Biopharmaceutical Powders Particle Formation and Formulation Considerations

Authors: Maa Y-F.; Prestrelski S.J.

Source: Current Pharmaceutical Biotechnology, Volume 1, Number 3, November 2000 , pp. 283-302(20)

Publisher: Bentham Science Publishers

Abstract:

It is well known that protein/peptide-based drug formulations are more stable in the solid state than in the liquid state, thereby offering stability advantages in ambient temperature storage, product shipping/distribution, and long-term shelf life. Novel powder-based drug delivery systems recently emerging for applications in sustained release, inhalation, intradermal delivery, etc. add more value to protein solid dosage forms. Despite great research interests in understanding the drying effects on protein stability and a large collection of publications focusing on this area, systematic accounts of powder formation techniques are lacking. This review is to summarize a number of methods currently available for protein powder preparation. Some are common methods such as lyophilization, spray drying, pulverization, and precipitation, and some methods are more recently developed such as supercritical fluid precipitation, spray-freeze drying, fluidized-bed spray coating and emulsion precipitation. In addition to examining the individual process effect on protein stability that is always the focus of formulation scientists, this review also likes to evaluate each method from a more practical sense in terms of process versatility and scalability. The conclusion is that each method has its own advantages and the use of a method is formulation and application specific. With the understanding of the principles and advantages of these methods, it can benefit our choice on selecting appropriate techniques for preparing a desired protein powder formulation for specific applications

Keywords: Protein based drug formulation; Peptide based drug formulation; Spray drying; Protein stability; Particle shape; Particle morphology

Language: English

Document Type: Review article

DOI: http://dx.doi.org/10.2174/1389201003378898

Publication date: 2000-11-01

• Current Pharmaceutical Biotechnology aims to cover all the latest and outstanding developments in Pharmaceutical Biotechnology. Each issue of the journal contains a series of timely in-depth reviews written by leaders in the field covering a range of current topics in both pre-clinical and clinical areas of Pharmaceutical Biotechnology. Current Pharmaceutical Biotechnology is an essential journal for academic, clinical, government and pharmaceutical scientists who wish to be kept informed and up-to-date with the latest and most important developments.

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• In this Subject: Nutrition & Food ,  Biotechnology ,  Pharmacology
• By this author: Maa Y-F. ;  Prestrelski S.J.

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