Pharmaceutical Suspensions: From Formulation Development to Manufacturing / Edition 1

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Suspension dosage form is a preferred and widely accepted dosage forms for insoluble or poorly soluble drugs for various therapeutic applications. The suspension dosage form has long been used for insoluble and poorly soluble drugs for making oral, topical and parenteral products. Pharmaceutical Suspensions, From Formulation Development to Manufacturing provides the reader with a broad overview of suspension drug product technology. Individual chapters in this book focus on suspension formulation principles, excipients, analysis, pharmaceutical development, preclinical, clinical and regulatory aspects, as well as the emerging technology of nanosuspensions as nanomedicine. Various chapters in the book are written by authors from academia, regulatory agencies and industries who are experts in their respective fields. The book includes over 600 bibliographic citations, numerous tables and illustrations. Pharmaceutical Suspensions is the only volume to date that systematically follows the suspension dosage development approach used widely in the pharmaceutical industries starting with pre-formulation/formulation development, pre-clinical evaluation and critical characterization method development, continuing to clinical trial essentials and ending with technology transfer essentials and regulatory filing guidance. Pharmaceutical Suspensions, From Formulation Development to Manufacturing provides a useful resource for pharmaceutical scientists, process scientists/engineers involved in the areas of research and development of pharmaceutical suspension dosage forms as well as for advanced pharmacy undergraduate and graduate students who want in-depth knowledge of suspension dosage form.

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Product Details

  • ISBN-13: 9781441910868
  • Publisher: Springer New York
  • Publication date: 11/5/2009
  • Edition description: 2010
  • Edition number: 1
  • Pages: 327
  • Sales rank: 1,263,682
  • Product dimensions: 6.30 (w) x 9.20 (h) x 1.00 (d)

Meet the Author

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 Ocular Focus Group of AAPS from 2002 to 2005 and has been a reviewer for AAPS abstracts, posters and symposia. Dr. Singh is a member of the American Association of Pharmaceutical Scientists (AAPS). Dr. Singh currently serves as an editorial board member of American Pharmaceutical Review Journal. Dr. Singh holds a B.S. in Pharmacy, M.S. in Pharmaceutics from Banaras Hindu University, India; Ph.D. in Pharmaceutics from University of Illinois at Chicago and M.B.A. from University of Texas at Arlington, Texas.

G. MICHAEL WALL, Ph.D., Senior Director of Pharmaceutical Products Development at Alcon Research, Ltd., Fort Worth, Texas, has over 21 years of pharmaceutical industrial experience in the development of intranasal, sterile ophthalmic and otic drug products. Dr. Wall is author or co-author of 2 patents and over 100 publications including peer-reviewed articles, abstracts, book chapters, book supplements and one book. Dr. Wall has led international, multidisciplinary teams in the development and approval of in the development and approval of Ciprodex® Sterile Otic Suspension and Patanase® Nasal Spray, as well as other products in countries around the world. Dr. Wall is a Scientific Fellow of the American Academy of Otolaryngology – Head and Neck Surgery. He has also served the American Chemical Society as a member for 30 years. Dr. Wall received a B.S. degree in chemistry from Auburn University, a M.S. degree in medicinal chemistry from Auburn University School of Pharmacy, a Ph.D. in medicinal chemistry from the University of Mississippi School of Pharmacy, and completed the Advanced Management Program (168th session) of the Harvard Business School.

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Table of Contents

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.

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