissions and waste management, which in turn raise the operational costs for manufacturers. The increased cost burden on the producers eventually trickles down to the final price of Penicillin G Sodium in the marketplace. Additionally, geopolitical tensions or trade restrictions between nations can affect the import and export of both raw materials and finished products, adding further volatility to the pricing. When key manufacturing countries face regulatory challenges or geopolitical instability, global supply can be disrupted, causing prices to surge as the market adjusts to the new realities of supply shortages or delays.

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The demand for Penicillin G Sodium is also closely tied to trends in healthcare. There are periods when the demand for antibiotics spikes, such as during outbreaks of bacterial infections or in regions where there is a resurgence of diseases that had previously been under control. During such times, the price of Penicillin G Sodium may rise as healthcare systems rush to stockpile the drug. This demand surge places additional pressure on suppliers, and any existing supply bottlenecks can further exacerbate price increases. Conversely, when new, more effective antibiotics are developed and released, there may be a temporary dip in demand for Penicillin G Sodium, which could result in a slight decrease in price. However, as Penicillin G Sodium remains a reliable and widely used antibiotic, it continues to hold a steady position in the market, with demand generally remaining consistent.

Another factor influencing Penicillin G Sodium prices is the level of competition among pharmaceutical companies. In markets where there are multiple manufacturers, competitive pricing can help keep costs relatively low for consumers. However, if a dominant manufacturer experiences production issues, or if smaller competitors exit the market, the resulting decrease in competition can lead to price increases. Mergers and acquisitions within the pharmaceutical industry also impact pricing, as consolidation can sometimes result in reduced competition, giving the remaining players greater pricing power. In addition to competition among manufacturers, the pricing of Penicillin G Sodium can be affected by government policies, including subsidies and price controls. In some countries, governments negotiate directly with pharmaceutical companies to set drug prices, while in others, market forces largely dictate pricing. These variations in regulatory approaches mean that the price of Penicillin G Sodium can differ significantly from one region to another.

The global nature of the pharmaceutical supply chain means that currency fluctuations also play a role in determining the price of Penicillin G Sodium. Since the raw materials and finished product are often traded internationally, shifts in currency exchange rates can influence the cost of importing or exporting the drug. For example, if the currency of a major producer weakens against the US dollar, the price of Penicillin G Sodium in that country could rise as manufacturers seek to offset the higher cost of imported materials. Conversely, a strong currency in a producer nation could make the drug cheaper to export, potentially leading to lower prices in international markets. However, currency fluctuations are just one part of the broader financial picture that affects the pricing of pharmaceuticals like Penicillin G Sodium.

The ongoing investment in research and development (R&D) by pharmaceutical companies also impacts the pricing of Penicillin G Sodium. While the drug itself is well-established, companies often invest in improving production processes, enhancing the efficacy of formulations, and developing new delivery mechanisms. These R&D efforts require significant financial resources, which can lead to higher prices for Penicillin G Sodium, as companies seek to recoup their investment. Additionally, regulatory approval processes for any changes in drug formulation or production methods can be costly and time-consuming, further contributing to the overall cost of the drug.

Another consideration is the role of healthcare reimbursement policies in influencing the price of Penicillin G Sodium. In countries with comprehensive public healthcare systems, the government often negotiates prices with pharmaceutical companies, ensuring that essential drugs like Penicillin G Sodium remain affordable for the population. In contrast, in countries where healthcare is largely privatized, the price of the drug may be driven more by market forces and the willingness of consumers or insurance companies to pay. The differences in healthcare systems around the world mean that the price of Penicillin G Sodium can vary widely depending on the region, with some countries benefiting from lower prices due to government intervention, while others may face higher costs driven by market dynamics.

Get Real Time Prices for Penicillin G Sodium: https://www.chemanalyst.com/Pricing-data/penicillin-g-sodium-1338

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New Post has been published on THIẾT BỊ KHOA HỌC CÔNG NGHỆ

New Post has been published on http://thietbikhoahoccongnghe.com.vn/giai-thuong-nobel-lien-quan-den-tinh-hoc-x-quang.html

Giải thư��ng Nobel liên quan đến tinh thể học X-quang 

Giải thưởng Nobel liên quan đến tinh thể học X-quang 

[hide]Year Laureate Prize Rationale 1914 Max von Laue Physics “For his discovery of the diffraction of X-rays by crystals”,[121] an important step in the development of X-ray spectroscopy. 1915 William Henry Bragg Physics “For their services in the analysis of crystal structure by means of X-rays”,[122] 1915 William Lawrence Bragg Physics “For their services in the analysis of crystal structure by means of X-rays”,[122] 1962 Max F. Perutz Chemistry “for their studies of the structures of globular proteins“[123] 1962 John C. Kendrew Chemistry “for their studies of the structures of globular proteins“[123] 1962 James Dewey Watson Medicine “For their discoveries concerning the molecular structure of nucleic acids and its significance for information transfer in living material”[124] 1962 Francis Harry Compton Crick Medicine “For their discoveries concerning the molecular structure of nucleic acids and its significance for information transfer in living material”[124] 1962 Maurice Hugh Frederick Wilkins Medicine “For their discoveries concerning the molecular structure of nucleic acids and its significance for information transfer in living material”[124] 1964 Dorothy Hodgkin Chemistry “For her determinations by X-ray techniques of the structures of important biochemical substances”[125] 1972 Stanford Moore Chemistry “For their contribution to the understanding of the connection between chemical structure and catalytic activity of the active centre of the ribonuclease molecule”[126] 1972 William H. Stein Chemistry “For their contribution to the understanding of the connection between chemical structure and catalytic activity of the active centre of the ribonuclease molecule”[126] 1976 William N. Lipscomb Chemistry “For his studies on the structure of boranes illuminating problems of chemical bonding”[127] 1985 Jerome Karle Chemistry “For their outstanding achievements in developing direct methods for the determination of crystal structures”[128] 1985 Herbert A. Hauptman Chemistry “For their outstanding achievements in developing direct methods for the determination of crystal structures”[128] 1988 Johann Deisenhofer Chemistry “For their determination of the three-dimensional structure of a photosynthetic reaction centre“[129] 1988 Hartmut Michel Chemistry “For their determination of the three-dimensional structure of a photosynthetic reaction centre“[129] 1988 Robert Huber Chemistry “For their determination of the three-dimensional structure of a photosynthetic reaction centre“[129] 1997 John E. Walker Chemistry “For their elucidation of the enzymatic mechanism underlying the synthesis of adenosine triphosphate (ATP)”[130] 2003 Roderick MacKinnon Chemistry “For discoveries concerning channels in cell membranes […] for structural and mechanistic studies of ion channels“[131] 2003 Peter Agre Chemistry “For discoveries concerning channels in cell membranes […] for the discovery of water channels“[131] 2006 Roger D. Kornberg Chemistry “For his studies of the molecular basis of eukaryotic transcription“[132] 2009 Ada E. Yonath Chemistry “For studies of the structure and function of the ribosome“[133] 2009 Thomas A. Steitz Chemistry “For studies of the structure and function of the ribosome“[133] 2009 Venkatraman Ramakrishnan Chemistry “For studies of the structure and function of the ribosome“[133]

