Development of semisolid preparations containing Nifedipine for anorectal application and in vitro evaluation
Nilufer Yuksel, Nuray Bagci, Zerrin Sezgin Bayindir, Ozge Inal and Nurten Altanlar
Ankara University, Turkey
: J Pharm Drug Deliv Res
Abstract
Anal fissure is the tear localized in the distal anal canal and it is one of the commonly observed painful pathology of this region. It is common in middle age or young adults, and if the disease is not cured it disturbs the patients in further periods. The disease considerably decreases quality of life and diminishes their physical-mental health. Although surgical operation is considered as the only option for the treatment of chronic anal fissures, the recent researches revealed that nonsurgical techniques have efficacy on the disease cure. This focused the interests on drug treatment. For this purpose there is a glyceryl nitrate ointment in Turkish drug market. But the severe headache that comes out as a side effect with a 40% incidence upon the usage of this ointment reduces the patient compliance and cause patients to quit the therapy. According to researches nifedipine came out to be an alternative to other therapeutic agents used in anal fissure treatment due to its high healing efficacy and reduced side effects. In this study, semisolid preparations containing nifedipine were developed for anorectal application. Semisolid preparations in the form of lipophilic gel and hydrophilic gel were prepared by different methods. These formulations were characterized in terms of organoleptic control, pH, viscosity, texture analysis, nifedipine assay, in vitro drug release and microbiological respect. By considering the patient comfort and ease of drug application and as the result of characterization studies a hydrophilic gel formulation containing Carbopol® 974P was selected as the most appropriate formulations.
Biography
Email: Nilufer.Yuksel@pharmacy.ankara.edu.tr
