The Research Of Ranolazine Extended-release Tablets Preparing Process

Ranolazine is a drug for the treatmeng of chronic angina, it is developed by the United states CV, and not listing in China. Tianjin Han Kang Pharmaceutical Biotechnology Co., Ltd. researched this species, and did a lot of research work for its sustained-release formulations.First of all, combination of physical and chemical properties of APIs, it was designed of the frame type for tablets of ranolazine sustained-release, and was screened in the skeleton, wetting agents and coating agents. Determined to Hydroxypropyl Methyl Cellulose (HPMC) as sustained release matrix and screened the best amount of the agents, determined the final prescription, and trialed the samples.Compared the release curve with the control drug (commercial products come from the United States CV), the release curve can represent the release characteristics in vitro. With two parameters the difference factor (f1) and the similarity factor (f2) to determine the release curve similarity, according to the release curve same, determined the release behavior in vitro same.In vivo release test by test formulation (ranolazine extended-release tablets) and reference formulation (ranolazine tablets) in Beagle dogs pharmacokinetic comparative study to enaluate the two formulations in the pharmacokinetics characteristics of ranolazine. The results show that the test formulations have certain characteristics of sustained-release compared with the reference formulation, and the extent of absorption was closed to the reference formulation in Beagle dogs.