Premixed materials development problems and solutions

With the increase in the level of domestic pharmaceutical preparations, more and more new types of pharmaceutical excipients have been widely used in the country. Especially in recent years, the development and application of premixed excipients has become a trend in the development of pharmaceutical excipients. The typical products of premixed auxiliary materials in recent years are mainly film coating powders. It is undeniable that its emergence has greatly promoted the improvement and development of the coating level of solid pharmaceutical preparations in the country, and it has also created a brand-new industry.

However, as the premixed auxiliary materials are still in a new stage of development in the country, the relevant laws and regulations of the state in the management of pre-mixed auxiliary materials are still blank, which greatly constrains the development and utilization of domestic pre-mixed auxiliary materials.

Registration management

According to the requirements of the registration requirements for pharmaceutical excipients, the new pharmaceutical excipients refer to pharmaceutical excipients that were first produced and applied in China. Therefore, the registration of premixed excipients is no doubt subject to new pharmaceutical excipients. However, according to the declaration requirements for 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 and it is difficult for most production companies.

Here, the author believes that premixed excipients are just physical mixtures of different components of pharmaceutical excipients and do not produce chemical reactions to generate new compounds. It can be considered that premixed excipients are neither new medicinal excipients nor are they completely equivalent to existing compounds. The pharmaceutical excipients should therefore be formulated with a reasonable registration requirement. As long as each component of the premixed excipients is approved for marketing and is widely used in the country, the pharmacological and toxicological information of each component is mature. Therefore, only the safety data of each component should be provided when applying. You can.

At the same time, in order to prove that there is no chemical reaction between each of the components that make up the premixed excipients, companies should provide relevant research information to explain; if you add new pharmaceutical excipients that are not approved for premixing or change the route of administration, you need to be safe. Sexual evaluation and safety evaluation should be performed after the drug is formulated.

Quality Standard

According to the requirements for the registration of pharmaceutical excipients, the registration of medicinal excipients must have quality standards. However, from the perspective of management of premixed foreign materials, for example, the United States and EU countries do not require quality standards for premixed excipients. Moreover, the main technical feature of premixed excipients is the composition of the formula, even if the formulations of the same type of premixed excipients are different for each manufacturer.

The most typical film coating powder. Several domestic companies specializing in the production of film coating powders have different formulations. They are developed according to market needs and their own R&D concepts. The differences in formulas determine the non-uniqueness of quality standards. In this article, the author believes that the management of quality standards for premixed auxiliary materials should learn to cancel quality standards for premixed auxiliary materials abroad. Even if registration requires quality standards, the manufacturer should provide quality standards according to the characteristics of his products. The focus of standards should be grasped. Trace impurities (chlorides, heavy metals, etc.) and functional tests (particle size distribution, angle of repose, etc.) were examined.

Use of product name

Since premixed excipients are a combination of various pharmaceutical excipients, it can only have a trade name but no generic name. From the nomenclature of foreign premixed excipients, there are several names such as colloidal cellulose, dispersible cellulose, and Avicel CL-611. However, the use of trade names rather than common names for premixed accessories is contrary to the “Notice on Further Regulating the Management of Drug Names”. Therefore, the name 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 specified in the instructions or labels.


The “Administrative Measures for Drug Registration” stipulates that if it is necessary to change excipients that have been approved for use as pharmaceuticals for listed drugs, they must submit a supplementary application to the State Food and Drug Administration. The "Drug Registration Administration Regulations" stipulates that the requirements for changing the application materials of existing excipients are relatively simple and there is no requirement for pharmacological and toxicological studies and clinical trials. Therefore, whether the use of pre-mixed excipients in drug manufacturers' pharmaceutical preparations is to carry out relevant experimental research again is still a question worthy of discussion.

If the pre-mixed excipients of the pre-mixed excipient manufacturing enterprises are registered to obtain the approval number, then the pharmaceutical excipients manufacturing enterprise can use the pre-mixed excipients research and related declarations as pharmaceutical production companies to change the citations of the pharmaceutical excipients that have been produced. It is not necessary to re-examine the relevant experimental studies. Only in this way is it more conducive to the promotion and due diligence of pre-mixed excipients.

Technical protection

The combination of pre-mixed excipients as a variety of pharmaceutical excipients focuses on the formulation of the formula, so the formula is the technical secret of the pre-mixed excipients manufacturer. In this regard, the national drug regulatory authorities should formulate relevant regulations in accordance with the regulations for protection of traditional Chinese medicines. For pre-mixed excipients that have been approved for listing, in principle, other enterprises are not allowed to make repeated declarations. Only in this way can the enthusiasm of innovation be protected.

In summary, the author believes that the current situation and future development trend of premixed auxiliary materials should be further improved by relevant regulations for the management 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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