Dissolution testing pharmacopoeial

The test apparatus chosen for disintegration testing and dissolution testing should be one of those described in the Ph Eur unless another pharmacopoeial or a noncompendia method can be justified. The test conditions and the proposed release rates should be justified in terms of batch reproducibility. 

British Pharmacopoeial Commission. Dissolution test for tablets and capsules. In British Pharmacopoeia 1980. London Her Majesty s Stationary Office, 1980 A114. 

Poirier, H. Lewis, G.A. Shott, M.J. Stevens, H.N.E. Problems with a pharmacopoeial dissolution test using a binary medium. Drug Dev. Ind. Pharm. 1983, 9, 443 52. 

Agut et al. (2011) assessed the different technology transfer options and reported that within Sanofi-Aventis that option 1 (comparative testing) is the approach of choice for critical methodologies, i.e. assay, degradation products, and in some cases water content and dissolution. Option 2 (co-validation) is reserved for less-critical methodologies, i.e. residual solvents by gas chromatography (GC), water content, dissolution and particle size methods whereas, option 4 (transfer waiver) is restricted to pharmacopoeial compendial methods, i.e. appearance, pH, particulate matter, etc. 

Pharmacopoeial applications include assays for single drugs and mixtures of drugs, analyses involving colour reactions (colorimetric methods), tests for tablet dissolution, limit tests for impurities, and assays of bulk drugs or an extract thereof. Further applications are for physicochemical measurements, such as pK or velocity constants in enzymatic reactions. The scope of such applications has been significantly extended by methods which can confer additional specificity, namely difference spectrophotometry and derivative spectrophotometry. 

Nevertheless, the problem of pellicle formation and eventual fall in dissolution rate is still of concern, as the drug bioavailability may be influenced if there is a severe challenge. There is a report where exposure of phenytoin capsules to high humidities resulted in poor dissolution as well as destruction of clinical efficacy. Moreover, the enzyme test is not official in pharmacopoeias other than USP and the products stand a chance of being recalled, if the normal pharmacopoeial dissolution limits are not met. 

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