Ứng dụng nhiễu xạ tia X  Nhiễu xạ tia X có nhiều ứng dụng khác nhau về hóa học, sinh hóa, vật lý, vật chất và khoa học khoáng vật học. Laue nói rằng “đã mở rộng sức mạnh của cấu trúc phút phục vụ gấp 10 nghìn lần so với kính hiển vi quang học. Sự nhiễu xạ tia X sản xuất kính hiển vi với độ phân giải nguyên tử cho thấy các nguyên tử và sự phân bố electron của chúng. Nhiễu xạ tia X, nhiễu xạ electron và nhiễu xạ neutron cung cấp thông tin về cấu trúc của vật chất, tinh thể và không tinh thể ở mức nguyên tử và phân tử. Ngoài ra, chúng được gắn liền với các tính chất của tất cả các vật liệu, vô cơ, hữu cơ hoặc sinh học. Do tầm quan trọng của nhiễu xạ và sự đa dạng của ứng dụng nhiễu xạ bằng tinh thể, một số lượng lớn giải Nobel đã được trình bày cho các nghiên cứu liên quan đến tia X. 

X-quang phương pháp điều tra của thuốc  Nhiễm xạ tia X được sử dụng để xác định các thuốc kháng sinh như: 8 β-lactam (ampicillin sodium, penicillin G procaine, cefalexin, ampicillin trihydrate, benzathine penicillin, benzylpenicillin natri, cefotaxime sodium, ceftriaxone sodium), ba tetracycline (doxycycline hydrochloride , oxytetracycline dehydrate, tetracycline hydrochloride) và hai thuốc kháng sinh macrolide (azithromycin, erythromycin estolate). Mỗi loại thuốc này đều có một mô hình XRD duy nhất làm cho việc nhận dạng của họ có thể xảy ra. 

X-quang phương pháp điều tra sợi dệt và polyme  Việc giám định pháp lý về bất kỳ dấu vết nào được dựa trên nguyên tắc trao đổi của Locard. Điều này nói rằng mỗi tiếp xúc sẽ để lại dấu vết. Trên thực tế, mặc dù đã có sự chuyển giao vật liệu nhưng có thể không thể phát hiện được, bởi vì số lượng chuyển nhượng rất nhỏ  Sợi dệt là hỗn hợp các chất tinh thể và vô định hình. Do đó phép đo mức độ tinh thể cho dữ liệu hữu ích trong việc xác định đặc tính của các sợi bằng cách sử dụng phương pháp nhiễu xạ tia X. Đã có thông báo rằng nhiễu xạ tia X được sử dụng để xác định một tinh thể “crystalline” đã được tìm thấy trên ghế. Các tiền gửi đã được tìm thấy là vô định hình, nhưng mô hình nhiễu xạ hiện tại phù hợp với polymethylmethacrylate. Phổ tử khối Pyrolysis sau đó xác định khoản tiền gửi đó là polymethylcyanoacrylaon của các thông số tinh thể Boin 

X-quang phương pháp điều tra xương  Hiller đã điều tra các ảnh hưởng của việc đốt nóng và đốt khoáng vật xương bằng kỹ thuật XRD. Các mẫu xương được gia nhiệt ở nhiệt độ 500, 700 và 900C trong 15 phút và 45 phút. Các kết quả cho thấy các tinh thể xương bắt đầu thay đổi trong 15 phút đầu tiên sưởi ấm ở 500 C0 trở lên. Ở nhiệt độ cao hơn, độ dày và hình dạng của tinh thể xương có vẻ ổn định, nhưng khi các mẫu được nung nóng ở nhiệt độ thấp hơn hoặc trong thời gian ngắn hơn, các dấu vết XRD cho thấy những thay đổi cực kỳ trong các thông số tinh thể

[robertjanitzeklove-blog]

AbstractThis invention relates to Ciprofloxacin Hydrochloride-containing composition, useful for the treatment of diseases. In particular, it relates to pharmaceutical composition comprising the following essential components: i) Ciprofloxacin Hydrochloride; ii) Magnesium stearate; iii) Starch; and iv) Carboxymethylstach Sodium.

Inventors:

Janitzek, Robert

;

(Olongapo City, PH)

Correspondence Address:

   ROTH & GOLDMAN, P.A.    523 W. 6TH STREET    SUITE 707    LOS ANGELES    CA    90014    US

Family ID:

29997606

Appl. No.:

10/519467

Filed:

December 27, 2004

PCT NO:

PCT/PH03/00006

Current U.S. Class:

424/464

; 514/253.08

Current CPC Class:

A61K 31/495 20130101

Class at Publication:

424/464

; 514/253.08

International Class:

A61K 031/496; A61K 009/20

Foreign Application Data

DateCodeApplication Number

Jun 27, 2002PH1-2002-000485

Claims

1. A pharmaceutical composition comprising the following essential components: i. Ciprofloxacin Hydrochloride; ii. Magnesium stearate; iii. Starch; and iv. Carboxymethylstach Sodium

2. The pharmaceutical composition of claim 1, the Ciprofloxacin Hydrochloride being in the amount of about 300 g of the composition.

3. The pharmaceutical composition of claim 1, the Magnesium stearate being in the amount of about 4 g of the composition.

4. The pharmaceutical composition of claim 1, the starch being in the amount of about 65 g of the composition.

5. The pharmaceutical composition of claim 1, the Carboxymethylstach being in the amount of 18 g of the composition.

6. A process for the preparation of a pharmaceutical composition containing Ciprofloxacin Hydrochloride comprising the following steps: i. Mixing the appropriate prescription amount of Ciprofloxacin Hydrochloride, Starch and Carboxymethylstach into a container; ii. Adding some amount of starch thick liquid and stir until a soft material is obtained; iii. Granulating the soft material formed in the previous step and then dry at a temperature of 70.degree. C. for 4 hours; iv. Take it out and arrange the grain; v. Adding some amount of Magnesium Stearate in order to fill well.

