Standardization of the excipients in gelatine capsules hard of dry extract of valerian (Valeriana officinalis) produced in the Living Pharmacy Project in Sobral, CE, Brazil

Abstract

The Living Pharmacy Project is the first pharmaceutical social assistance project developed in Brazil based on the scientific use of medicinal plants. Among the standardized formulations in hard gelatin capsules, stands out the dry extract of valerian. The formulation of these capsules requires an addition of excipients, which play a major role in the quality, safety, and efficacy of the drug. The purpose of this study was to standardize the excipients for capsule formulations produced in the Living Pharmacy Project. A bibliographic review was conducted, about excipients and herbal medicines, as well an analysis on the package leaflet of the medicines. Thirty capsules of the valerian herbal extract were produced and subjected to quality control to evaluate the average weight variation, including the coefficient of variation and standard deviation, and the variation in the theoretical contents of the capsules. The suggested excipients for using in the valerian formulation were: magnesium stearate (0.5 %) as a lubricant, colloidal silicon dioxide (1 %) as a glidant, pharmaceutical talc (1 %) as adsorbent, pharmaceutical starch (73 %) as a hydrophobic diluent, and lactose monohydrate (24.5 %) as a hydrophilic diluent. All quality
control results met the Brazilian Pharmacopoeia specifications.