Abstract
The present study aimed to evaluate the pharmaceutical equivalence of propranolol hydrochloride tablets, through physical and physical-chemical quality tests such as weight variation, friability, assay, uniformity of dosage units, dissolution test and dissolution profile. A comparative study was carried out with tablets from three laboratories, designated as A (reference), B (generic) and C (similar), with two different and random batches. All products showed satisfactory results in pharmacopoeial quality tests, however, the results of the propranolol hydrochloride dissolution profiles of the samples B1, B2, C1 and C2 evidenced that, when compared to the reference A1, the similar medicines are not pharmaceutically equivalent, but when compared to the reference A2 only the generic medicine B2 was not considered pharmaceutically equivalent. The homogeneity lack between reference medicines batches can lead to mistakes in comparison to other brands.
Highlights
The present study aimed to evaluate the pharmaceutical equivalence of propranolol hydrochloride tablets, through physical and physical-chemical quality tests such as weight variation, friability, assay, uniformity of dosage units, dissolution test and dissolution profile
Resultado de variação de peso, friabilidade e teor de cloridrato de propranolol em comprimidos de 40 mg das amostras A, B e C, Lotes 1 e 2
Os valores individuais obtidos no teste de uniformidade de conteúdo das amostras que apresentaram F dentro dos intervalos anteriormente mencionados foram recalculados utilizando-se os respectivos fatores de correção (Tabela 2)
Summary
Foram avaliados comprimidos de cloridrato de propranolol 40,00 mg, adquiridos em farmácias comerciais provenientes de três empresas, sendo dois lotes distintos e aleatórios (1 e 2) de cada. As amostras foram designadas: A1 e A2 (medicamento referência), B1 e B2 (medicamento genérico) e C1 e C2 (medicamento similar). A substância química de referência utilizada foi o cloridrato de propranolol, padrão secundário (99,89%). Os reagentes utilizados foram de grau analítico (ácido clorídrico 1,0% e metanol) e água destilada
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