7. Use of the pharmaceutical composition according to claim 1 for the treatment of upper respiratory tract infections including tonsillitis, sinusitis, otitis media and pharynx inflammation; lower respiratory tract infections including acute and chronic bronchitis, bronchiectasis and pneumonia; urinary tract infections including urethritis, cystitis, pyelonephritis, prostates and pelvic inflammatory; gastrointestinal infections including enteric fever and infective diarrhea; skin and soft tissue infections; wounds infections; and infections caused by other sensitive bacteria.

Description

[0001] This invention relates to Ciprofloxacin Hydrochloride-containing compositions, useful for the treatment of diseases.

[0002] The main composition is Ciprofloxacin Hydrochloride and the chemical name in accordance with the Merck Index II.sup.th Edition, page 360 (1989) has the International Non-propriety Name (INN) for I-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(I-piperazinyl)-3-quinolinecar- boxylic acid of the structural formula: 1

[0003] disclosed, together with the process for the preparation thereof, in U.S. Pat. No. 4,670,444. Ciprofloxacin is a broad-spectrum antibacterial active principle.

[0004] The Ciprofloxacin Hydrochloride may easily be obtained on the market place or may be prepared by any of the methods disclosed in Spanish Patents Es-2006099 and ES-2006098.

[0005] Ciprofloxacin Hydrochloride is a white or off-white powder, which is odorless and has a bitter taste with a wide range antibacterial activity against Excherichia Coli, Klebsiella SPP., and other Enterobacter SPP., Bacillus–negative. The antibacterial action against Pseudomonas aerugenosa, golden yellow Staphylococcus and Streptococcus pneumoniae is better than other known derivatives i.e. Norfloxacin and Peifloxacin but the antibacterial action against Streptococcus SPP. Is less than Penicillin kinds of antibiotic.

[0006] The antibacterial action results from the inhibition of bacterial DNA gyrase for combating various types of disorders. Ciprofloxacin Hydrochloride may be used in combination with an amino glycoside or with beta-lactam antibiotics.

[0007] The present inventor is aware of the existence of prior art describing ciprofloxacin pharmaceutical preparations which may be used for combating diseases whereby, in view of the high efficacy and broad spectrum of this antibacterial active principle, there is a felt the desirability of developing new compositions containing it, suitable for such application.

[0008] The invention seeks to provide aqueous ciprofloxacin compositions suitable for use in the treatment of the following infections caused by sensitive bacteria:

[0009] 1. Upper respiratory tract infections including tonsillitis, sinusitis, otitis media and pharynx inflammation.

[0010] 2. Lower respiratory tract infections including acute and chronic bronchitis, bronchiectasis and pneumonia.

[0011] 3. Urinary tract infections including urethritis, cystitis, pyelonephritis, prostatitis and pelvic inflammatory.

[0012] 4. Gastro-intestinal infections including enteric fever and infective diarrhea.

[0013] 5. Skin and soft tissue infections.

[0014] 6. Wounds infections.

[0015] 7. Infections caused by other sensitive bacteria.

[0016] This objective is achieved by composition according to the present invention characterized in that they comprise the following essential components, in the amounts given hereinafter.

[0017] i. 300 g of Ciprofloxacin;

[0018] ii. 65 g of starch;

[0019] iii. 18 g of Carboxymethyl starch Sodium;

[0020] iv. 4 g of Magnesium Stearate

[0021] The technical specifications of the component of the present invention are as follows:

1 2.1 Technical specifications of Ciprofloxacin Hydrochloride Items Specifications 1. Identification A. IR Test Conform B. TLC Test Conform C. Chloride Test Conform 2. pH 3.0.about.4.5 3. Water 4.7.about.6.7% 4. Residue of ignition .quadrature. 0.1% 5. Sulfate .quadrature. 0.04% 6. Heavy metals .quadrature. 0.002% 7. Limit of fluoroquin-olonic acid .quadrature. 0.2% 8. Chromatographic purity Single impurity: .quadrature. 0.2% Total impurities: .quadrature. 0.5% 9. Assay 98.0.about.102.0%

[0022]

2 2.2 Technical specifications of Magnesium Stearate Items Specifications 1. Identification A. Magnesium test Conform B. The retention time test Conform 2. Microbial limits A. The total aerobic and microbial count .quadrature. 1000 per g B. The total combined molds and .quadrature. 500 per g yeast count C. Salmonella and Escherichia coli Absence 3. Acidity or alkalinity .quadrature. 0.05 ml of 0.1 N HCL 4. Loss of drying .quadrature. 6.0% 5. Specific surface area 0.05.about.0.15 6. Limit of chloride .quadrature. 0.1% 7. Limit of sulfate .quadrature. 1.0% 8. Lead .quadrature. 0.001% 9. Relative content of stearic Meet the Acid and palmitic acid requirements of USP24 10. Assay 4.0.about.5.0% Mg (dried basis)

[0023]

3 2.3 Technical specifications of starch Items Specifications 1. Identification A. Solubility A translucent, whitish jelly B. Color test Reddish violet to deep blue 2. Microbial limits Salmonella species and Absence Escherichia coli 3. pH 4.5.about.7.0 for Corn starch, Tapioca starch and wheat Starch; 5.0.about.8.0 for Potato starch 4. Loss of drying .quadrature.14.0% 5. Residue on ignition .quadrature. 0.5% 6. Iron .quadrature. 0.002% 7. Oxidizing substances .quadrature. 0.002% 8. Sulfur dioxide .quadrature. 0.008%

[0024]

4 2.4 Technical specification of Carboxymethylstach Sodium Items Specifications 1. Identification A. Color test Add iodine indicator, produce blue B. Sodium sact test Conform Acidity and alkalinity 5.5.about.7.5 Total chlorine content .quadrature. 3.5% (dried basis) Loss of drying .quadrature. 10.0% Iron .quadrature. 0.004% Heavy metals .quadrature. 0.002% Assay Contain Sodium 2.0.about.4.0% (Calculated on dried basis)

[0025] The daily dose of the composition of the present invention can vary over broad limits depending on several factors, e.g. on the activity of the active ingredients, the patient’s condition and age, the severity of the disease.

[0026] The oral dose as a rule: usual dose; single dose is 200-250 mg; severe symptom; single dose is 400-500 mg, twice a day taken with boiled water. It has to be stressed that these doses figures are intended for information only, and administered dose must be determined each time by the physician therapeutist.

[0027] When healthy adults take orally 200 mg, 1.5-2 hours later the peak concentration will reach 1.21+-0.03 ug/ml; if take orally, 1.5-2 hours later the peak concentration will reach 2.73+-0.43 ug/ml. The half-life is four hours (t.sub.1/2=4 h). In the majority of indications twice dosage may be taken orally. The product distribute mainly in bile, mucus, saliva, bone and prostate gland but the concentration is lower in brain tissue. It may be metabolized partly in liver and pharmaceutical concentration in urine may be retainable.

