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. In the hot melt extrusion process, the api and the excipients are fed into the extruder. 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. Participants of tablet manufacturing process training will finish with a working knowledge of.
Hotmelt extrusion is one of the most widely applied processing technologies in the plastic. Process technology to pharmaceutical products find, read and cite all the research you need on researchgate. Over the last three decades industrial adaptability has allowed hotmelt extrusion hme to gain wide acceptance and has already established its place in the. Hme has proven to be a robust method of producing numerous drug delivery systems like modified, controlled and targeted drug delivery systems. 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. Process based monitoring watches production process conditions such as melt temperature and pressure. For meltprocessible fluoropolymers, melt extrusion is the most common process of film production. Highlighting physicochemical factors to be investigated while designing and optimizing a hot melt extrusion process roberta censi, maria rosa gigliobianco id. Hot melt extrusion hme is a wellaccepted and extensively studied method for preparing numerous types of drug delivery systems and dosage forms. Industrial application of the extrusion process dates back to 1930s 1. Process technology joseph brama first invented the extrusion process for the manufacturing of lead pipes at the end of the eighteenth century 7. What is melt extrusion and how does it help us make new. The hot melt extrusion process is easily monitored which provide comprehensive documentation and simplifies quality control 10. 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.
Hme has a potential for automation, with reduction of capital investment and labor costs. Coperion has launched a completely flexible continuous pharma extrusion system suitable for research and development, as well as for smallscale production. 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. This billet is heated in hot extrusion or remains at room temperature and placed into a. In the 1980s, basf became the first company to apply it to the production of pharmaceuticals for enhancing. Hme has a potential for automation, with reduction of. Hot melt extrusion parameters optimize formulation optimize process excipient ingredients extrusion system polymeric binders system scale plasticizers and lubricants. 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 force it though an orifice in a continuous process. Extrusion is a simple compressive metal forming process. Hot melt extrusion hme is one of the most widely used processing techniques within the plastics industry. Today, hme is an accepted process for creating solid dispersions of apis. In addition, solvents are not 9 required in hot melt extrusion which makes the process environmentally friendly 12.
Extrusion process an overview sciencedirect topics. 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. 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. In this chapter, the hotmelt extrusion to date hme has emerged as a. The process involves distributing active pharmaceutical ingredients apis through a specialized matrix to form a solid solution with known potency. 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 is wellknown, developed to produce polymer products of uniform shape and density, and its industrial application dates back to the 1930s1. Productbased monitoring follows properties of the product, such as, clarity 4. 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.
The hotmelt extrusion process is easily monitored which provide comprehensive documentation and simplifies quality control 10. 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. Hot melt extrusion hme is a common manufacturing operation in the food and polymer industries and is becoming increasingly deployed in the pharmaceutical industry. Extrusion process the extrusion process converts a solid. 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. 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. Furthermore, the use of reverseconveying and forwardconveying elements, kneading blocks and other intricate designs as. 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 is a wellaccepted and extensively studied method for preparing numerous types of drug delivery systems and dosage forms. 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. The role of polymer excipients in hot melt extrusion a.
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. During hotmelt extrusion of pharmaceutical dosage forms, a blend of active ingredient, thermoplastic poly meric carrier, and other processing aids, including. Fluid bed operations dry granulation wet granulation hotmelt extrusion tablet coating tablet press operations. Melt extrusion materials, technology and drug product.
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. Appropriate thermoplastic behavior is a prerequisite of any polymer to be used in hot melt extrusion. Hotmelt extrusion hme is one of the most widely used processing techniques within the plastics industry. 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. Please note that during the production process errors may be. 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 in the pharmaceutical and food industries. Hotmelt extruded dosage forms are complex mixtures of active medicaments, functional excipients, and processing aids. Optimization procedure for hot melt extrusion as a. Hme is wellknown, developed to produce polymer products of uniform shape and density, and its industrial application dates back to the 1930s 1. Pdf hotmelt extrusion is one of the most widely applied processing technologies in the plastic, rubber and food industry. The fluoropolymer beads are loaded into a feed hopper and are gravity feed into a heated barrel that has a screw within it. A greater degree of conveying and much shorter residence times are achievable with an intermeshing setup.
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. Hotmelt extrusion of sugarstarchpellets pdf free download. 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 a promising technology for the production of new chemical. It was the researchers goal to prepare a dosage form in a simple and continuous manner. This zsk 18 megalab extruder fulfills the requirements for both wet extrusion and hot melt extrusion hme processes.
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. Bioavailability enhancement using hot melt extrusion basf. All components are sheared, heated, plastified, mixed and dispersed, and finally shaped by. 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. The aim of this study was to evaluate a pharmaceutical. Purpose the aim of this paper is the development of a process control concept for a hot melt extrusion hme and pelletization process. Hotmelt extrusion technique was first invented for the manufacturing of. 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. A greater degree of conveying and much shorter residence times are. 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. Thermal degradation was recognized as a limitation of this hotmelt process. 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.
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. Materials addition, surging, poor mixing, melt toughness or fracture, overheating, moisture release, trapped air, contamination. Polyvinyl alcohol in hot melt extrusion to improve the. Hotmelt extrusion is the process of pumping raw materials with a rotating. Repkas most important scientific accomplishments involve the advancement of melt extrusion technology. 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 technology has gained considerable popularity in the pharmaceutical industry due to the advantages it offers over traditional manufacturing techniques and provides an. 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.
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. First billet or ingot metal work piece of standard size is produced. The extrusion equipment is classified into three main categories. 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. For melt processible fluoropolymers, melt extrusion is the most common process of film production. 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. 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. Extrusion is a process used to create objects of a fixed crosssectional profile. In this process, piston or plunger is used to apply compressive force at work piece. Hme involves the mixing of a drug with one or more. With the use of hme we can increase solubility and bioavailability of the api. 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. Process technology to pharmaceutical products find, read and cite all the research you need.
260 1414 1183 957 568 1147 816 558 724 1115 37 1433 1051 386 865 395 232 1 260 1449 1388 928 675 1246 1460 417 1358 263 1373 410 1416 636