New preparations of domestic market: four research directions dosage form to look forward to - preparation, medicine, medicine - pharmaceutical indust
The development of new formulations and develop new compounds entity compared with the cost of small, short period and quick advantage. According to data released today the successful development of a new compound entities spent an average of about 10 to 12 years, the consumption will amount to about 6 to 8 million. Unless the drug is a "heavy gold" (most new drugs are not), or sales peak is difficult to over one billion U.S. dollars / year. The development of a new formulation of existing drugs on average only 50 million U.S. dollars, 3 to 6 years, peak sales could reach 3 500 million U.S. dollars / year. Currently, new drug delivery systems market represents about 10% of the pharmaceutical industry this year is expected to expand to 20% of global pharmaceutical sales.
In the domestic market, with the development of the domestic pharmaceutical industry, the market is no longer simply attracted to new compounds, new formulations and product R & D more and more the concern of manufacturers. According to The Honor Tong (Beijing) Medical Technology Co., Ltd. Lifeng introduction of new drug delivery systems around the world in the next 5 years will be more than 20% average annual rate of growth. 2010 sales forecast to reach 129 billion U.S. dollars. He believes that this situation for two reasons: on the one hand, the emergence of a new compound entities more difficult, FDA approved new molecular entities in recent years the number of only about 20 remained between 30 and few break of progress; the other hand, patent medicine, especially after another blockbuster drugs expire, companies need to find effective means to protect and extend the product's revenue cycle. These two pressures lead companies to seek a breakthrough in the preparation technology has become an inevitable trend.
Ascendant medicine industry
2003 , FDA approved Sanofi alfuzosin hydrochloride controlled-release tablet form of the new compounds listed, in fact, as the main drug alfuzosin in general preparations as early as 1991, listed in Italy and Denmark, is already an "old" products, FDA of this change in the foreign markets that use advanced technology to prepare the formulations as newly developed compounds, like attention. The domestic market, the new agent a few years ago has been tepid, too hope that the new industrial policy has long been a "compound" ignored the emergence of a new preparation technique is equally important to technological innovation, for example, a new compound for the State Fund support and related research expenses are obvious tilt, and preparation of new technologies are increasingly being excluded from the national level of industry support, the new preparation technique more and more difficult to apply to the state of various pharmaceutical R & D funding support. Meanwhile, very few health insurance directory of new agents into the scope of insurance reimbursement. Judging from the present situation, although the industry fund for the support of a great new compounds, but few results appear, but now most of the domestic market so-called market performance of a class of drugs is also unsatisfactory.
New preparation technology for traditional medicine can play in promoting innovative, traditional Chinese medicine compound Danshen Dripping Pill products and Huoxiangzhengqi soft capsule preparation is improved and the traditional model of success. In fact preparations for a new development of traditional medicine's greatest strength lies in the early stage does not require too many doctors and patient education, market awareness for the product easy to build.
So, what is the most noteworthy of the new agents do? Sino Hua Tong (Beijing) Medical Technology Co., Ltd. approved 2004 foreign-listed the statistics of new pharmaceutical preparations, the following categories is a new drug delivery trends: First, rapidly disintegrating oral tablets, such as clozapine Rapidly Disintegrating tablets, Sumatriptan succinate oral rapidly disintegrating tablets of donepezil hydrochloride oral rapidly disintegrating tablets, compound carbidopa / levodopa oral rapidly disintegrating tablet, rapidly disintegrating Tamsulosin Hydrochloride oral tablets, etc., this is a bright spot, is worthy of attention; second controlled release preparation is still the focus of a number of enterprise development, such as Tamsulosin hydrochloride oral controlled release tablets, controlled-release carbamazepine capsules, darifenacin controlled release tablets, in particular, the slow release compound agents such as fexofenadine hydrochloride / pseudoephedrine hydrochloride 24-hour controlled release tablet, ultra-long-acting controlled-release technologies are emerging, such as the March 1 meeting of the two-hydroxybutyric acid, naphthalene long-acting injections of triptorelin and April 1 of acetic acid bright injection of LA, June 1 times leuprolide injection reservoir-type controlled-release agent; third compound to be a development direction, amlodipine besylate / atorvastatin calcium, according to Ze for Ezetimibe / Simvastatin Tablets, abacavir / lamivudine, tenofovir ester / emtricitabine tablets, oxycodone hydrochloride / ibuprofen tablets, etc.; 4 is a new route of administration also concern, such as ion permeability of lidocaine transdermal drug delivery systems, transdermal drug delivery system of lidocaine ultrasound, micro-embolization agent reservoir and controlled release morphine sulfate injection, Histrelin long-term implants, 5% of the microphone quinoline Mott cream, ipratropium bromide aerosol hydrogen halothane, Triamcinolone nasal aerosol hydrogen halothane, in accordance with carbonate Loteprednol / tobramycin eye drops, nitroglycerin ointment, vaginal lubricants, such as clindamycin phosphate vaginal cream.
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