Gregory K Webster, Robert G Bell, J Derek Jackson

Poorly Soluble Drugs

Dissolution and Drug Release

• Gebundenes Buch

Produktbeschreibung

This book is the first text to provide a comprehensive assessment of the application of fundamental principles of dissolution and drug release testing to poorly soluble compounds and formulations. Such drug products are, vis-à-vis their physical and/or chemical properties, inherently incompatible with aqueous dissolution. However, dissolution methods are required for product development and selection, as well as to fulfill regulatory obligations with respect to biopharmaceutical assessment and product quality understanding.

Produktdetails

• Verlag: Jenny Stanford Publishing
• Seitenzahl: 728
• Erscheinungstermin: 16. Dezember 2016
• Englisch
• Abmessung: 233mm x 151mm x 48mm
• Gewicht: 1140g
• ISBN-13: 9789814745451
• ISBN-10: 9814745456
• Artikelnr.: 47441356

Autorenporträt

Gregory K. Webster is a senior principal research scientist with AbbVie Inc.¿s Global Analytical Research and Development. He obtained his BS in chemistry from St. Xavier College, USA, MS in analytical chemistry from Governors State University, USA, and PhD in analytical chemistry from Northern Illinois University. Dr. Webster¿s industrial career spans an employment history with several major pharmaceutical companies. His first book with Pan Stanford Publishing, Supercritical Fluid Chromatography: Advances and Applications in Pharmaceutical Analysis, was published in 2014. Robert G. Bell is president of Drug and Biotechnology Development LLC, USA, a consultancy to the pharmaceutical industry and academia for biological, drug, and device development. He received his education from the University of Florida and has worked with the pharmaceutical industry for over 30 years. Dr. Bell is adjunct faculty at Virginia Commonwealth University and the University of Florida College of Pharmacy and a member of the Council of Experts, General Chapters¿Biological Analysis for United States Pharmacopeia. J. Derek Jackson is director of Analytical Development at Flexion Therapeutics Inc, USA. He earned his BS and MA in chemistry from the College of William and Mary in Virginia. Derek has been engaged in all stages of pharmaceutical discovery, research, and development for 20 years, in both large pharma and small- to midcap biotech companies.

Inhaltsangabe

Introduction. Solubility determination for pharmaceutical API. Use of
surfactants in dissolution testing. Intrinsic dissolution evaluation of
poorly soluble drugs. Oral delivery of poorly soluble drugs. A staged
approach to pharmaceutical dissolution testing. Development and application
of in vitro two-phase dissolution method for poorly water soluble drugs.
The use of Apparatus 3 in dissolution testing of poorly soluble drug
formulations. Use of Apparatus 4 in dissolution testing, including
sparingly and poorly soluble drugs. Dissolution of nanoparticle drug
formulations. Dissolution of lipid based drug formulations. Dissolution of
stabilized amorphous drug formulations. Dissolution of pharmaceutical
suspensions. Dissolution testing of poorly soluble drugs: `Biorelevant
dissolution¿. Clinically relevant dissolution for low solubility immediate
release products. The QbD approach to method development and validation for
dissolution testing. Regulatory considerations in dissolution and drug
release of BCS class II and IV compounds. Dissolution of liquid-filled
capsules based formulations. Current and emerging non-compendial methods
for dissolution testing.