May 19, 2017 hot melt extrusion hme is the process of applying heat and pressure to melt a polymer and force it though an orifice in a continuous process. Hme has a potential for automation, with reduction of capital investment and labor costs. The role of polymer excipients in hot melt extrusion a. Hot melt extrusion hme is a wellaccepted and extensively studied method for preparing numerous types of drug delivery systems and dosage forms. This zsk 18 megalab extruder fulfills the requirements for both wet extrusion and hot melt extrusion hme processes. Process technology of hot melt extrusion hme hot melt extrusion technique was first invented for the manufacturing of lead pipes at the end of the eighteenth century 7. 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.
Apr 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. For melt processible fluoropolymers, melt extrusion is the most common process of film production. In the 1980s, basf became the first company to apply it to the production of pharmaceuticals for enhancing. 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. Hot melt extrusion hme is the process of applying heat and pressure to melt a polymer and force it though an orifice in a continuous process. Hme is wellknown, developed to produce polymer products of uniform shape and density, and its industrial application dates back to the 1930s1. The fluoropolymer beads are loaded into a feed hopper and are gravity feed into a heated barrel that has a screw within it. Hot melt extrusion in the pharmaceutical industry hot melt extrusion technology has gained considerable popularity in the pharmaceutical industry due to the advantages it offers over traditional manufacturing techniques and provides an efficient production process that enhances the quality of products. Thermal degradation was recognized as a limitation of this hotmelt process. Please note that during the production process errors may be. What is melt extrusion and how does it help us make new. Industrial application of the extrusion process dates back to 1930s 1.
Over the last three decades industrial adaptability has allowed hotmelt extrusion hme to gain wide acceptance and has already established its place in the. With the use of hme we can increase solubility and bioavailability of the api. Hme involves the mixing of a drug with one or more. Hotmelt extrusion is the process of pumping raw materials with a rotating. Hme is wellknown, developed to produce polymer products of uniform shape and density, and its industrial application dates back to the 1930s 1. Hotmelt extruded dosage forms are complex mixtures of active medicaments, functional excipients, and processing aids. Optimization procedure for hot melt extrusion as a. Mar 20, 2012 hot melt extrusion parameters optimize formulation optimize process excipient ingredients extrusion system polymeric binders system scale plasticizers and lubricants lengthtodiameter ratio glidants barrel configuration fillers and dilutents screw configuration disintigrants extrudate forming.
Since then, it has been used in the plastic, rubber, and food manufacturing industry to produce items ranging from pipes to sheets and bags. Hotmelt extrusion techniques are pragmatic in the manufacture of a variety of dosage forms and formulations such as granules, pellets, tablets, suppositories, implants, stents, transdermal. Hot melt extrusion technology has gained considerable popularity in the pharmaceutical industry due to the advantages it offers over traditional manufacturing techniques and provides an efficient production process that enhances the quality of products. Jan 21, 2020 hot melt extrusion hme is a common manufacturing operation in the food and polymer industries and is becoming increasingly deployed in the pharmaceutical industry. Today, hme is an accepted process for creating solid dispersions of apis. This inclusive text describes hot melt extrusion for pharmaceutical applications, focusing on the materials used for the preparation of solid dispersions, fundamentals for preparing such. Hotmelt extrusion hme is a wellaccepted and extensively studied method for preparing numerous types of drug delivery systems and dosage forms. Extrusion is a simple compressive metal forming process. Hot melt extrusion hot melt extrusion hme is the process of applying heat and pressure to melt a polymer and force it though an orifice in a continuous process. In this process, piston or plunger is used to apply compressive force at work piece. The process involves distributing active pharmaceutical ingredients apis through a specialized matrix to form a solid solution with known potency. Extrusion process the extrusion process converts a solid. Hme has a potential for automation, with reduction of.
Hot melt extrusion hme is a common manufacturing operation in the food and polymer industries and is becoming increasingly deployed in the pharmaceutical industry. The hotmelt extrusion process is easily monitored which provide comprehensive documentation and simplifies quality control 10. Pdf hotmelt extrusion is one of the most widely applied processing technologies in the plastic, rubber and food industry. Materials addition, surging, poor mixing, melt toughness or fracture, overheating, moisture release, trapped air, contamination. Hot melt extrusion hme is the process of applying heat and pressure to melt a polymer and forcing it through an orifice in a continuous process. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. Hot melt extrusion hme is a solid dispersion technology whereby the api is dispersed, often down to the molecular level, into a polymer matrix through application of heat and mechanical energy and processes to form an amorphous solid solution 2. Process based monitoring watches production process conditions such as melt temperature and pressure. In this chapter, the hotmelt extrusion to date hme has emerged as a. It was the researchers goal to prepare a dosage form in a simple and continuous manner. Hot melt extrusion hme is a promising technology for the production of new chemical.
