#proprietary hot melt extrusion
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What is Hot-Melt Extrusion?
Hot melt extrusion(HME) services have evolved as a unique processing technology in producing molecular dispersions of active pharmaceutical ingredients (APIs) into various polymer or/and lipid matrices, which has led to time-regulated, modified, extended, and targeted drug delivery. HME now allows us to use compounds to conceal the bitter taste of active drugs.
Since the industrial application of the extrusion process in the 1930s, proprietary hot melt extrusion has gotten a lot of attention from the pharmaceutical industry and academia for a variety of applications for pharmaceutical dosage forms like tablets, capsules, films, and implants for drug delivery via oral, transdermal, and transmucosal routes.
As a result, HME services are an ideal alternative to other commonly used processes such as roll spinning and spray drying which we make use of at Abbvie Contract Manufacturing. In addition to being a tried-and-true manufacturing process, meets the goal of the US Food and Drug Administration's (FDA) process analytical technology (PAT) scheme for designing, analysing, and controlling the manufacturing process through quality control measurements during the active extrusion process.
Advantages of Proprietary Hot Melt Extrusion
Proprietary hot melt extrusion has a number of benefits over currently used pharmaceutical processing methods, including
(a) Increased solubility and bioavailability of water-insoluble compounds:
This is because binder components of HME dissolve easily in water, yielding the free soluble API inside the drug delivery matrix.
(b) Solvent-free nonambient process:
HME is a solvent-free process that is capable of producing the active pharmaceutical ingredient in an ambient process.
(c) Automation:
HME allows for quick and simple processing and manufacturing of dosage forms, which translates into higher yields and a shorter time to market.
(d) More economical:
The economic process with reduced production time, fewer processing steps, and a continuous operation is an advantage of HME.
(e) Capabilities of sustained, modified, and targeted release:
HME allows for the extended, modified, and targeted release of drugs for more specific drug delivery.
(f) Better content uniformity in extrudates:
HME has a superior variability to other conventional uses such as spray drying. This is a major benefit since it allows for a more uniform content of the active ingredient because of the uniformity in the flow rate of material and the consistency of pressure distribution during extrusion.
(g) No requirements for compressibility:
This is due to its low operating pressure, which does not require a high vacuum.
Disadvantages of Proprietary Hot Melt Extrusion
Like everything that has an advantage, HME has certain downsides as well.
1. The heating process (drug and polymer stability): Since HME is a process that derives its energy from heat, it cannot be controlled as easily as other extrusion processes such as heat treatment or freeze-drying. This means that the API and active ingredient cannot be added to the polymer matrix during the extrusion stage.
2. The use of a restricted number of polymers: HME cannot tolerate many additives like in other processing methods such as spray drying, so HME is limited to a few polymers.
3. The high flow characteristics of polymers: HME is a process that pulls in the polymer through the pump; hence a high flow rate of material is inevitable.
4. Requirement of excipients that are not suitable for relatively high heat sensitive molecules such as microbial species and proteins are the primary limitations of HME.
We at Abbvie Contract Manufacturing are the best among all manufacturers who offer Hot melt extrusion services. Our manufacturing is one of the best in the industry.
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Metallocene Polyethylene Market Key Drivers AND on-Going Trends 2018 – 2026
Metallocene polyethylene, also referred to as mPE, is a unique grade of polyethylene, which is produced using metallocene catalyst. The resultant grade of polyethylene produces polyethylene grade with pure and consistent properties. Desirable properties exhibited by metallocene polyethylene include processability, toughness, and stiffness. Metallocene polyethylene provides a better solution in terms of extrusion output compared to blends of Ziegler-Natta catalyzed linear low density polyethylene (LLDPE) and high pressure low density polyethylene (HP-LDPE). Its dart impact strength is much higher than that of products manufactured through ZN-LLDPE. Furthermore, films made from metallocene polyethylene exhibit fast hot tack. As a result, the films produced from metallocene polyethylene allow rapid sealing. The usage of metallocene catalyst allows producers to provide tailor-made solutions, with desired properties such as soft, low melting point to high melting point, and high heat resistance for specific applications. Metallocene polyethylene resin is substituting PVC and EVA as a raw material in the manufacture of films in various applications. The technology employed for manufacturing metallocene polyethylene is environmentally-friendly and safety oriented. Metallocene polyethylene is being employed on a large scale in the production of films, which are used in a wide range of packaging applications in end-user industries such as consumer goods, hygiene, food, industrial packaging, and agricultural films. Asia Pacific is anticipated to offer lucrative opportunities for metallocene polyethylene manufacturers owing to the expansion in the packaging industry.
Based on product type, the metallocene polyethylene market can be segmented into mLLDPE, mMDPE, and mHDPE. Currently, the market is dominated by the mLLDPE segment. The segment is anticipated to continue its dominance during the forecast period, as mLLDPE exhibits outstanding optical properties and better impact & puncture strength vis-à-vis other resins. The mLLDPE segment is estimated to expand at a significant pace during the forecast period, owing to the increase in demand for these in films in the packaging industry.
In terms of application, the metallocene polyethylene market can be divided into films, sheets, injection molding, and extrusion coating. Currently, the films segment dominates the metallocene polyethylene market. Films produced from metallocene polyethylene exhibit enhanced properties. These films are ideal for applications such as packaging, heavy-duty bags, refuse bags, shrink films, stretch films, agricultural films, etc. The films segment is anticipated to continue its dominance during the forecast period, and register a significant growth rate during the forecast period.
In terms of geography, Asia Pacific is the major consumer of metallocene polyethylene. Demand for metallocene polyethylene has been increasing constantly, due to the rise in usage in packaging applications. Asia Pacific is one of the rapidly growing markets for the packaging industry. Furthermore, solar and automotive industries, which are among the end-user industries of metallocene polyethylene, are also anticipated to exhibit significant growth during the forecast period. This, in turn, is boosting the demand for metallocene polyethylene. Countries expected to be attractive markets for metallocene polyethylene include China, India, Indonesia, Thailand, and Vietnam.
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Key players operating in the metallocene polyethylene market include Braskem, China Petrochemical Corporation, ExxonMobil Corporation, Mitsui & Co., Ineos, LyondellBasell Industries Holdings B.V., Nova Chemicals Corporation, Prime Polymer Co., Ltd., Reliance Industries Limited, SABIC, Sasol Limited, The Dow Chemical Company, Univation Technologies, Westlake Chemical Corporation, Borealis AG, Total Petrochemicals & Refining USA, Inc., and Formosa Plastics Corporation.
