Design of Films for Oral Dosage Formulations PDF Download
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Author: K. J. Laru
Publisher:
ISBN:
Category :
Languages : en
Pages :
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Book Description
A novel method for tablet coating was studied where a thin polymer film was cast (pre-formed film), dried and applied as a coating hence eliminating the need for using any solvent during the actual coating process. A pre-formed film is initially heating to a temperature where it becomes flexible, a vacuum is applied and the film is then pulled around the tablet. The proposed films (gelatine or cellulose-based) were characterised in terms of their dissolution, swelling, mechanical and thermal properties prior to using them in the novel coating process; selected films were then coated onto tablets containing paracetamol or ibuprofen and the effect of the film on the subsequent dissolution was evaluated. It was found that the pre-formed films could be designed to be fast dissolving and mechanically strong to withstand the stress from the coating process. Also metoclopramide was incorporated in a gelatine film-coating formulation which was then successfully coated on paracetamol-containing core. Gelatin-based films were found to be successful in the novel coating process therefore to be suitable as finished coatings for immediate release dosage forms. Orally disintegrating dosage forms have been identified as a favourable dosage form due to the following reasons: fast onset of drug release, easy to use, not painful and possible increase of amount absorbed to systemic circulation. Selected films formulated for coating studies were also successfully formulated to contain active ingredient suitable for orally disintegrating dosage form; cellulose-based naratriptan-films were studied as orally disintegrating dosage forms of where the effect of formulation on the film properties was studied. It was found that strength of the film can affect the dissolution of the film but it may be the inclusion of specific excipients in the formulation which affect the penetration of the drug through mucosa.
Author: K. J. Laru
Publisher:
ISBN:
Category :
Languages : en
Pages :
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Book Description
A novel method for tablet coating was studied where a thin polymer film was cast (pre-formed film), dried and applied as a coating hence eliminating the need for using any solvent during the actual coating process. A pre-formed film is initially heating to a temperature where it becomes flexible, a vacuum is applied and the film is then pulled around the tablet. The proposed films (gelatine or cellulose-based) were characterised in terms of their dissolution, swelling, mechanical and thermal properties prior to using them in the novel coating process; selected films were then coated onto tablets containing paracetamol or ibuprofen and the effect of the film on the subsequent dissolution was evaluated. It was found that the pre-formed films could be designed to be fast dissolving and mechanically strong to withstand the stress from the coating process. Also metoclopramide was incorporated in a gelatine film-coating formulation which was then successfully coated on paracetamol-containing core. Gelatin-based films were found to be successful in the novel coating process therefore to be suitable as finished coatings for immediate release dosage forms. Orally disintegrating dosage forms have been identified as a favourable dosage form due to the following reasons: fast onset of drug release, easy to use, not painful and possible increase of amount absorbed to systemic circulation. Selected films formulated for coating studies were also successfully formulated to contain active ingredient suitable for orally disintegrating dosage form; cellulose-based naratriptan-films were studied as orally disintegrating dosage forms of where the effect of formulation on the film properties was studied. It was found that strength of the film can affect the dissolution of the film but it may be the inclusion of specific excipients in the formulation which affect the penetration of the drug through mucosa.
Author: Hong Wen
Publisher: John Wiley & Sons
ISBN: 1118060326
Category : Science
Languages : en
Pages : 571
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Book Description
This book describes the theories, applications, and challenges for different oral controlled release formulations. This book differs from most in its focus on oral controlled release formulation design and process development. It also covers the related areas like preformulation, biopharmaceutics, in vitro-in vivo correlations (IVIVC), quality by design (QbD), and regulatory issues.