Hotmelt extrusion hme is one of the most widely used processing techniques within the plastics industry. Hot melt extrusion hme is the process of applying heat and pressure to melt a polymer and forcing it through an oriice in a continuous process. In addition, solvents are not 9 required in hot melt extrusion which makes the process environmentally friendly 12. Process technology of hotmelt extrusion hme hotmelt extrusion technique was first invented for the manufacturing of lead pipes at the end of the eighteenth century 7. Due to the continuous, efficient nature of hme, which combines several polymer drug mixing and processing steps, it is often used to manufacture large, expensive batches of. Process monitoring during extrusion both process based monitoring and productbased monitoring are used to achieve product improvements. A greater degree of conveying and much shorter residence times are. Hotmelt extrusion of sugarstarchpellets pdf free download.
Fluid bed operations dry granulation wet granulation hotmelt extrusion tablet coating tablet press operations. Extrusion process an overview sciencedirect topics. Hme is a well known process, developed to produce polymer products of uniform shape and density, and its industrial application dates back to the 1930s1. Hot melt extrusion in the pharmaceutical and food industries. Hotmelt extrusion technique was first invented for the manufacturing of. Process technology to pharmaceutical products find, read and cite all the research you need. Purpose the aim of this paper is the development of a process control concept for a hot melt extrusion hme and pelletization process. Introduction process via quality control measurements during active extrusion process 6.
Pdf over the last three decades industrial adaptability has allowed hotmelt extrusion hme to gain wide acceptance and has already established its. Hotmelt extrusion is one of the most widely applied processing technologies in the plastic. Hot melt extrusion hme is one of the most widely used processing techniques within the plastics industry. This billet is heated in hot extrusion or remains at room temperature and placed into a. Melt extrusion materials, technology and drug product. Extrusion is a process used to create objects of a fixed crosssectional profile. Productbased monitoring follows properties of the product, such as, clarity 4.
All components are sheared, heated, plastified, mixed and dispersed, and finally shaped by. Repkas most important scientific accomplishments involve the advancement of melt extrusion technology. From process to pharmaceutical applications 7 equivalent from a processing perspective. Hme has proven to be a robust method of producing numerous drug delivery systems like modified, controlled and targeted drug delivery systems. Furthermore, the use of reverseconveying and forwardconveying elements, kneading blocks and other intricate designs as. The extrusion process is a multivariable system where product qualities e. Hot melt extrusion technology has gained considerable popularity in the pharmaceutical industry due to the advantages it offers over traditional manufacturing techniques and provides an. Participants of tablet manufacturing process training will finish with a working knowledge of. A greater degree of conveying and much shorter residence times are achievable with an intermeshing setup. The aim of this study was to evaluate a pharmaceutical. This inclusive text describes hot melt extrusion for pharmaceutical applications, focusing on the materials used for the preparation of solid dispersions, fundamentals for preparing such systems and novel applications using extrusion technology. Hot melt extrusion can be operated as a continuous process, capable of consistent product flow at relatively high throughput rates 1, making it suitable for large scale production. Hot melt extrusion hme is well known process for the plastic industries but it is well accepted by the pharmaceutical industries for the last three decays. Process technology to pharmaceutical products find, read and cite all the research you need on researchgate.
Polyvinyl alcohol in hot melt extrusion to improve the. Highlighting physicochemical factors to be investigated while designing and optimizing a hot melt extrusion process roberta censi, maria rosa gigliobianco id. Many of these systems are directed toward the solubilization and delivery of poorly soluble bioactives via hot melt extrusion technology, which is a primary focus of his research. Hot melt extrusion parameters optimize formulation optimize process excipient ingredients extrusion system polymeric binders system scale plasticizers and lubricants. During hotmelt extrusion of pharmaceutical dosage forms, a blend of active ingredient, thermoplastic poly meric carrier, and other processing aids, including. 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. Extrusion working principle and process parameters. In the hot melt extrusion process, the api and the excipients are fed into the extruder. The technology itself can be described as a process in which a material melts or softens under elevated temperature and pressure and is forced through an orifice by screws. Hotmelt extrusion manufacturing process melt extrusion is an excellen t process to formulate poorly soluble drugs and to improve bioavailability advantages vs spray drying continuous. For meltprocessible fluoropolymers, melt extrusion is the most common process of film production. 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.
The extrusion equipment is classified into three main categories. Hotmelt extrusion manufacturing process melt extrusion is an excellen t process to formulate poorly soluble drugs and to improve bioavailability advantages vs spray drying continuous process choice of an appropriate polymer is crucial for the formulation and the process most important polymer features aretg and melt viscosity. The hot melt extrusion process is easily monitored which provide comprehensive documentation and simplifies quality control 10. Coperion has launched a completely flexible continuous pharma extrusion system suitable for research and development, as well as for smallscale production. Process technology joseph brama first invented the extrusion process for the manufacturing of lead pipes at the end of the eighteenth century 7. Apr 28, 2017 extrusion is a simple compressive metal forming process. Appropriate thermoplastic behavior is a prerequisite of any polymer to be used in hot melt extrusion. Bioavailability enhancement using hot melt extrusion basf. 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. Hot melt extrusion hme is a solid dispersion technology whereby the api is dispersed, often down to the molecular level, into a polymer matrix through application of heat and mechanical. First billet or ingot metal work piece of standard size is produced.
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