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Development and standardization of capsules and tablets containing Calendula officinalis L. hydroethanolic extract.

2018; Volume: 46; Issue: 1 Linguagem: Inglês

0370-5943

Helison de Oliveira Carvalho, L. D. M. Góes, N. M. B. Cunha, Ana Ferreira, Caio P. Fernandes, Hugo Alexandre Silva Favacho, J. O. C. Silva, Brenda Lorena Sánchez-Ortíz, Andrés Navarrete, José Carlos Tavares Carvalho,

Pomegranate: compositions and health benefits

Due to the importance of Calendula officinalis L. as a medicinal plant extensively used in traditional medicine around the world, this study aimed to develop and standardize solid pharmaceutical forms (capsules and tablets) from granulated containing Calendula officinalis L. hydroethanolic extract (CoHEE), and outline the profile of dissolution and release of its phytochemical-pharmacological marker (flavonoids). The analyses of the granulated by Scanning Electron Microscopy (SEM) showed a mix of homogeneous granules of irregular and semi-spherical surfaces, with a predominance of sizes of 180-250 uM from 10 to 37%. The quality control of pharmaceutical forms, as the average weight, disintegration test, hardness and thickness were satisfactory according to specifications of the Brazilian Pharmacopoeia. The dissolution profiles of the capsules and the tablets were effective in both dissolution media, hydrochloric acid buffer and distilled water. The distilled water was more effective for the release of flavonoids, with maximum release level of 7.64 % (0.0013 mg/mL) for tablets. The hydrochloric acid buffer medium showed maximum release of 4.7% (0.0008 mg/mL) of flavonoids (capsules). Therefore, it is concluded that the methods employed to obtain the granulated with further achievement of capsules and tablets were effective for maintain a standard of quality and guarantee the dissolution profile and the release of the appropriate phytochemical-drug marker, and a possible standard pharmacological effect in terms of reproducibility and efficiency.