Author: Yihong Qiu
Publisher: Academic Press
ISBN: 008093272X
Category : Medical
Languages : en
Pages : 976
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Book Description
Developing Solid Oral Dosage Forms is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with: Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies
Author: Verena Ingeborg Garsuch
Publisher: Cuvillier Verlag
ISBN: 3736930151
Category : Medical
Languages : en
Pages : 140
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Book Description
Oral films, also called oral wafers, are intended for the application in the oral cavity and they are an innovative and promising dosage form especially for use in pediatrics and geriatrics. On the one hand the studies focused on the development of such a dosage form for pediatric use with an appropriate active substance. On the other hand it was planned to develop adequate analytical methods for their characterization as well as improving already existing approaches. Drug-free films were prepared according to the patent literature starting with a pre-evaluation of different film formers such as cellulose ethers, polyethylene glycol-polyvinyl alcohol copolymer (Kollicoat® IR), pullulan and sodium alginate. Gelatin, hypromellose, polyvinyl alcohol and pullulan were evaluated for further use in drug-loaded oral films in which caffeine was chosen as the API. The best compromise between fast dissolution and pleasant taste was shown for oral films made of gelatin and pullulan. Improving their palatability by using different sweeteners, flavors and dyes led to two formulations with pleasant taste without any bitterness. The oral films, based on different formulations, were evaluated with regard to their morphology, mechanical and thermal properties. Recrystallization of caffeine occurred within the drug-loaded oral wafers, which led to non-uniform distribution of API and caused limited content uniformity for oral wafers made of gelatin and one hypromellose type (HM50PA2910). Furthermore, residual solvent was determined by different methods. In the formulations that contained ethanol as solvent, this alcohol could not be quantified in the finished products making the oral wafers safe for pediatric use. The results from the investigations of osmolalities of dissolved films in appropriate medium showed values far below the critical threshold for cell necrosis which additionally approves the applicability of oral wafers to pediatrics. An attempt to simulate the disintegration and dissolution behavior in the human oral cavity was made by developing methods using a fiber-optic sensor, contact angle meter or determination of swelling. Since only a small amount of saliva is present in the oral cavity, the development of an adequate method proved to be difficult. It was revealed that oral wafers showed fast-dissolving behavior, both in vitro and in vivo, although they had a drug-load of 10 mg caffeine. However, the present study revealed that recrystallization of API may be problematic. Further studies should be aimed at preventing the recrystallization which occurred in the case of caffeine. The developed approaches, especially for dissolution testing, should be improved to better mimic the natural conditions. Adequate methods to determine mucoadhesion are another possibility for prediction of the suitability of film formers for use in the oral cavity. Ultimately, the packaging of those oral wafers will play a considerable role in ascertaining and increasing their stability. In conclusion, in the present work, the development of oral drug-loaded wafers was successful. Although the wafers contain 10 mg caffeine, which is a bitter tasting substance, the taste was assessed as comfortable and pleasant. The manufactured oral wafers were characterized by several methods and found out to be stable even without primary packaging. An evaluation of appropriate film formers for oral use could be undertaken.
Author: Thu Pham
Publisher:
ISBN:
Category :
Languages : en
Pages :
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Book Description
Author:
Publisher: Academic Press
ISBN: 012814422X
Category : Medical
Languages : en
Pages : 810
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Book Description
Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design
Author: Geoffrey D Tovey
Publisher: Royal Society of Chemistry
ISBN: 1849739412
Category : Medical
Languages : en
Pages : 432
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Book Description
Formulation is a key step in the drug design process, where the active drug is combined with other substances that maximise the therapeutic potential, safety and stability of the final medicinal product. Modern formulation science deals with biologics as well as small molecules. Regulatory and quality demands, in addition to advances in processing technologies, result in growing challenges as well as possibilities for the field. Pharmaceutical Formulation provides an up to date source of information for all who wish to understand the principles and practice of formulation in the drug industry. The book provides an understanding of the links between formulation theory and the practicalities of processing in a commercial environment, giving researchers the knowledge to produce effective pharmaceutical products that can be approved and manufactured. The first chapters introduce readers to different dosage forms, including oral liquid products, topical products and solid dosage forms such as tablets and capsules. Subsequent chapters cover pharmaceutical coatings, controlled release drug delivery and dosage forms designed specifically for paediatric and geriatric patients. The final chapter provides an introduction to the vital role intellectual property plays in drug development. Covering modern processing methods and recent changes in the regulatory and quality demands of the industry, Pharmaceutical Formulation is an essential, up to date resource for students and researchers working in academia and in the pharmaceutical industry.