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Carbon Fiber Prepreg Market : Present Scenario And The Growth Prospects With Forecast 2025
Carbon fiber prepreg is a conventional carbon fiber material that is specially pre-impregnated with catalyzed resins. The resin is mixed with its hardener in the prepreg form. The prepreg form allows carbon fibers to be impregnated on a flat workable surface. The carbon fiber prepreg is required to be stored at very low temperatures to prevent the resin from getting cured before the application. Carbon fiber prepregs should be kept at around –20?C, otherwise they may get cured even before application, and this creates problems especially during processes such as polymer injection molding and extrusion molding.
The manufacturing of prepreg parts involves the application of pressure, resulting in excellent fiber consolidation, further enhancing the structural performance of the composite. Carbon fiber prepreg application requires a composite vacuum pump, vacuum bagging supplies, and high temperature tolerant molds and oven to cure the parts. Presently, carbon fiber prepregs are extensively used due to the rising demand from the aerospace, automobile, and wind turbine industries owing to the properties such as high strength, light weight, and chemical resistance. The commonly employed methods for the synthesis of carbon fiber prepregs are hot melt process and solvent dip process.
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The carbon fiber prepreg market is primarily driven by the increasing demand for fuel efficient vehicles. Furthermore, there is increasing demand for carbon fiber prepregs from various applications such as aerospace and defense. The light weight and excellent strength of carbon fiber prepregs attracts manufacturers, retailers, and consumers, and thereby have become key factors driving the expansion of this market. Moreover, increasing usage of carbon fiber prepregs for the manufacture of sports goods, such as tennis rackets, bicycles, fishing rods, and golf shafts is further propelling the expansion of the market. However, high processing and manufacturing costs of carbon fiber prepregs, along with issues related to their recyclability, are major factors that are expected to restrain the expansion of the carbon fiber prepreg market
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Based on the resin type, the carbon fiber prepreg market can be classified as epoxy, cyanate ester, polyimide and phenolics. In terms of application, global carbon fiber prepreg market is classified into aerospace & defense, automotive, and wind applications. The carbon fiber prepreg market is classified on the basis of manufacturing process as hot melt and solvent dip methods
The global carbon fiber prepreg market has witnessed robust expansion in 2016, and the trend is estimated to continue during the forecast period. North America accounted for a significant share of the carbon fiber prepreg market due to availability of raw material processing and technological advancements in the region. The aerospace industry in North America is a key market and is anticipated to expand further due to fleet expansion activities. The demand for highly fuel efficient vehicles and strong protective coating is increasing in the region. Similarly, in Europe, the carbon fiber prepreg market is expanding. Germany and France are considered as the key countries in Europe. The demand from the aerospace and defense industry fuels the carbon fiber prepreg market in Europe. Asia Pacific, is also considered as a key country for the market of carbon fiber prepreg due to strong demand from China and India.
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Carbon Fiber Prepreg Market to Register a Stout Growth by End 2025
Carbon fiber prepreg is a conventional carbon fiber material that is specially pre-impregnated with catalyzed resins. The resin is mixed with its hardener in the prepreg form. The prepreg form allows carbon fibers to be impregnated on a flat workable surface. The carbon fiber prepreg is required to be stored at very low temperatures to prevent the resin from getting cured before the application. Carbon fiber prepregs should be kept at around –20?C, otherwise they may get cured even before application, and this creates problems especially during processes such as polymer injection molding and extrusion molding. The manufacturing of prepreg parts involves the application of pressure, resulting in excellent fiber consolidation, further enhancing the structural performance of the composite. Carbon fiber prepreg application requires a composite vacuum pump, vacuum bagging supplies, and high temperature tolerant molds and oven to cure the parts. Presently, carbon fiber prepregs are extensively used due to the rising demand from the aerospace, automobile, and wind turbine industries owing to the properties such as high strength, light weight, and chemical resistance. The commonly employed methods for the synthesis of carbon fiber prepregs are hot melt process and solvent dip process
The carbon fiber prepreg market is primarily driven by the increasing demand for fuel efficient vehicles. Furthermore, there is increasing demand for carbon fiber prepregs from various applications such as aerospace and defense. The light weight and excellent strength of carbon fiber prepregs attracts manufacturers, retailers, and consumers, and thereby have become key factors driving the expansion of this market. Moreover, increasing usage of carbon fiber prepregs for the manufacture of sports goods, such as tennis rackets, bicycles, fishing rods, and golf shafts is further propelling the expansion of the market. However, high processing and manufacturing costs of carbon fiber prepregs, along with issues related to their recyclability, are major factors that are expected to restrain the expansion of the carbon fiber prepreg market
Based on the resin type, the carbon fiber prepreg market can be classified as epoxy, cyanate ester, polyimide and phenolics. In terms of application, global carbon fiber prepreg market is classified into aerospace & defense, automotive, and wind applications. The carbon fiber prepreg market is classified on the basis of manufacturing process as hot melt and solvent dip methods
The global carbon fiber prepreg market has witnessed robust expansion in 2016, and the trend is estimated to continue during the forecast period. North America accounted for a significant share of the carbon fiber prepreg market due to availability of raw material processing and technological advancements in the region. The aerospace industry in North America is a key market and is anticipated to expand further due to fleet expansion activities. The demand for highly fuel efficient vehicles and strong protective coating is increasing in the region. Similarly, in Europe, the carbon fiber prepreg market is expanding. Germany and France are considered as the key countries in Europe. The demand from the aerospace and defense industry fuels the carbon fiber prepreg market in Europe. Asia Pacific, is also considered as a key country for the market of carbon fiber prepreg due to strong demand from China and India. The change in lifestyles, the nature of emerging economy and overseas studies are key factors that fuel the expansion of the market for carbon fiber prepreg in Asia Pacific. In Latin America, demand for carbon fiber prepreg is primarily from Brazil due to the recent progress made in the country. Middle East and Africa, since being considered as a global connectivity hub, is considered to be a market attractive region in the future.
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Key players operating in the global carbon fiber prepreg market include Hexcel Corporation, Cytec Solvay Group, Royal Ten Cate N.V, Teijin Limited, and Mitsubishi Rayon Co., Ltd.
