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.
Зміст
Forward.- Excipient Applications in Formulation Design and Drug Delivery: An Introduction.- Drug Excipient Interactions.- Reactive Impurities in Excipients.- Reactive Impurities in PEG: A Case Study.- Impact of Excipient Interactions on Solid Dosage Form Stability.- Protein – Surfactant Interactions at the Air-Water Interface.- Smart Polymers in Drug Delivery.- Tailoring the Oral Release of Drugs Using Polymeric Excipients.- Solid lipid excipients as matrix agents for sustained drug delivery.- Impact of Excipient Interactions on Drug Bioavailability from Solid Dosage Forms.- Biopolymers in Medical Implants.- Selection of Excipients Based on the Biopharmaceutics Classification System of Drugs.- Excipient Selection in Oral Solid Dosage Formulations Containing Moisture Sensitive Drugs.- Silicone excipients in pharmaceutical drug delivery applications.- Excipients that Facilitate Amorphous Drug Stabilization.- Excipients in Pediatric Formulations: Biopharmaceutical and Toxicological Considerations.- Role of Innovator Product Characterization in Generic Product Development.- Addressing Excipient Variability in Formulation Design and Drug Development.- Improved Polymer Functionality by Cross-linking with Glutaraldehyde to Achieve Controlled Drug Release.- Excipient Design by Co-processing for Direct Compression Applications.- Excipients and Non-medicinal Agents as Active Pharmaceutical Ingredients.- Drug Delivery Applications of Chitosan and its Derivatives.
Про автора
Ajit Narang earned his Ph.D. from the University of Tennessee in Memphis, his Masters in Pharmaceutics from the Banaras Hindu University in India, and his Bachelors in Pharmaceutical sciences from the University of Delhi in India. He has over 13 years of pharmaceutical industry experience and is currently a Principal Scientist for the Drug Product Science & Technology Department of Bristol-Myers Squibb, Co. (BMS) in New Brunswick, NJ. He also serves as Adjunct Faculty at the Universities of Tennessee and Phoenix, Industrial Advisory Board member of Western Michigan University, Editor of Bentham Pharmaceutical Journal, and as a panel member of the Biopharmaceutics Technical Committee (BTC) of the Pharmaceutical Quality Research Institute (PQRI) in Arlington, VA. Ajit is also a long standing AAPS member and has served the AAPS in many different capacities. He has published over 40 peer reviewed articles, 2 books, 7 patent applications, 20 invited talks, and 60 presentations at various scientific meetings.
Sai HS. Boddu, Ph.D, is an Assistant Professor of Pharmaceutics at The University of Toledo (UT). Prior to joining UT, he received his Ph.D. in Pharmaceutical Sciences from The University of Missouri-Kansas City (UMKC). His research areas include Drug Delivery, Bioanalysis and Pharmacokinetics. He was the recipient of the prestigious UMKC-Chancellor’s Doctoral Fellowship Award for the years 2008-2010. He has been named as Vice Chancellor for Student Affairs and Enrollment Management Honor Recipient for the Fall of 2010. With more than twelve years of experience in drug delivery, he has authored and co-authored many scientific papers, book chapters and patents in the areas of pre-formulation, formulation development, nanotechnology and bioanalysis. He served as a Steering Committee member of the AAPS Excipient Focus Group from 2010-2012.