Formulation, Development and Evaluation of Nifedipine Emulgel for Treatment of Anal Fissures Using Polymeric Emulsifiers

Abstract:

Aim/Background: Nifedipine (NIF) is act as Calcium channel blocker which belongs to chemical class dihydropyridine and used in the treatment of hypertension. An anal fissure (AF) is the most common anorectal conditions encountered in clinical practice. Patient anal fissures experience anal pain with defecation and minor bleeding. Emulgel formulations are considered a combination of emulsion and gels and emulgel has advantages of both. Emulgels have better penetration of actives than conventional topical formulations. Materials and Methods: Emulgel formulations are prepared with the lowest concentration of emulsifiers 1.5-4.0%. Carbomer homopolymer type C used as a polymeric emulsifier while formulating the formulation. The concentrations of Polymeric emulsifiers, high HLB surfactant and low HLB surfactants are varied to two level concentrations two optimize the formulations. Sorbitan monooleate and Polysorbate 20 used as surfactants. Results: Emulgel formulations are evaluated for homogeneity, consistency, grittiness, compatibility, pH, Viscosity, drug content, spreadability, extrudability and in-vitro drug release from the formulations. The optimized formulation has been charged for stability study at room temperature and accelerated storage condition. Stability results are similar to the initial results. In-vitro drug release profile of the initial time point versus 3M stability time point at accelerated and room temperature storage condition is similar. Conclusion: Carbomer homopolymer type C can be employeed as polymeric emulsifiers to stabilize unstable to stable emulsion.

Key words: Nifedipine, Polymeric emulsifiers (PE), Anal fissures, Emulgel, Evaluation of emulgel formulation.