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Self-Reinforced Polymers Market Growth, Share, Demand and Analysis of Key Players to 2026
Self-reinforced polymers are materials with enhanced properties, which are achieved by controlling the molecular orientation of polymer chains. Self-reinforced polymers have low weight and recyclability with good mechanical properties and excellent impact strength. Polypropylene and PET (poly ethylene terephthalate) are polymers that are highly used as self-reinforced polymers. The two major processes adopted for the manufacture of self-reinforced plastic are hot-compaction and co-extrusion. The process of production of self-reinforced polymers results in lightweight, strong composites. Self-reinforced polymers are preferred in the automotive industry as they can be used as replacement materials for heavier non-structural components. Compared to commonly used glass fiber reinforced polypropylene, the surface finish of self-reinforced polymers is smoother. Self-reinforced polymer is an emerging composite material type, wherein both the reinforcement material and matrix are polymers with high compatibility with each other. Self-reinforced polymers can be used to make numerous products such as automotive components, and luggage and sporting goods.
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The global self-reinforced polymers market is driven by the rise in demand for lightweight components in the automotive industry. Manufacturers are engaged in the production of vehicles with light weight and increased fuel efficiency. Non-toxicity and recyclability are the other key factors driving the global self-reinforced polymers market. Active research and development in science and technology is driving the market for self-reinforced polymers. Demand for self-reinforced polymers in sporting goods such as tennis rackets and protective helmets has been increasing. Significant potential exists in terms of application of self-reinforced plastics in other areas such as machine casings and housings, transport containers, and industrial cladding. However, challenges associated with excessive heating in the manufacturing process are likely to hamper the market in the next few years. Excessive heating may affect the relaxation properties of fibers and finally damages the molecular relaxation properties.
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Based on technology, the global self-reinforced polymers market can be classified into hot compaction, overheating, co-extrusion, film stacking, and traditional melting or powder impregnation. Hot compaction and co-extrusion are the major technologies for the production of self-reinforced polymers. Based on application, the self-reinforced polymers market can be divided into automotive components, sporting goods, luggage, machine casings and housings, transport containers, industrial cladding, and others. However, demand for self-reinforced polymers is high in the automotive industry than that in other industries.
The global self-reinforced polymers market witnessed moderate expansion in 2016. This trend is estimated to continue during the forecast period. North America accounted for significant share of the self-reinforced polymers market in 2016 due to the well-established high performing automobiles, construction, and military equipment industries. Europe, with significant share from the automobile sector, is fuelling the self-reinforced polymers market. Germany and France are the key countries of the self-reinforced polymers market in Europe. In Asia Pacific, demand for automobiles is on the rise due to the increase in population. Urbanization and economic progress in the region are driving the self-reinforced polymers market. The polymer industry is not performing well In Latin America owing to the government policies that curb the usage of polymers. However, the industry may recover in the near future. This is estimated to boost the self-reinforced polymers market in the region. Middle East & Africa is also likely to offer lucrative opportunities to the self-reinforced polymers market.
Key players operating in the global self-reinforced polymers market include Solvay, Regoplas AG, and Polisilk S.A.
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Metallocene Polyethylene Market Progresses for Huge Profits During 2026
Metallocene polyethylene, also referred to as mPE, is a unique grade of polyethylene, which is produced using metallocene catalyst. The resultant grade of polyethylene produces polyethylene grade with pure and consistent properties. Desirable properties exhibited by metallocene polyethylene include processability, toughness, and stiffness. Metallocene polyethylene provides a better solution in terms of extrusion output compared to blends of Ziegler-Natta catalyzed linear low density polyethylene (LLDPE) and high pressure low density polyethylene (HP-LDPE).
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Its dart impact strength is much higher than that of products manufactured through ZN-LLDPE. Furthermore, films made from metallocene polyethylene exhibit fast hot tack. As a result, the films produced from metallocene polyethylene allow rapid sealing. The usage of metallocene catalyst allows producers to provide tailor-made solutions, with desired properties such as soft, low melting point to high melting point, and high heat resistance for specific applications.
Metallocene polyethylene resin is substituting PVC and EVA as a raw material in the manufacture of films in various applications. The technology employed for manufacturing metallocene polyethylene is environmentally-friendly and safety oriented. Metallocene polyethylene is being employed on a large scale in the production of films, which are used in a wide range of packaging applications in end-user industries such as consumer goods, hygiene, food, industrial packaging, and agricultural films. Asia Pacific is anticipated to offer lucrative opportunities for metallocene polyethylene manufacturers owing to the expansion in the packaging industry.
Based on product type, the metallocene polyethylene market can be segmented into mLLDPE, mMDPE, and mHDPE. Currently, the market is dominated by the mLLDPE segment. The segment is anticipated to continue its dominance during the forecast period, as mLLDPE exhibits outstanding optical properties and better impact & puncture strength vis-à-vis other resins. The mLLDPE segment is estimated to expand at a significant pace during the forecast period, owing to the increase in demand for these in films in the packaging industry.
In terms of application, the metallocene polyethylene market can be divided into films, sheets, injection molding, and extrusion coating. Currently, the films segment dominates the metallocene polyethylene market. Films produced from metallocene polyethylene exhibit enhanced properties. These films are ideal for applications such as packaging, heavy-duty bags, refuse bags, shrink films, stretch films, agricultural films, etc. The films segment is anticipated to continue its dominance during the forecast period, and register a significant growth rate during the forecast period.
In terms of geography, Asia Pacific is the major consumer of metallocene polyethylene. Demand for metallocene polyethylene has been increasing constantly, due to the rise in usage in packaging applications. Asia Pacific is one of the rapidly growing markets for the packaging industry. Furthermore, solar and automotive industries, which are among the end-user industries of metallocene polyethylene, are also anticipated to exhibit significant growth during the forecast period. This, in turn, is boosting the demand for metallocene polyethylene. Countries expected to be attractive markets for metallocene polyethylene include China, India, Indonesia, Thailand, and Vietnam.
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Key players operating in the metallocene polyethylene market include Braskem, China Petrochemical Corporation, ExxonMobil Corporation, Mitsui & Co., Ineos, LyondellBasell Industries Holdings B.V., Nova Chemicals Corporation, Prime Polymer Co., Ltd., Reliance Industries Limited, SABIC, Sasol Limited, The Dow Chemical Company, Univation Technologies, Westlake Chemical Corporation, Borealis AG, Total Petrochemicals & Refining USA, Inc., and Formosa Plastics Corporation.
