Novel controlled release polymerlipid formulations processed. Xplores pharma melt extruder pme 5 is a high quality, gmp compliant instrument for hot melt extrusion hme. Novel controlled release polymerlipid formulations processed by hot melt extrusion mohammed maniruzzaman,1 muhammad t. Nonconventional polymers as matrix excipients for hot. Suitability of pure and plasticized polymers for hot melt. What is melt extrusion and how does it help us make new medicines. Here the use of the spraydried copolymer did not show any benefit concerning the kinetic miscibility of the drug and copolymer, but it resulted in a remarkable decrease in the torque experienced by the extruder allowing extrusion at lower temperature and torque. Melt rheology of selected pharmaceutical polymers for hot melt extrusion daniel treffer1, alexander troiss1,2. Jun 26, 2012 hot melt extrusion hme melting a substance and forcing it through an orifice under controlled conditions to form a new material is an emerging processing technology in the pharmaceutical industry for the preparation of various dosage forms and drug delivery systems, for example granules and sustained release tablets. As introduced, the compendium contains practical instructions for use and extensive descriptions of all the relevant. Compared with other pharmaceutical technologies, such as granulation and compression, hotmelt extrusion is still an emerging method, and its potential has not been explored fully yet. Process and thermal stabilizers for specialty polymers basf. Processtechnologyofhotmelt extrusionhme hotmelt extrusion technique was.
Solid dispersions can be obtained using different processes. Hotmelt extrusion hme is a manufacturing process adapted from the. Prior to joining basf he worked for croda international in uk, japan and usa. You can find detailed information on our product range by looking up your industry or using our product finder.
Over the last three decades hotmelt extrusion hme has emerged as an influential processing technology in developing molecular dispersions of active pharmaceutical ingredients apis into polymers matrices and has already been demonstrated to provide time controlled, modified, extended and targeted drug delivery resulting in improved bioavailability 1, 2, 3, 4. Sincethen,ithasbeenusedintheplastic,rubber, and food manufacturing industry to produce items ranging from pipes to sheets and bags. This study was aimed at enhancing the physical stability of the drug clotrimazole ct and the polymer contained within hotmelt extrusion hme films usin the hme films were investigated for solidstate characteristics, moisture sorption, bioadhesivity, mechanical properties, glass transition temperature, release characteristics, and physical. Stamixco smbr extrusion melt blender with the standard eight 8 mixing elements, flanged. Polymers amenable to production via reactive extrusion. The new edition provides readers with an even better understanding of solid dispersions and the hotmelt extrusion process. Years of experience in the polymerization of acrylates allow the targeted implementation of structureefficacy principles that ensures an adjustment of adhesive qualities across a wide gamut of applications. Challenges and strategies in thermal processing of amorphous. Hot melt extrusion hme is a promising technology for the production of new chemical. Through science and innovation we provide our customers with products to meet the current and future needs of business and society.
Hotmelt extrusion hme has been revealed as a successful technology for a large. Hotmelt extrusion resulted in an even higher mixing capability. A polymer soluplus was fed into the extruder and molten, after which a stable nanosuspension was added via sidefeeding devices. Hot melt extrusion hme is a wellknown process in plastic industry to. The medicine maker is delighted to partner with basf to publish this. Drugpolymer intermolecular interactions in hotmelt. During the hot melt extrusion process, different zones of the barrel are preset to specific temperatures before the process is started. Effective delivery of many of bcs class ii compounds with low solubility can be enabled with amorphous dispersions made by hot melt extrusion hme. One major advantage is the fact that no solvents are required. Pharmaceutical hot melt extrusion market to reach a value of. Apply to extrusion operator, pharmacy technician, engineer and more. Products made from melt extruded polymers range from pipes to hoses through to the insulated wires, cables, rubber sheeting, and polystyrene tiles. A blend of the thermoplastic polymers and other processing aids is fed into the barrel of the extruder through the hopper and transferred by a rotating screw inside the heated barrel. Hotmelt extrusion an emerging drug delivery technology 01 aug 2011 1 d.
Expanding the range of polymers currently used for hmeim could potentially solve the problems associated with the current formulations. Hot melt extrusion hme is a process with fast increasing importance for the. The extrudability of a polymer is mainly determined by t g or t m and melt viscosity. Hotmelt extruded filaments based on pharmaceutical grade. The objective of this doctoral thesis was to evaluate the use of several nonconventional polymers as matrix excipients for hot melt extruded oralrelease formulations. Polymers for hotmelt extrusion hme should have the thermoplastic behavior to enable melt extrusion to take place. Submit your paper as a pdf file without page numbers by may 31, 2015.
