Author: Phillip Douglas LunneyPublisher:
ISBN:
Category :
Languages : en
Pages :
Book Description
Improvement of Release Criteria for Immediate Release Solid Oral Dosage Forms
Author: Phillip Douglas LunneyGuidance for Industry
Author: Guidance for industry
Author: Generic Drug Product Development
Author: Leon ShargelPublisher: CRC Press
ISBN: 1420086367
Category : Medical
Languages : en
Pages : 397
Book Description
In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns.Generic Drug Product Development: Solid Oral
In Vitro-In Vivo Correlations
Author: David B. YoungPublisher: Springer Science & Business Media
ISBN: 1468460366
Category : Medical
Languages : en
Pages : 299
Book Description
This book represents the invited presentations and some of the posters presented at the conference entitled "In Vitro-In Vivo Relationship (IVIVR) Workshop" held in Sep tember, 1996. The workshop was organized by the IVIVR Cooperative Working Group which has drawn together scientists from a number of organizations and institutions, both academic and industrial. In addition to Elan Corporation, which is a drug delivery com pany specializing in the development of ER (Extended Release) dosage forms, the IVIVR Cooperative Working Group consists of collaborators from the University of Maryland at Baltimore, University College Dublin, Trinity College Dublin, and the University of Not tingham in the UK. The principal collaborators are: Dr. Jackie Butler, Elan Corporation Prof. Owen Corrigan, Trinity College Dublin Dr. lain Cumming, Elan Corporation Dr. John Devane, Elan Corporation Dr. Adrian Dunne, University College Dublin Dr. Stuart Madden, Elan Corporation Dr. Colin Melia, University of Nottingham Mr. Tom O'Hara, Elan Corporation Dr. Deborah Piscitelli, University of Maryland at Baltimore Dr. Araz Raoof, Elan Corporation Mr. Paul Stark, Elan Corporation Dr. David Young, University of Maryland at Baltimore The purpose of the workshop was to discuss new concepts and methods in the devel opment of in vitro-in vivo relationships for ER products. The original idea went back ap proximately 15 months prior to the workshop itself. For some time, the principal collaborators had been working together on various aspects of dosage form development.
Guidance for industry
Author: Oral Drug Absorption
Author: Jennifer B. DressmanPublisher: CRC Press
ISBN: 1420077341
Category : Medical
Languages : en
Pages : 432
Book Description
Oral Drug Absorption, Second Edition thoroughly examines the special equipment and methods used to test whether drugs are released adequately when administered orally. The contributors discuss methods for accurately establishing and validating in vitro/in vivo correlations for both MR and IR formulations, as well as alternative approaches for MR an
How to Develop Robust Solid Oral Dosage Forms
Author: Bhavishya MittalPublisher: Academic Press
ISBN: 0128047321
Category : Medical
Languages : en
Pages : 192
Book Description
How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval uses a practical and hands-on approach to cover the development process of solid oral dosage forms in one single source. The book details all of the necessary steps from formulation through the post-approval phase and contains industry case studies, real world advice, and troubleshooting tips. By merging the latest scientific information with practical instructions, this book provides pharmaceutical scientists in formulation research and development with a concrete look at the key aspects in the development of solid oral dosage forms. Focuses on important topics, such as robustness, bioavailability, formulation design, continuous processing, stability tests, modified release dosage forms, international guidelines, process scale-up, and much more Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin Discusses common, real-world problems and offers both theoretical and practical solutions to these everyday issues
The Design and Manufacture of Immediate-release Optimal Solid Dosage Forms
Author: Aron H. BlaesiPublisher:
ISBN:
Category :
Languages : en
Pages : 250
Book Description
Pharmaceutical manufacturing has traditionally been considered largely a matter of regulatory compliance. Consequently, it has been inefficient, but it is now increasingly being recognized as an opportunity for cost reduction. Recent initiatives by regulatory authorities, and by the industry, aim at easing regulations and encouraging process innovation. Even though significant improvements, especially in process control and minimization of process interruptions, have been achieved, the underlying process technology has not changed for decades. For example, typical process steps to produce the most common pharmaceutical products, immediate-release solid dosage forms, from drug substance and excipient are: blending, wet granulating, drying, milling and screening, blending, tableting, coating, and so on. A new process, such as blending combined with solvent-less, multi-component injection-molding could greatly simplify manufacturing. Injection-molding, however, yields a non-porous material, intrinsically different from the state-of-the-art powder-compacted, porous dosage forms. This may appear problematic, because current products rely on a large surface area-to-volume ratio to achieve immediate drug release. In addition, process rates previously achieved by injection-molding solid dosage forms have been comparably low -- offsetting some of the benefits offered by that process. In this thesis, an analytical approach is first developed to model drug release from non-porous dosage forms, comprising a fast eroding excipient and randomly distributed drug particles in it. The model considers the central role of microstructure in drug release. Particular importance is given to the role of clusters of connected, slowly eroding drug particles, and to the effect of drug particle protrusion, due to their slow erosion rate, from the eroding excipient surface. The model is validated by dissolution experiments. Good agreement is observed between the model and the experimental data. The drug release model is then used in product design for manufacturing as an optimization problem -- with manufacturing performance as objective function and design specifications as constraints. It is found that the drug volume fraction needs to be about 0.5 to efficiently produce non-porous dosage forms in specification, which implies that an excessive amount of excipient material is required. Therefore, new product designs are proposed: a cellular excipient micro-structure with up to ten-fold reduction in excipient content. The new designs are further shown to allow injection-molding of immediate-release dosage forms that meet specifications with a three-fold increase in injection-molding process rate compared with conventional designs.
Developing Solid Oral Dosage Forms
Author: Yihong QiuPublisher: Academic Press
ISBN: 008093272X
Category : Medical
Languages : en
Pages : 976
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