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Transparency Market Research (TMR) is a global market intelligence company providing business information reports and services. The company’s exclusive blend of quantitative forecasting and trend analysis provides forward-looking insight for thousands of decision makers. TMR’s experienced team of analysts, researchers, and consultants use proprietary data sources and various tools and techniques to gather and analyze information.
TMR’s data repository is continuously updated and revised by a team of research experts so that it always reflects the latest trends and information. With extensive research and analysis capabilities, Transparency Market Research employs rigorous primary and secondary research techniques to develop distinctive data sets and research material for business reports.
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Extrusion Coating Market Size to Expand Significantly by the End of 2025
Extrusion coating is a highly versatile industrial process used to coat a molten web of extruded polymer onto a substrate. In the extrusion coating process, a polymer is melted under heat and pressure in an extruder. The produced extruded hot melt is applied as a thin film coating onto substrate which is continuously passed through nip-roll assembly. The substrate may be paper board, polyester film, BOPP film, aluminium foil, or woven fabric. Extrusion coating is widely used in various industries such as building & construction, automotive, consumer goods, imaging, medical & pharmaceutical, and industrial applications. Extrusion coating includes a variety of applications such as liquid packaging, aseptic drink containers, toothpaste tubes, photographic films, flexible packaging, mill & industrial wrappings, transport packaging, sack linings, envelopes, and medical/hygiene. Extrusion coating helps reduce the emission of VOCs, improved quality, cost reduction, and increased productivity.
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The polymer used in extrusion coating process comprises low-density polyethylene (LDPE), ethylene vinyl acetate (EVA), polypropylene, and polyethylene terephthalate. LDPE is projected to be the dominant polymer material for the extrusion coating process due to its extraordinary characteristics, such as higher melt strength, superior optical properties, and easy recyclability. It features good sealability and offers a good barrier against moisture. Hence LDPE-based extrusion coating is used in a wide variety of applications, such as food packaging, liquid packaging, and the folding of cartons. Polypropylene has high temperature and grease resistance and therefore it is commonly used in the pet food packaging or for microwave oven applications.
Rising demand from the food & beverages packaging and automotive sector are some of the key factors driving the extrusion coating market. Flexible packaging is an important application segment of the extrusion coating market. Flexible packaging is majorly used in food packaging such as for bakery goods, dairy products, frozen food, meat & poultry, candy, and cookies. Flexible packaging provides various advantages such as lower cost, consumer friendliness, longer shelf life, environment friendliness, and the capability to retain the freshness of products. Extrusion coating is widely used in the automotive sector to provide numerous advantages such as wear resistance, reinforcement, weight reduction, and acoustical improvement. Price escalation for raw material, crude oil, and natural gas are some of the factors impeding the market’s growth. However, the development of renewable-resource-based polymers further enhances the growth opportunities for the extrusion coating market in various applications.
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Geographically, the global market for extrusion coating is segmented into Europe, Asia Pacific, North America, Latin America, and Middle East & Africa. Asia Pacific, Europe and North America are expected to dominate the extrusion coating market through the forecast period. This is primarily due to the rapid economic and industrial expansion in the developing economies of Asia Pacific such as India, Malaysia, Vietnam, and Indonesia. Extrusion coating is adopted by most builders to make infrastructure presentable and protect it from hostile climatic conditions. Countries such as the U.S., Germany, and Brazil are also expected to notice significant growth due to increasing demand for food packaging. Changing consumer lifestyle is directly or indirectly influencing the extrusion coating market. Government initiatives to reduce food wastage and recent advances in environment-friendly packaging are helping manufacturers meet the demand for recyclable products. This, in turn, has made the development of extrusion coating market robust.
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Pharmaceutical Hot Melt Extrusion Market: Emerging Market Trends, Size, Share & Growth Analysis Market Research Report Forecast to 2016- 2024
Global Pharmaceutical Hot Melt Extrusion Market: Overview
This report provides forecast and analysis of the pharmaceutical hot melt extrusion market on the global and regional levels. It provides historical data of 2015 along with forecast from 2016 to 2024 in terms of revenue (US$ Mn) and volume (units). The report also includes macroeconomic indicators along with an outlook on hot melt extrusion equipment consumption globally. It includes drivers and restraints of the pharmaceutical hot melt extrusion market and their impact on each region during the forecast period.
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The report also comprises the study of current issues with end users and opportunities for extruder manufacturers. It also includes detailed pricing analysis by product type and value chain analysis with a list of vendors and industry stakeholders at each node in the value chain. In order to provide users of this report with comprehensive view of the market, we have included detailed competitiveness analysis and company players with unique selling propositions. The dashboard provides detailed comparison of hot melt extruder manufacturers on parameters such as collective market share and geographic concentration. The study encompasses market attractiveness analysis, by product, by end users and region.
Global Pharmaceutical Hot Melt Extrusion Market: Scope of the Study
The report includes revenue generated from sales of hot melt extruders in all regions and important countries in these regions. By product, the global pharmaceutical hot melt extrusion market has been segmented into twin screw extruder, single screw extruder, laboratory extruders and RAM extruders. On the basis of end users, the global pharmaceutical hot melt extrusion market is segmented into research laboratories, contract manufacturing organizations and pharma companies. On the basis of region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East and Africa.
Market numbers have been estimated based on average procurement of new units and average pricing of hot melt extruders by product type and the revenue is derived through regional pricing trends. Market size and forecast for each segment have been provided in the context of global and regional markets. The pharmaceutical hot melt extrusion market has been analyzed based on expected demand. Prices considered for the calculation of revenue are average regional prices obtained through primary quotes from numerous regional hot melt extruder manufacturers and distributors. Most of the key end users have been considered and potential applications have been estimated on the basis of secondary sources and feedback from primary respondents.
Regional demand patterns have been considered while estimating the market for various end users of hot melt extrusion in different regions. Top-down approach has been used to estimate the hot melt extrusion market by regions. Market numbers for global products have been derived using the bottom-up approach, which is cumulative of each region’s demand. Company-level market share has been derived on the basis of revenues reported by key manufacturers. The market has been forecast based on constant currency rates. A number of primary and secondary sources were consulted during the course of the study. Secondary sources include Factiva, NCBI, Google books, company annual reports, websites, and publications.