[0028] According to the further aspect of the present invention there is provided a process appropriate for preparing the compositions of the invention comprising the following steps:

[0029] i. Mixing the appropriate prescription amount of Ciprofloxacin Hydrochloride, Starch and Carboxymethyl starch into a container;

[0030] ii. Adding some amount of starch thick liquid and stir until a soft material formed in the previous step and then dry it at a temperature preferably 70 C for 4 hours;

[0031] iii. Granulating the soft material formed in the previous step and then dry it at a temperature preferably 70 C for 4 hours;

[0032] iv. Take it out and arrange the grain;

[0033] v. Adding some amount of Magnesium Stearate in order to fill well in a capsule using an automatic filling machine;

[0034] According to a preferred feature, the capsules are packaged in a blister foil. It does obtained compositions, which have excellent properties with regard to physical and microbial stability, without the need to use preservatives and are particularly appropriate for oral administration.

[0035] The following example is given for a better understanding of this description, without being deemed to be a limitation of the scope of the present invention.

EXAMPLE I

[0036] Weight 200 kg of Ciprofloxacin Hydrochloride, 37.73 kg of starch and 12.00 kg of Carboxymethyl starch sodium into a container, mix well. Using 5.60 kg of starch and 80 kg of water prepare starch thick liquid (7%). Then add these liquids to the container until soft material is obtained. The total quantity of starch is 43.33 kg. After drying and arranging grains add 2.76 kg of Magnesium Stearate in order to fill well.

[0037] Through drying about 80 kg of water may be lost, but no ingredients may be removed and overage. Before filling capsules, the tester must sample and test. According to the test result adjust quantity of each capsule.

[0038] The technical specification of the present composition is shown by the following:

5 Items Specifications Identification The retention time of sample A. The retention time test corresponds to that of the standard. B. TLC test The result obtained from test solution corresponds to that of Standard Solution Dissolution Not less than 80% Uniformity of dosage units Meet the requirements Assay 90.0.about.110.0%

[0039] Details of the assay and other test procedure for finished product including data analysis:

[0040] [Identification]

[0041] A: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that of the standard preparation obtained as directed in the Assay.

[0042] B: Place a number of capsules, equivalent to about 1500 mg of Ciprofloxacin, in a suitable flask containing about 750 mL of water, and sonicate for about 20 minutes. Dilute with water to 1000 mL, add mix. Centrifuge a portion of this suspension, and use the clear supernatant solution obtained as the test solution. Dissolve a quantity of USP Ciprofloxacin Hydrochloride RS in water to obtain a standard solution containing 1.5 mg per ML. Proceed as directed for Identification test B under Ciprofloxacin Hydrochloride. Starting with Separately apply, as 1-cm bands, 5 uL each. “Except to use 10 uL each of the test solution and the standard solution: the specified result is obtained.

[0043] [Dissolution]

6 Medium: Water 900 mL Apparatus: 50 rpm Time: 30 minutes

[0044] Procedure–Determine the amount of Ciprofloxacin Hydrochloride (C.sub.17H.sub.18FN.sub.3O.sub.3.HCl) dissolved from ultraviolet absorbance at the wavelength of absorbance at about 276 nm of filtered portions of the solution under test, suitably diluted with Dissolution Medium, if necessary, in comparison with a standard solution having a known concentration of USP Ciprofloxacin Hydrochloride RS in the same medium.

[0045] Tolerances–An amount Of C.sub.17H.sub.18FN.sub.3O.sub.3. HCl equivalent to not less than 80% (Q) of the labeled amount of Ciprofloxacin C.sub.17H.sub.18FN.sub.3O.sub.3 is dissolved in 30 minutes.

[0046] Calculated Formula: 1 Q = A T .times. 900 A S .times. L .times. D S .times. 100 %

7 A.sub.T Absorbance obtained from test Solution A.sub.S Absorbance obtained from Standard Solution D.sub.S Diluted multiple of Standard solution L Labeled quantity

[0047] Uniformity of Dosage Units:

[0048] Take 20 pills Ciprofloxacin Hydrochloride capsules, weigh their internal drug, and the weight discrepancy is .+-.7.5%.

[0049] [Assay]

[0050] Mobile phase, Resolution solution and Chromatographic system–prepare as directed in the Assay under Ciprofloxacin Hydrochloride.

[0051] Standard preparation–Dissolve an accurately weighed quantity of USP Ciprofloxacin Hydrochloride RS quantitatively in water to obtain a solution having a known concentration of about 0.3 mg per mL.

[0052] Assay preparation–Transfer 5 capsules to a 500-mL volumetric flask, add about 400 mL of water, and sonicate for about 20 minutes. Dilute with water to volume, and mix. Dilute an accurately measured volume of this solution quantitatively with water to obtain containing the equivalent of about 0.25 mg of Ciprofloxacin per mL.

[0053] Procedure–proceed as directed for Procedure in the Assay under Ciprofloxacin Hydrochloride. Calculate the quantity in mg of Ciprofloxacin (C.sub.17H.sub.18FN.sub.3O.sub.3) in each capsule taken by the formula:

(331.35/367.81)(CL/D)(rL/rs)

[0054] In which 331.35 and 3 7.81 are the molecular weights of Ciprofloxacin and anhydrous Ciprofloxacin Hydrochloride, respectively, C is the concentration, in mg per mL, of USP Ciprofloxacin Hydrochloride RS in the Standard preparation, calculated on the anhydrous basis. L is the labeled quantity, in mg per mL of Ciprofloxacin in the Assay preparation, based on the labeled quantity per capsule and the extend of dilution, and rL and rs are the ciprofloxacin peak responses obtained from the Assay preparation and the Standard preparation, respectively.

[0055] Detailed report of stability studies to justify shell life (accelerated or long terms).

[0056] 1. Long Term Testing

[0057] 1.1 Scope

[0058] Three batches (980 01, 980 02, 980 03) of Ciprofloxacin Hydrochloride capsules have been subjected to stability tests under 20.degree. C..+-.2.degree. C. and 0% RH.+-.5%. So far, two year’ stability results are available.

[0059] 1.2 Packaging

[0060] The container to be used is the same as the actual packaging used for storage and distribution.

[0061] 1.3 Storage Condition

[0062] Temperature and humidity is 25.degree. C..+-.2.degree. C. and 0% RH.+-.5%.

