Study on Preparation of Methylphenidate Hydrochloride Bipolar Controlled Release Osmotic Pump Tablets / 中国药师

ABSTRACT

Objective: To study the preparation method and process optimization of methylphenidate hydrochloride biphasic controlled-release osmotic pump tablets.Methods: Based on the preparation technology of double-layer osmotic pump slow-release tablets and combined with the principle of biphasic drug release behavior, the two-release preparation with two different release phases was prepared.Through the single-factor investigation of the drug-containing layer and the booster layer, the amount of the auxiliary materials was determined.The optimum compression method and the optimum coating parameters were obtained by studying the process parameters of tabletting and coating.Results: The prepared methylphenidate biphasic controlled-release osmotic pump tablets had two different release phases.The methylphenidate hydrochloride controlled-release osmotic pump tablets produced by the optimal formulat were good in appearance and reproducibility of drug content.In vitro release curves showed that the drug was released rapidly in the intial 0-2 hour time interval and was in line with zero-order release in 2-10 hour with good reproducibility.Conclusion: The preparation method is scientific, simple and complete, and can be used for preparation of methylphenidate hydrochloride biphasic controlled-release osmotic pump tablets.