Design and In-Vitro Evaluation of Sustained Release Matrix Tablet of Complexed Nicardipine Hydrochloride

The objective of present work is to develop and characterize an oral sustained release matrix tablet of complexedNicardipine Hydrochloride by employing hydrophilic and hydrophilic polymers. Due to poor water solubility of the drug its bioavailability is dissolution rate limited. The purpose of the study was to increase the solubility of Nicardipine by cyclodextrin inclusion complex technique. Complexes of different molar ratio were prepared. Kneading method was employed for preparation of inclusion complexes. Among different complexes, a complex with 1:1 molar ratio of drug and β‐CD showed the highest dissolution rate. Matrix tablets were prepared by direct compression technique using different concentration of polymers and selected complex. The blended powders and tablets were evaluated for various physico‐chemical parameters as per official protocol. The in-vitrodissolution study was carried out in acidic medium (pH 1.2) for 2 hrs, followed by phosphate buffer dissolution medium (pH 6.8) for next 12 hrs. The blended powders showed satisfactory flow properties and compressibility. All the tablet formulations showed acceptable pharmacotechnical properties and complied with official specifications. The invitrorelease pattern indicated that formulation F7 was good releasing the drug for period of 12 hrs and was best fitted to Higuchi release profile. The present study has demonstrated that combination of hydrophobic and hydrophilic polymers effectively sustained the drug release for prolonged period of time and a minimum of 28 % sodium alginate is required to retard the release of nicardipine from matrix tablet for the period of 12 hours.