[0063] 2. Accelerated Testing

[0064] 2.1 Scope

[0065] Our factory has performed a new stability program according to the “Stability testing guideline for medicinal products in European Union”.

[0066] 2.2 Packaging

[0067] The container to be used in the same as the actual packaging used for storage and distribution.

[0068] 2.3 Storage Condition

[0069] Under 40.degree. C..+-.2.degree. C. and 75% RH.+-.5% for 6 months.

[0070] 3. Analytical Items

[0071] The following items were carried out in order to determine any changes in this product.

[0072] 3.1. Appearance.

[0073] 3.2. Dissolution.

[0074] 3.3. Uniformity of dosage units.

[0075] 3.4. Assay.

[0076] Item 3.1 was tested by estimation, items 3.2, 3.3, 3.4 were tested in accordance with section 7 “Test procedure for finished products”.

[0077] 4. Results

[0078] Please see table I, II, III, IV.

[0079] 5. Conclusion

[0080] In well-closed containers, no significant change was observed up on storage at 25.degree. C..+-.2.degree. C. and 60% RH.+-.5% for two years. In no case degradation products were observed. We will continue long term testing in order to confirm the final validity of this product, but it should be up to two years.

8TABLE I Long term testing results of Ciprofloxacin Hydrochloride capsules Batch No.: 980601 Items Uniformity of Month Appearanced dosage units Dissolution Assay 0 Off-white Conform 94% 98.4% particle 3 No change Conform 93.5% 98.0% 6 No change Conform 93.2% 98.1% 9 No change Conform 93.0% 97.6% 12 No change Conform 93.3% 97.5% 18 No change Conform 92.5% 96.8% 24 No change Conform 92.1% 97.0%

[0081]

9TABLE II Long term testing results of Ciprofloxacin Hydrochloride capsules Batch No.: 980602 Items Uniformity of Month Appearanced dosage units Dissolution Assay 0 Off-white Conform 94.2% 97.5% particle 3 No change Conform 94.0% 97.2% 6 No change Conform 94.1% 97.3% 9 No change Conform 93.8% 97.0% 12 No change Conform 93.6% 96.9% 18 No change Conform 93.3% 96.5% 24 No change Conform 93.2% 96.6%

[0082]

10TABLE III Long term testing results of Ciprofloxacin Hydrochloride capsules Batch No.: 980603 Items Uniformity of Month Appearanced dosage units Dissolution Assay 0 Off-white Conform 93.8% 98.0% particle 3 No change Conform 93.5% 97.8% 6 No change Conform 93.6% 97.6% 9 No change Conform 93.2% 97.1% 12 No change Conform 93.4% 97.0% 18 No change Conform 92.9% 96.5% 24 No change Conform 92.6% 96.3%

[0083]

11TABLE IV Accelerated testing results of Ciprofloxacin Hydrochloride capsules Batch No.: 980601; 980602; 980603 Uniformity of Storage Time Batch No. Apperance Dosage units Dissolution Assay Initial 980601 Conform Conform 94.0% 98.4% (15/06,1998) 980602 Conform Conform 94.2% 97.5% 980603 Conform Conform 93.8% 98.0% 980601 No change Conform 94.1% 97.9% I month 980602 No change Conform 94.0% 97.2% 980603 No change Conform 93.6% 97.5% 980601 No change Conform 93.7% 97.4% 2 month 980602 No change Conform 93.9% 96.8% 980603 No change Conform 93.6% 96.9% 980601 No change Conform 93.5% 96.6% 3 month 980602 No change Conform 93.4% 96.1% 980603 No change Conform 93.5% 96.2% 980601 No change Conform 93.0% 96.0% 6 month 980602 No change Conform 92.7% 95.4% 980603 No change Conform 92.8% 95.0% Appearance of capsules: Off-white particle in hard capsule.

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Penicillin G Sodium Prices Trend, Pricing, Database, Index, News, Chart, Forecast

 Penicillin G Sodium Prices, a widely used antibiotic, plays a crucial role in treating a variety of bacterial infections. Its importance in the medical field cannot be overstated, as it is often the first line of defense against serious infections. However, the price of Penicillin G Sodium is a subject of concern for many healthcare providers and patients. The cost of this antibiotic can fluctuate due to several factors, including production costs, raw material availability, regulatory changes, and market demand. These variations can significantly impact the overall expenditure on healthcare, especially in settings where budget constraints are a major issue.

One primary factor influencing Penicillin G Sodium prices is the cost of production. The manufacturing process of this antibiotic involves several stages, each requiring specific raw materials and energy inputs. Any changes in the prices of these raw materials, such as phenylacetic acid, can directly affect the production costs. Additionally, the energy costs associated with maintaining the controlled environments necessary for the fermentation process can also influence the final price. When production costs rise, manufacturers often pass these increases on to consumers, resulting in higher prices for Penicillin G Sodium.

Another significant aspect affecting the price of Penicillin G Sodium is regulatory oversight. In many countries, the production and sale of antibiotics are tightly regulated to ensure safety and efficacy. Compliance with these regulations often requires substantial investments in quality control and testing. While these measures are essential for patient safety, they can add to the overall cost of production. Furthermore, any changes in regulatory requirements, such as stricter guidelines or new testing procedures, can lead to additional costs for manufacturers, which again may be reflected in the price of the antibiotic.

Market demand also plays a critical role in determining the price of Penicillin G Sodium. When demand for this antibiotic increases, whether due to a rise in bacterial infections or increased awareness and diagnosis, prices tend to go up. Conversely, if demand decreases, perhaps due to the introduction of new antibiotics or improved infection prevention measures, prices may fall. However, the relationship between demand and price is not always straightforward. For instance, in some cases, manufacturers may reduce production in response to lower demand, which can keep prices stable or even increase them due to reduced supply.

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Global supply chain dynamics can also influence the price of Penicillin G Sodium. The production of antibiotics is often a global enterprise, with raw materials sourced from one country, production occurring in another, and distribution spanning multiple regions. Disruptions in any part of this supply chain, such as transportation delays, trade restrictions, or geopolitical tensions, can lead to shortages and price increases. For example, if a major supplier of a critical raw material faces export restrictions, it could cause a ripple effect, leading to higher production costs and, consequently, higher prices for the end product.

Additionally, competition within the pharmaceutical industry can impact Penicillin G Sodium prices. When multiple manufacturers produce and sell this antibiotic, competition tends to drive prices down as companies strive to offer the most attractive options to buyers. However, if the market is dominated by a few large players, they may have more control over pricing, potentially leading to higher costs for consumers. Mergers and acquisitions within the industry can also alter the competitive landscape, affecting pricing strategies and market dynamics.

