Abstract
The aim of this work is to present the two one-sided test (TOST) as an alternative approach to compare dissolution profiles of extended-release dosage forms. The dissolution profiles of oxycodone extended-release tablets containing 10 mg, 20 mg and 40 mg (reference and generic) were evaluated according to the requirements described in United States Pharmacopeia. These dissolution profiles were compared using the conventional similarity factor (f2) and the proposed TOST as an equivalence test. TOST is a simple and alternative approach to compare dissolution profiles of extended-release dosage forms. It allows us to identify the time-point (or time-points) that did not show similarity. We concluded that the two one-sided test performed at a significance level of 5% and defined as D = 10 showed results comparable to those obtained by the conventional similarity factor (f2).
Highlights
The absorption of a solid dosage form after oral administration depends on three factors: the release of the substance taken, the dissolution of the drug under physiological conditions and the permeability across the gastrointestinal tract
The similarity factor (f2) is a logarithmic reciprocal square root transformation of the sum of squared error and works as a measurement of the similarity in the dissolution percentage between the two curves (FDA, 1997). This model independent method becomes the most suitable for dissolution profile comparison when the following recommendations are taken into account: (a) five or more dissolution time points must be available; (b) dissolution measurements of the test and reference batches must be made under the same conditions; (c) only one measurement must be considered after an 85% dissolution of both products; (d) the use of a mean will only be possible if the relative standard deviation (RSD) at the earlier time points is not superior to 20% and to 10% at other time points (FDA, 1997; O’Hara et al, 1998; Shah et al, 1998)
Equivalence was tested by the determination of 90% confidence intervals based on the standard deviations obtained from the results of each time-point of the dissolution profiles
Summary
The absorption of a solid dosage form after oral administration depends on three factors: the release of the substance taken, the dissolution of the drug under physiological conditions and the permeability across the gastrointestinal tract. The similarity factor (f2) is a logarithmic reciprocal square root transformation of the sum of squared error and works as a measurement of the similarity in the dissolution percentage between the two curves (FDA, 1997) This model independent method becomes the most suitable for dissolution profile comparison when the following recommendations are taken into account: (a) five or more dissolution time points must be available; (b) dissolution measurements of the test and reference batches must be made under the same conditions; (c) only one measurement must be considered after an 85% dissolution of both products; (d) the use of a mean will only be possible if the relative standard deviation (RSD) at the earlier time points is not superior to 20% and to 10% at other time points (FDA, 1997; O’Hara et al, 1998; Shah et al, 1998). The two one-sided test has been employed in the assessment of pharmaceutical equivalence (Lourenço, Pinto, 2012)
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