Over the last three decades hot melt extrusion hme has emerged as an influential processing technology in developing molecular dispersions of active pharmaceutical ingredients apis into polymers matrices and has already been demonstrated to provide time controlled, modified, extended and targeted drug delivery resulting in improved bioavailability 1, 2, 3, 4. Hotmelt extruded filaments based on pharmaceutical grade polymers for 3d printing by fused deposition modeling. Submit your paper as a pdf file without page numbers by. Basfs vanessa occhipinti and dejan djuric describe the properties of a new excipient developed for hotmelt extrusion. Coperion and coperion ktron can provide single source solutions for all of your extrusion, feeding and conveying needs in the pharmaceutical and nutraceutical industries. Basf has now published the first compendium on hot melt extrusion, a method that is being increasingly used in the pharmaceutical industry to help an active drug substance to dissolve properly in the stomach and provide more effective treatment. It offers an overview of basfs polymers, more realworld application. Over the last three decades industrial adaptability has allowed hotmelt extrusion hme to gain wide acceptance and has already established its place in the broad spectrum of manufacturing operations and pharmaceutical research developments.
Development of an amorphous solid dispersion for an insoluble drug from miniscale to clinical scale. In developing an hme drug system, the glass transition and melting temperatures are critical factors. New novel processes of melt extrusion techniques involving two or more carriers matrices such as lipid and polymers, along with the active substance, can be proven advantageous over the traditional hme processing. Reactive extrusion of high temperature resins for additive.
Hot melt extrusion is the new mixer extrusion range that builds on the proven umang technology and its benefits. Basf publishes first hot melt extrusion compendium. It is the responsibility of the recipient of product to ensure that any proprietary rights and existing. Interest in hotmelt extrusion techniques for pharmaceutical applications is growing rapidly with well over 100 papers published in the pharmaceutical scientific literature in the last 12 years. Carbomers 974p and 971p are most widely used polymers for bioadhesion. The focus was to identify materialsparing approaches to develop bioavailable and stable asd including scale. Islam,1 sheelagh halsey,2 devyani amin,1 and dennis douroumis1,3. Pharmaceutical hot melt extrusion market to reach a value. Hotmelt extrusion hme is a promising technology for the production of new chemical entities in the developmental pipeline and for improving products already on the market. Hot melt extrusion system for pharmaceutical applications.
Hme manufacture of amorphous dispersion involves the melting of a drug substance with an appropriate polymeric excipient in a corotating twinscrew extruder. Alice melocchi, federico parietti, alessandra maroni, anastasia foppoli, andrea gazzaniga, lucia zema pmid 27215535. Jul 10, 2015 hot melt extrusion hme is a promising technology for the production of new chemical entities in the developmental pipeline and for improving products already on the market. Melt extrusion materials, technology and drug product. Author bart claeys ugent promoter chris vervaet ugent and jean paul remon ugent organization. Pdf pharmaceutical applications of hotmelt extrusion. The use of hotmelt extrusion hme within the pharmaceutical industry is steadily. We produce excipients and active ingredients of outstanding quality and performance. Basf publishes first hot melt extrusion compendium plastics.
Hot melt extruded filaments based on pharmaceutical grade polymers for 3d printing by fused deposition modeling. In the 1980s, basf became the first company to apply it to the production of pharmaceuticals for enhancing the solubility and bioavailability of poorly soluble actives. They should have a suitable glass transition temperature tg in the range of 50180 c, low hygroscopicity, stability at extrusion temperature and no. Basf is the leading supplier of highquality, agingresistant polyacrylates. The interest in hotmelt extrusion has increased rapidly in the pharmaceutical industry during the last years which has led to a demand in developing new pharmaceutical polymers and modified release formulations suitable for. Pharmaceutical applications is an essential multidisciplinary guide to the emerging pharmaceutical uses of this processing technology for researchers in academia and industry working in drug formulation and delivery, pharmaceutical engineering and. Over the last three decades industrial adaptability has allowed hot melt extrusion hme to gain wide acceptance and has already established its place in the broad spectrum of manufacturing operations and pharmaceutical research developments. Polymers for hot melt extrusion must exhibit thermoplastic characteristics and must be thermally stable at the proper extrusion temperature. In drug discovery and development, industry estimates that more than 50% of. Hotmelt extrusion an emerging drug delivery technology. By drawing on continuous processing, hot melt extrusion is more economical and can be used for abuse deference and taste masking applications. Polymers for hotmelt extrusion must exhibit thermoplastic characteristics and must be thermally stable at the proper extrusion temperature. Solid dispersions by hotmelt extrusion pharmaceutical.
