Formulation development of a stable solid oral dosage form of Valproic acid using colloidal silica
Keywords:
Valproic acid (VA), AEROSIL® 300 Pharma, AEROPERL® 300 Pharma, solid dosage from, GCAbstract
Valproic acid (VA) is a liquid drug used as an anticonvulsant. Although Valproic acid or its salts have known utility as anticonvulsants, a number of problems are associated in formulating them in a solid form. The aim of present study was to develop a stable solid dosage form for plain VA by a simple adsorption process Various solid and inert carriers like Soluplus®, Kollidon® VA 64, Magnesium oxide (MgO), AEROSIL®300 Pharma and AEROPERL® 300 Pharma were selected for the study. As desirable results were not obtained with Soluplus®, Kollidon® VA 64, Magnesium oxide (MgO). Further work was continued with silica AEROSIL® 300 Pharma and AEROPERL®300 Pharma. Maximum drug loading of 60% and 66.7% was achieved with VA: AEROPERL® 300 Pharma with a ratio of 1.5:1 and 2:1 for VA: AEROSIL® 300 Pharma. By characterization studies like flow property, FTIR, DSC, the optimized batch was found to show good flow property and absence of chemical interaction between drug and excipients. It was found by SEM study AEROPERL® 300 Pharma has better adsorption potential because of its granular nature and pearl like cavity. Drug content analysis of VA:Silica system by GC method showed high drug content uniformity with 104% VA. Dissolution study of developed capsule dosage revealed 100% drug release at the end of 90 min of dissolution. Optimized batches was kept for stability study at 25°C, 60% RH and 40°C, 75% RH for 3 months as per ICH guidelines. Stability study result was found to be uniform for the drug content and dissolution behaviour showed insignificant changes.
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