DISSOLUTION PROFILE STUDY FOR INNOVATION ANTI-RETROVIRAL DRUG PRODUCT NIKAVIR® AND ITS FIXED COMBINATION WITH LAMIVUDINE (PHOSPHALADINE®)
Abstract
Biopharmaceutical solubility was experimentally determined for innovation anti-retroviral API phosphazide (Nikavir®) which was classified as BCS Class 3 drug. Dissolution profile test for Nikavir® 200 mg and 400 mg in three media pH 1.2, 4.5, 6.8 was conducted, and equivalence for both dosages was shown. Also dissolution profile test for phosphazide and lamivudine fixed combination 150 mg + 400 mg (Phosphaladine®) was performed in three media pH 1.2, 4.5, 6.8 against two reference drug products Nikavir® 400 mg and Epivir® (lamivudine) 150 mg. Dissolution profiles for lamivudine were equivalent in all three media, and phosphazide profiles were equivalent in pH 1.2. Studied batch of phosphazide and lamivudine fixed combination was recommended to be a clinical biobatch for further BE studies.
About the Authors
I. E. Shohin
Center of Pharmaceutical Analytics Ltd.;
FSBIS SCBMT FMBA
Russian Federation
Russian Federation
Yu. V. Medvedev
Center of Pharmaceutical Analytics Ltd.;
I.M. Sechenov First Moscow State Medical University
Russian Federation
Russian Federation
T. N. Komarov
Center of Pharmaceutical Analytics Ltd.
Russian Federation
Russian Federation
O. V. Klimova
I.M. Sechenov First Moscow State Medical University
Russian Federation
Russian Federation
B. V. Brovchenko
LLC «AZT PHARMA K.B.»
Russian Federation
Russian Federation
References
1. Регистр лекарственных средств России: РЛС. Энциклопедия лекарств. URL: http://www.rlsnet.ru/mnn_index_id_3057.htm (дата обращения 11.04.2016).
2. Электронная версия справочника «Регистр лекарственных средств России». URL: http://www.rlsnet.ru/mnn_index_id_2338.htm (дата обращения 11.04.2016).
3. United States Pharmacopoeia 38-NF 33.
4. The Japanese Pharmacopoeia 16. 2007.
5. Инструкция по медицинскому применению препарата Никавир®.
6. S. Strauch et al. Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Lamivudine // Journal of Pharmaceutical Sciences. 2011. V. 100. № 6. P. 2054-2063.
Review
For citations:
Shohin I.E., Medvedev Yu.V., Komarov T.N., Klimova O.V., Brovchenko B.V. DISSOLUTION PROFILE STUDY FOR INNOVATION ANTI-RETROVIRAL DRUG PRODUCT NIKAVIR® AND ITS FIXED COMBINATION WITH LAMIVUDINE (PHOSPHALADINE®). Drug development & registration. 2016;(2):136-145. (In Russ.)
Views:
975
Email this article 