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Pharmaceutical Pelletization Technology

Author : Isaac Ghebre-Selassie
Publisher : CRC Press
Page : 288 pages
File Size : 33,15 MB
Release : 2022-02-24
Category : Medical
ISBN : 1000105601

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This book serves as a formulation and processing guide during the development of pelletized dosage forms. It provides the pharmaceutical technologist with basic information about the design aspects of the relevant processing equipment.

Pharmaceutical Pelletization Technology

Author : Isaac Ghebre-Selassie
Publisher : CRC Press
Page : 0 pages
File Size : 43,16 MB
Release : 2022-02-24
Category : Medical
ISBN : 1000148815

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This book serves as a formulation and processing guide during the development of pelletized dosage forms. It provides the pharmaceutical technologist with basic information about the design aspects of the relevant processing equipment.

Granulation

Author : Agba D. Salman
Publisher : Elsevier
Page : 1403 pages
File Size : 49,11 MB
Release : 2006-11-24
Category : Science
ISBN : 0080467881

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Granulation provides a complete and comprehensive introduction on the state-of-the-art of granulation and how it can be applied both in an academic context and from an industrial perspective. Coupling science and engineering practices it covers differing length scales from the sub-granule level through behaviour through single granules, to bulk granule behaviour and equipment design. With special focus on a wide range of industrially relevant areas from fertilizer production, through to pharmaceuticals. Experimental data is complemented by mathematical modelling in this emerging field, allowing for a greater understanding of the basis of particle products and this important industry sector.Four themes run through the book: 1. The Macro Scale processing for Granulation – including up to date descriptions of the methods used for granulation and how they come about and how to monitor – on-line these changes.2. The Applications of granulation from an industrial perspective, with current descriptive roles and how they are undertaken with relevance to industry, and effective properties.3. Mechanistic descriptions of granulation and the different rate processes occurring within the granulator. This includes methods of modelling the process using Population – Balance Equations, and Multi-level Computational Fluid Dynamics Models.4. The Micro Scale: Granules and Smaller, looking at single granules and there interactions and modelling, while also considering the structure of granules and their constituent liquid bridges. * Covers a wide range of subjects and industrial applications * Provides an understanding of current issues for industrial and academic environments* Allows the reader an understanding of the science behind engineered granulation processes

Hot-Melt Extrusion

Author : Dennis Douroumis
Publisher : John Wiley & Sons
Page : 404 pages
File Size : 45,98 MB
Release : 2012-04-24
Category : Science
ISBN : 1118307879

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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: Pharmaceutical Applications covers the main instrumentation, operation principles and theoretical background of HME. It then focuses on HME drug delivery systems, dosage forms and clinical studies (including pharmacokinetics and bioavailability) of HME products. Finally, the book includes some recent and novel HME applications, scale -up considerations and regulatory issues. Topics covered include: principles and die design of single screw extrusion twin screw extrusion techniques and practices in the laboratory and on production scale HME developments for the pharmaceutical industry solubility parameters for prediction of drug/polymer miscibility in HME formulations the influence of plasticizers in HME applications of polymethacrylate polymers in HME HME of ethylcellulose, hypromellose, and polyethylene oxide bioadhesion properties of polymeric films produced by HME taste masking using HME clinical studies, bioavailability and pharmacokinetics of HME products injection moulding and HME processing for pharmaceutical materials laminar dispersive & distributive mixing with dissolution and applications to HME technological considerations related to scale-up of HME processes devices and implant systems by HME an FDA perspective on HME product and process understanding improved process understanding and control of an HME process with near-infrared spectroscopy Hot-Melt Extrusion: 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. This is the first book from our brand new series Advances in Pharmaceutical Technology. Find out more about the series here.

Melt Extrusion

Author : Michael A. Repka
Publisher : Springer Science & Business Media
Page : 472 pages
File Size : 16,67 MB
Release : 2013-10-11
Category : Medical
ISBN : 1461484324

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This volume provides readers with the basic principles and fundamentals of extrusion technology and a detailed description of the practical applications of a variety of extrusion processes, including various pharma grade extruders. In addition, the downstream production of films, pellets and tablets, for example, for oral and other delivery routes, are presented and discussed utilizing melt extrusion. This book is the first of its kind that discusses extensively the well-developed science of extrusion technology as applied to pharmaceutical drug product development and manufacturing. By covering a wide range of relevant topics, the text brings together all technical information necessary to develop and market pharmaceutical dosage forms that meet current quality and regulatory requirements. As extrusion technology continues to be refined further, usage of extruder systems and the array of applications will continue to expand, but the core technologies will remain the same.

Continuous Manufacturing of Pharmaceuticals

Author : Peter Kleinebudde
Publisher : John Wiley & Sons
Page : 645 pages
File Size : 21,24 MB
Release : 2017-09-05
Category : Science
ISBN : 1119001323

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A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.

Pharmaceutical Blending and Mixing

Author : P. J. Cullen
Publisher : John Wiley & Sons
Page : 508 pages
File Size : 33,54 MB
Release : 2015-07-20
Category : Technology & Engineering
ISBN : 0470710551

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Written in four parts, this book provides a dedicated and in-depth reference for blending within the pharmaceutical manufacturing industry. It links the science of blending with regulatory requirements associated with pharmaceutical manufacture. The contributors are a combination of leading academic and industrial experts, who provide an informed and industrially relevant perspective of the topic. This is an essential book for the pharmaceutical manufacturing industry, and related academic researchers in pharmaceutical science and chemical and mechanical engineering.

Handbook of Pharmaceutical Granulation Technology

Author : Dilip M. Parikh
Publisher : CRC Press
Page : 905 pages
File Size : 24,43 MB
Release : 2021-05-11
Category : Medical
ISBN : 1000366383

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Theoretical discussions covering granulation and engineering perspectives. Covers new advances in expert systems, process modelling and bioavailability Chapters on emerging technologies in particle engineering Updated Current research and developments in granulation technologies

Excipient Applications in Formulation Design and Drug Delivery

Author : Ajit S Narang
Publisher : Springer
Page : 700 pages
File Size : 22,42 MB
Release : 2015-10-07
Category : Medical
ISBN : 3319202065

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In recent years, emerging trends in the design and development of drug products have indicated ever greater need for integrated characterization of excipients and in-depth understanding of their roles in drug delivery applications. This book presents a concise summary of relevant scientific and mechanistic information that can aid the use of excipients in formulation design and drug delivery applications. Each chapter is contributed by chosen experts in their respective fields, which affords truly in-depth perspective into a spectrum of excipient-focused topics. This book captures current subjects of interest – with the most up to date research updates – in the field of pharmaceutical excipients. This includes areas of interest to the biopharmaceutical industry users, students, educators, excipient manufacturers, and regulatory bodies alike.

Formulation and Analytical Development for Low-Dose Oral Drug Products

Author : Jack Zheng
Publisher : John Wiley & Sons
Page : 506 pages
File Size : 40,11 MB
Release : 2009-02-09
Category : Medical
ISBN : 0470056096

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There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.