subject: Transdermal Formulations International Market Gradually Heat [print this page] "Provides an eye-catching results reveal a new strategy on transdermal transport macromolecules"; "will be used in transdermal enhancer in vivo phage display area of research is innovative"; "by completion of an order people who are interested, thought-provoking papers. "March 27, the United States," Nature Biotechnology "magazine gave Wunlong such comments in the calm of his study groups.
Wunlong Ping is Physical Sciences at Microscale USTC, Hefei National Laboratory for the project leader, Professor, College of Life Sciences. Not long ago, he led the research team to be original in vivo phage display technology for transdermal research, and successfully found a 11 amino acids, can efficiently help the protein drugs 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, that is able to produce good hypoglycemic effect. In addition, this peptide can also help human growth hormone transdermal shows that it may have a generic protein drugs.
According to Professor Wunlong level, the results are obtained in animal experiments, while the transdermal peptide is equally effective on the human body need to be further verified. At present, the research team is working with a Shanghai medical technology companies to conduct pre-clinical studies. Transdermal enhancer peptide found in the significance of this is: Over the years, application of chemical penetration enhancers and physical assistance to two major categories of protein by means of transdermal drug formulations of macromolecules has been little breakthrough results, if the results of successful human trials, will herald the emergence of a huge market.
The international market gradually heat the so-called penetration enhancers are used to improve transdermal drug delivery system (TDS) in the penetration rate of drugs as a way of Pharmacy. In recent years, researchers have national enthusiastic study of this approach, because once the study is a breakthrough in transdermal drug delivery formulations will be applied to a wider range of areas, which means the market potential of transdermal formulations will be fully released .
Transdermal preparations derived from 70 years in the last century, its principle is drug absorption through the skin, and then into the blood to play a curative effect, it is also known as transdermal preparations, or transdermal delivery system Transdermal Therapeutic System (TTS). This drug delivery system appeared, with its lasting, constant and controllable blood concentration to avoid the liver first-pass effect, increasing the bioavailability, routes of administration simple and patient compliance advantages of high concern by the market. At present, the United States and Europe will be transdermal preparation as 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, sales of nicotine patches to quit 10 million; As of 2004, the United States has more than 35 drugs available transdermal preparations. In 2005, the United States more than 20% of the pharmaceutical companies have begun production of TTS. The relevant statistics showed, the international pharmaceutical company producing transdermal formulations have been dozens of other, about 1 / 3 of the manufacturers will use the new forms. At present, transdermal drug delivery system developed by the United States share of the global class of drugs for 56% of the amount of drug sub-Europe accounted for 32%, Japan 7%. Recently, there have been a number of foreign companies listed on transdermal formulations. Produced by Mylan's first for the treatment of adult patients with severe depression selegiline transdermal formulations (selegiline, Emsam) recently received U.S. FDA approval.
Also at the January 4, 2006, the U.S. FDA has approved Schering AG, Germany (Schering), a subsidiary of Berlex's hormone therapy patch estradiol / L -18 - methyl-norgestrel (Climara Pro) for the prevention of osteoporosis. In addition, Novartis (Novartis) and the Japanese pharmaceutical industry Ono (Ono Pharmaceutical Co., Ltd) is also common in Japan, the development of Alzheimer's disease drug benefit cutting neostigmine (rivastigmine) transdermal absorption dosage form, at present in this product is 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 (treating menopausal syndrome, osteoporosis and hypogonadism), cardiovascular diseases (high blood pressure and angina pectoris), and central nervous system diseases (smoking, halo motion sickness and pain / inflammation). In 1999, the global market, sales of transdermal formulations of about 11 billion U.S. dollars in 2000 to 13 billion U.S. dollars in 2005 is expected to reach 12.7 billion by 2010, is expected to increase to 80 billion to 1000 billion U.S. dollars. The U.S. pharmaceutical industry believes that the next 10 to 15 years, there were 1 / 3 of the current medication will be used transdermal preparation; By 2005, over 40% of U.S. pharmaceutical companies will produce transdermal preparations.
To open up the domestic market to be
At present, the world has listed a variety of transdermal drug formulations of scopolamine (scopolamine), clonidine (clonidine), nitroglycerin (nitroglycerin), fentanyl (fentanyl) and so on. In recent years, new varieties are listed compound salicylic acid / triclosan patch, Zhou Xiao-estradiol transdermal patch and so on, a considerable portion of which has been in the domestic market. 16 major cities in the domestic market, according to hospital statistics, in 2004 total sales of fentanyl 33.332 million yuan, while sales of fentanyl patches 17.1285 million yuan, accounting for 51.39% of fentanyl market; Johnson & Johnson (Xian -Janssen Pharmaceutical Ltd) occupied the top spot of the patch market (sales of 10.763 million yuan, accounting for 62.83% of the transdermal patch market share), the remaining market is the United States Alaz company (sales 626 million yuan, accounting for 36.54 %) and Jiangsu Huarui (sales was 10.4 million, representing 6.1%) divided. Not long ago, Shanxi reflex Pharmaceutical antihypertensive drugs clonidine transdermal patch available. And this product sales in the United States in 2004, which amounts to 260 million U.S. dollars.
The Chinese market to be awakened
But the stark contrast, China's current annual sales of transdermal formulations of drugs is only a rough estimate of about 1 billion yuan, compared with other formulations, its share of the market share is relatively small. Currently transdermal formulations reason why a relatively small size of the market, it may be subject to restrictions on technical level of domestic agents. According to statistics, China's current transdermal preparations have been made public yet the number of patents to 20, the number of published literature is not much.
Xi'an, 1000, and Pharmaceutical Chai Wenjing believes that the domestic processes in the transdermal patch indeed flawed, "for example viscosity, or on too strong, or would not." Asia and the Shanxi Pharmaceutical Production Technology Division Po Ming-Jun Li believes that the domestic formulations technological level may not be the main factor, the real problem may come from the market level of acceptance. As the current domestic market, the prices of similar preparations of transdermal drug formulations is much higher than normal, so a limited degree of market acceptance, while the impact of clinical drug habits are also one of the factors.
Transdermal Formulations International Market Gradually Heat
