Pharmaceutical Suspensions, 2010 From Formulation Development to Manufacturing

Langue : Anglais

Coordonnateurs : Kulshreshtha Alok K., Singh Onkar N., Wall G. Michael

Couverture de l’ouvrage Pharmaceutical Suspensions

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The suspension dosage form has long been used for poorly soluble active ingre- ents for various therapeutic indications. Development of stable suspensions over the shelf life of the drug product continues to be a challenge on many fronts. A good understanding of the fundamentals of disperse systems is essential in the development of a suitable pharmaceutical suspension. The development of a s- pension dosage form follows a very complicated path. The selection of the proper excipients (surfactants, viscosity imparting agents etc.) is important. The particle size distribution in the finished drug product dosage form is a critical parameter that significantly impacts the bioavailability and pharmacokinetics of the product. Appropriate analytical methodologies and instruments (chromatographs, visco- ters, particle size analyzers, etc.) must be utilized to properly characterize the s- pension formulation. The development process continues with a successful scale-up of the manufacturing process. Regulatory agencies around the world require cli- cal trials to establish the safety and efficacy of the drug product. All of this devel- ment work should culminate into a regulatory filing in accordance with the regulatory guidelines. Pharmaceutical Suspensions, From Formulation Development to Manufacturing, in its organization, follows the development approach used widely in the pharmaceutical industry. The primary focus of this book is on the classical disperse system ? poorly soluble active pharmaceutical ingredients s- pended in a suitable vehicle.

Various Pharmaceutical Disperse Systems.- General Principles of Suspensions.- Commonly Used Excipients in Pharmaceutical Suspensions.- Pharmaceutical Development of Suspension Dosage Form.- Preclinical Development for Suspensions.- Analytical Tools for Suspension Characterization.- Clinical Trials of Suspension Drug Products.- Scale Up and Technology Transfer of Pharmaceutical Suspensions.- The Science and Regulatory Perspectives of Pharmaceutical Suspensions.- Solid Nanosuspensions: The Emerging Technology and Pharmaceutical Applications as Nanomedicine.

ALOK K. KULSHRESHTHA, Ph.D., Associate Director, Pharmaceutical Technology at Alcon Research Ltd., Fort Worth, Texas, has 20 years of experience in the development of sterile ophthalmic, contact lens care, and dry eye products. During this tenure in pharmaceutical industry, Dr. Kulshreshtha has worked on several suspension drug products in different stages of development. Dr. Kulshreshtha’s interest in the suspension area started almost 30 years ago when he began his doctoral dissertation on suspension rheology. Over the years, Dr. Kulshreshtha has worked on many new technologies for producing sterile suspensions. Dr. Kulshreshtha is the inventor/co-inventor of several Patents and has authored many peer reviewed publications. Dr. Kulshreshtha is a member of the American Association of Pharmaceutical Scientists (AAPS) and has been reviewer for AAPS abstracts screening for posters and symposia. Dr. Kulshreshtha holds a Ph.D. and M.S. in Chemical Engineering from Purdue University, and a Bachelor’s degree in Chemical Engineering from the Indian Institute of Technology, Kanpur, India.

ONKAR N. SINGH, Ph.D., M.B.A., Assistant Director, Development at Alcon Research Ltd., Fort Worth, Texas, has over 16 years of pharmaceutical product research and development of nasal, sterile ophthalmic, sterile otic, and parentral products. Dr. Singh is inventor/co-inventor of many patents related to formulations, process and formulation technology and has authored several peer reviewed articles. Prior to joining Alcon Inc., Dr. Singh was Manager at Access Pharmaceuticals, Dallas, Texas, leading efforts in the area of site specific targeted drug delivery systems for diagnostic and therapeutic areas of cancer therapy. At Access Pharmaceuticals, Dr. Singh worked on nanoparticles, liposomes, emulsion formulations, protein pharmaceuticals and gene delivery technology. Dr. Singh served as Secretary/Treasurer of the

Written by experienced experts in applicable field from academia/industry/regulatory agencies, volume will systematically discuss the development of stable pharmaceutical suspensions