Economic conditions and healthcare policies in different regions can further influence the price of Penicillin G Sodium. In countries with robust healthcare systems and strong insurance coverage, the cost of antibiotics might be lower for patients due to subsidies or negotiated pricing with manufacturers. In contrast, in regions with limited healthcare infrastructure or economic challenges, the price of antibiotics can be prohibitively high, limiting access for many patients. Policies aimed at controlling drug prices, such as price caps or reimbursement limits, can also play a role in determining the final cost to consumers.

In summary, the price of Penicillin G Sodium is shaped by a complex interplay of factors, including production costs, regulatory requirements, market demand, supply chain dynamics, industry competition, and regional economic conditions. Understanding these factors is essential for healthcare providers, policymakers, and patients as they navigate the challenges of ensuring access to this vital antibiotic. As the global healthcare landscape continues to evolve, ongoing attention to the pricing of essential medicines like Penicillin G Sodium will be crucial in maintaining effective and affordable healthcare for all.

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ROBERT JANITZEK

Abstract This invention relates to Ciprofloxacin Hydrochloride-containing composition, useful for the treatment of diseases. In particular, it relates to pharmaceutical composition comprising the following essential components: i) Ciprofloxacin Hydrochloride; ii) Magnesium stearate; iii) Starch; and iv) Carboxymethyl stach Sodium.Inventors:Janitzek, Robert; (Olongapo City, PH)Correspondence Address:    ROTH & GOLDMAN, P.A.    523 W. 6TH STREET    SUITE 707    LOS ANGELES    CA    90014    US Family ID:29997606Appl. No.:10/519467Filed:December 27, 2004PCT NO:PCT/PH03/00006Current U.S. Class:424/464 ; 514/253.08Current CPC Class:A61K 31/495 20130101Class at Publication:424/464 ; 514/253.08International Class:A61K 031/496; A61K 009/20 Foreign Application Data Date Code Application Number Jun 27, 2002PH1-2002-000485Claims1. A pharmaceutical composition comprising the following essential components: i. Ciprofloxacin Hydrochloride; ii. Magnesium stearate; iii. Starch; and iv. Carboxymethyl Starch Sodium 2. The pharmaceutical composition of claim 1, the Ciprofloxacin Hydrochloride being in the amount of about 300 g of the composition.3. The pharmaceutical composition of claim 1, the Magnesium stearate being in the amount of about 4 g of the composition.4. The pharmaceutical composition of claim 1, the starch being in the amount of about 65 g of the composition.5. The pharmaceutical composition of claim 1, the Carboxymethyl Starch being in the amount of 18 g of the composition.6. A process for the preparation of a pharmaceutical composition containing Ciprofloxacin Hydrochloride comprising the following steps: i. Mixing the appropriate prescription amount of Ciprofloxacin Hydrochloride, Starch and Carboxymethylstach into a container; ii. Adding some amount of starch thick liquid and stir until a soft material is obtained; iii. Granulating the soft material formed in the previous step and then dry at a temperature of 70.degree. C. for 4 hours; iv. Take it out and arrange the grain; v. Adding some amount of Magnesium Stearate in order to fill well.7. Use of the pharmaceutical composition according to claim 1 for the treatment of upper respiratory tract infections including tonsillitis, sinusitis, otitis media and pharynx inflammation; lower respiratory tract infections including acute and chronic bronchitis, bronchiectasis and pneumonia; urinary tract infections including urethritis, cystitis, pyelonephritis, prostates and pelvic inflammatory; gastrointestinal infections including enteric fever and infective diarrhea; skin and soft tissue infections; wounds infections; and infections caused by other sensitive bacteria.Description[0001] This invention relates to Ciprofloxacin Hydrochloride-containing compositions, useful for the treatment of diseases.[0002] The main composition is Ciprofloxacin Hydrochloride and the chemical name in accordance with the Merck Index II.sup.th Edition, page 360 (1989) has the International Non-propriety Name (INN) for I-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(I-piperazinyl)-3-quinolinecar- boxylic acid of the structural formula: 1[0003] disclosed, together with the process for the preparation thereof, in U.S. Pat. No. 4,670,444. Ciprofloxacin is a broad-spectrum antibacterial active principle.[0004] The Ciprofloxacin Hydrochloride may easily be obtained on the market place or may be prepared by any of the methods disclosed in Spanish Patents Es-2006099 and ES-2006098.[0005] Ciprofloxacin Hydrochloride is a white or off-white powder, which is odorless and has a bitter taste with a wide range antibacterial activity against Excherichia Coli, Klebsiella SPP., and other Enterobacter SPP., Bacillus–negative. The antibacterial action against Pseudomonas aerugenosa, golden yellow Staphylococcus and Streptococcus pneumoniae is better than other known derivatives i.e. Norfloxacin and Peifloxacin but the antibacterial action against Streptococcus SPP. Is less than Penicillin kinds of antibiotic.[0006] The antibacterial action results from the inhibition of bacterial DNA gyrase for combating various types of disorders. Ciprofloxacin Hydrochloride may be used in combination with an amino glycoside or with beta-lactam antibiotics.[0007] The present inventor is aware of the existence of prior art describing ciprofloxacin pharmaceutical preparations which may be used for combating diseases whereby, in view of the high efficacy and broad spectrum of this antibacterial active principle, there is a felt the desirability of developing new compositions containing it, suitable for such application.[0008] The invention seeks to provide aqueous ciprofloxacin compositions suitable for use in the treatment of the following infections caused by sensitive bacteria:[0009] 1. Upper respiratory tract infections including tonsillitis, sinusitis, otitis media and pharynx inflammation.[0010] 2. Lower respiratory tract infections including acute and chronic bronchitis, bronchiectasis and pneumonia.[0011] 3. Urinary tract infections including urethritis, cystitis, pyelonephritis, prostatitis and pelvic inflammatory.[0012] 4. Gastro-intestinal infections including enteric fever and infective diarrhea.[0013] 5. Skin and soft tissue infections.[0014] 6. Wounds infections.[0015] 7. Infections caused by other sensitive bacteria.