Dosage forms development

J. D. Baggot and S. A. Brown, Basis for selection of the dosage form. Development and Formulation of Veterinary Dosage Forms, 2nd ed. (Gregory E. Hardee and J. Desmond Baggot, Eds.), Marcel Dekker, New York, 1998, pp. 9-27. 

W Addicks, G Flynn, N Weiner, C Chiang. Drug transport from thin applications of topical dosage forms Development of methodology. Pharm Res 6 377, 1988. 

LX Yu, LA Gatlin. Dosage form development aid Oral drug absorption. Glaxo Wellcome Dosage Form Development Guidelines, 1997. 

Bulk API synthesis (GMP and non-GMP) and clinical dosage forms development and manufacture... 

The beauty of science is its ability to predict the future. A fundamental understanding of the properties that affect powder compaction and flow, indeed a fundamental understanding of any aspect of pharmaceutical technology, will make dosage form development more scientific and predictable. This ability to... 

Extended Release Solid Oral Dosage Forms Development, Evaluation and Application of In vitro/In vivo Correlations. Center for Drug Evaluation and Research (CDER) FDA 1997. 

Guidance for Industry, extended release oral dosage forms development, evaluation, and application of in vitro/in vivo... 

Food and Drug Administration Guidance for Industry. Extended Release Oral Dosage Forms Development, Evaluation, and Application of In Vitro/In Vivo Correlations, September 1997. 

Qiang, D., Gunn, J. A., Schultz, L., Li, J. Evaluation of the impact of sodium lauryl sulphate source variability on solid oral dosage form development. Drug Dev. Ind. Pharm., 36(12), 2010, 1486-1496. 

Overview of Dosage-Form Development and Process Scale-Up.22... 

Drug-delivery systems are essentially specialized dosage forms developed to overcome the limitations of conventional dosage forms, such as simple tablets, capsules, injectable solutions, etc. Some of the reasons behind the development of oral DDSs are listed below ... 

Sweetana, S. and Akers, M.J., Solubility principles and practices for parenteral drug dosage form development, /. Pharm. Sci. Technol., 50, 330, 1996. 

Drugs can be beneficially used in therapy as solids, liquids, and gases. The form most commonly used in drug therapy is solid, followed by liquid and then gas. Liquid drugs can pose an interesting challenge in dosage-form development since many of the liquids are volatile substances and, as such, must be physically sealed from the atmosphere to prevent their loss. 

Aulton ME, ed. Pharmaceutics The Science of Dosage Form Development, 2nd edn. London Churchill Livingstone, 2002. 

McGilveray, I. J. 1996. Overview of workshop In vitro dissolution of immediate release dosage forms Development of i n vivo relevance and quality control issfibsg I nformation Journal30 1029-1037. 

Analytical methods validation is a critical component of the entire company validation program. A method is not declared acceptable until a collaborative crossover study is conducted between two development laboratories and at least one quality control laboratory to ensure proper precision, accuracy, and efficiency. In the new world of outsourcing, it is imperative that an analytical crossover study be conducted between the client and supplier before any work is begun on dosage form development. 

As part of the preformulation activities, investigations include physiochemical character, purity, solubility, stability, and optimal pH studies. In preparation for clinical studies, potential product formulations considering route of administration and solution stability are also studied. Unique to dosage form development studies for lyophilized products, thermal analysis of the drug substance and product formulations are also necessary. Data generated during this phase of product development is useful for future development activities, along with validation. 

Serajuddin ATM, Morris KR, Newman AW, Bugay DE, Ranadive SA, Singh AK, Szyper M, Yaria SA, Brittain HG. Characterization of humidity-depen-dent changes in crystal properties of a new HMG-CoA reductase inhibitor in support of its dosage form development. Int J Pharm 1994 108 195-206. 

Preformulation in Solid Dosage Form Development, edited by Moji Christianah Adeyeye and Harry G. Brittain... 

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