Preparation Of Compound Excipients In Orally Disintegrating Tablets By Spray Drying

Orally Disintegrating Tablet(ODT)is a special type of tablet.Even if there is only a small amount of saliva in the mouth,Orally Disintegrating Tablet can also disintegrate rapidly.Because of its rapid disintegration and release,Orally Disintegrating Tablets are often used in the elderly,children and patients with dysphagia.Some drugs that need to work quickly,such as those for treating migraine and first aid,are often made into Orally Disintegrating Tablets.Because of the rapid disintegration and release of Orally Disintegrating Tablets,they often bring out the bitter taste of the drug substance itself in the disintegration process,which affects the compliance of patients.In order to cover up the bitterness of the drug substance itself and meet the requirements of rapid drug release,some sweeteners and disintegrating agent are usually added to the Orally Disintegrating Tablets.Because the properties of different excipients are very different,it needs to be re granulated before making tablets,which increases the process steps and production costs.Based on the above problems,this study mainly selected and integrated different types of e xcipients to prepare Compound Excipients through spray drying technology.Good fluidity can be used for direct tablet pressing,rapid disintegration and taste masking ability can be used for oral tablets.In the early stage,the formula combination of the Compound Excipients was determined to be Mannitol,Polacrilin Potassium,Microcrystalline Cellulose and PVPP.The proportion of Mannitol and Polacrilin Potassium was 10:3,and the amount of PVPP was 12% of the total amount.The Compound Excipients prepared by this formula have the characteristics of high yield,good fluidity and fast disintegration.Spray drying is the core method for preparing Compound Excipients.Spray drying process parameters have great influence on the properties of the prepared Compound Excipients.The experimental parameters are as follows: the inlet air temperature is 170℃,the outlet temperature is 75℃,the fan frequency is 45 HZ,the atomizer frequency is 35 HZ,the pump speed is 30 rpm,the solid content is 10%～20%.The Compound Excipients prepared by the spray drying process parameters have the characteristics of high yield,no sticking wall,no agglomeration,loose granules and good fluidity.DSC and XRD analysis of spray drying products and physical mixtures of Compound Excipients showed that there was no chemical reaction between different excipients during spray drying.Compared with the physical mixture,the product homogeneity of the Compound Excipients is better.DSC,TGA and DVS analysis showed that the Composite Excipients were stable at room temperature,which was good for preservation and downstream process development;moisture absorption was rapid at high humidity,which was good for disintegration.Orally Disintegrating Tablets were prepared by using Oseltamivir Phosphate as raw material and Composite Excipients.The results showed that the disintegration time of tablets was less than 60 s when the drug loading was 10%～30%,and the coverage rate of bitterness was as high as 70%～85%.Through the selection,preparation and application of the Compound Excipient formula,it is shown that the Compound Excipient prepared in this study can be directly used for tablet pressing,and the tablet has the characteristics of rapid disintegration and flavor masking.The successful preparation of the Compound Excipients has provided a very good help for the development of the new dosage form of Orally Disintegrating Tablet,which can provide opportunities for the development of new dosage forms for more new and old drugs.