| Background and Objective:Recent years,a rising dosage form in the world named Orally disintegrating tablet.It can be disintegrated or dissolved rapidly without water or only using a small amount of water.When taking these pills,they contact with saliva releasing effective components into stomach by swallowing.This new dosage form has the advantage of easy carrying,without the help of professional equipment,high bioavailability and suitable for special patients which is a good solution to those patients who have the convenience problem.However,We still do not have related products about compound vitamins(B1,C)orally disintegrated tablets.According to the actual situation of our country and production of our company,we select the vitamin B1 and vitamin C as the research objects for the Study of compound vitamins orally disintegrated tablet.In order to receive the suitable compound vitamins(B1,C)orally disintegrating tablet formulation,and to get the Process regulations adapting to large production,the formula is screened and the production process is groped.Finally we worked out the quality standard draft which lays the foundation for our company to declare the goods to go on the market.We got the designs of optimum formulation and process regulation for mass production.Meanwhile,we initially work out the quality standard draft of compound vitamins(B1,C)orally disintegrating tablet.The main results of the study are as follows:First,the optimum formulation screen.Reviewing the prescriptions of vitamin B1 tablets&Vitamin C tablets and the designed formula of Adefovir dipivoxil orally disintegrating tablets,5 groups of experimental formulas of compound vitamins orally disintegrating tablets was designed by ourselves.Five groups of tablets were obtained based on the group of experimental formulas by wet granulation production,and the optimum prescription was determined by evaluating the appearance,hardness,disintegration time and tablet weight variation.Finally we got the optimum formulation of each batch(400,000 pieces 200kg)as follows,vitamin B1 2kg,vitamin C 40 kg,lactose 49.3kg,microcrystalline cellulose 49.3kg,anhydrous ethanol 17.5kg,purified water 17.5kg,L-HPC 5.47 kg,CMS-Na 12.78 kg,PVPP 12.78 kg,silica powder 2.73 kg,Aas Patan 1.83 kg,anhydrous citric acid 1.83 kg,magnesium stearate 2.73 kg.Second,the research on production process.Direct compression was compared with wet granulation method.According to each method,three batches of tablets were produced,and the process regulation of compound vitamins(B1,C)orally disintegrating tablet was finally determined through quality control of intermediates.We got a result that the intermediates produced by direct compression method are not up to the standard in content determination,weight variation and particle content detection while the intermediates produced by wet granulation method perform better through comparing with the intermediates from the two different process regulation.Therefore,it is suitable for the mass production of the wet granulation method.Third,We worked out the quality standard draft based on the requirements of registered information of chemical drug registration in the current version of Pharmaceuticals Register Specialist Regulation,the Guidelines for standardization process technology for the establishment of the quality standards for chemical drugs,and China Pharmacopoeia 2010 version.According to the key steps,key parameters and evaluation indicators in the production process,we initially determined the inspection items in the draft quality standard for identification,inspection and content determination.The identification test results of vitamin B1 and vitamin C should be positive in accordance with the results of the Pharmacopoeia;The time of disintegration should less than 1min,and the difference limit of chip weight was 4%.The results of microbial limit should be consistent with Pharmacopoeia.The content of vitamin B1 and vitamin C should be 97.0%~103.0% of the indicator. |
PDF Full Text Request