Solid pharmaceutical dosage forms immediate release

Hussain AS. A collaborative search for efficient methods for ensuring unchanged product quality and performance during scale-up of immediate release solid oral dosage forms. In Michael Levin ed. Pharmaceutical Process Scale-Up. Marcel Dekker, Drugs and the Pharmaceutical Sciences, Volume 118, 2002. 

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). 

Food and Drug Administration CDER, Guidance for industry waiveinofivo bioavailability and bioequivalence studies for immediate release solid oral dosage forms based on a bio pharmaceutics classi cation system, 2000. 

Becker, C., Dressman, J.B., Amidon, G.L., Junginger, H.E., Kopp, S., Midha, K.K., Shah, V.P., Stavchansky, S. and Barends, D.M. (2008) Biowaiver monographs for immediate release solid oral dosage forms pyrazinamide. Journal of Pharmaceutical Sciences, 97 (9), 3709-3720. 

Proposal to waive in vivo bioequivaience requirements for the WHO Model List of Essential Medicines immediate release, solid oral dosage forms. In WHO Expert Committee on Specifications for Pharmaceutical Preparations. 

Workshop Report Scale up of Immediate Release Oral Solid Dosage Forms, Pharmaceutical Research, 10 (2) 313-16, Skelly et al. 

Same pharmaceutical form. Oral solid pharmaceutical forms of immediate release, such as tablets and capsules, are regarded as the same dosage form. 

The BCS is a scientific framework for classifying active pharmaceutical ingredients based upon their aqueous solubility and intestinal permeabihty. When combined with the dissolution of the pharmaceutical product, the BCS takes into account three major factors that govern the rate and extent of drug absorption (exposure) from immediate-release oral solid dosage forms dissolution, solubility, and intestinal permeability. 

Combining the dissolution of the pharmaceutical product with these two properties of the API, takes the three major factors that govern the rate and extent of drug absorption from immediate-release solid dosage forms into account (27). On the basis of their dissolution properties, immediate-release dosage forms can be categorized as having very rapid , rapid , or not rapid dissolution characteristics. 

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