Avaliação da Água boricada para aplicações oftalmológicas

AUTOR(ES)
DATA DE PUBLICAÇÃO

2005

RESUMO

Boric acid solution can be presented as non-sterile solution, whose ophthalmic application is one of several others. However, according to pharmacopoeial monographs, solutions for ophthalmic use have to be sterile, for preventing the risk of serious ophthalmic infections. In order to verify the consumption level and the product commerce, two investigation protocols were applied, either for consumers or pharmacies and drugstores. To evaluate the quality of boric acid solution for ophthalmic use and its risks for the users, 47 samples were analyzed, from 25 manufacturers distributed in 7 Brazilian States, evaluating requirements such as packaging (material, inviolability, volume contained), labeling (period of validity, formulation, therapeutic indications and any other relevant information), microbiological tests (counting of total viable cells and pathogens research), physiochemical (pH and content of boric acids) and visual aspect (clarity). Intrinsic antimicrobial activity was also evaluated on 4 samples prepared in the laboratory (using distilled and deionized water, either in acid or neutral medium). Investigation protocols indicated that boric acid solution is a very popular drug for ophthalmic use, largely merchandised in Brazil. Relevant differences were shown in packaging and labeling of the products; 63,83% of the analyzed samples presented non-conformity to one or more pharmacopoeial requirements for ophthalmic solutions. Significant differences were evidenced among the 4 samples produced at the laboratory for antimicrobial activity. These results point out the need of controlling the production and commerce of boric acid solutions, since the use of non-conformity products present a serious risk of ocular damage.

ASSUNTO(S)

engenharia medica oftalmologia engenharia biomédica medicamentos - efeitos colaterais Ácido bórico

ACESSO AO ARTIGO

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