Studies On Sustained-Release And Controlled-Release Tablets Of Insoluble Lovastatin

In this paper,lovastatin was selected as the model drug to prepare matrix sustained-release tablets (MST) and mono-layer macromolecular polymers osmotic pump controlled-release tablets (MOPT).And the drug release character and mechanism were studied. At last,the pharmacokinetic study of MOPT was performed.In the formulation study of MST,hydroxypropyl methylcelluse (HPMC) , lactose and polyvinylpyrolidone K30(PVPK30) were used to make the tablets.The effects of many factors including formulation and technique on the release behavior of tablets were investigated. Based on the results of single factor tests, an optimal self-prepared MST was screened. The results of quality studies on self-prepared MST showed the homogeneity of one batch and the repeatability of three batches were good, but the in vitro release condition influenced its release behavior greatly. The in vitro drug release mechanism was confirmed as the combination result of matrix erosion and drug diffusion.Then,in the formulation study of MOPT, Polyehylene oxide(PEO), lactose and SDS were selected as the main materials to make the tablet core, cellulose acetate(CA) and polyethylene glycol 400(PEG400) were selected as the coating materials and acetone solvent was employed as the coating medium.The effects of many factors including composition of tablet core and coating membrane, arts of preparing tablet and the conditon of drug release on the in vitro release behavior of MOPT were investigated.Based on the single-factor and factor-screening experiments, weight of coating and amount of PEG400 were selected as the causal factors.The formulation optimized according to multiple factorial experiment design was proved to have...