Preparation and quality evaluation of divided medicinal powders containing captopril for pediatric use

Abstract

Background: Pediatric patients require different dosage forms from adults due to differences in swallowing capacities, taste preferences, and dosage requirements. Most medicines are produced for adults as capsules and tablets. These formulations are not suitable for children, which often leads to off-label and unlicensed use of adult medicines. These preparations are often prescribed by pediatricians due to the absence of others replace them. In this context, consider the drug preparation in another pharmaceutical dosage form is the responsibility of the pharmacist.

Objectives: the aim of the present study was to design solid dosage forms containing captopril for prior solubilization in small volumes of water before administration. Solid dosage forms are more stable than liquids and the reconstituted solutions can be sweetened and flavored

Methods: quality control tests were performed in the captopril and in the each batch of dosage forms in accordance with official and validated methods. The formulations were compounded by geometric dilution.

Results: captopril complied with the pharmacopoeial requirements (aspect, identification, pH, solubility, and melting point). The use of compressible sucrose and sorbitol as singles diluents, as well as the combination thereof with lactose M200, originated solutions clear, without particles in suspension, and sweetened. The divided powders were approved in the quality assays (average weight, dose uniformity and drug content).

Conclusions: according with the results, it was possible to prepare medicated powders containing 6.25 mg of captopril, with intention to minimize the lack of existing antihypertensive pediatric formulations in the national market.