Drug research and development is becoming increasingly difficult new pharmaceutical excipients research and development to promote the development of dosage forms

In recent years, the research and development of new drugs are becoming more and more difficult, which leads to the research of innovative drugs gradually turning to the development of new drug preparations, and new excipients provide the material basis for new drug preparations According to statistics, the annual growth rate of global pharmaceutical excipients market is more than 10%, while the annual growth rate of new pharmaceutical excipients is more than 20% Industry insiders pointed out that it is necessary to change the trend of focusing on APIs and light preparations and excipients, promote the development of new dosage forms with the research and development of new excipients, and speed up the domestic excipients industry to be in line with international standards At present, pharmaceutical preparations are developing in the direction of high efficiency, quick effect, long-term effect, small dosage and side effects Pharmaceutical dosage forms are transforming into timing, positioning and quantitative drug delivery systems, and new pharmaceutical excipients play a decisive role in this process Ouyang Jingfeng, an associate researcher of the Chinese Academy of traditional Chinese medicine, believes that the future development direction of new pharmaceutical excipients is excellent slow-release and controlled-release materials, excellent enteric and gastric dissolution materials, targeted preparation materials, non-toxic and high-efficiency drug carriers, non-toxic and high-efficiency skin penetration enhancers and composite materials suitable for various drug dosage forms Europe and the United States are the R & D centers of pharmaceutical excipients in the world Especially in the past decade, more than 300 new pharmaceutical excipients have been developed in developed countries in Europe and the United States Among them, hundreds of products in the United States get national patents every year At present, many foreign-funded enterprises have monopolized the market of high-end pharmaceutical excipients in China through new varieties, including coating agents, oral liquid excipients, cavity delivery excipients, suspension excipients, surfactants and transdermal release agents Foreign countries attach great importance to the research and development of excipients The development of pharmaceutical excipients is closely related to the development of new pharmaceutical preparations With the continuous emergence of new pharmaceutical dosage forms and new processes, the quality of traditional excipients continues to improve, and a batch of new pharmaceutical excipients or new specifications have been put on the market Yin Zhenglong, chairman of Anhui Shanhe pharmaceutical excipients Co., Ltd., said that at present, the R & D and application of new pharmaceutical excipients in the world revolve around new pharmaceutical preparations, such as functional excipients needed for slow release, controlled release and rapid release, as well as low toxicity and stable injection excipients The overall trend is to develop into more functional, less impurity residue and better stability , such as composite auxiliary materials, etc The development of pharmaceutical excipients industry in China started late In the past ten years, the industry scale and production level have been greatly improved and developed Many relatively mature excipients have been mass produced in China, such as microcrystalline cellulose, sodium (carboxymethyl) cellulose, Carbomer, sodium alginate, etc Yin Zhenglong pointed out that the key points of the development of pharmaceutical excipients in China are: new dosage forms, systems and excipients for liposomes and transdermal drug delivery; coating materials such as gastrolysis, enterolysis and dampness resistance; excellent controlled-release materials; filling agents, flow aids and anti viscosity materials with excellent compressibility, fluidity and anti viscosity; rapid disintegration materials and quick release materials, and excellent transdermal accelerators And pressure-sensitive adhesive; biodegradable polymer excipients "In general, the domestic research and development of new pharmaceutical excipients is not paid enough attention." Zhang Jiawei, R & D director of Hunan Erkang Pharmaceutical Co., Ltd., said that because the pharmaceutical excipients industry in China has been in a state of "small, scattered and disordered" for a long time, the investment of local production enterprises in R & D of new excipients is far less than that of foreign giants, which mainly focus on imitation and lack of independent R & D, mainly occupying the low-end pharmaceutical excipients market However, with the healthy development of pharmaceutical auxiliary industry in China, in order to maintain long-term competitiveness, the industry leader is bound to increase investment in research and development, and continue to expand to the field of high-tech, high added value pharmaceutical auxiliary deep processing Yin Zhenglong believes that there are still many problems in the research and development and application of new pharmaceutical excipients in China Firstly, the scale of enterprises is small, the level of production automation is low, the research and development cost of new excipients is huge, and the research and development of enterprises lacks technology and talents In addition, what's more important is that the level of preparation technology in China is generally low, which lacks pulling effect on excipients In the future, with the development of new pharmaceutical preparations and the improvement of product quality in China, as well as the stricter supervision of pharmaceutical excipients, it will further arouse the attention of relevant domestic enterprises and scientific research institutions on the research and development of pharmaceutical excipients The government should improve the laws and regulations of industry management, establish unified regulatory standards, avoid low-level duplication and low price competition, and create a fair competition market environment Yin Zhenglong pointed out that the key technologies for the development of new pharmaceutical excipients were included in the research topic for the first time during the 12th Five Year Plan period in the major science and technology project of "new drug creation", but the supported projects were few and the sustainability was insufficient The state should issue a series of policies to encourage industrial development, support enterprises to invest in scientific research and technological transformation, and implement industrial upgrading For example, to guide and support enterprises to lead the establishment of pharmaceutical excipients production, learning and research innovation alliance, pharmaceutical excipients Association organizations should also participate in the formulation and implementation of industrial policies.