Thermal characterization is proposed as analytical methodology for the purity assay of lapachol, and for determination of
the quality parameters of capsules containing this molecule. The TG data revealed that lapachol is more stable in the presence
of adjuvants, showing the good quality of the formulation. The kinetic parameters obtained were lower for lapachol drug than
for the formulated lapachol. The DSC data demonstrated good compatibility between lapachol drug and the adjuvant in the formulated
lapachol, and did not reveal impurities such as secondary products of the isolation and recrystallization processes. The data
were confirmed by the DSC-photovisual findings.
The compatibilities and stabilities of some binary mixtures and generic hydrochlorothiazide formulations were studied by using
TG, DSC and a DSC-photovisual system. The kinetic parameters were determined via the Arrhenius equations. Tablet B presented
higher compatibility and thermal stability than those of tablets A and C. The photovisual system demonstrated that the decomposition
of tablet A occurs before the melting point, due to the Maillard reaction between the hydrochlorothiazide and lactose present
in the formulation. The behaviour and rate constants of binary mixtures suggest that lactose can be substituted for microcrystalline
cellulose, MC(101), in tablet A. The DSC and TG data revealed different characteristics of compatibility and stability in
generic formulations from different manufacturers.
Authors:R. Macêdo, T. Gomes do Nascimento, and J. Veras
This study demonstrates the thermalanalysis applications in compatibility and stability studies of the propranolol binary
mixture sand tablets A and B. The propranolol binary mixtures were prepared in the laboratory and compared to the fully formulated
tablets using the thermogravimetric (TG) and calorimetric(DSC) methods. DSC of binary mixtures showed similar phase transition
to propranolol drug. The tablets phase transition decreased and there was no detectable significant interaction in propranolol–lactose
mixture and tablets. The DSC-photovisual test revealed an interaction similar to the Maillard reaction. The TG isothermal
study showed a difference in the profile between the drug and tablets due excipients quality and problems in manufacture process.
The kinetic parameters indicated a lower stability for the tablets than propranolol drug. The thermal techniques thermally
differentiated the propranolol preparations demonstrating the importance in the design development of pharmaceuticals solid-dosage
Authors:R. Macêdo, T. Gomes do Nascimento, C. Soares Aragăo, and A. Barreto Gomes
The present work reports studies of the thermal behaviour of some anti-hypertensive drugs. Their purities were determined
by DSC and specialized pharmacopeial methods. The activation energy values suggest the following sequence of satability: nifedipine>propanolol
hydrochloride>captoril. Analysis of the DSC data indicated that the degrees of purity of nifedipine, captopril and propanolol
hydrochloride were similar to those found by pharmacopeial methods BP 93 and USP 23. The simplicity, speed and low operational
costs of thermal analysis justify its application in the quality control of pharmaceutical drugs.