[0016] This objective is achieved by composition according to the present invention characterized in that they comprise the following essential components, in the amounts given hereinafter.[0017] i. 300 g of Ciprofloxacin;[0018] ii. 65 g of starch;[0019] iii. 18 g of Carboxymethyl starch Sodium;[0020] iv. 4 g of Magnesium Stearate[0021] The technical specifications of the component of the present invention are as follows:1 2.1 Technical specifications of Ciprofloxacin Hydrochloride Items Specifications 1. Identification A. IR Test Conform B. TLC Test Conform C. Chloride Test Conform 2. pH 3.0.about.4.5 3. Water 4.7.about.6.7% 4. Residue of ignition .quadrature. 0.1% 5. Sulfate .quadrature. 0.04% 6. Heavy metals .quadrature. 0.002% 7. Limit of fluoroquin-olonic acid .quadrature. 0.2% 8. Chromatographic purity Single impurity: .quadrature. 0.2% Total impurities: .quadrature. 0.5% 9. Assay 98.0.about.102.0%[0022]2 2.2 Technical specifications of Magnesium Stearate Items Specifications 1. Identification A. Magnesium test Conform B. The retention time test Conform 2. Microbial limits A. The total aerobic and microbial count .quadrature. 1000 per g B. The total combined molds and .quadrature. 500 per g yeast count C. Salmonella and Escherichia coli Absence 3. Acidity or alkalinity .quadrature. 0.05 ml of 0.1 N HCL 4. Loss of drying .quadrature. 6.0% 5. Specific surface area 0.05.about.0.15 6. Limit of chloride .quadrature. 0.1% 7. Limit of sulfate .quadrature. 1.0% 8. Lead .quadrature. 0.001% 9. Relative content of stearic Meet the Acid and palmitic acid requirements of USP24 10. Assay 4.0.about.5.0% Mg (dried basis)[0023]3 2.3 Technical specifications of starch Items Specifications 1. Identification A. Solubility A translucent, whitish jelly B. Color test Reddish violet to deep blue 2. Microbial limits Salmonella species and Absence Escherichia coli 3. pH 4.5.about.7.0 for Corn starch, Tapioca starch and wheat Starch; 5.0.about.8.0 for Potato starch 4. Loss of drying .quadrature.14.0% 5. Residue on ignition .quadrature. 0.5% 6. Iron .quadrature. 0.002% 7. Oxidizing substances .quadrature. 0.002% 8. Sulfur dioxide .quadrature. 0.008%[0024]4 2.4 Technical specification of Carboxymethylstach Sodium Items Specifications 1. Identification A. Color test Add iodine indicator, produce blue B. Sodium sact test Conform Acidity and alkalinity 5.5.about.7.5 Total chlorine content .quadrature. 3.5% (dried basis) Loss of drying .quadrature. 10.0% Iron .quadrature. 0.004% Heavy metals .quadrature. 0.002% Assay Contain Sodium 2.0.about.4.0% (Calculated on dried basis)[0025] The daily dose of the composition of the present invention can vary over broad limits depending on several factors, e.g. on the activity of the active ingredients, the patient’s condition and age, the severity of the disease.[0026] The oral dose as a rule: usual dose; single dose is 200-250 mg; severe symptom; single dose is 400-500 mg, twice a day taken with boiled water. It has to be stressed that these doses figures are intended for information only, and administered dose must be determined each time by the physician therapeutist.[0027] When healthy adults take orally 200 mg, 1.5-2 hours later the peak concentration will reach 1.21+-0.03 ug/ml; if take orally, 1.5-2 hours later the peak concentration will reach 2.73+-0.43 ug/ml. The half-life is four hours (t.sub.1/2=4 h). In the majority of indications twice dosage may be taken orally. The product distribute mainly in bile, mucus, saliva, bone and prostate gland but the concentration is lower in brain tissue. It may be metabolized partly in liver and pharmaceutical concentration in urine may be retainable.[0028] According to the further aspect of the present invention there is provided a process appropriate for preparing the compositions of the invention comprising the following steps:[0029] i. Mixing the appropriate prescription amount of Ciprofloxacin Hydrochloride, Starch and Carboxymethyl starch into a container;[0030] ii. Adding some amount of starch thick liquid and stir until a soft material formed in the previous step and then dry it at a temperature preferably 70 C for 4 hours;[0031] iii. Granulating the soft material formed in the previous step and then dry it at a temperature preferably 70 C for 4 hours;[0032] iv. Take it out and arrange the grain;[0033] v. Adding some amount of Magnesium Stearate in order to fill well in a capsule using an automatic filling machine;[0034] According to a preferred feature, the capsules are packaged in a blister foil. It does obtained compositions, which have excellent properties with regard to physical and microbial stability, without the need to use preservatives and are particularly appropriate for oral administration.[0035] The following example is given for a better understanding of this description, without being deemed to be a limitation of the scope of the present invention.EXAMPLE I[0036] Weight 200 kg of Ciprofloxacin Hydrochloride, 37.73 kg of starch and 12.00 kg of Carboxymethyl starch sodium into a container, mix well. Using 5.60 kg of starch and 80 kg of water prepare starch thick liquid (7%). Then add these liquids to the container until soft material is obtained. The total quantity of starch is 43.33 kg. After drying and arranging grains add 2.76 kg of Magnesium Stearate in order to fill well.[0037] Through drying about 80 kg of water may be lost, but no ingredients may be removed and overage. Before filling capsules, the tester must sample and test. According to the test result adjust quantity of each capsule.[0038] The technical specification of the present composition is shown by the following:5 Items Specifications Identification The retention time of sample A. The retention time test corresponds to that of the standard. B. TLC test The result obtained from test solution corresponds to that of Standard Solution Dissolution Not less than 80% Uniformity of dosage units Meet the requirements Assay 90.0.about.110.0%[0039] Details of the assay and other test procedure for finished product including data analysis:[0040] [Identification][0041] A: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that of the standard preparation obtained as directed in the Assay.[0042] B: Place a number of capsules, equivalent to about 1500 mg of Ciprofloxacin, in a suitable flask containing about 750 mL of water, and sonicate for about 20 minutes. Dilute with water to 1000 mL, add mix. Centrifuge a portion of this suspension, and use the clear supernatant solution obtained as the test solution. Dissolve a quantity of USP Ciprofloxacin Hydrochloride RS in water to obtain a standard solution containing 1.5 mg per ML. Proceed as directed for Identification test B under Ciprofloxacin Hydrochloride. Starting with Separately apply, as 1-cm bands, 5 uL each. “Except to use 10 uL each of the test solution and the standard solution: the specified result is obtained.