Biopharmaceuticals disintegration

The Committee decided that in cases where the disintegration time is less than 10 minutes (non-rifampicin-containing products), a dissolution test would normally not be necessary depending on the biopharmaceutics classification system (BCS) category. 

Drug materials administered orally are required to dissolve in the GI fluids before absorption can take place. Dissolution occurs most rapidly from the primary particles of the drug substance, hence the importance of rapid disintegration to this state. However, disintegration studies only demonstrate that a tablet will break up when immersed in fluid there are many other factors that can influence the dissolution of a material. A carefully designed dissolution test will, therefore, be a better indication of the performance of a dosage form. The design of dissolution tests and the correlation between in vitro dissolution and in vivo performance is discussed in Chapter 7, Biopharmaceutical Support in Formulation Development . The optimisation of the dissolution of a substance is discussed in Chapter 8. 

There are two major functional classifications of tablet excipients. The first class includes those additives which affect the compressional characteristics of the tablet, including diluents, binders and adhesives, lubricants, antiadherents, and glidants. The second class of excipients includes those which affect the biopharmaceutics, chemical and physical stability, and marketing considerations of the tablet. This category includes disintegrants, colors, flavors and sweeteners, and miscellaneous components such as buffers and adsorbents. All of these must meet certain criteria as follows ... 

Gebre-Mariam, T., WinnemoUer, M. Schmidt, P.C. (1996a) An evaluation of the disintegration efficiency of a sodium starch glycolate prepared from Enset starch in compressed tablets, European Journal of Pharmaceuticals and Biopharmaceuticals, 43, 124-32. 

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