Abstract
Aims & Objectives: Sildenafil citrate is employed for pulmonary arterial hypertension treatment in neonates and children. In Brazil, the drug is only available as tablets. The pharmaceutical derivation (trituration and dilution) is performed in order to fractionate doses and obtain a liquid presentation capable to be taken by children. Nurses and pharmacists commonly perform sildenafil citrate pharmaceutical derivation and there is lack of evidences regarding stability. The aim of this study was to verify the pH of crushed sildenafil citrate tablets after dissolution with five diluents. Methods: Experimental study developed under controlled environmental conditions. Tablets of 25 mg of sildenafil citrate, from the same manufacture and batch number, were crushed and diluted in 20 ml of each diluent (distilled water, mineral water, grape juice, apple juice and whole milk), dissolved in vortex magnetic stirrer before pH analysis (pH analyzer Kasvi, China), and measured in triplicates. Data obtained is presented according to mean and standard deviation. Results: The pH of the studied solutions were: distilled water 6.55(±0.36), mineral water 5.09(±0.11), grape juice 3.30(±0.02), apple juice 3.76(±0.02) and whole milk 6.58(±0.04). After pharmaceutical derivations the pH of sildenafil citrate in distilled water 4.88(±1.18); in mineral water 4.96(±0.66); grape juice 3.41(±0.07); apple juice 3.99(±0.16) and whole milk 6.34(±0.16). The sildenafil citrate tablets were not completely dissolve in grape juice.Conclusions: The pH of sildenafil citrate solutions presented variation from 3.41 to 6.34. The future direction of the study is this analyses of sildenafil citrate pharmacology stability in different solutions.
Published Version
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