Companies Mentioned in the Report
The report provides detailed competitive dashboard and company profiles of key participants operating in the global market. Some of the players in the global pharmaceutical hot melt extrusion market includes Baker Perkins Limited, Coperion GmbH, Gabler GmbH & Co. KG, Leistritz AG, Milacron Holdings Corp., Thermo Fisher Scientific, Inc., and Xtrutech Ltd.
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The market has been segmented as below:
Global Pharmaceutical Hot Melt Extrusion Market – By Product Type
Twin Screw Extruder
Single Screw Extruder
Laboratory Extruder
RAM Extruder
Global Pharmaceutical Hot Melt Extrusion Market – By End Users
Research Laboratory
Contract Manufacturing Organization
Pharma Companies
Global Pharmaceutical Hot Melt Extrusion Market – By Region
North America
Europe
Asia Pacific (APAC)
Latin America
Middle East & Africa (MEA)
U.S.
Canada
Germany
France
Italy
U.K.
Spain
Rest of Europe
China
Japan
India
Australia
New Zealand
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How Does Hot-Melt Extrusion Work
A continuous process of melting a polymer under pressure and heat and forcing it through an aperture is known as hot melt extrusion (HME). We largely use Proprietary hot-melt extrusion at Abbvie Manufacturing.
Known for being created to create polymer goods with uniform shape and density, proprietary hot-melt extrusion has been used in industry since the 1930s.
We have some fun facts for you below about hot-melt extrusion
1. More than half of all plastic goods, such as bags, films, sheets, tubes, fibres, foams, and pipes, are prepared using this technology, which is one of the most commonly utilized in plastic, rubber, and food industries.
2. HME is now more commonly employed in the healthcare sector, where it is combined with polymers to create medical devices and combine active pharmaceutical ingredients (APIs) with them
3. Hot-melt extrusion services are utilized to increase the bioavailability of the API or to create the building blocks for thermoplastic drug-eluting devices such as intravaginal rings and subcutaneous and intraocular implants.
How does Proprietary Hot-Melt Extrusion work?
HME entails compacting and refining blends from a powder or granular mix into a uniformly shaped product. By forcing polymeric components and active substances, including any additives or plasticizers, through an orifice or die at controlled temperatures, pressures, feeding rates, and screw speeds, polymers are melted and formed into products of various shapes and sizes such as plastic bags, sheets, and pipes.
The entire HME services compaction process can be categorized into the following steps:
(1) feeding the extruder through a hopper,
(2) mixing, grinding, reducing the particle size, venting, and kneading,
(3) flow through the die, and
(4) extrusion from the die and subsequent downstream processing.
The extruder typically consists of one or two spinning screws inside of a stationary cylindrical barrel that is either corotating or counter-rotating. To reduce the amount of time molten materials must stay inside the barrel, it is frequently built in pieces. The barrel's sections are then bolted or fastened together. According to the shape of the extruded materials, an end-plate die is linked to the end of the barrel.
Types of Extruders
We generally use two types of extruders: single and twin screw extruders. Twin screw extruders are used for melt-mixing polymers with extra ingredients (pigments, fillers, reinforcers, and APIs), for devolatilization, and for melting and transporting polymers to extrude them into continuous structures.
A twin screw extruder is preferred for the creation of pharmaceutical formulations that call for the homogenous and consistent mixing of numerous formulation ingredients because the rotation of the inter-meshing screws improves mixing to create a homogeneous solid comprising finely dispersed API particles or a solid-solution of API in a polymer.
Poorly water-soluble API formulations can have their bioavailability and dissolution rate increased by using twin screw extrusion to consistently mix the melt. To create drug-eluting devices with reproducible drug-release kinetics within and within batches, uniformly dispersed API is also necessary.
Applications
Due to its many benefits over conventional processing techniques like roll spinning and grinding, HME technology has already established a solid presence in the pharmaceutical business and academics which we use at Abbvie Contract Manufacturing.
Proprietary hot melt extrusion has recently arisen as a revolutionary technology in pharmaceutical applications because, in addition to being an effective manufacturing process, it improves the quality and performance of made goods. HME is primarily used to molecularly disperse active pharmaceutical ingredients (APIs) in a matrix, resulting in solid solutions.
Hot-melt extrusion serviceshave been used in the pharmaceutical industry for a variety of purposes, including
Increasing the bioavailability and dissolution rate of poorly soluble drugs by creating a solid dispersion or solid solution.
regulating or modifying the drug's release.
masking the taste of bitter APIs
formulating different thin films
Abbvie Contract Manufacturing is the solution for hot-melt extrusion services. We are very good at what we do.
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A Quick Evaluation of the Hot Melt Extrusion Process
Hot melt extrusion (HME) is the technique of heating polymeric materials far beyond their glass transition temperature (abbreviated Tg in pharmaceutical production circles) to achieve molecular level mixing of active compounds, polymers, and thermoplastic binders. HME is a mix of mechanical and melting energy that is used in a variety of sectors to improve continuous processing for dust reduction, online monitoring, and reproducible material analysis.
HME services are applied in pharmaceutical production to diffuse APIs in a matrix at the molecular level for the purpose of getting solid solutions. This allows for the development of drug delivery methods for poorly soluble medicines or specialty drug forms such as antidiabetic drugs and transdermal patch films.
Today, hot melt extrusion has an exalted position in pharmaceutical production and is used to make a variety of medication forms such as implants, granules, pellets, prolonged release tablets, and ophthalmic inserts. Polymers may be molded into a film by hot melt extrusion, eliminating the need for traditional solvent-casting procedures.
The pharmaceutical industry's focus on hot melt extrusion is primarily on the creation of bio-enhanced formulations, mass production of medications in the form of pellets, beads, and transdermal systems, and the formation of solid solutions from water soluble pharmaceuticals. This highlights hot melt extrusion as having advantages over more typical drug production procedures, but not without some cons.
Pros and Cons of HME Services
When it comes to pharmaceutical manufacturing, hot melt extrusion has several benefits over traditional drug manufacturing methods. Below are these pros and cons:
Pros
There are fewer procedures involved, along with the elimination of drying steps, which boosts productivity and saves time. The procedure is straightforward and may be carried out uninterruptedly and efficiently.
Because of the high temperatures and powerful mixing that ensue during the production process, active chemicals are more uniformly distributed in the polymer, resulting in higher bioavailability.
Hot melt extrusion allows for the production of a broad range of dosage forms, which is one of the main reasons why contract manufacturing pharma businesses are adopting the method on a larger scale.
