DOI: https://doi.org/10.22263/2312-4156.2026.3.105
V.B. Klimashevich, A.I. Zhebentyaev, V.A. Beznosik
Comparative analysis of physicochemical characteristics of ranolazine substances
State Enterprise “AKADEMFARM”, Minsk, Republic of Belarus
Vestnik VGMU. 2026;25(3):105-114.
Abstract.
This paper presents a comparative analysis of the physicochemical properties of the following ranolazine substances: ranolazine base (India), ranolazine base Unichem (India), and ranolazine dihydrochloride B&K Technology Group (China). Microscopic examination of the substances was conducted, pharmaceutical and technological characteristics were determined, particle size distribution (X10, X50, X90) was established, biopharmaceutical solubility was determined in the physiological pH range from 1.2 to 6.8, and hygroscopicity was assessed. A method for particle size determination using laser diffraction has been developed: the optimized air pressure (factor x1) was 3.5 bar, and the optimized feed rate (factor x2) was 40%. The optical concentration (Copt) value was used as the response (Y). Biopharmaceutical solubility studies revealed that ranolazine dihydrochloride exhibits high biopharmaceutical solubility across the entire pH range studied, placing it within Class I of the biopharmaceutical classification system. The biopharmaceutical solubility of ranolazine base manufactured by Cipla and Unichem is high in dissolution media with pH 1.2 and 4.5, but low in a dissolution media with pH 6.8. According to these data, ranolazine base from these manufacturers is classified as a Class II compound of the biopharmaceutical classification system. Based on the need to level out differences in the physicochemical characteristics of substances in order to achieve equivalence with the original drug, ranolazine base substances manufactured by Cipla (India) and Unichem (India) are recommended for the development of a generic prolonged-release drug “Ranolazine-NAN, 500 mg”.
Keywords: ranolazine base, ranolazine dihydrochloride, biopharmaceutical solubility, dose number, hygroscopicity, particle size.
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Submitted 25.05.2026
Accepted 19.06.2026
Information about authors:
Viktoriya B. Klimashevich – leading technologist of the Laboratory of Finished Dosage Forms Technology of the Research and Development Department, State Enterprise “AKADEMFARM’’, e-mail: Этот адрес электронной почты защищён от спам-ботов. У вас должен быть включен JavaScript для просмотра.;
A.I. Zhebentyaev – Doctor of Pharmaceutical Sciences, professor;
V.A. Beznosik – chemist of the Pharmaceutical Research Laboratory, State Enterprise “AKADEMFARM’’.
