Dosage form innovation bring gonadorelin polypeptide drugs market

Current clinical polypeptide drugs mainly through injection drug delivery. Dosage form for injection, suspension injection and commonly booster injection, etc. And the new injection drug delivery systems including controlled release microspheres injection, injection with implants, infusion pump, dosing system and the dosage of PEG system, etc.
Announced on September 22, astrazeneca PLC's Reid (generic name: goserelin acetate) 10.8 mg officially listed in China. It is a long-acting slow-release implant dose in March, and will provide more convenience for prostate cancer patients, economic treatment.
Gonadorelin drugs refers to gonadotropin-releasing hormone (GnRH) structure on the basis of a large family of synthetic polypeptide drugs, known as luteinizing hormone releasing hormone (LHRH) is generated. When exogenous GnRH or its analogues in physiological pulse frequency every 90 min (l), the short-term small doses on pituitary gonad system, clinical treatment for sexual function is low, not ovulation, symptoms such as delay puberty; Instead of physiological pulse frequency to long-term, large doses can inhibit pituitary secretion of LH and FSH, led to the decrease of the secretion of gonadal hormone ability and genitals atrophy, clinical treatment for some hormone-dependent diseases, such as prostate cancer, uterine fibroids, breast cancer, endometriosis and precocious puberty.
LHRH analogues of metastatic prostate cancer endocrine therapy is the preferred first-line chemical castration drugs, according to m Intranet - 2011 competition, according to the endocrine treatment goserelin and QuPu gonadorelin market share rank.
Polypeptide drugs dosage is small, but need to for a long time, it offered opportunities for innovative dosage forms. Slow-release microsphere technique is to drug coating in microspheres carrier, through the skin or muscle, slow drug release, change of transport process, prolong action time. Listed for the first time is the development of French Ipsen company QuPu gonadorelin slow-release microspheres, went public in 1986. Implants were divided into non injectable implants and injectable implants and injectable implants is through the way to deliver drugs into the surgery, and drugs can slow and even after a long time to release, birth control pills are commonly used this method at present. Is injected into agent mixed with PLGA melt, and then by porous device into strips, cutting into a certain length of 1 mm or so, after the sterilization load special disposable syringes. Direct subcutaneous or intramuscular injection, clinical drug along with the degradation of skeleton material and give play to the role of long-acting release. Injectable implants without like non injectable implants need surgery into or take out, easy to use, simple preparation. And infusion pump dosing system controlled by computer can do it for a long time, accurate delivery, is a kind of safe and effective for treatment of chronic diseases medicine approach. With PEG (polyethylene glycol) modified compound process called PEG, protein and polypeptide drugs combined with PEG of different molecular weight and structure, solubility and stability increases, immunogenicity and toxicity can be reduced, the body obviously prolong half-life, drug treatment index increase, the effect is better. The infusion pump drug delivery systems due to the expensive, it is not convenient to use, there is no related products listed in our country, the rest three have the product listed. In only the first two polypeptide drug dosage form.
Table 1 class gonadorelin polypeptide drugs already on the market in our country innovative dosage forms
Drug name light c gonadorelin QuPu gonadorelin goserelin
Controlled release dosage form microspheres agent slow-release implants
Domestic manufacturer Shanghai method shows Beijing / / burns
Takeda Germany hui ling foreign manufacturer astrazeneca
For chronic diseases patients require long-term treatment, drug price and application is convenient or not is you most concerned about two aspects. Is QuPu gonadorelin, injection, the average is 0.1 mg/teams, usage of once-daily subcutaneous injection of 0.5 mg, seven day in a row, then 0.1 mg, 1 times a day as a maintenance dose; Controlled release agent, the specifications of 3.75 mg/teams, usage for subcutaneous injection once every 4 weeks. Ordinary injection price is 80 yuan /, 1850 yuan/controlled release agent. From the point of long-term treatment, innovative dosage form can save money for patients and easy to be accepted. In adapt to market development, astrazeneca company is thoughtful, even as its specification is 3.6 mg noriega to goserelin slow-release implants (acetic acid), already in the endocrine treatment market, has now launched the sustainable of the specifications of the drug release three months, on the basis of equivalent with the original specifications, tolerance is better, less injection time, and monthly cost of treatment can save up to 23%. It is definitely a better choice for patients.
The long-acting formulations has thousand of benefits, but m Intranet drug approval according to the domestic enterprises for the lack of power, investigate its reason is various. At present our country is in a critical period of transformation and upgrading of enterprise, innovation is the enterprise products and upgrades. But the status quo is occupied by a foreign high-end field, low-grade product profit is not big, and most companies still at a low level repetition. How to innovate and upgrade of how the product manufacturer is not just a thing, in relation to the whole industrial chain. As the above slow-release microspheres and slow-release implants, a high requirement on the material, and as a preparation for manufacturer's upstream accessories manufacturers due to various reasons, the injection level of related accessories approved hard, causing domestic basic out of stock, and imported accessories and more expensive, which dampened the enthusiasm of domestic pharmaceutical r &d and production enterprises. How to make products with high added value, get rid of the phenomenon of low water to repeat always, need more efforts to encourage innovation, and government work together to achieve the whole industry chain.
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