When compared to traditional processes, the advantages clearly make this method of production enticing, but it is not without its problems.
Cons
Because it is a thermic process, there may be problems with the API/polymer stability. The flow characteristics of the polymer are critical in effective processing, and heat manufacturing can occasionally be a concern during the process.
The required number of polymers may be limited due to the fact that getting polymers that can be treated at low temperatures for this process can be difficult.
Looking For Quality Contract Pharma Services? AbbVie is here to meet those needs
AbbVie is a contract pharmaceutical manufacturer specializing in controlled release technologies such as fluid bed processing and hot melt extrusion (HME).
AbbVie Contract Manufacturing advances your science with proprietary hot melt extrusion technology and services.
AbbVie offers different kinds of customized and proprietary hot melt extrusion services such as:
• End-to-end manufacturing from extrudate to packaged drug product.
• Expertise in bioavailability enhancement
• Solvent-free and continuous processing
• Support for good process control and scalability
• Abuse deterrent and taste masking capabilities.
Learn more about our processes here.
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Looking Into the Processes Involved in HME Services
HME is a solvent-free production method that improves the bioavailability of poorly soluble and powerful APIs. HME is less expensive than other formulation choices due to continuous processing and may be utilized for taste masking. This can result in a higher-quality, more marketable product consistent with your marketing strategy.
In this article, we will be looking at the polymers used, the technology involved, and the process parameters in HME services.
Polymers Used in Hot Melt Extrusion
In HME, selecting an appropriate polymer as a matrix to produce stable solid solutions is critical. Polymers with a high solubilization capacity are ideal because they can dissolve huge amounts of drugs. Polymers for HME experimentations are composed of various chemical structures and monomers, including copolymers, amphiphilic copolymers, homopolymers, and plasticizers and solubilizers.
The polymer's solubility in a solvent, ranging from high hydrophilicity to high lipophilicity, must be considered for each substance. For the manufacture of solid solutions by spray drying, a suitable solvent must be used, where polymer and medication must be dissolved in a volatile solvent.
Polymers for hot-melt extrusion must be thermoplastic and thermally stable at the appropriate extrusion temperature. Also, glass transition and melting temperatures are essential criteria in developing an HME medication system. Tg or Tm and melt viscosity are the primary determinants of a polymer's extrudability. Most polymers display thixotropic behavior, where viscosity decreases as shear force increases.
Pharmaceutical Extrusion Technology
The current drug development technique generates candidate medications with increasing lipophilicity and molecular size, resulting in poor permeability and solubility. Less than ten percent of novel drug candidates display both high solubility and permeability, while about thirty to forty per cent of medications on the World Health Organization Essential Drug List have been observed to be poorly water-soluble or lipophilic. HME diffuses the medication in the matrix at the molecular phase by producing a solid solution.
HME is used in a variety of applications such as controlled release systems, amorphous solid dispersion, innovative cocrystallization (solvent-free continuous cocrystallization), polymorph production, porous polymeric systems, and Process Analytical Technology (PAT).
Process Parameters for HME Processing
During the HME process, the active pharmaceutical ingredient and excipients are introduced into the extruder. All components are sheared, fired up, plastified, blended and distributed before being formed by squeezing them through a die aperture.
When developing an HME manufacturing project, controlling many processing factors that impact residence time distribution is required, and specific mechanical energy consumption (SMEC), such as melt temperature at the extruder die, pressure at the die, and torque must be considered.
Conclusion
AbbVie is a pharmaceutical contract manufacturing company offering proprietary hot melt extrusion services suitable to your specific product and marketing strategy.
AbbVie offers different kinds of proprietary hot melt extrusion services, such as:
• End-to-end manufacturing from extrudate to packaged drug products.
• Expertise in bioavailability enhancement
• Solvent-free and continuous processing
• Support for good process control and scalability
• Abuse deterrent and taste masking capabilities.
We advance your science with customized pharmaceutical hot melt extrusion technology and services.
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Pharmaceutical Hot Melt Extrusion: A Cost-Effective Process to Surge Solubility
Hot Melt Extrusion (HME) has captivated the pharmaceutical industry for the manufacture of medicinal solid dispersions over the last decade. It's a flexible processing method for increasing the solubility and dissolution of water-insoluble active therapeutic components (APIs). HME services are superior to traditional formulation technologies because they can treat a wide range of ingredients, including inorganic excipients, hydrophilic polymers, and cocrystal formers. In this review study, we explore recent advances in enhanced solubility/dissolution of water-insoluble actives utilizing HME and prediction tools for process optimization.
Proprietary Hot-melt extrusion, a well-known method in the polymer industry, is making its way into pharmaceutical manufacture. HME enables novel solid oral dosage form formulations.
Its primary benefit in pharmaceutical applications is the potential to improve a drug's bioavailability by producing solid dispersions of the dynamic pharmaceutical ingredient (API) in a polymer matrix. The formulator's primary focus is achieving the right release profile (immediate or prolonged release) or increased API bioavailability.
HME services have shown unique processing technology for creating molecular dispersions of active pharmaceutical ingredients (APIs) into the various polymer or lipid matrices, allowing for time-controlled, extended, modified and targeted drug supply.
HME has received significant attention from both the pharmaceutical industry and academia in various submissions for pharmaceutical dosage forms such as tablets, capsules, films, and implants for drug delivery via oral, transdermal and transmucosal routes since the industrial application of the extrusion process in the 1930s.
As a result, HME service is an excellent alternative to other often-used processes like roll spinning and spray drying.
HME fits the purpose of the US Food and Drug Administration's (FDA) process analytical technology (PAT) system for designing, analyzing, and controlling the manufacturing process via quality control measures during the active extrusion process, in addition to being a proven manufacturing method. The hot-melt extrusion technique is discussed from a holistic standpoint, including its numerous components, processing technologies, materials, and innovative formulation design and developments in its various applications in oral drug delivery systems.
