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“offers a striking results show a new strategy for the transdermal transport of macromolecules,” “will in transdermal enhancer in vivo phage-display area of research will be used is innovative,” “through the completion of an order people who are interested, thought-provoking papers. “March 27, gave the United States,” Nature Biotechnology “magazine Wunlong such comments in the quiet of his study groups.

Wunlong Ping Physical Sciences at Microscale USTC, Hefei National Laboratory for the project leader, Professor, School of Life Sciences. Not long ago, he led the research team to in vivo phage display technology for transdermal original research and successfully found a 11 amino acids, protein drugs can help efficient transdermal short peptides.

Studies have shown that such a short peptide and insulin in a simple saline solution to mix and apply on the skin of diabetic rats, which is able to generate good blood glucose lowering effect. In addition, this peptide also contribute to human growth hormone transdermal shows that it can have a generic protein drugs.

According to Professor Wunlong level, the results are obtained in animal experiments, while the transdermal peptide is as effective on the human body must be further examined. Currently, the research team with a Shanghai medical technology companies are working to carry out pre-clinical studies. Transdermal enhancer peptide found in the importance of this knowledge: Over the years, the use of chemical and physical penetration enhancer has support for two main groups of proteins by transdermal dosage forms of macromolecules have been little breakthrough results when the results of successful tests on humans will herald the emergence of a huge market.

The international market gradually heat of the so-called penetration enhancers to improve transdermal drug delivery system (TDS) in the penetration rate of drugs as a way of Pharmacy . In recent years, researchers have national enthusiasm study of this approach, for if a breakthrough in the study of transdermal drug delivery formulations to a wider range of areas, which is the market potential of transdermal formulations are released in full by means are applied.

transdermal preparations from 70 years in the last century come, its principle is the drug absorption through the skin, and then play in the blood on a healing effect, it is also available as transdermal preparations or transdermal administration system known transdermal therapeutic system (TTS). This drug delivery system appeared, with its continuous, steady and controllable concentration in the blood to the liver to avoid first-pass effect, increasing the bioavailability, routes of administration simple and patient compliance advantages of a high concern of the market. Currently, the United States and Europe as a transdermal preparation, the focus of pharmaceutical research.

Transdermal formulations to the birthplace of the United States as an example. It was reported that in 1992, the U.S. market to end sales of nicotine patches 10 million from 2004, the United States more than 35 drugs available for transdermal preparations was. In 2005, the United States more than 20% of the pharmaceutical companies started the production of TTS. The relevant statistics showed, the international pharmaceutical company produces dozens of other transdermal formulations, have about one third of the manufacturers have been using the new forms. At present, transdermal drug delivery system of the United States part of the global class of drugs for 56% of the quantity of the drug sub-developed Europe accounted 32%, Japan 7%. Recently there were a number of foreign companies listed on transdermal formulations have been. Produced by Mylan first for the treatment of adult patients with severe depression selegiline transdermal formulations (Selegiline, Emsam) recently received U.S. FDA approval.

, Germany (Schering), a subsidiary of Berlex’s hormone patch estradiol / L -18 – methyl-norgestrel (Climara Pro) for prevention of osteoporosis. In Novartis (Novartis) and the Japanese pharmaceutical industry also Ono (Ono Pharmaceutical Co., Ltd.) is also common in Japan, is the development of Alzheimer’s drugs benefit cut neostigmine (rivastigmine) transdermal absorption dosage form, currently this product in Phase II clinical trials. It is evident from the heat of transdermal formulations market. According to statistics, most of transdermal preparations for hormone replacement therapy (treatment of menopausal syndrome, osteoporosis and hypogonadism), cardiovascular diseases (hypertension and angina pectoris) and central nervous system (smoking, Halo sickness and pain / inflammation). In 1999, the global market sales of transdermal formulations about 11 billion U.S. dollars in 2000 to 13 billion U.S. dollars in 2005 is expected to reach to 12. 7 billion in 2010, is expected to increase to 8-10000000000 U.S. dollars. The U.S. pharmaceutical industry believes that the next 10-15 years there was a third of the current medication be used transdermal preparation; produce by the year 2005 over 40% of U.S. pharmaceutical companies transdermal preparations is.
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To the opening of the domestic market to be
Currently the world is a variety of transdermal dosage forms of scopolamine (scopolamine has listed), clonidine (clonidine), nitroglycerin (GTN), fentanyl (Fentanyl) and so on. In recent years new varieties compound salicylic acid / triclosan patch, Zhou Xiao-estradiol patch and listed so on, a considerable part of which was on the domestic market. 16 large cities in the domestic market, according to hospital statistics, in 2004 a total of fentanyl 33rd 332 million yuan, while sales of fentanyl patches 17th 1.285 billion yuan, accounting for 51st 39% of fentanyl-market, Johnson & Johnson (Xian-Janssen Pharmaceutical Ltd) shows the top position of the patch market (turnover of 10 763 million yuan, a figure of 62 83% market share of the transdermal patch), the rest of the market The United States Alaz (turnover 626 million Yuan, a share of 36 54%) and Jiangsu Huarui (10th turnover was EUR 4 million, was divided 6th 1%). Not long ago, clonidine Shanxi Reflex Pharmaceutical antihypertensive transdermal patch available. And the product sales in the United States in 2004, amounting 260 million U.S. dollars.

The Chinese market is to be woken
But the contrast that China’s current annual revenue of transdermal formulations of drugs only a rough estimate of about 1 billion yuan, compared with other formulations, a share of the market share corresponds to relatively small. Currently, transdermal formulations reason why a relatively small size of the market, it may be subject to restrictions at the technical level of domestic agents. According to statistics, China’s current transdermal preparations have been made public nor the number of patents to 20, the number of published literature, not much.

Xi’an, 1000, and Pharmaceutical Wenjing Chai believes that the domestic political processes in the transdermal patch actually poor “, such as viscosity, or too strong, or not.” Asia and the Shanxi Pharmaceutical Production Technology Division Po Ming-Jun Li believes that the domestic formulations may not technological level is the most important factor, can come to the real problem out of the market acceptance. Since the current domestic market, the prices of similar preparations of transdermal dosage forms is much higher than normal, so a limited degree of market acceptance, while the effects are of clinical drug development patterns also one of the factors.