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Evaluation of innovated formula of Bisacodyl suppository following the dissolution profile and stability data by using developed HPLC method

Esraa G. Jabar, Hassanien S. Taghi, Kahtan J. Hasson, Ihab I. Alkhalifa


Objective: Bisacodyl is a laxative drug, used in the treatment of constipation. It is soluble in mineral acids but it is practically insoluble in distilled water, therefore; dissolving of Biscodyl in alkaline medium is a very difficult task. So, the objective of this study was to develop a proper dissolution method for a new formulation of the Bisacodyl suppositories in a rectal-simulated medium. Most of the preparation products of bisacodyl suppositories will produce low percentages of dissolution in the alkaline phosphate buffer (pH 7.2).  Methods: Complex preparation inclusion of Bisacodyl with the solubilizing agent beta-cyclodextrin will be integrated into the suppository base. A developed and validated HPLC method has been carried out for quantitative analysis of Bisacodyl in the suppositories. Results: The dissolution rates for the innovative formula of Bisacodyl suppositories were about 97.5 percent and the stored suppositories of this formulation retained their defined physical and chemical properties along with the actual stability test.  Conclusion: The application of Bisacodyl's inclusion complexation technique (Innovated formula) in the development of suppositories with Beta-cyclodextrin increases the rate of dissolution and enhances the stability of the efficiency of suppositories‎.

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