Advantages of HME
There are specific issues with HME. Thermal process (drug/polymer stability), usage of a restricted number of polymers, high flow characteristics of polymers, and excipients required are the main disadvantages of HME, which make it unsuitable for relatively high heat-sensitive molecules like microbial species and proteins. However, HME has several advantages over currently existing pharmaceutical processing procedures, including the following:
(a) Improved solubility and bio-availability of liquid-insoluble compounds;
(b) Solvent-free-non-ambient process;
(c) A cost-effective process with condensed production time, fewer processing steps, and constant operation;
(d) Sustained, modified, and targeted release capabilities;
(e) Better content uniformity in extrudates;
(f) No necessities for active ingredient compressibility;
(g) Uniform dispersion of fine particles;
(h) better steadiness at altering pH and moisture levels and safe application in mankind;
(i) Fewer unit procedures and the manufacture of a diverse variety of performance dosage forms
(j) Various screw geometries.
Conclusion
HME has proven to be a reliable way of manufacturing a variety of drug delivery systems; therefore, it has been adopted by the pharmaceutical industry, with the scope expanded to include a variety of polymers and APIs that can be processed with or without plasticizers. HME has also been demonstrated to be a solvent-free, robust, fast, and cost-effective manufacturing process for various medicinal dosage forms.
When we talk of proprietary hot-melt extrusion, AbbVie Contract Manufacturing advances your science with customized pharmaceutical hot melt extrusion technology and services. Learn more about our processes.
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How To Mill Hot Melt Extrusion Without Destroying Product Quality
HME (hot melt extrusion) is a validated method for increasing the bioavailability of poorly soluble APIs. Unlike other formulation methods, hot melt extrusion does not require the use of solvents. Hot melt extrusion is more cost-effective since it uses continuous manufacturing and can be utilized for abuse deference and taste masking. In line with your commercialization strategy, this could result in a higher-quality, more marketable pharmaceutical product.
Today, proprietary hot melt extrusion manufacturing has found a position in pharmaceutical manufacturing, where it is used to make pellets, granules, implants, ophthalmic inserts, and prolonged release tablets, among other things. Polymers can be formed into a film via hot melt extrusion, which eliminates the need for traditional solvent-casting procedures.
Pharmaceutical companies are primarily interested in developing bio-enhanced formulations, generating solid solutions from water soluble pharmaceuticals, and mass producing drugs in the form of pellets, beads, and transdermal systems via hot melt extrusion.
HME services are becoming more popular in the pharmaceutical sector as more pharmacological components, particularly Pharmaceutical APIs, become insoluble or unstable during standard wet granulation processing.
The procedure of hot melt extrusion
A powder combination of API and polymers is fed into a heated processing zone within the extruder during the hot melt extrusion (HME) process. The intense shear and mixing action of twin screws disperses the API into a polymer matrix. The mixture is driven through a hole to form an extrudate, which is then quickly cooled to solidify. The extrudate can be easily molded into tablet form if necessary. However, before moving on to the solid dosage manufacturing procedures, extrudates are usually further processed (i.e. milled) into a powder.
How to grind the HME with care
Because melt granulation is a size-enlargement process, the resultant material is frequently outside of the optimal particle size range for direct injection into compression machines like tablet presses. As a result, it has to be processed further.
When milling the extrudate, it's important to have a powder with appropriate flow characteristics and the right bulk density for a high-quality tablet. As a result, equipment selection is critical, as it will have a substantial impact on the end product's quality.
Fitz mills can be supplied with chilled water jackets that are placed in key spots to reduce the heat of impact. Because the collision of the process material and the blades performs the majority of the size reduction, the sizing screen can be substantially larger than the target particle top size. Blinding and the aforementioned extrusion effect are avoided because of the big aperture screen.
As a result, a stable milling technique for heat-sensitive melt-extruded or melt-agglomerated materials has been developed.
Conclusion
Hot Melt Extrusion adds variety and flexibility to the manufacturing process, making it a great alternative to traditional methods like spray drying. Raw material selection, screw design, and post-extrusion equipment all aid in determining the best method for various dosage forms.
AbbVie Contract Manufacturing advances your science with customized pharmaceutical hot melt extrusion technology and services. Contact us today.
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HME Basics: Overview of Hot Melt Extrusion Process
Hot Melt Extrusion (HME) has gained widespread recognition over the last three decades. It has already established itself in a wide range of manufacturing activities and pharmaceutical research breakthroughs.
Hot melt extrusion (HME) is a manufacturing technology that has traditionally been used in the plastic and food sectors but is currently gaining traction in the pharmaceutical industry due to its increased flexibility. This is because HME allows the continuous production of a wide range of dosage formulations, including solid dose form, which is especially important for poorly soluble active pharmaceutical ingredients (APIs).
HME services have found use in the healthcare sector as the technology has progressed. It is used in various applications, including:
Manufacturing of medical devices,
Production of drug-eluting systems, and
Mixing of active pharmaceutical ingredients (APIs) with polymers
The hot melt extrusion process is solvent-free, unlike other preparation selections. Hot melt extrusion is more cost-effective than continuous processing.
How Hot Melt Extrusion Works
Extrusion is a continuous process that incorporates conveying, melting, blending, kneading, and degassing. The various components involved are continually added into the extruder's processing portion or "barrel" in a highly regulated manner. Material transportation and mixing are controlled by co-rotating screw shafts, which also influence the duration spent in each zone.
Different temperature profiles can be used in each zone to match the polymer and API processing needs. Air or other gasses can be removed from the molten mass by means of a vacuum element to deliver a bubble-free ejection of molten residue through a spout after the dispensation section. When the molten residue cools, a solid product is created.
Benefits of Using Hot Melt Extrusion
Pharmaceutical hot melt extrusion aims to spread an active medicinal ingredient uniformly in a carrier polymer. Some of the benefits of using HME in a pharmaceutical setting are as follows:
Improved Solubility and Bioavailability
Poor solubility results from a stable crystalline state that water cannot penetrate effectively. Because less energy is required for dissolution, the amorphous form of an active pharmaceutical ingredient (API) is frequently more soluble. Solid dispersions were developed to spread the API in a carrier polymer and prevent it from forming. These formless solid dispersals can be developed using hot melt extrusion.
When opposed to spray drying, proprietary hot melt extrusion technology offers the benefit of being solvent-free, continuous, and scalable.
Controlled Drug Delivery
The advantages of implantable drug-eluting systems which are also identified as drug-eluting strategies) over traditional oral drug distribution methods are many. They can, for example, administer drugs to particular locations, boost therapeutic effectiveness and reduce side effects. These systems usually provide API over a longer period of time to ensure a continuous therapeutic impact and improved patient compliance.
