Developing Solid Oral Dosage Forms

• Author : Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lawrence Yu,Rao V. Mantri
• Publisher : Academic Press
• Release : 08 November 2016

Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations. This book covers the essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their application to the research and development process of oral dosage forms. Chapters have been added, combined, deleted, and completely revised as necessary to produce

• Author : Bhavishya Mittal
• Publisher : Academic Press
• Release : 05 October 2016

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

• Author : Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lirong Liu,William Porter
• Publisher : Academic Press
• Release : 10 March 2009

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

• Author : Jack Zheng
• Publisher : John Wiley & Sons
• Release : 04 March 2009

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

• Author : Beverly Nickerson
• Publisher : Springer Science & Business Media
• Release : 05 August 2011

This book is intended to serve as a resource for analysts in developing and troubleshooting sample preparation methods. These are critical activities in providing accurate and reliable data throughout the lifecycle of a drug product. This book is divided into four parts: • Part One covers dosage form and diluent properties that impact sample preparation of pharmaceutical dosage forms and the importance of sampling considerations in generating data representative of the drug product batch. • Part Two reviews specific sample preparation techniques

• Author : Edmund S. Kostewicz,Maria Vertzoni,Heather A. E. Benson,Michael S. Roberts
• Publisher : John Wiley & Sons
• Release : 26 April 2022

ORAL DRUG DELIVERY FOR MODIFIED RELEASE FORMULATIONS Provides pharmaceutical development scientists with a detailed reference guide for the development of MR formulations Oral Drug Delivery for Modified Release Formulations is an up-to-date review of the key aspects of oral absorption from modified-release (MR) dosage forms. This edited volume provides in-depth coverage of the physiological factors that influence drug release and of the design and evaluation of MR formulations. Divided into three sections, the book begins by describing the gastrointestinal tract (

• Author : Susan M. Rosencrance,Lawrence Yu
• Publisher : Academic Press
• Release : 01 March 2018

FDA Quality Standards for Generic Drug Products features the history and evolution of the FDA’s generic drug program, along with an overview of the quality assessment process performed by the FDA and an in-depth look at quality standards for a variety of dosage forms. Chapters cover important topics such as quality by design, the ANDA structure, CMC, process analytical technology and other emerging technologies, design of experiments and statistics and the similarities and differences between the FDA and international

• Author : Elizabeth Kwong
• Publisher : John Wiley & Sons
• Release : 03 January 2017

Detailing formulation approaches by stage of discovery to early development, this book gives a “playbook” of practical and efficient strategies to formulate drug candidates with the least chance of failing in clinical development. • Comes from contributing authors with experience developing formulations on the frontlines of the pharmaceutical industry • Focuses on pre (or non-) clinical and early stage development, the phases where most compounds are used in drug research • Features case studies to illustrate practical challenges and solutions in formulation selection •

• Author : Ali R. Rajabi-Siahboomi,Amitava Mitra
• Publisher : Wiley
• Release : 05 February 2018

Outlining the steps for developing fixed dose combination (FDC) drugs, this book gives a systematic approach to the full scope of FDCs – concept, design, formulation, and commercialization. • Includes case studies to illustrate best practices and challenges • Deals with a growing part of the pharmaceutical industry, as FDCs are ideal for targeting many chronic illnesses and for reducing the number of medications an increasingly-aging population needs to take • Ensures consistency in the delivery of FDC medication, which can be pivotal in

• Author : Tentu Nageswara Rao,Tentu Srinivasa Rao,Parvatamma Botsa
• Publisher : LAP Lambert Academic Publishing
• Release : 12 November 2015

The aim of present study is to design and develop a solid oral extended release dosage form (tablet) of Niacin to deliver controlled release of drug at desired site at specific time comparable to the innovator product with better stability, high production feasibility, and excellent patient compatibility. The objective of the study is to evaluate the release pattern of the drug from fabricated extended release tablets and compare with marketed sample of the same drug Niaspan 1000mg ER tablet over

• Author : Antoine Al-Achi,Mali Ram Gupta,William Craig Stagner
• Publisher : John Wiley & Sons
• Release : 07 September 2022

This work is an examination of all aspects of the science in developing effective dosage form for drug delivery Pharmaceutics refers to the subfield of pharmaceutical sciences that develops drug delivery products or devices to optimize the drug's performance once administered. This multidisciplinary field draws on physical chemistry, organic chemistry, and biophysics to generate and refine these crucial elements of medical care. Moreover, incorporating such disparate dimensions of drug product design as material properties and legal regulation bridges the gap

• Author : Michael E. Aulton,Kevin M.G. Taylor
• Publisher : Elsevier Health Sciences
• Release : 26 August 2017

From a review of the previous edition: ‘For all the pharmacy students out there part of your pharmacy degree will be to study formulation design and pharmaceutics. This is the holy grail of pharmaceutical technology books. The text reads well and introduces difficult concepts in a more easy-to-understand way, it is definitely worth the money to help you get through the module, if you’re doing a research project in pharmaceutical design then this would also be an excellent buy...

• Author : Sarfaraz K. Niazi
• Publisher : CRC Press
• Release : 06 December 2019

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

• Author : Mark Gibson
• Publisher : CRC Press
• Release : 19 April 2016

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 need for advanced information for drug preformulation and formulation and addresses the current trends in the continually evolving pharmaceutical industry. Topics include: Candidate drug selection Drug discovery and development Preformulation predictions

• Author : Sarfaraz K. Niazi
• Publisher : CRC Press
• Release : 25 November 2019

The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Two, Uncompressed 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 second 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