[0043] [Dissolution]6 Medium: Water 900 mL Apparatus: 50 rpm Time: 30 minutes[0044] Procedure–Determine the amount of Ciprofloxacin Hydrochloride (C.sub.17H.sub.18FN.sub.3O.sub.3.HCl) dissolved from ultraviolet absorbance at the wavelength of absorbance at about 276 nm of filtered portions of the solution under test, suitably diluted with Dissolution Medium, if necessary, in comparison with a standard solution having a known concentration of USP Ciprofloxacin Hydrochloride RS in the same medium.[0045] Tolerances–An amount Of C.sub.17H.sub.18FN.sub.3O.sub.3. HCl equivalent to not less than 80% (Q) of the labeled amount of Ciprofloxacin C.sub.17H.sub.18FN.sub.3O.sub.3 is dissolved in 30 minutes.[0046] Calculated Formula: 1 Q = A T .times. 900 A S .times. L .times. D S .times. 100 %7 A.sub.T Absorbance obtained from test Solution A.sub.S Absorbance obtained from Standard Solution D.sub.S Diluted multiple of Standard solution L Labeled quantity[0047] Uniformity of Dosage Units:[0048] Take 20 pills Ciprofloxacin Hydrochloride capsules, weigh their internal drug, and the weight discrepancy is .+-.7.5%.[0049] [Assay][0050] Mobile phase, Resolution solution and Chromatographic system–prepare as directed in the Assay under Ciprofloxacin Hydrochloride.[0051] Standard preparation–Dissolve an accurately weighed quantity of USP Ciprofloxacin Hydrochloride RS quantitatively in water to obtain a solution having a known concentration of about 0.3 mg per mL.[0052] Assay preparation–Transfer 5 capsules to a 500-mL volumetric flask, add about 400 mL of water, and sonicate for about 20 minutes. Dilute with water to volume, and mix. Dilute an accurately measured volume of this solution quantitatively with water to obtain containing the equivalent of about 0.25 mg of Ciprofloxacin per mL.[0053] Procedure–proceed as directed for Procedure in the Assay under Ciprofloxacin Hydrochloride. Calculate the quantity in mg of Ciprofloxacin (C.sub.17H.sub.18FN.sub.3O.sub.3) in each capsule taken by the formula:(331.35/367.81)(CL/D)(rL/rs)[0054] In which 331.35 and 3 7.81 are the molecular weights of Ciprofloxacin and anhydrous Ciprofloxacin Hydrochloride, respectively, C is the concentration, in mg per mL, of USP Ciprofloxacin Hydrochloride RS in the Standard preparation, calculated on the anhydrous basis. L is the labeled quantity, in mg per mL of Ciprofloxacin in the Assay preparation, based on the labeled quantity per capsule and the extend of dilution, and rL and rs are the ciprofloxacin peak responses obtained from the Assay preparation and the Standard preparation, respectively.[0055] Detailed report of stability studies to justify shell life (accelerated or long terms).[0056] 1. Long Term Testing[0057] 1.1 Scope[0058] Three batches (980 01, 980 02, 980 03) of Ciprofloxacin Hydrochloride capsules have been subjected to stability tests under 20.degree. C..+-.2.degree. C. and 0% RH.+-.5%. So far, two year’ stability results are available.[0059] 1.2 Packaging[0060] The container to be used is the same as the actual packaging used for storage and distribution.[0061] 1.3 Storage Condition[0062] Temperature and humidity is 25.degree. C..+-.2.degree. C. and 0% RH.+-.5%.[0063] 2. Accelerated Testing[0064] 2.1 Scope[0065] Our factory has performed a new stability program according to the “Stability testing guideline for medicinal products in European Union”.[0066] 2.2 Packaging[0067] The container to be used in the same as the actual packaging used for storage and distribution.[0068] 2.3 Storage Condition[0069] Under 40.degree. C..+-.2.degree. C. and 75% RH.+-.5% for 6 months.[0070] 3. Analytical Items[0071] The following items were carried out in order to determine any changes in this product.[0072] 3.1. Appearance.[0073] 3.2. Dissolution.[0074] 3.3. Uniformity of dosage units.[0075] 3.4. Assay.[0076] Item 3.1 was tested by estimation, items 3.2, 3.3, 3.4 were tested in accordance with section 7 “Test procedure for finished products”.[0077] 4. Results[0078] Please see table I, II, III, IV.[0079] 5. Conclusion[0080] In well-closed containers, no significant change was observed up on storage at 25.degree. C..+-.2.degree. C. and 60% RH.+-.5% for two years. In no case degradation products were observed. We will continue long term testing in order to confirm the final validity of this product, but it should be up to two years.8TABLE I Long term testing results of Ciprofloxacin Hydrochloride capsules Batch No.: 980601 Items Uniformity of Month Appearanced dosage units Dissolution Assay 0 Off-white Conform 94% 98.4% particle 3 No change Conform 93.5% 98.0% 6 No change Conform 93.2% 98.1% 9 No change Conform 93.0% 97.6% 12 No change Conform 93.3% 97.5% 18 No change Conform 92.5% 96.8% 24 No change Conform 92.1% 97.0%[0081]9TABLE II Long term testing results of Ciprofloxacin Hydrochloride capsules Batch No.: 980602 Items Uniformity of Month Appearanced dosage units Dissolution Assay 0 Off-white Conform 94.2% 97.5% particle 3 No change Conform 94.0% 97.2% 6 No change Conform 94.1% 97.3% 9 No change Conform 93.8% 97.0% 12 No change Conform 93.6% 96.9% 18 No change Conform 93.3% 96.5% 24 No change Conform 93.2% 96.6%[0082]10TABLE III Long term testing results of Ciprofloxacin Hydrochloride capsules Batch No.: 980603 Items Uniformity of Month Appearanced dosage units Dissolution Assay 0 Off-white Conform 93.8% 98.0% particle 3 No change Conform 93.5% 97.8% 6 No change Conform 93.6% 97.6% 9 No change Conform 93.2% 97.1% 12 No change Conform 93.4% 97.0% 18 No change Conform 92.9% 96.5% 24 No change Conform 92.6% 96.3%[0083]11TABLE IV Accelerated testing results of Ciprofloxacin Hydrochloride capsules Batch No.: 980601; 980602; 980603 Uniformity of Storage Time Batch No. Apperance Dosage units Dissolution Assay Initial 980601 Conform Conform 94.0% 98.4% (15/06,1998) 980602 Conform Conform 94.2% 97.5% 980603 Conform Conform 93.8% 98.0% 980601 No change Conform 94.1% 97.9% I month 980602 No change Conform 94.0% 97.2% 980603 No change Conform 93.6% 97.5% 980601 No change Conform 93.7% 97.4% 2 month 980602 No change Conform 93.9% 96.8% 980603 No change Conform 93.6% 96.9% 980601 No change Conform 93.5% 96.6% 3 month 980602 No change Conform 93.4% 96.1% 980603 No change Conform 93.5% 96.2% 980601 No change Conform 93.0% 96.0% 6 month 980602 No change Conform 92.7% 95.4% 980603 No change Conform 92.8% 95.0% Appearance of capsules: Off-white particle in hard capsule.