Pharmaceutical Suspensions: From Formulation Development to Manufacturing
Alok K. Kulshreshtha, Onkar N. Singh, G. Michael Wall
Springer Science & Business Media, Nov 5, 2009 - Medical - 327 pages
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.
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absorption acid active administration adsorbed analysis application aqueous artificial membrane assay assessment batch bioavailability cellulose characterization chemical clinical trials colloidal components compounds concentration containing continuous phase crystal deflocculated diameter dispersed phase dispersed systems dispersion medium dissolution rate dosage form dose droplets drug delivery drug discovery drug product drug substance effect emulsion equation evaluation excipients flocculation hepatocytes hydrophilic increase interaction Journal of Pharmaceutics layer liposomes liquid manufacturing material measurement metabolism method micelles microemulsion Microfluidizer microspheres molecular molecules nanoparticles nanosuspensions NCEs ophthalmic oral paraben parameters parenteral particle size distribution permeability Pharm pharmaceutical suspensions PLGA poloxamers polymeric polymers polymorphic powder preclinical preparation preservative properties range reduce regulatory release sedimentation shear sodium solid solubility solution solvent sterile studies supercritical fluid surface area surfactants suspension formulations techniques temperature tion vehicle viscosity vitro vivo volume zeta potential