Pharmaceutical Suspensions

by Kulshreshtha, Alok K.; Singh, Onkar N.; Wall, G. Michael

• ISBN13: 9781441910868
• ISBN10: 1441910867
• Edition: 1st
• Format: Hardcover
• Copyright: 2009-11-03
• Publisher: Springer Verlag

Summary

The suspension dosage form has long been used for poorly soluble active pharmaceutical ingredients (API) for various therapeutic indications. Development of stable suspensions (a disperse system) over the shelf life of the drug product continues to be a challenge on many fronts. There are several aspects to develop a stable suspension and successfully launch the product. A good understanding of fundamentals of disperse systems is essential towards successful formulation of pharmaceutical suspensions. The selection of proper excipients (surfactants, viscosity imparting agents, osmolality building agents, etc.) is of paramount importance. The particle size distribution in the finished drug product is a critical parameter towards determining the bioavailability and thus the efficacy of the product. At the same time, toxicity/safety and pharmacokinetic profiles of the formulation must meet requirements for the intended therapy. Appropriate analytical methodologies and analytical instruments (chromatographs, viscometers, particle size analyzers, surface tensiometers, etc.) have to be carefully selected in order to properly characterize and optimize the suspension formulations. Furthermore, the development process continues with development of good clinical protocols, sound technology transfers and successful scale-up of the manufacturing processes. Eventually, all of this development work culminates into a regulatory filing which must address issues and concern that arise during the regulatory agency's review process. The proposed twelve chapters in this volume, dealing with pre-formulation to commercial manufacturing stages, will systematically discuss the development of stable pharmaceutical suspensions.