Oral dosage form evaluation

Waiver of in vivo bioavailability and bioequivalence studies for immediate release solid oral dosage forms based on a biopharmaceutics classification system. Center for Drug Evaluation and Research, Food and Drug Administration, issued 8/2000, posted 8/31/2000. http //www.fda.gov/cder/guidance/ index, htm... 

U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). Guidance for Industry Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. 2000. 

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

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

For formulations not meeting the criterion for very fast release of drug substance, similarity of profiles may be evaluated by model-independent or model-dependent methods as stated in the Guidance for Industry—Dissolution Testing of IR Solid Oral Dosage Forms (1,2). 

FDA. Guidance for Industry. Dissolution Testing of Immediate Release Solid Oral Dosage Forms. Rockville Center for Drug Evaluation and Research, 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. 

Large animal models represent a more costly yet valuable tool in the evaluation of the gastrointestinal absorption of oral dosage forms. The dog has been considered by many groups as a popular model, despite considerable differences in physiology of the GIT compared to humans (Gardner et al. 

As noted earlier, this chapter is focused on the design and evaluation of oral dosage forms. A few thoughts are provided to introduce some of the different biopharmaceutical issues that confront the design of some nonoral dosage forms. 

Solid oral dosage forms containing new chemical entities (NCEs) are commonly formulated into tablets or capsules as their first market image formulation. Subsequent drug product line extension development on these NCEs may evaluate more specialized drug delivery systems. Dissolution testing of standard oral tablets or capsules will commonly utilize the paddle or basket apparatus. In this chapter we focus primarily on the development and subsequent validation of dissolution testing methods that use these two devices. 

A systematic approach should be adopted in the presentation and evaluation of the stability information, incorporating, as appropriate, results from the physical, chemical, biological, and microbiological tests, including particular attributes of the dosage form (e.g., dissolution rate for solid oral dosage forms). 

For the pharmaceutical product development scientist, there is clearly a need for objective information about the practical performance of different excipients and their various grades. In this chapter we set out to bring together the results of some of our ongoing evaluations of the physical and mechanical properties of excipients commonly used for the manufacture of solid oral dosage forms. In this particular article, we have chosen to focus on the fillers that are most commonly used in the manufacture of immediate release tablets microcrystalline cellulose (MCC), lactose, calcium phosphate, and mannitol (1). 

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