2010-07-02 3091
Re-research and development of popular products has become the main direction of innovation for domestic small and medium-sized pharmaceutical companies, and formulation innovation is also a major breakthrough point.
Recently, at a clinical medicine symposium on cefminox held by Guangdong Zhuhai Jinhong Pharmaceutical Co., Ltd., attending experts and production companies engaged in intense discussions on the clinical use and market development of antibiotics. It was unanimously agreed upon by the attendees that many varieties of antibiotics need to develop new formulations that are more suitable for clinical applications.
"For many drugs widely used in clinical practice, developing formulations with better compliance can greatly extend the drug's life cycle, enhance its clinical value, and achieve the goal of alleviating patients' concerns and difficulties. It also provides more development space for China's pharmaceutical industry, which has developed along the path of generic drugs. Jinhong Pharmaceutical has taken an important step in the field of immediate-release formulations," said one attending expert.
Jinhong Pharmaceutical Chairman Shang Guanqing revealed, "Jinhong Pharmaceutical has developed a dispersible tablet of cefminox using orally disintegrating tablet technology, which has been approved by the National Medical Products Administration and is about to be launched. This is the first domestically developed dispersible tablet formulation of cefminox using orally disintegrating tablet technology and represents an important exploration in the field of immediate-release formulations." This is a research and development approach suitable for the company's own strength. Currently, the level of formulation innovation in China is far lower than that of developed countries, but companies can still make progress in this area, according to Shang Guanqing.
New formulations for market adaptation
As a leading sector in clinical medicine, the re-development of antibiotic products has become a hot topic in the research and development of domestic pharmaceutical companies. In recent years, cefminox, which has had good sales, needs to develop more formulations, especially in the field of immediate-release formulations, due to its clinical advantages.
Cefminox has a wide range of antibacterial effects against Gram-positive and Gram-negative bacteria. Additionally, it has a longer elimination half-life in the human body, requiring only 1-2 doses per day, which has earned it widespread recognition among clinicians and patients.
It is understood that among the currently available formulations for children and vulnerable groups, the cefminox formulations on the market in China are relatively simple and have poor compliance. The poor compliance of cefminox formulations affects its further clinical use.
In fact, as an antibiotic, cephalosporin has always provided important support for clinical use. However, the cephalosporin products currently used in clinical practice are mostly injectables, and oral formulations have always been in a disadvantaged position among cephalosporin drugs. In 2006, oral cephalosporin drugs accounted for only about 13% of the total cephalosporin drug market sales.
Some industry experts believe that the weakness of oral cephalosporin drugs lies not in their clinical efficacy but in the convenience and practicality of their formulations. Especially for many varieties that have been used in clinical practice for many years but have not seen a market breakthrough, developing formulations that both doctors and patients find compliant is undoubtedly an important direction to open up the market.
Currently, the commonly used formulations of cefminox in clinical practice include ordinary tablets, suspensions, and capsule formulations. When taking solid oral formulations, water is required for swallowing, which brings inconvenience to patients who are busy with work or have difficulty swallowing, reducing patient compliance and clinical efficacy.
As a result, formulation improvement has become a new challenge for most oral cephalosporin enterprises. Either letting the market decline naturally or investing in further research and development to seek a "second spring."
Promising prospects for orally disintegrating tablet technology
In fact, as the development of generic drugs in China has reached this stage, formulation improvement has become an important approach for many widely used products. There are also many varieties on the market that have achieved breakthroughs in sales through formulation re-development. Among them, orally disintegrating tablets are undoubtedly one of the most effective formulations for market improvement in the international market.
Since the listing of orally disintegrating tablet FlashTab by Ethpharm in France, this formulation has gained wide recognition in the international pharmaceutical market. According to statistics, there are currently 80 to 90 orally disintegrating tablet products on the market worldwide, including levocetirizine and famotidine, and there are hundreds of new orally disintegrating tablet products expected to be launched soon.
With the continuous increase of orally disintegrating tablet products in the US market, orally disintegrating tablets are expected to account for 8% of the total sales of the pharmaceutical formulation market, reaching $7.5 billion. The total global sales of oral fast-disintegrating tablet products in 2010 may even reach $10 billion.
It is reported that there are currently no domestically or internationally available dispersible tablets of cefminox using orally disintegrating tablet technology, and no manufacturers have applied for new drugs or patents for such products. However, several domestic companies and institutions are currently conducting related research on orally disintegrating tablets of cefminox.
The head of R&D at Jinhong Pharmaceutical revealed that through extensive research, the company has conducted screening of components and content such as fillers, disintegrants, and flavor correctors in orally disintegrating tablets, and has improved the preparation process. Its characteristic is that it can rapidly disintegrate in the oral cavity without the need for water during administration, providing great convenience for the elderly, infants, busy workers, or patients who have no access to water. Compared with conventional oral formulations, orally disintegrating formulations cover a wide area of the gastrointestinal mucosa, allowing for faster attainment of effective blood drug concentrations, bypassing the first-pass effect of the liver, rapidly taking effect, reducing the dosage, and following the trend of "high efficiency, low toxicity" in drugs
Shang Guanqing stated that currently, most drugs in China have shown insufficient research in prescription formulation and a lack of targeted product development. "But with the promulgation and implementation of the new GMP, the re-development capabilities of Chinese pharmaceutical companies that have developed along the path of generic drugs will become a core part of the new round of market competition."