Comparative Study of the In-Vitro Dissolution Profile of Griseofulvin Tablets Formulated with Kolliphor HS-15, Sodium Lauryl Sulphate and PEG 4000

Abstract

Objective: Griseofulvin, an antifungal drug belongs to the class II of the Biopharmaceutical Classification System (BCS). It has the characteristics of poor aqueous solubility and good lipid permeability. Attempts have been made severally to improve the solubility and hence release of griseofulvin from different dosage forms. The study aimed to evaluate the effect of the different surfactants- Kolliphor® HS-15 (KHS 15), Sodium lauryl sulphate (SLS) and Polyethylene glycol (PEG) 4000 on the in-vitro dissolution and release of griseofulvin from compressed tablets. Method: Griseofulvin tablets were formulated with different concentrations of the surfactants and a control batch without surfactants using the wet granulation method. Dissolution test was carried out on the formulated tablets in 1000ml of 80% methanol. Comparisons were made amongst the dissolution profiles of the formulated tablets and a commercial brand using model dependent and independent methods. MANOVA was used in the analysis of percent drug release of the tablets.Result: All the different methods of comparing in-vitro dissolution are important. The tablets formulated with surfactants had better dissolution profiles than the control batch. Tablets containing PEG 4000 exhibited the best dissolution. The PEG 4000 containing tablet batches exhibited anomalous mechanism of drug release while the other batches of griseofulvin tablets including the commercial brand all exhibited quasi- Fickian mechanism of drug release.Conclusion: PEG 4000 containing tablets had the best dissolution profile. At the concentrations used, SLS and Kolliphor® HS 15 only had marginal improvement of griseofulvin dissolution compared with the control batch.