Comparison of In-vitro Dissolution Profiles – An Overview

P. Kumar and B. Mishra

Abstract: Dissolution testing has been recognized as an important element in drug development and quality assessment of pharmaceutical products. In- vitro dissolution testing is one of the primary USP/ NF test that is performed to ensure that a drug product meet the USP/NF standards of identity, strength, quality, purity, stability and reproducibility. For drug products with minor post-approval changes, the US FDA SUPAC (scale-up and post-approval changes) guidelines indicate that in-vitro dissolution testing with profile comparison can be used as a surrogate for in-vivo bioequivalence testing. In addition, the general bioavailability and bioequivalence guidance allows biowaivers for lower strength (s) of immediate release as well as modified release drug products based on formulation proportionality and dissolution profile comparison. The comparison of dissolution profiles is considered to be very critical test for assessing the performance of a drug product. Dissolution profiles of two drug products can be compared by various model independent methods (i.e. mean dissolution time, similarity and difference factor, sampling time) reported in literature. This review article gives an overview of various model independent approaches used for comparing dissolution profiles with their merits, demerits and applications in pharmaceutical industries.

In vitro dissolution has been recognized for the past two decades as an important tool both in drug development and quality assessment of the pharmaceutical dosage forms. Release of drug and its further dissolution from the solid dosage forms often constitute a determining step in the in vivo absorption process and is thus used in conjunction with in-vivo/in-vitro correlations to establish quality control parameters. This is especially relevant in checking batch to batch consistency in clinical trials, bioavailability and routine production. In the development of a new product, dissolution testing can aid in drug release modeling, e.g. through selection of excipients, optimization of the manufacturing process, scale-up, and formulation of test products matching desired dissolution characteristics. It may also be used to determine the long term stability of a dosage form and assess the impact of post-approval changes in the manufacturing process.

The dissolution method and specification are set by considering the solubility, permeability, dissolution, and pharmacokinetic of drug substances. Three categories of dissolution test specification for immediate release dosage forms are described in the guidance provided by the Centre for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) (i) single point specification, (ii) two-point specification, (iii) dissolution profile comparison. Though the ‘point estimates’ approach is suitable for drug product containing substances with high solubility and high permeability, it may not be adeq uate for drugs with low solubility or products with modified release characteristics. In these situations, sometimes the drug products with inherently different dissolution profiles may inadvertently lead to the declaration of similar dissolutions. The dissolution profile comparison seems to be more precise than the point estimate approach to characterise the drug product.


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