Study Of Excipients' Effect On The Drug Dissolution In Different Dissolution Media

Dissolution test usually was used to measure the release of drug from the dosage forms,such as tablet,capsule or pellets to the dissolution medium.Dissolution test could effectively control the quality of the dosage forms,also it had strong connection with the drug release in the body,therefore the dissolution test played an important role in the dose and the formulation design.There were many factors,which could affect the drug release,such as the physical and chemical properties of the drug,the amount and type of the fillers and binders,and the hardness of the tablets.The aim of this thesis was to investigate how the amount and type of binders affect the dissolution of propranolol tablet at different dissolution medium(pH1.2,pH4.5 and pH6.8),and it was anticipated that such study could help the formulation design of new compounds and genetic drugs' development.By using propranolol as a model drug,this research studied the drug release performance of tablets with different binders at three levels(HPMC E5(1%,3%and5%),PVP K30(3%,5%and8%)and HPC SSL(1%,3%and5%)with single filler inside(lactose,starch and microcrystalline cellulose(MCC)).If MCC was used as the filler,for three binders at three levels,there were no signicant difference of the dissolution among all dissolution mediums.When lactose and starch were used as the filler,and the binders were at HPMC E5(5%)and HPC SSL(5%),there were significant dissolution difference among different mediums.Normally there were two or more fillers inside the dosage form,and it was necessary to investigate how the drug dissolution changed under different mediums when two fillers applied.Lactose and MCC(3:1)as fillers,the drug dissolution profiles showed significant difference at different dissolution media at high level of three different binders;Starch and MCC(1:3)as fillers,there was a significant dissolution difference observed when PVP K30 was used as binder.The dissolution profiles displayed no change under other investigated conditions.