Biopharmaceuticals formulation factors, dissolution

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. 

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