COMPATIBILITY AND STABILITY STUDIES OF ANTIHYPERTENSIVE/EXCIPIENTS BY THERMAL METHODS, USED IN THE PREFORMULATION PHASE
ANCA MOISEI1, FELICIA GLIGOR1*, MARIUS BOJIŢĂ2, ADRIANA CHIŞ1, MARIA TOTAN1, LOREDANA ANDREEA VONICA-GLIGOR1, ADRIANA CIURBA3
1.“Lucian Blaga” University, Sibiu
2.“Iuliu Haţieganu” University of Medicine and Pharmacy, Cluj-Napoca
3.University of Medicine and Pharmacy of Tîrgu Mureş, Romania
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The objective of this study was to investigate the quality of the interactions
between the active antihypertensive substances and the possible excipients in order to guide
the preformulation process of a triple layered tablet. The active substances chosen were
Candesartan Cilexetil (CC), Amlodipine Besylate (AB), Hydrochlorothiazide (HCTZ) and
the excipients were Croscarmellose sodium (AcDiSol), Magnesium Stearate (StMg), and
Colloidal silica (Aerosil).
For this purpose we studied the thermal behaviour (differential scanning
calorimetry - DSC and thermogravimetry -TG) of CC, AB, HCTZ and the possible
excipients Aerosil, AcDiSol, StMg and of the binary mixtures active pharmaceutical
ingredient (API) - excipient.
The study was performed at T0 (initial moment) and at different time intervals (1
month, 2 months, 3 months, 6 months and 12 months) under normal temperature and
humidity conditions and under accelerated degradation conditions.