Concern of multinational pharmaceutical companies: joy and worry of new drug delivery system

Although the world-class pharmaceutical companies have successively reduced their R & D costs or closed down their R & D centers, they still retain their technical support and enthusiasm for the new drug delivery system According to relevant data, the US market size of new drug delivery system in 2011 is about US $153.5 billion, with an annual growth rate of about 15.6% compared with us $74.4 billion in 2006 For the original research and development plants seeking shorter R & D cycle, less clinical risk and greater product profit, there is no doubt about the value of new drug delivery system Drug delivery system (DDS) is a kind of drug preparation with special drug delivery function In the era of frequent "lights off" of new chemical solid drugs, new drug delivery systems are emerging, which is why at the 2012 IPCP conference, the leading-edge reports on drug delivery systems accounted for more than 80% of the total reports in the industrial pharmacy conference hall Nano drug delivery system, slow and controlled release drug delivery system, targeted drug delivery system, transdermal drug delivery system, painless injection drug delivery system and other emerging fields not only catch the eye, but also cause reverie: will the next heavy bomb fall into it? Rise of preparations "The development of new drug delivery system is very in line with the needs and actual situation of China's development." Zhang Qiang, a professor from the school of pharmacy, Peking University, who has been engaged in the basic research and application development of innovative pharmaceutical preparations for a long time, pointed out that the special preparations approved for new drugs are generally new drug delivery systems, and the annual sales of several DDS in China after they are listed have reached 1 billion yuan, which indicates that the pharmaceutical industry has made great contribution to the Chinese pharmaceutical market besides API In fact, nano preparations such as Abraxane injection paclitaxel (albumin binding nano particle Paclitaxel injection preparation), Kaishi (alprostadil emulsion for injection), Lipitor (paclitaxel liposome for injection) and so on have opened a good situation for developers of new drug delivery system with their remarkable post market performance Taking elan, a developer of nano crystal technology, as an example, five products of nano crystal technology, including Rapamune, have been continuously approved by FDA On the one hand, it shows the recognition of foreign review agencies on the prospect of using nano technology in insoluble oral drugs On the other hand, it also shows the rapid development of export nano drug delivery system, which may become an important direction of DDS development in the future "The absorption rate of insoluble or insoluble drugs is generally poor After the oral nano system is made, the first problem to be solved is solubility, and then it may have the effect of improving bioavailability." Zhang Qiang said that because the oral preparation first touches the gastrointestinal tract and then can be exposed to the blood after passing through the mucosal barrier of the gastrointestinal tract, it is relatively less difficult to develop it than the injection drug delivery system Under the increasingly difficult environment of new drug passing rate, the oral nano preparation can quickly pass the FDA's approval, which has a lot to do with its own characteristics Zhang Qiang predicted that it will soon Oral nano preparations have been approved for marketing At present, the creation of new drug delivery system has attracted the attention of a number of pharmaceutical enterprises, such as Shandong LVYE, Sichuan Kelun, Jiangsu Yangzi River, Shaanxi Libang, etc they generally hope to seize the commanding point of drug delivery technology with the "east wind" of global competition However, enterprises are also faced with some puzzles Taking nano preparations as an example, although China's basic research in the field of nano medicine is basically close to and reaches the advanced level in the world, especially in the synthesis of nano materials, nano biomedical research and other aspects, the transformation of the achievements from the laboratory to the workshop is difficult Transforming short board "In the past, no matter in R & D or production, domestic enterprises did not pay enough attention to preparation equipment and talents." One expert attending the meeting pointed out that preparations such as solutions and injections only need to undergo simple physical processes such as dissolution, and it is easy to scale up in the workshop But now many new drug delivery systems, such as sustained-release preparations, microspheres, liposomes, etc., contain more and more new technologies, so it will be difficult to scale up in the industry simply In Europe and the United States, some specialized pharmaceutical machinery manufacturers will design matching medium-sized and large-scale instruments according to the principle of small instruments for experiment, so as to facilitate the transition of achievements from laboratory to workshop What's more, there are many cases that doctoral students go to the workshop to engage in industrial research and management after graduation In addition to R & D, the production line of pharmaceutical companies needs such senior technical personnel who are familiar with the process flow and can improve the preparation production process "This kind of professional engineering technician is an effective accelerator for upstream and downstream docking The technical support of these personnel is needed for the results of how to match the instruments and equipment, how to enlarge the changes of preparation process, etc Our colleges and universities or enterprises are lack of awareness of training talents in this field " Said the expert "In a very simple example, the increase of tablet dosage from 100mg to 200mg does not seem to be a big problem, but it may not be a tablet, because after the increase of dosage, if the proportion of excipients remains unchanged, the tablet will be very large." Zhang Qiang also pointed out that a seemingly small change in the prescription or technology is a big change in the pilot test and scale-up There must be something practical to match it, otherwise the new preparation will fall into the dilemma of unable to produce In addition, the national support for new drug delivery system, technology and equipment, devices, excipients and other related industries during the "12th Five Year Plan" period will become a key to promote the development of new pharmaceutical technologies It is understood that during the 11th Five Year Plan period, the key technologies and technical platforms of the new drug delivery system received partial support from 863 and other national science and technology plans, but the 12th Five year plan was basically suspended, and specific innovative varieties lacked special support At present, the first batch of major new drug creation projects in the 12th Five Year Plan have started the excipients project, and the important pharmaceutical innovation projects are still expected to enter the next batch of application guidelines Some experts pointed out that new preparation products can not enjoy the same treatment as new drugs, process patents are difficult to be recognized and other series of reality or become the main factors affecting the enthusiasm of enterprises The new drug delivery system has become the commanding point for pharmaceutical enterprises to seize, especially the original pharmaceutical research plant However, the shortage of preparation equipment and talents for a long time makes the innovation of drug delivery system particularly difficult