Mask bitter tastes
Bitter APIs have also been investigated using proprietary hot melt extrusion. The API is mixed with a taste buds masking agent. The interaction of the polymer and API protects the tongue from the API's bitter flavor.
Conclusion
The use of hot-melt extrusion technology to make various medication delivery devices is becoming increasingly popular. It's a valuable formulation tool for increasing solubility and bioavailability and creating drug-eluting systems for long-term release.
AbbVie Contract Manufacturing has decades of experience with HME. We offer a wide range of HME services and are always available to handle any drug manufacturing.
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What are HME Services?
Hot-melt extrusion (HME) is a well-known applied process in the plastics industry. HME services have recently been feasible to produce various dosage forms and drug delivery systems. Hot-melt extruded dosage forms are complex mixtures of active drugs, processing aids, and functional excipients.
HME continuous manufacturing has numerous advantages in terms of production and speeding up new drug development cycles.
What is Hot Melt Extrusion?
The most common oral solid dose form in the pharmaceutical industry is tablets and capsules. Tablets and capsules containing tiny particles of the active ingredient dissolve faster.
By employing HME services, even the processing of poorly soluble carrier/active substance combinations is no longer a big issue in the pharmaceutical sector.
Hot-melt extrusion is a cost-effective method for creating solid molecular dispersions that outperform solvent-based methods like spray drying and co-precipitation. Proprietary hot melt extrusion has been shown to give sustained, modified, and targeted drug delivery by embedding drugs in a polymeric carrier. It is used to create controlled drug release dosage forms using conventional and non-conventional polymeric materials.
How Hot Melt Extrusion is Used
Hot-melt extrusion is used for the following:
● Covering up the bitter taste of an active ingredient.
● Development of controlled-release dosage formulations.
● Polymer-drug solutions/dispersions formation: These include:
● A higher rate of drug dissolution
● Higher drug solubility
● Creating dosage formulations with a controlled release (including implants).
These are some of the ways proprietary hot melt extrusion is used:
The Process of Hot Melt Extrusion
Hot-melt extrusion is driving raw materials through a die at a raised temperature with a spinning screw into a product of even shape. The procedure is anhydrous as it requires fewer processing stages because it is a continuous operation, uses no organic solvents, does not compress the actives, and improves bioavailability by dispersing the drug at the molecular level in the final dosage forms.
The extrusion method includes converting the API and excipients under controlled conditions to produce a product with a homogeneous shape and density (such as a fast-dissolving film or tablet).
Extrudate should be managed into the preferred dosage form after extrusion, e.g., intravaginal rings, mini-matrices, tablets, granules, films, pellets, and porous matrices.
Advantages of using HME Services
Hot-melt extrusion offers several advantages over typical pharmaceutical processing processes, including:
● Better content uniformity.
● Improved bioavailability of poorly soluble substances.
● Clinically beneficial dosage forms.
● Processing without the use of solvents or water
● Few processing steps
● Sustained, modified, and targeted release capabilities.
● There are no criteria for active ingredients compressibility, and the entire operation is straightforward, continuous, and efficient.
● Uniform dispersion of fine particles occurs.
● Excellent stability at different pH and moisture levels.
● Because they are non-swellable and water-insoluble, they are safe to use in people.
● Reduced number of unit operations.
● A wide range of performance dose forms is produced.
● Creation of a variety of geometries
These advantages are a simplification of multi-stage, complex operations.
Conclusion
Hot-melt extrusion is a rapidly evolving technology platform for addressing challenging formulation difficulties, particularly in the solubilization area.
AbbVie Contract Manufacturing offers various proprietary hot melt extrusion solutions for the pharmaceutical industry. We have numerous items that can satisfy the needs of customers depending on the intended process.
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How Does Proprietary Hot-Melt Extrusion Work
How Does Proprietary Hot-Melt Extrusion Work
Hot-melt extrusion is the dispensation of polymeric materials above their glass transition temperature. This is done in order to effect molecular level mixing of polymers and/or thermoplastic binders of active compounds.
This blog focuses on how Hot-melt extrusion works. Continue reading to learn more.
At Abbvie, our service package provides terminal sterilization. This includes a hundred percent vial visual inspection with the use of labeling and packaging, polarized light, and batch certification.
How it Works
The process of proprietary hot-melt extrusion combines kneading, blending, degassing, melting, and conveying into a continuous process. The various substances involved are constantly added into the processing barrel or section of the extruder in an accurately controlled way. Co- screw shafts are responsible for regulating material mixing and transportation. It also determines the residence time in the different zones.
Temperatures Involved
Diverse temperature profiles can be put in each zone to meet the processing needs of the active pharmaceutical ingredient and that of the polymer. On the other hand, gasses and air are removed from the molten mass. This is achieved by using a vacuum unit to assure a bubble-free discharge of molten extrudate via a nozzle at the end of the processing section. Upon cooling of the molten extrudate, a solid product is formed.
Twin-Screw Extruders
Twin-screw extruders can be configured in many ways to meet various blending, kneading, and conveying requirements. The essential parameters of the screw elements are the number of flights, the element pitch, and the inner and outer diameter of the screws.
Compensation and mixing of the concentration differences are attained by mixing elements of the equipment. The use of reverse-conveying screw elements increases intermixing. This means that the ability to arrange the screw element of the extruder in nearly any combination allows the extruder to be adapted for almost all extrusion tasks.
Essential Parameters
For the extruder of active pharmaceutical ingredients, feed rate and screw speed are the most essential process parameters. Low screw speeds lead to long residence time of the material possessed by the extruder. And this leads to an increase in impurities and degradation. On the other hand, high screws high screw rotation speeds may lead to physical instability and incomplete mixing, which results in recrystallization of an amorphous active pharmaceutical ingredient.
Shaping of the Molten Mass
Shaping of the molten mass takes place when passing under pressure via a die having a tiny cross-section. The die flow channel must be aerodynamically modeled. This is to enable appropriate melt flow to be attained. In addition to this, the elasticity of the cooling rate of the polymer melt and the polymer melt itself after passing through the die is essential. At this point, the temperature and pressure must be constant to attain a uniform product.
Active pharmaceutical ingredients, excipients, and solid carriers are either combined or dosed individually in a specifically controlled mixture for dosing. This is done with gravimetric dosing systems that are selected over volumetric systems of dosing in pharmaceutical applications. Gaseous or liquid components may be introduced directly into the melt via side feeding devices. Contact Abbvie today for all your hme services.
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