Study On Development Of Tenofovir Disoproxil Fumarate Tablets And Its Quality Evaluation

HIV/AIDS and hepatitis B are two big threat to human health.Tenofovir Disoproxil Fumarate is relatively mature drug for resisting HIV and HBV,and its advantages consist of good effect,small side-effect,and difficult for drug resistance,but attention should be paid to certain renal toxicity.1.The study on preformulation of tenofovir disoproxil.fumarate tablets and stability of TDF.The experiment investigated the solubility of TDF in different solvents,and the saturated solubility of TDF in different dissolution medium,and the stability of TDF under harsh conditions.The physical and chemical properties and stability of TDF were preliminarily understanded.The basic data and the basis premise of preparation and quality testing of tenofovir disoproxil fumarate tablets were acquired.2.The study on preparation of tenofovir disoproxil fumarate tablets.According to the original viread(?)'s constitute,the author selected MCC,Lactose and PS as diluents,CCMC-Na as disintegrant,MS as lubricant after analyzing the compatibility of excipients and preformulation study.This thesis compared quality of tablet with different prescription,different preparation technology,different methods of disintegrant adding,etc.The paper determined the prescription and preparation technology after comparing the dissolution of original drug with self-made tablets and the experiments of influencing factors.Every core contain TDF 300mg,lactose 50mg,PS 48.5mg,CCMC-Na 20mg,MS 6.5mg,coated with Opadry(?)?,taking wet granulation as the final preparation technology using water as binding agent.3.The preliminary study on quality standard of tenofovir disoproxil fumarate tablets.The author investigated the quality standard from the characters,identification,examination and determination of the aspects of self-made tablets refering to the registration standards for imported drugs.The study verified the methods of detecting the content of TDF,Mono-POC PMPA and dissolution rate using methodology.Results showed that the quality of the selt-made tablets is conform to the requirements,and the methods for detecting the content of TDF,Mono-POC PMPA and dissolution rate of the tablets which are contained in the registration standards for imported drugs are suitable.