With the improvement of the level of domestic pharmaceutical preparations, more and more new pharmaceutical excipients have been widely used in China. Especially in recent years, the development and application of premixed excipients has become a trend in the development of pharmaceutical excipients. The typical product of premixed excipients in recent years is mainly film coating powder. It is undeniable that its appearance has greatly promoted the improvement and development of the coating of solid pharmaceutical preparations in China, and it has also created a brand new industry.
However, as premixed excipients are still in an emerging stage of development in China, the relevant regulations on pre-mixed excipient management in the country are still blank, which greatly restricts the development and utilization of domestic premixed excipients.
Registration Management
According to the requirements of the registration requirements for the registration of pharmaceutical excipients, the new pharmaceutical excipients refer to the pharmaceutical excipients produced and applied for the first time in China. Therefore, the registration of premixed excipients is undoubtedly declared according to the new excipients. However, according to the new pharmaceutical excipients, the provision of pharmacological and toxicological research data and clinical research data is very difficult. In particular, it is necessary to provide comprehensive clinical research data, which is difficult for most manufacturers.
In this paper, the author believes that premixed excipients are only physical mixing of different pharmaceutical excipient components, and do not produce chemical reactions to form new compounds. It can be considered that premixed excipients are neither new pharmaceutical excipients nor completely equivalent to existing The medicinal excipients should therefore be developed with a reasonable registration declaration requirement. As long as each component that constitutes the premixed excipient is approved for marketing and is widely used in China, the pharmacological and toxicological information of each component is mature. Therefore, it is only necessary to provide the safety information of each component when filing. Just fine.
At the same time, in order to prove that there is no chemical reaction between each component of the premixed excipients, the company should provide relevant research materials to explain; if you add unapproved new pharmaceutical excipients for premixing or change the route of administration, you need to be safe. Sexual evaluation, safety evaluation should be carried out after the drug is formulated.
Quality Standard
From the requirements of the registration materials for pharmaceutical excipients, the registration of pharmaceutical excipients must have quality standards. However, from the perspective of foreign management of premixed excipients, such as the United States and the European Union do not require premixed excipients to have quality standards. Moreover, the main technical feature of premixed excipients is the composition of the formulation, even if the formulation of the same type of premixed excipients is different.
The most typical ones are film coating powders. The formulation of several professional film coating powder manufacturers in China is different, and they are developed according to market needs and their own research and development concepts. The difference in formula determines the non-uniqueness of quality standards. In this paper, the author believes that the management of premixed excipient quality standards should learn from abroad to eliminate the quality standards of premixed excipients. Even if the registration requires quality standards, the production enterprises should provide the enterprise quality standards according to their own product characteristics. Detection of trace impurities (chloride, heavy metals, etc.) and functional tests (particle size distribution, angle of repose, etc.).
The use of trade names
Since the premixed excipient is a combination of various excipients, it can only have a trade name without a common name. From the naming of foreign premixed excipients, such as microcrystalline cellulose and sodium carboxymethylcellulose composite powder, there are several names such as colloidalcellulose, dispersiblecellulose and AvicelCL-611. However, premixed excipients use the trade name instead of the common name, and are inconsistent with the Notice on Further Regulating the Management of Drug Names. Therefore, the naming of premixed excipients should not be managed with reference to drugs. The author suggests that premixed excipients should be named after the trade name, but the main ingredients of the formula should be indicated in the instructions or labels.
Application of
The Measures for the Administration of Drug Registration stipulates that if the excipients that have approved the medicinal requirements for approved drugs are changed, they must submit a supplementary application to the State Food and Drug Administration. The "Regulations on the Administration of Drug Registration" stipulates that the requirements for changing the application materials for excipients that have been medicinal requirements are relatively simple, and no pharmacological and toxicological studies and clinical trials are required. Then, whether premixed excipients are used in pharmaceutical preparations of pharmaceutical manufacturers is still a problem worthy of discussion.
If the premixed excipients of the premixed excipients are approved by the registration, then the pharmaceutical excipients' production research and related declarations for premixed excipients may be used as reference materials for the pharmaceutical manufacturers to change the pharmaceutical excipients of the produced preparations. It is not necessary to re-examine the correlation test, which is the only way to promote the promotion and properness of premixed excipients.
Technical protection
As a combination of various pharmaceutical excipients, premixed excipients focus on the composition of the formula, so the formula is the technical secret of the premixed excipients. In this regard, the national drug regulatory authorities should refer to the relevant provisions of the Chinese medicine protection regulations to protect the relevant provisions, for the pre-mixed auxiliary materials that have been declared for approval, in principle, other enterprises are not allowed to repeat the declaration, in order to protect the enthusiasm of enterprise innovation.
In summary, the author believes that the development of premixed excipients should be further improved according to the current situation and future development trends of premixed excipients to break the ice that hinders the development of premixed excipients, thereby promoting the development of domestic pharmaceutical excipients. Further promote the improvement of the level of domestic pharmaceutical preparations.
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