First billet or ingot metal work piece of standard size is produced. The extrusion process is a multivariable system where product qualities e. 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. 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. In the 1980s, basf became the first company to apply it to the production of pharmaceuticals for enhancing. 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. Hme has a potential for automation, with reduction of capital investment and labor costs. Hme has proven to be a robust method of producing numerous drug delivery systems like modified, controlled and targeted drug delivery systems. Since then, it has been used in the plastic, rubber, and food manufacturing industry to produce items ranging from pipes to sheets and bags. Introduction process via quality control measurements during active extrusion process 6.
Bioavailability enhancement using hot melt extrusion basf. 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. For meltprocessible fluoropolymers, melt extrusion is the most common process of film production. The role of polymer excipients in hot melt extrusion a. Furthermore, the use of reverseconveying and forwardconveying elements, kneading blocks and other intricate designs as. With the use of hme we can increase solubility and bioavailability of the api. This billet is heated in hot extrusion or remains at room temperature and placed into a. Hot melt extrusion hme is a common manufacturing operation in the food and polymer industries and is becoming increasingly deployed in the pharmaceutical industry. Hotmelt extrusion of sugarstarchpellets pdf free download.
Appropriate thermoplastic behavior is a prerequisite of any polymer to be used in hot melt extrusion. Hme is wellknown, developed to produce polymer products of uniform shape and density, and its industrial application dates back to the 1930s1. Hotmelt extrusion hme is a wellaccepted and extensively studied method for preparing numerous types of drug delivery systems and dosage forms. Participants of tablet manufacturing process training will finish with a working knowledge of. In this chapter, the hotmelt extrusion to date hme has emerged as a.
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. 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. The fluoropolymer beads are loaded into a feed hopper and are gravity feed into a heated barrel that has a screw within it. During hotmelt extrusion of pharmaceutical dosage forms, a blend of active ingredient, thermoplastic poly meric carrier, and other processing aids, including. Pdf hotmelt extrusion is one of the most widely applied processing technologies in the plastic, rubber and food industry. Melt extrusion materials, technology and drug product. Extrusion process an overview sciencedirect topics. 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. 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. Industrial application of the extrusion process dates back to 1930s 1. 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. 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. Thermal degradation was recognized as a limitation of this hotmelt process. 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. Hotmelt extruded dosage forms are complex mixtures of active medicaments, functional excipients, and processing aids. 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. Hot melt extrusion in the pharmaceutical and food industries. 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. Hotmelt extrusion technique was first invented for the manufacturing of. For melt processible 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. Hotmelt extrusion hme is one of the most widely used processing techniques within the plastics industry.
In the hot melt extrusion process, the api and the excipients are fed into the extruder. 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. Optimization procedure for hot melt extrusion as a. Extrusion process the extrusion process converts a solid. A greater degree of conveying and much shorter residence times are achievable with an intermeshing setup. Extrusion is a simple compressive metal forming process. The hotmelt extrusion process is easily monitored which provide comprehensive documentation and simplifies quality control 10.
Process technology to pharmaceutical products find, read and cite all the research you need on researchgate. 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. Hme has a potential for automation, with reduction of. In this process, piston or plunger is used to apply compressive force at work piece. Materials addition, surging, poor mixing, melt toughness or fracture, overheating, moisture release, trapped air, contamination.
Hot melt extrusion parameters optimize formulation optimize process excipient ingredients extrusion system polymeric binders system scale plasticizers and lubricants. Extrusion is a process used to create objects of a fixed crosssectional profile. Extrusion working principle and process parameters. The process involves distributing active pharmaceutical ingredients apis through a specialized matrix to form a solid solution with known potency. 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. 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. 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. 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. Pdf over the last three decades industrial adaptability has allowed hotmelt extrusion hme to gain wide acceptance and has already established its.
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 monitoring during extrusion both process based monitoring and productbased monitoring are used to achieve product improvements. From process to pharmaceutical applications 7 equivalent from a processing perspective. 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.
Process based monitoring watches production process conditions such as melt temperature and pressure. Apr 28, 2017 extrusion is a simple compressive metal forming process. In addition, solvents are not 9 required in hot melt extrusion which makes the process environmentally friendly 12. What is melt extrusion and how does it help us make new. The aim of this study was to evaluate a pharmaceutical. 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. 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. 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. Polyvinyl alcohol in hot melt extrusion to improve the. Today, hme is an accepted process for creating solid dispersions of apis. 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.
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. A schematic of a typical extruder is shown in figure 11. 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. Hot melt extrusion hme is a wellaccepted and extensively studied method for preparing numerous types of drug delivery systems and dosage forms. 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. 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. 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. Hme is wellknown, developed to produce polymer products of uniform shape and density, and its industrial application dates back to the 1930s 1. 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. Productbased monitoring follows properties of the product, such as, clarity 4. All components are sheared, heated, plastified, mixed and dispersed, and finally shaped by. Fluid bed operations dry granulation wet granulation hotmelt extrusion tablet coating tablet press operations. Please note that during the production process errors may be. Hme involves the mixing of a drug with one or more.
Hotmelt extrusion is the process of pumping raw materials with a rotating. Highlighting physicochemical factors to be investigated while designing and optimizing a hot melt extrusion process roberta censi, maria rosa gigliobianco id. 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. This zsk 18 megalab extruder fulfills the requirements for both wet extrusion and hot melt extrusion hme processes. 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. A greater degree of conveying and much shorter residence times are.
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