Handbook of Pharmaceutical Manufacturing Formulations

Handbook of Pharmaceutical Manufacturing Formulations
Author: Safaraz K. Niazi
Publisher: CRC Press
Total Pages: 458
Release: 2016-04-19
Genre: Medical
ISBN: 1420081314

No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing ster

Pharmaceutical Manufacturing Handbook

Pharmaceutical Manufacturing Handbook
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
Total Pages: 1386
Release: 2008-03-11
Genre: Science
ISBN: 0470259809

This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.

Handbook of Pharmaceutical Manufacturing Formulations

Handbook of Pharmaceutical Manufacturing Formulations
Author: Sarfaraz K. Niazi
Publisher: CRC Press
Total Pages: 258
Release: 2004-04-27
Genre: Medical
ISBN: 1420048457

The third volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers liquid drugs, which include formulations of non-sterile drugs administered by any route in the form of solutions (monomeric and multimeric), suspensions (powder and liquid), drops, extracts, elixirs, tinctures, paints, sprays, colloidons, emul

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
Author: Sarfaraz K. Niazi
Publisher: CRC Press
Total Pages: 816
Release: 2019-12-06
Genre: Medical
ISBN: 1351594907

The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume One, Compressed Solid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this first volume of a six-volume set, compiles data from FDA new drug applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of GMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
Author: Sarfaraz K. Niazi
Publisher: CRC Press
Total Pages: 453
Release: 2019-12-09
Genre: Medical
ISBN: 1351592238

The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Six, Sterile Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this sixth volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including author’s own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent. Features: Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines

Handbook of Pharmaceutical Manufacturing Formulations

Handbook of Pharmaceutical Manufacturing Formulations
Author: Sarfaraz K. Niazi
Publisher: CRC Press
Total Pages: 263
Release: 2004-04-27
Genre: Medical
ISBN: 9781135498771

The fourth volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers semi-solid drugs. It includes ointments, lotions, gels, and suppositories, from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and the BASF book of generic formulations. Each entry begins with a fully validated scaleable manufacturing formula that includes compendial specification requirement for each ingredient, in-process controls for manufacturing and release of product, a summary of manufacturing process, and details of packaging.

The Magnesium Stearate Handbook

The Magnesium Stearate Handbook
Author: Patrick C. Okoye
Publisher: iUniverse
Total Pages: 103
Release: 2016-11-18
Genre: Medical
ISBN: 1532011121

Magnesium stearate (MgSt) is widely used in cosmetic, food, and pharmaceutical formulations as lubricant in capsule and tablet manufacture at concentrations between 0.25% and 5%. A recent review of the top two hundred prescription drugs showed over 50% contained magnesium stearate. This book covered a broad spectrum of concentration from 1% to 10% for the purpose of presenting their unique properties during powder rheology, tableting, and effect on drug dissolution. MgSt also has both scientifi c and economic signifi cance, given its wide application in global pharmaceutical manufacturing. An understanding of polymorphism (or pseudopolymorphism) in magnesium stearate and the impact on tablet lubrication process and drug dissolution would provide a valuable tool to pharmaceutical scientists during excipient selection process for new product development and even during reformulation of existing products. Preformulation scientists spend a great deal of time reviewing excipients for new product development both in silico and on the bench. As a result, accurate selection of excipients, such as lubricants, could avoid potential issues with clinical batches, product scale-up, and product transfer during commercialization.

Pharmaceutical Preformulation and Formulation

Pharmaceutical Preformulation and Formulation
Author: Mark Gibson
Publisher: CRC Press
Total Pages: 562
Release: 2016-04-19
Genre: Medical
ISBN: 1420073184

Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, as well as the shift from developing small molecules to the growth of biopharmaceuticals. The book meets the ne

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms
Author: Yihong Qiu
Publisher: Academic Press
Total Pages: 976
Release: 2009-03-10
Genre: Medical
ISBN: 008093272X

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

Handbook of Stability Testing in Pharmaceutical Development

Handbook of Stability Testing in Pharmaceutical Development
Author: Kim Huynh-Ba
Publisher: Springer Science & Business Media
Total Pages: 389
Release: 2008-11-16
Genre: Medical
ISBN: 0387856277

This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.