Opportunity VS Challenge: On the Development Strategy of the New Drug Administration System

currently, global drug supply system (DDS) sales growth trend, accounting for more than 10% of the entire pharmaceutical marketThe new concept of treatment has promoted the research and development of new drug administration system, and the new technology has promoted the introduction of new formulation productsFrom the international and domesticdrugdevelopment trend, the research and development of the new drug administration system is facing severe challenges, but also contains great opportunities and commercial value, Chinese researchers should choose the appropriate strategy for research and development workTargetingdrugs whose patents are about to expireto 2007, the global "heavy gold mine" worth 80 billion U.Sdollarsdrugpatent has been expired, which provides a good opportunity for domestic pharmaceutical product developmentIn the next few years, we can target the patent has expired in the pharmaceutical market sales of "heavy gold" drugs, through dosage form improvement to launch new products, seize the marketOf course, there will also be some "heavy gold mine" drug preparation patents expire, for developers also a good opportunityExcavation of new Chinese medicine preparationsabundant resources of plants and marine life in China, less affected by foreign competition, so the research and development of new Chinese medicine preparations for the development of new drugs in China has expanded a broad roadAccording to the incomplete statistics of nearly 2000 kinds ofChinese medicine literature , chinese medicine each subject has a name and no name of the prescription more than 130,000 Digging up a large number of secret recipes existing in the private sector, paying attention to the comprehensive effect sandals of chinese medicine compound, drawing on Japan's experience in the study of Chinese preparations, etc., can improve some traditional dosage forms, and can also apply advanced formulation technology to the current commercially available Chinese medicine preparations, research new dosage forms The secondary development of traditional Chinese medicine preparations will be a potentially huge market The drug preparations that focus on the treatment of major diseases in the selection of innovative formulations, can focus on the development of some major diseases therapeutic drugs, focus on the main technical force and limited capital focus on the development of some fist products, such as cancer treatment drugs, diabetes drugs, cardiovascular drugs, central nervous system drugs, hepatitis treatment drugs, influenza treatment drugs, AIDS treatment drugs and other innovative preparations The danger of cancer in our country is increasing, with one in five deaths dying from cancer The trend in cancer treatment will no longer be to simply make drugs into new formulations with different routes of administration, but to target them Treatment is not only complementary to routine chemotherapy and radiotherapy, but also to prevent damage to normal tissues and drug resistance The cancer release system market is projected to increase from $3 billion today to $15.4 billion in 2007 and $23.5 billion in 2012 In addition, the number of people with diabetes is rising sharply as people's living standards rise At present, China's insulin market size is about 400 million yuan, the average annual growth rate of 24.4%, which means that the development of diabetes treatment drugs is also extremely urgent Increasing the of new compounds may be a good trend to combine existing compounds into compound formulations In today's increasingly difficult time for new chemical structure drugs, we can reflect that the value of existing drugs may not be fully developed, and when two or more existing drugs are combined, may produce some new pharmacological effects, or enhance the role of the original drugs, or improve the safety of the original drugs, and so on Another feature of the compound formulation is that it can be combined in a variety of proportions to meet different clinical treatment needs Although the research and development of new compound formulations is a huge challenge for us, it can also generate new intellectual property rights, create new technical barriers, and ultimately achieve significant economic benefits The development of new dosage forms the development of existing drugs into new pharmaceutical preparations, is also an important research and development strategy Foreign a raw material sinoped drug generally has 8 to 10 preparations, China generally in 4 or less China produces more than 1400 kinds of raw materials, the total output ranks second in the world, more than 70 kinds of preparations, a total of more than 3500 varieties of specifications, while the United States preparation varieties specifications 150,000 (43 times for our country), Germany more than 60,000 (17 times for our country) The application of new technologies, new accessories, new processes, the traditional dosage form of existing drugs (tablets, injections, capsules, etc.) to develop a slow release control release preparation (slow release capsules, slow release skeleton tablets, permeable pump tablets, controlled release micro-pills, controlled release agents, transdermal controlled release agents) or targeted preparations (lipids, microsphere preparations, nano-granuators, monoanti-resistance or receptor-targeted drugs) is the main way to develop new drugs However, in the process of developing new dosage forms should pay full attention to the nature of the drug and clinical requirements, etc , to provide adequate basis for the project, such as cephalosporinandine and quinolones are concentration-dependent antimicrobial drugs, generally not suitable for slow-control release preparations Consider new drug-giving devices
in some ways of administration, the dosing device is essential For some mucosal administration systems (e.g lungs, nasal cavity, eye, oral , vagina, etc.) new dosing devices may be considered to achieve different therapeutic purposes For various devices such as inhalants, the effect is very different Choosing the right dosing device is key to solving the problem of lung administration, and the dry powder inhaler studied by the Department of Innovate Biomed
has a deposition rate of 30%, three times that of a normal inhaler Inhalant feeding device develops rapidly, now has capsule type, bubble type, storage type and other options, can adapt to the needs of different patients If long-term administration should be used to choose multi-dose storage device, the main drug is unstable in nature should choose a single dose of the drug device Change the route of administration
analysis of existing drug varieties can be found that most of the drug route is still relatively single Therefore, according to the needs of clinical drug use, the appropriate development of some new ways of drug administration Such as protein and peptide drugs in the body instability, short half-life, vulnerable to enzyme degradation, such as insulin, thymus peptides, interferon and other drugs, the main clinical dosage form is solution-type injections and freeze-dried powder needles In order to solve the problem of long-term drug use, to overcome the inconvenience and shortcomings of injection, the development of suitable methods of drug delivery non-injection transmission system is a challenge in pharmacy At present, domestic and foreign researchers are trying to find nasal cavity, lungs, oral, transdermal and other drug administration systems, in order to find a suitable way to solve the protein and polypeptide drug injection access to various problems Small-molecule drugs can also change the way of administration, such as small doses, strong action of certain oral or injection preparations, can be changed to transdermal dosing of the patch, and so on Similarly, researchers should provide detailed test data, etc., to justify changing the route of administration At present, the research of the new drug administration system in the world has shown a clear growth trend, specializing in the research and development of the drug release system of the of the public department has more than 350 Among the more prominent divisions are johnson and the division of johnson and Alza, Alkermes, Atrix, Cardinal Health
, Sima, Elan, Euland, Ethypharm, Nessa, In recent years, with the implementation of the research projects of drug preparations in the "85th", "95" and "15th" national key science and technology projects, the research and development capability of new pharmaceutical preparations and new dosage forms in China is also improving, and the number of new preparations and new dosage forms approved for production has been increasing On the whole, China's new drug system research and development is closely followed by the international advanced level, in some areas are still relatively advanced, but there are still many problems, mainly reflected in the research and development funding less, innovation ideas are not broad enough, lack of multidisciplinary cooperation, so the real source of innovation work is less For example, specializing in the new drug system research units are not many, mainly colleges and universities and state-level drug research institutes, with the limited national research fund in the conduct of a part of the new dosage form research, and mainly tracking The pharmaceutical production enterprises in the research and development of the new drug system investment is very limited, mainly for the imitation or secondary development of pharmaceutical preparations At present, China's own research and development of new drug system in the entire pharmaceutical market proportion is very small For a developing country, it may also be normal, a phase that we have to go through We believe that with the continuous development of new technologies, new processes and new accessories, new drug preparations in China will continue to emerge, and the market prospects of new drug-giving systems are very bright (Zhang Qiang) (reproduced from China Medical Daily)