Author: Nikoletta Fotaki
Publisher: John Wiley & Sons
ISBN: 1118341473
Category : Science
Languages : en
Pages : 312
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Book Description
Guides readers on the proper use of in vitro drug release methodologies in order to evaluate the performance of special dosage forms In the last decade, the application of drug release testing has widened to a variety of novel/special dosage forms. In order to predict the in vivo behavior of such dosage forms, the design and development of the in vitro test methods need to take into account various aspects, including the dosage form design and the conditions at the site of application and the site of drug release. This unique book is the first to cover the field of in vitro release testing of special dosage forms in one volume. Featuring contributions from an international team of experts, it presents the state of the art of the use of in vitro drug release methodologies for assessing special dosage forms’ performances and describes the different techniques required for each one. In Vitro Drug Release Testing of Special Dosage Forms covers the in vitro release testing of: lipid based oral formulations; chewable oral drug products; injectables; drug eluting stents; inhalation products; transdermal formulations; topical formulations; vaginal and rectal delivery systems and ophthalmics. The book concludes with a look at regulatory aspects. Covers both oral and non-oral dosage forms Describes current regulatory conditions for in vitro drug release testing Features contributions from well respected global experts in dissolution testing In Vitro Drug Release Testing of Special Dosage Forms will find a place on the bookshelves of anyone working with special dosage forms, dissolution testing, drug formulation and delivery, pharmaceutics, and regulatory affairs.
Author: Jack Zheng
Publisher: John Wiley & Sons
ISBN: 0470056096
Category : Medical
Languages : en
Pages : 506
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Book Description
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.
Author: Kevin M.G. Taylor
Publisher: Elsevier Health Sciences
ISBN: 0702053937
Category : Medical
Languages : en
Pages : 909
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Book Description
Pharmaceutics is one of the most diverse subject areas in all of pharmaceutical science. In brief, it is concerned with the scientific and technological aspects of the design and manufacture of dosage forms or medicines. An understanding of pharmaceutics is therefore vital for all pharmacists and those pharmaceutical scientists who are involved with converting a drug or a potential drug into a medicine that can be delivered safely, effectively and conveniently to the patient. Now in its fourth edition, this best-selling textbook in pharmaceutics has been brought completely up to date to reflect the rapid advances in delivery methodologies by eye and injection, advances in drug formulations and delivery methods for special groups (such as children and the elderly), nanomedicine, and pharmacognosy. At the same time the editors have striven to maintain the accessibility of the text for students of pharmacy, preserving the balance between being a suitably pitched introductory text and a clear reflection of the state of the art. New to this edition New editor: Kevin Taylor, Professor of Clinical Pharmaceutics, School of Pharmacy, University of London. Twenty-two new contributors. Six new chapters covering parenteral and ocular delivery; design and administration of medicines for the children and elderly; the latest in plant medicines; nanotechnology and nanomedicines, and the delivery of biopharmaceuticals. Thoroughly revised and updated throughout. provides a logical, comprehensive account of drug design and manufacture includes the science of formulation and drug delivery designed and written for newcomers to the design of dosage forms New to this edition New editor: Kevin Taylor, Professor of Clinical Pharmaceutics, School of Pharmacy, University of London. Twenty-two new contributors. Six new chapters covering parenteral and ocular delivery; design and administration of medicines for the children and elderly; the latest in plant medicines; nanotechnology and nanomedicines, and the delivery of biopharmaceuticals. Thoroughly revised and updated throughout.
