Pharmaceutical Applications of Hot-Melt Extrusion: Part I
TL;DR: The pharmaceutical applications of hot-melt extrusion, including equipment, principles of operation, and process technology, are reviewed and the physicochemical properties of the resultant dosage forms are described.
Abstract: Interest in hot-melt extrusion techniques for pharmaceutical applications is growing rapidly with well over 100 papers published in the pharmaceutical scientific literature in the last 12 years. Hot-melt extrusion (HME) has been a widely applied technique in the plastics industry and has been demonstrated recently to be a viable method to prepare several types of dosage forms and drug delivery systems. Hot-melt extruded dosage forms are complex mixtures of active medicaments, functional excipients, and processing aids. HME also offers several advantages over traditional pharmaceutical processing techniques including the absence of solvents, few processing steps, continuous operation, and the possibility of the formation of solid dispersions and improved bioavailability. This article, Part I, reviews the pharmaceutical applications of hot-melt extrusion, including equipment, principles of operation, and process technology. The raw materials processed using this technique are also detailed and the physicochemical properties of the resultant dosage forms are described. Part II of this review will focus on various applications of HME in drug delivery such as granules, pellets, immediate and modified release tablets, transmucosal and transdermal systems, and implants.
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TL;DR: The applicability of TSE in formulating ranges of dosage forms is evident from the large numbers of research papers (more than 100) that have been published and marketed formulations that have entered the market in the last 10 years as mentioned in this paper.
Abstract: Twin-screw extruder (TSE), originally built and developed for plastic and rubber industries approximately 100 years ago, is now slowly but steadily gaining popularity in the pharmaceutical industry for manufacturing various dosage forms. TSE has proven to be a robust, multi-purpose, and environment-friendly instrument that has displayed the potential to revolutionize the manufacturing processes in the pharmaceutical industry. Having the facility to arrange process analytical tools at various segments, TSE has given an opportunity to the manufacturers for monitoring the quality of the product at critical stages of the manufacturing process and thus helped in shifting the focus of the pharmaceutical industry from “end product testing” to “building the quality at each stage.” The broad applicability of TSE in formulating ranges of dosage forms is been evident from the large numbers of research papers (more than 100) that have been published and marketed formulations that have entered the market in the last 10 years. The published research papers have demonstrated the applicability of TSE in preparing a variety of dosage forms and intermediates such as pharmaceutical salts, co-crystals, solid dispersions, transdermal gels, solid lipid nanoparticles, and ready to compressed granules.
7 citations
TL;DR: In this article, the authors present a revision of the information disponible sobre different types of bolos intrarruminales de liberacion controlada (BILC) of minerales traza.
Abstract: Los minerales traza son nutrientes esenciales para el mantenimiento de la vida, el crecimiento y la reproduccion. Las deficiencias de minerales en rumiantes afectan las funciones fisiologicas y metabolicas que con frecuencia causan enfermedades. El diseno y uso de los bolos intrarruminales de liberacion controlada (BILC) es una alternativa para corregir la falta de los microelementos en el organismo. El proposito de esta revision es evidenciar la informacion disponible sobre los diferentes tipos de BILC de minerales traza, asi como de los metodos de fabricacion que incluye: tecnicas de extrusion en caliente, granulacion por fusion y fusion directa. Ademas, se describen los efectos de BILC relacionados en la salud, en los parametros productivos y reproductivos en rumiantes.
7 citations
Cites background from "Pharmaceutical Applications of Hot-..."
...Finalmente el extruido es conducido hacia la matriz para darle la forma y las dimensiones requeridas((47,49))....
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TL;DR: A robust hot-melt extrusion and strand pelletization process for manufacturing pellets with an immediate release (IR) of a poorly water-soluble active pharmaceutical ingredient (API), nimodipine was developed and a technical control strategy was developed to ensure a robust process.
7 citations
01 Jan 2016
TL;DR: In this paper, the authors present techniques for processing modified and unmodified natural polymers for various purposes such as film formation for transdermal patches, composite and blends production to form films with improved mechanical properties, magnetic decoration for production of tough membranes with magnetic properties.
Abstract: This chapter covers recent techniques applied in processing and characterization of natural polymers. This includes techniques in processing natural polymers from their natural forms into modified forms for more varied application and functionality. It also looks at techniques for processing modified and unmodified natural polymers for various purposes such as film formation for transdermal patches, composite and blends production to form films with improved mechanical properties, magnetic decoration for production of tough membranes with magnetic properties. The characterization methods covered in this chapter include X-ray diffraction, microscopy, and Fourier transform infrared spectrometry. We look at recent reported processing and characterization techniques which are applicable to the major industries today for natural polymer-based materials.
7 citations
Cites background from "Pharmaceutical Applications of Hot-..."