Hotmelt extrusion hme melting a substance and forcing it through an orifice under controlled conditions to form a new material is an emerging processing technology in the pharmaceutical industry for the preparation of various dosage forms and drug delivery systems, for example granules and sustained release tablets. Hme has already been demonstrated as a robust, novel technique to make solid dispersions in order to provide time controlled, modified, extended, and. Hotmelt extrusion is a sophisticated technology used to develop solid dispersion dosage forms for improved drug solubility and bioavailability, a common challenge for formulation scientists in the development of drug products today. It offers an overview of basfs polymers, more realworld application data and factors to consider in the formulation process.
Oct 20, 2015 the objective of the study was to develop an amorphous solid dispersion asd for an insoluble compound x by hot melt extrusion hme process. Dec 11, 2010 basf has now published the first compendium on hot melt extrusion, a method that is being increasingly used in the pharmaceutical industry to help an active drug substance to dissolve properly in the stomach and provide more effective treatment. Discover more about our hot melt extrusion solutions. Hot melt extrusion an emerging drug delivery technology. Today, hme is an accepted process for creating solid dispersions of apis. Abstract the objective of this doctoral thesis was to evaluate the use of several nonconventional polymers as matrix excipients for hot melt extruded oralrelease formulations. Hot melt extrusion an emerging drug delivery technology 01 aug 2011 1 d. The interest in hot melt extrusion has increased rapidly in the pharmaceutical industry during the last years which has led to a demand in developing new pharmaceutical polymers and modified release formulations suitable for hot melt extrusion.
The objective of this phase i project was to produce high temperature, lowmelt viscosity thermoset and thermoplastic polyimide resins as candidate materials for use in additive manufacturing am, such as the rtm370 oligomer shown in figure 1. The extrusion operator is responsible for the set up and operation of extrusion machinery designated to melt plastic materials and shape plastic sheets to be. Hot melt extrusion of the pure polymers was performed on a leistritz nano16 hme. Our complete line of equipment is engineered to meet the rigid requirements of the industry, including strict adherence to cgmp guidelines and standards as well as the use of. Crystalline ibuprofen was kindly donated by basf 25 us quality and eudragit rs powder po grade by evonik rohm pharma polymers. Smb extrusion melt blender mixing equipment with no moving parts for the extrusion of viscous polymers, resins, foods.
A new excipient for hotmelt extrusion manufacturing chemist. T e t p d i s k t h i c k n e s s t 10 % where disk thickness is the mean of values measured along the inner and central circumferences n 12, in order to consider the surface exposed to the medium only. Hot melt extrusion is a sophisticated technology used to develop solid dispersion dosage forms for improved drug solubility and bioavailability, a common challenge for formulation scientists in the development of drug products today. Hot melt extruder pharmaceutical machine manufacturers and. Hot melt extrusion hme is a proven technology for bioavailability enhancement of poorly soluble apis. Pharmaceutical applications is an essential multidisciplinary guide to the emerging pharmaceutical uses of this processing technology for researchers in academia and industry working in drug formulation and delivery, pharmaceutical engineering and processing, and polymers and materials science.
Hot melt extrusion with basf pharma polymers extrusion compendium 2nd revised and enlarged edition k. However, as with other innovations, numerous obstacles have to be overcome before the technology and resulting dosage forms can be exploited commercially. Hot melt extrusion is the upgraded version of twin screw extruder with heating as an element, the whole process involves hopper for feeding the raw material along with waxes which is pre mixed in solid form. Effective delivery of many of bcs class ii compounds with low solubility can be enabled with amorphous dispersions made by hotmelt extrusion hme. Compared with other pharmaceutical technologies, such as granulation and compression, hot melt extrusion is still an emerging method, and its potential has not been explored fully yet. The choice of an appropriate polymer is crucial for extrusion process. Over the last decades hot melt extrusion hme has emerged as a novel processing technology in developing solid dispersions of active pharmaceutical ingredients apis into polymer matrices and has already been demonstrated to provide time controlled, modified, extended and targeted drug delivery resulting in improved bioavailability. Novel controlled release polymerlipid formulations. Hotmelt extrusion technology and pharmaceutical application. Jun 10, 2011 hot melt extrusion system for pharmaceutical applications.
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