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Molecules 2014, 19(10), 16824-16836;

Quality Evaluation of Pharmaceutical Formulations Containing Hydrochlorothiazide

Departamento de Ciências da Saúde, Centro Universitário Norte do Espírito Santo, UFES, Rodovia BR 101 Norte, km 60, 29932-540 São Mateus, ES, Brazil
Departamento de Química, Universidade Federal de Minas Gerais, Av. Pres. Antônio Carlos, 6627-31270-901 Belo Horizonte, MG, Brazil
Author to whom correspondence should be addressed.
Received: 23 July 2014 / Revised: 13 October 2014 / Accepted: 15 October 2014 / Published: 20 October 2014
(This article belongs to the Section Medicinal Chemistry)
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Hydrochlorothiazide is a diuretic used to treat hypertension that belongs to class IV of the Biopharmaceutics Classification System. The drug was evaluated by quality control, thermal characterization tests, and pharmaceutical formulation compatibility studies. It was concluded that the generic drug, Lab 2, was not a pharmaceutical equivalent. The compounded drugs, Lab 5 and Lab 6, produced unsatisfactory but expected results, since there is no requirement for dissolution and dissolution profile testing for the commercialization of these products. In a compatibility study, lactose and mannitol were shown to be incompatible with HCTZ, which may explain the lack of equivalence of the generic pharmaceutical product, associated with other situations. View Full-Text
Keywords: hydrochlorothiazide; quality control; dissolution profile; polymorphism hydrochlorothiazide; quality control; dissolution profile; polymorphism

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de Oliveira, M.A.; Yoshida, M.I.; Silva, D.C.G.M. Quality Evaluation of Pharmaceutical Formulations Containing Hydrochlorothiazide. Molecules 2014, 19, 16824-16836.

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