Open AccessAlternative Methods for Dissolution Profile Comparison in the Dissolution Test
Author(s) -
Д. П. Ромодановский,
Д. В. Горячев
Publication year - 2021
Publication title -
razrabotka i registraciâ lekarstvennyh sredstv
Language(s) - English
Resource type - Journals
eISSN - 2658-5049
pISSN - 2305-2066
DOI - 10.33380/2305-2066-2021-10-4-197-207
Subject(s) - dissolution , equivalence (formal languages) , dissolution testing , similarity (geometry) , mathematics , computer science , comparability , statistics , data mining , chemistry , artificial intelligence , biopharmaceutics classification system , discrete mathematics , combinatorics , image (mathematics)
. The article discusses the problem of assessing the similarity of the dissolution profiles of two batches of the nebivolol. The use of a generally accepted similarity factor for assessing equivalence is unacceptable in some cases, for example, for drugs with a high variability in the values of the release of the active substance from the formulation. At the same time, at present, there are no generally accepted approaches to comparing the profiles of the dissolution kinetics of drugs, with the exception of the method for assessing the comparability of profiles based on the mathematical calculation of the similarity factor f2, which has certain criteria that limit its application. Aim. To demonstrate alternative methods for assessing the similarity between the dissolution profiles of two drugs using a practical example. Materials and methods . The results of the comparative dissolution test of two series of nebivolol at a dosage of 5 mg. Five model-independent methods for assessing the equivalence of drug dissolution were used. Statistical data processing was performed using Microsoft Excel software. Results and discussion . The paper presents a practical example of using five alternative model-independent methods for assessing the equivalence of the dissolution profile. An example is used to illustrate the proposed equivalence limits and statistical methodology. Also, various approaches to determining the boundaries of equivalence have been proposed to assess the similarity of the dissolution profiles of an active substance. Conclusion. According to the results of the comparative dissolution test of two batches of nebivolol, it was shown that the use of the similarity factor as a criterion for assessing dissolution profiles led to a false positive result. In such cases, the possibility of using alternative methods for assessing the equivalence of dissolution profiles described in the article, or other methods presented in the scientific literature, should be considered, with a justification of their acceptability in each specific case.