Study On Enteric-Coated Tablets Of Compound Alendronate Sodium And Vitamin D₃

Objective To meet clinical need for long time use of drugs for prevent and treatment of osteoporosis disease;To attain the aim of reducing times of administration and side effects and increasing the synergistic reaction and the bioavailability and fitting bigproduction of industrialization;To study on enteric-coated tablets of compound ALN\VitD3 and preclinical pharmacy.Methods Ultraviolet spectrophotometry was developed for assaying during the study of content and drug release;HPLC with ELSD detection was developed for studying the stability of ALN;HPLC with UV detection was developed for studying the content of VitD3. Applying Shapes, compressibility , flowability, hardness ,friability and dissolution as main index to evaluate the quality of tablets.By means of adopted adjuvant whether influence assaying and detecting related substances ,the effect of different amounts ,category or concentration of diluents were investigated,then compound ALN\VitD3 tablets were manufactured as compressed tablets by wet granulation processes.Using fluid bed coating equipment,the enteric-coated with aqueous acrylic polymers dispertions (Eudragit LE30 D-55 ),compound ALN \ VitD3 enteric-coated tablets of weekly administration were prepared.Applying cumulative release percent of ALN,f2(similarity factor) and Chow's method to evaluate the drug release behavior of ALN in this combined matrix systems.The related substances of ALN were investigated in compound enteric-coated tablets.Results The dissolution test indicated uncoated tablets dissolved in 30 minutes and enteric-coated tablets dissolved in 45 minutes.The studies on destroy tests showed that high temperature and light had little effect on it respectively and the related substances of ALN were relatively higher in acid,alkali and dioxogen environment . The chemical stability of compound enteric-coated tablets was observed,the result of which indicated that the content of ALN decreased slightly under high temperature and high humidity,which the stability of ALN in accelerated test and long test run was relatively stable,the related substances of ALN had slight increasing in it.Conclusion The methods are reproducible,simple,accurate and suitable for quality control of the preparations;The release of ALN from the enteric-coated tablets were reasonable and perfected with the reference preparations;The study on the related substances and the stability of ALN can be effectively controlled by the methods established;The compound enteric-coated tablets achieved the ideal goal.