...Hot melt extrusion is often preferred over other methods such as compression molding of casting due to its continuity which makes automation more possible as all processes (mixing, melting, and shaping) can be completed in a single equipment (Repka et al. 2007; Crowley et al. 2007)....
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TL;DR: A detailed review of additive manufacturing methods and materials used for the AM of oral tablets is presented in this article, where the challenges in additive manufacturing of pharmaceutical formulations and potential strategies to overcome these challenges are discussed.
Abstract: Additive manufacturing (AM), also known as three-dimensional (3D) printing, enables fabrication of custom-designed and personalized 3D constructs with high complexity in shape and composition. AM has a strong potential to fabricate oral tablets with enhanced customization and complexity as compared to tablets manufactured using conventional approaches. Despite these advantages, AM has not yet become the mainstream manufacturing approach for fabrication of oral solid dosage forms mainly due to limitations of AM technologies and lack of diverse printable drug formulations. In this review, AM of oral tablets are summarized with respect to AM technology. A detailed review of AM methods and materials used for the AM of oral tablets is presented. This article also reviews the challenges in AM of pharmaceutical formulations and potential strategies to overcome these challenges.
7 citations
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1,883 citations
Book•
01 Jan 1995
TL;DR: The authors provided the basic building blocks of polymer science and engineering by coverage of fundamental polymer chemistry and materials topics given in Chapters 1 through 7 and provided information on the exciting new materialsnow available and the emerging areas of technological growth that could motivate a new generation of scientists and engineers.
Abstract: From the Book:
PREFACE: At least dozens of good introductory textbooks on polymer science and engineering are now available. Why then has yet another book been written?
The decision was based on my belief that none of the available texts fully addresses the needs of students in chemical engineering. It is not that chemical engineers are a rare breed, but rather that they have special training in areas of thermodynamics and transport phenomena that is seldom challenged by texts designed primarily for students of chemistry or materials science. This has been a frustration of mine and of many of my students for the past 15 years during which I have taught an introductory course, Polymer Technology, to some 350 chemical engineering seniors. In response to this perceived need, I had written nine review articles that appeared in the SPE publication Plastics Engineering from 1982 to 1984. These served as hard copy for my students to supplement their classroom notes but fell short of a complete solution.
In writing this text, it was my objective to first provide the basic building blocks of polymer science and engineering by coverage of fundamental polymer chemistry and materials topics given in Chapters 1 through 7.
As a supplement to the traditional coverage of polymer thermodynamics, extensive discussion of phase equilibria, equation-of- state theories, and UNIFAC has been included in Chapter 3. Coverage of rheology, including the use of constitutive equations and the modeling of simple flow geometries, and the fundamentals of polymer processing operations are given in Chapter 11.
Finally, I wanted to provide information on the exciting new materialsnowavailable and the emerging areas of technological growth that could motivate a new generation of scientists and engineers. For this reason, engineering and specialty polymers are surveyed in Chapter 10 and important new applications for polymers in separations (membrane separations), electronics (conducting polymers), biotechnology (controlled drug release), and other specialized areas of engineering are given in Chapter 12. In all, this has been an ambitious undertaking and I hope that I have succeeded in at least some of these goals.
Although the intended audience for this text is advanced undergraduates and graduate students in chemical engineering, the coverage of polymer science fundamentals (Chapters 1 through 7) should be suitable for a semester course in a materials science or chemistry curriculum.
Chapters 8 through 10 intended as survey chapters of the principal categories of polymers commodity thermoplastics and fibers, network polymers (elastomers and thermosets), and engineering and specialty polymers may be included to supplement and reinforce the material presented in the chapters on fundamentals and should serve as a useful reference source for the practicing scientist or engineer in the plastics industry.
981 citations
TL;DR: A comparison of the carbonyl stretching region of γ indomethacin, known to form carboxylic acid dimers, with that of amorphous indometHacin indicated that the amorphously phase exists predominantly as dimers.
Abstract: Purpose. To study the molecular structure of indomethacin-PVP amorphous solid dispersions and identify any specific interactions between the components using vibrational spectroscopy.
904 citations
Book•
01 Jan 1988
TL;DR: In this article, the elastic properties of polymeric solids and their properties of rubber are discussed. But they focus on the structure of the molecule rather than the properties of the solids.
Abstract: Introduction. 1: Structure of the molecule. 2: Structure of polymeric solids. 3: The elastic properties of rubber. 4: Viscoelasticity. 5: Yield and fracture. 6: Reinforced polymers. 7: Forming. 8: Design. Further reading, Answers, Index
790 citations
TL;DR: Improved bioavailability was achieved again demonstrating the value of the technology as a drug delivery tool, with particular advantages over solvent processes like co-precipitation.
790 citations