Abstract

A NOVEL COMBINATION OF DRUGS INCORPORATED INTO EMULGEL FOR THE EFFECTIVE TREATMENT OF ANAL FISSURE: FORMULATION DEVELOPMENT AND EVALUATION

Dr. R. Suresh Kumar*, S. Ashoka, Dr. P. Ram Kumar and P. Nethravathi

ABSTRACT

Introduction: Anal fissure or Hemorrhoids are the normal vascular structure in the anal canal that aid in stool control. Emulgels have emerged as a promising drug delivery system for the delivery of hydrophobicdrugs. In the present study an attempt has been made with combination of Nifedipine and Lignocaine HCl incorporated into the emulgel for the effective treatment of anal fissures. Material and method: The combination of Nifedipine, a calcium channel blocker along with lignocaine HCl, a local anaesthetic, an emulgel was prepared using Carbopol ETD2020 as a gelling agent. Based on drug solubility studies cetomacrogol 1000 and glycerylmonostearate as emulsifiers and cetostearyl alcohol as co-surfactant, glycerin as emollient were selected for preparation of emulgel. The O/W emulsion was prepared and incorporated in a gel base. Results and discussion: The emulgel was prepared and evaluated for their physical characteristics. The optimized formulation T-9 was evaluated for spreading coefficient studies, in vitro release andanimal studies.The optimized emulgel formulationwas smooth, shiny and homogenous with pH of 5.89, viscosity of 53015cps, spreadability of 20g.cm/sec, extrudability of 7g. In vitro study was performed and the cumulative drug release of Nifedipine and Lignocaine HCl was 72.0% and 72.70% at 420min respectively. The optimized formulation T9 heals anal fissure on 8th day of treatment whereas with drug suspension it took 12d of treatment for complete cure. Therefore the healing can achieved with once daily application. Conclusion: The combination of Nifedipine and Lignocaine HCl in the form of emulgel can be used for the treatment of fissures relieved the symptoms of pain by the effect of analgesic action due to Lignocaine and wound healing by Nifedipine. This novel approach of emulgel in topical drug delivery is easy in preparation, more economic and has better pharmaceutical as well as therapeutic effect. Further improvement in topical formulations for the treatment of anal fissure could be done for better life of the effected patients.

Keywords: Topical drug delivery, Emulgel, Nifedipine, Lignocaine HCl, Anal fissure (Haemorrhoids).