All the FDA approved dispersive tablets are here!

In recent years, the rapid development of oral fast-release preparations, dispersible tablets also rely on its disintegration time limited similar performance riding the east wind rise for a while Short disintegration time, good dispersion state, rapid dissolution and absorption of drugs are all the characteristics of dispersible tablets that can not be ignored, but they are widely recognized by the industry and patients at home and abroad, mainly because they are easy to take, adapt to different treatment needs (the elderly, children, people with dysphagia), and improve the compliance of patients Next, I will analyze and analyze the dispersible tablets: tablet (for dispersion) refers to the tablets that can disintegrate rapidly and disperse uniformly in water FDA defines it as a table that forms a suspension when placed in a liquid The dispersible tablet originated from British Pharmacopoeia The principle of formulation design is to make the tablet become small particles and form a uniform suspension in the shortest possible time after encountering water The key to ensure the quality of dispersible tablet is to select suitable excipients that can provide rapid disintegration and control the particle size of drug excipients Dispersible tablets can be taken orally after dispersing with water, and can also be sucked or swallowed in the mouth 1、 Analysis of the development of dispersive tablets at home and abroad the development of dispersive tablets in the United States up to now, FDA has approved 21 varieties of dispersive tablets (1-4 varieties are approved each year), a total of 40 specifications (the number of varieties is counted according to the registration number, and the data is from the drug database of FDA) Among them, the number of approved new drug applications (NDA; 10 varieties) and generic drug applications (anda; 11 varieties) accounted for half of the total, among which 41% were prescription drugs, 32% were temporarily approved, and 27% were withdrawn from the market Data source: among 21 kinds of dispersible tablets approved by FDA, 11 generic drug applications (anda) were removed, and the remaining 10 new drug applications (NDA) were mainly new formula or new manufacturer, accounting for 27%; the rest were new drug combination (9%), new dosage form (9%) and NME (5%) Data source: exjade (derasirox), a dispersible tablet drug of Novartis, a Swiss pharmaceutical giant, is the most prescribed iron chelator It has been listed in the United States for more than 10 years, with an annual sales volume of more than $1 billion Appendix: 21 FDA approved dispersible tablets (tablet, For suspension) variety data source: the declaration situation of drug intelligence data dispersible tablets in China is in China The peak of declaration of CFDA dispersible tablets is mainly in 2004, 2005 and 2006 After 2007, the number of declaration gradually tends to calm down, from 250-700 varieties in the first three years to less than 100 varieties, even within 50 varieties in the last eight years Since 2000, 2233 varieties of dispersible tablets have been declared in China, of which the proportion of new drugs (1796 varieties) is 80.4%, and the rest are generic drugs (296 varieties) and supplementary applications (141 varieties) After the fanatical period, since 2008, the number of application for dispersive tablets in China is only 330 varieties, among which the number of new drugs (134 varieties) and generic drugs (133 varieties) are basically equal, and the proportion of supplementary applications (63 varieties) accounts for about 19% (statistical rule: the weight of drugs and manufacturers is removed, that is, the unified products of the same manufacturer are only calculated once; data source: drug intelligence data) Among the dispersive tablets declared in China since 2000, the proportion of chemical drugs (1496 varieties) is 67%; from 2008 to now, the proportion of chemical drugs (312 varieties) is 95% Since 2000, only one biological product has been declared Since 2000, the number of domestic chemical drug applications has mainly concentrated in 5 categories, 6 categories and 4 categories, with the largest number of 5 categories; since 2008, they have mainly concentrated in 6 categories, 5 categories and 3.1 categories, with the largest number of 6 categories Since 2000, the application of traditional Chinese medicine in China has mainly concentrated in 8 categories and 9 categories, of which 8 categories account for about 76% Among all the declared varieties, the number of Azithromycin Dispersible Tablets (124) was the most, and that of Xianlinggubao dispersible tablets (21) was the most (statistical rule: weight removal of drugs and manufacturers, i.e unified products of the same manufacturer are only calculated once; data source: intelligence data of drugs) up to now, the number of approval documents of dispersive tablets in China is 701, including 577 chemical drugs and 124 traditional Chinese medicines Among the chemicals approved for marketing by CFDA, the number of Azithromycin Dispersible Tablets (83) is the largest, while that of Xuesaitong dispersible tablets (14) is the largest The following are the top 10 drugs in the list of dispersive tablets on the market: (statistical rules: the weight of drugs and manufacturers is removed, that is, the unified products of the same factory are only calculated once; data source: intelligence data of drugs) 2、 Because dispersible tablets are so popular, the curative effect is not the key point The clinical advantage is that the curative effect of Wangdao dispersible tablets is not much better than that of ordinary tablets The improvement of dosage form is mainly to adapt to different treatment needs (special population) and improve the compliance of patients The clinical advantage is significant The main differences between dispersible tablets and common tablets are as follows: (1) preparation of dispersible tablets requires micronization of raw and auxiliary materials (the particle size of slags after disintegration is less than 710 μ m), which increases the production process; (2) quality standard control of dispersible tablets is also more difficult than that of common tablets; (3) dispersible tablets need higher quality disintegrating agents and better packaging materials (dispersible tablets rely on them) A large number of disintegrating agents contained in it absorb water and expand, so that the tablets can be broken into particles as small as possible The disintegrating agents contained in it have strong moisture absorption capacity, so the requirements for the moisture-proof performance of packaging materials and storage environment are relatively high), which improves the production cost and storage cost Therefore, the price of dispersible tablets is generally higher than that of ordinary tablets In addition, dispersible tablets are not suitable for all purposes, such as hypertension For patients with hypertension, the slow and controlled release dosage form can make the drug release continuously and stably, not only reducing the number of times of medication, but also avoiding the situation of too fast blood pressure reduction after medication It is not easy to choose dispersible tablets for long-term use of drugs with high irritation or high concentration which are easy to cause serious side effects Note: the content of this article is original by the author of yaozhi.com, welcome to reprint, please indicate the source and author when reprint, thank you!