Desenvolvimento de suspensão oral de hidroclorotiazida para uso em pediatria

Abstract

Hydrochlorothiazide (HCTZ) is widely used in children for the treatment of hypertension and edematous diseases. In Brazil, there is no suitable dosage form for pediatric needs and it is available only in the form of tablets. As is known, the liquid dosage forms are ideal for pediatrics, therefore the aim of this study is the pharmaceutical transformation of the 25 mg HCTZ tablets in suspensions and to perform its quality control. The physicochemical characterization of the tablets was made according to the Brazilian Pharmacopoeia. The tablets were within specifications with respect to the content (103.74%), to the weight variation and identification. The accelerated degradation was carried out in acidic, basic, oxidant and aqueous mediums, at temperature of 50 °C. HCTZ showed similar stability in acidic and aqueous mediums and a lower stability in basic and oxidant mediums. A suspension from the raw material and another from the tablets were produced. Half of each suspension was stored under refrigeration, the other half at room temperature. The suspensions were evaluated for content by spectrophotometry, pycnometry density, velocity of sedimentation, pH in potentiometer, rheological behavior in rotational viscometer and the identification of the active suspensions was performed by thin layer chromatography. Within 60 days, the suspensions showed some degree of stability. Since this is an extemporaneous suspension, this period of chemical stability was considered satisfactory. Suspensions of tablets showed greater density than the suspensions of raw material, but all showed good stability. With regard to viscosity, all suspensions presented characteristics of a pseudoplastic fluid, and the suspension from tablets stored under-cooling showed greater physical stability. The pH of the raw material suspensions varied between 5.5 and 6.0, while the pH of the suspensions of tablets ranged between 6.5 and 7.0. Both suspensions showed low sedimentation rate, but the one from tablets had a higher amount of sediment. This study showed that it is technically feasible to produce suspensions of hydrochlorothiazide from tablets and that GUTE is an excellent vehicle for pharmaceutical suspensions, as it provides physical stability and does not affect the analysis of the physicochemical quality control.