EVALUATION OF INNOVATED FORMULA OF BISACODYL SUPPOSITORY FOLLOWING THE DISSOLUTION PROFILE AND STABILITY DATA USING DEVELOPED HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD
Objective: Bisacodyl is a laxative drug used in the treatment of constipation, it is soluble in mineral acids, but it is practically insoluble in water. Therefore, it is very hard task to dissolve bisacodyl in alkaline medium so the objective of this study was the development of proper dissolution method for a new formulation of bisacodyl suppositories in a medium simulated to rectal region. Obviously, most of the bisacodyl suppositories preparation products will yield low percentages of dissolution in the alkaline medium of phosphate buffer pH 7.2.
Methods: Preparation inclusion complex of bisacodyl with the solubilizing agent beta-cyclodextrin then incorporated in a suppository base. The quantitative analysis of bisacodyl in suppositories was carried by a developed and validated high-performance liquid chromatography method.
Results and Discussion: The dissolution rates for the innovated formulation of bisacodyl complexed with beta-cyclodextrin suppositories were in average of 97.5% and the stored suppositories of this formulation maintained their specified physical and chemical properties along the real stability study.
Conclusion: The application of the inclusion complexation technique of bisacodyl with beta-cyclodextrin in the production of suppositories enhances the dissolution rate and improves the stability of suppositories performance.
2. Flig E, Hermann TW, Zabel M. Is bisacodyl absorbed at all from suppositories in man? Int J Pharm 2000;196:11-20.
3. Nugent SG, Rampton DS, Kumar D, Evans DF. Intestinal luminal pH in inflammatory bowel disease: Possible determinants and implications for therapy with aminosalicylates and other drugs. Gut 2001;48:571-7.
4. Park SH, Choi HK. The effects of surfactants on the dissolution profiles of poorly water-soluble acidic drugs. Int J Pharm 2006;321:35-41.
5. Hargoli S, Farid J, Azarmi SH, Ghanbarzadeh S, Zakeri-Milani P. Preparation and in vitro evaluation of naproxen suppositories. Indian J Pharm Sci 2013;75:143-8.
6. Othman S, Muti H. The effect of bases and formulation on the release of indomethacin from suppositories. Drug Dev Ind Pharm 1986;12:1813-31.
7. Hasson KJ. Complexation of diclofenac sodium with hydroxy propyl betacyclodextrin improves its solubility and stability in ampoule solution which is determined by HPLC. J Pharm Res Reviews 2018;16:1-9.
8. Sambasevam KP, Mohamad S, Sarih NM, Ismail NA. Synthesis and characterization of the inclusion complex of ?-cyclodextrin and azomethine. Int J Mol Sci 2013;14:3671-82.
9. Holvoet C, Heyden YV, Plaizier-Vercammen J. Inclusion complexation of lorazepam with different cyclodextrins suitable for parenteral use. Drug Dev Ind Pharm 2005;31:567-75.
10. Rivai H, Pratama N, Asra R. Development and validation of bisacodyl analysis method in tablet with absorbance method and area under curves method in ultraviolet spectrophotometry. Int J Pharm Sci Med 2017;2:1-8.
11. Bradshaw KM, Burnett J, Sidhu AS. High-performance liquid chromatographic determination of bisacodyl in pharmaceutical dosage forms marketed in Australia. J Pharm Biomed Anal 1995;13:1355-62.
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