Dissolution Consistency Evaluation Of Aspirin Enteric Tablet

National Medical Products Administration issued the list of generic drugs that must complete the consistency evaluation by the end of 2018.There are 309 approval documents about aspirin enteric tablet.But up to now,no company submit the application of aspirin enteric tablet.There is still a big difference between aspirin enteric tablets in the domestic market and the original product.In the manufacture process,the formulation technology,enteric coating,packaging and storage condition all can affect on the quality of aspirin enteric tablets.Based on the research of original product,we chose the compression process,screened the type of raw materials and excipients,adjusted the proportion of excipients and achieved the optimized formulation including 100 mg aspirin(20-60mesh),7.2mg corn starch and 12.8mg microcrystalline.We also compared different coating formulations,coating parameters and coating weight gains in order to reach the similar release profiles.Enteric formulation 494O690008 was chosen and the enteric coating process should be coated at higher bed temperature and then coated at lower bed temperature.Aspirin enteric tablets made in lab and original product were sealed in bottle and placed in 40℃/75% RH for 6 months and in 30℃/65% RH for 12 months respectively.Tablet appearance,aspirin content,dissolution and salicylic acid content were determined.The samples with desiccants are stable under accelerated and long-term conditions.Tablet adhesion occurred in the samples and original product without desiccants.In a word,the optimized tablet core was direct compressed and coated with enteric formulation.The enteric tablets showed similar release profiles with the original products in different p H media.Tablet appearance and dissolution of the samples under accelerated and long-tern conditions was similar with the original products.