Study On Pantoprazole Sodium Enteric Coated Tablets

Pantoprazole sodium is the third generation of proton pump inhibitor.The enteric preparation was developed by German Nycomed Company.It was first time on the Africa market in 1994.Then it was on the China market in 2001.It is widely used for healing of gastric ulcers,upper gastrointe-estinal bleeding and gastroesophageal reflux disease in clinical.It is effective in the treatment of acid-related disorders.The market demand is bountiful.To expand the choice of drugs,we study on this drug.The main contents as follows.Object:The prescription and process of pantoprazole sodium enteric coated tablets were selected and the optimal preparation and process of pantoprazole sodium enteric coated tablets were determined.Preparation pantoprazole sodium enteric coated tablets which is consistent with reference listed drug.Method:The analysis methods in vivo were established.The HPLC method was developed for determination of pantoprazole sodium cotent and related substances in tablets.The dissolution rate of pantoprazole sodium enteric coated tablets was detected with UV.We methodologically validated these method.The saturation solubility and stability of pantoprazole sodium were detected in different pH buffer salt.The excipients were selected by excipients compatibility experiment.To take the hardness test,friability test,disintegration time limited,weight variation and stability of the tablet as index,the above factors were observed by single factor experiment.The optimal prescription and process of tablets were determined.By screening the coating material and film thickness of isolation layer and coating layer regulates drug disintegration time.To evaluate its dissolution rate consistency with reference listed drug were used by f₂ similarity factors.The content uniformity of pantoprazole sodium enteric coated tablets were determined.The stability of self made pantoprazole sodium enteric coated tablets were investigated under influence factor test,accelerated test and long-term test.Results:The HPLC and UV method with good reproducibility and high accuracy can determine pantoprazole sodium sample in vitro.The solubility of pantoprazole sodium is pH dependence and the solubility of the drug increases with the increasing of pH value.The stability of pantoprazole sodium increases with the increasing of pH value.The compatible admixture of Pantoprazole sodium with excipients is stability.The optimal prescription and process of pantoprazole sodium enteric coated tablets were determined by using single factor experiment.Three batches of pantoprazole sodium enteric coated tablets were prepared according to the optimal formulation process.The three batches of tablets had good reproducibility and stability.The F₂ factors of self made tablets were more than 50 compared with the reference listed drug.The content uniformity of self made tablets conform to Chinese Pharmacopoeia.The results of influence factor experiment showed that high temperature,high humidity and light can affect pantoprazole sodium enteric coated tablets.The results of the accelerated experiment and long term experiment showed self made tablets were stable for 6 months.Conclusion:The quality of the self made pantoprazole sodium enteric coated tablets is consistent with the reference listed drug in vitro and the self made tablets quality is stable.