2015 Pharmacopoeia will focus on the collection and loading of pharmaceutical excipients

Source: on October 14, 2015, for the formulation development of biological products, it is necessary to focus on the addition and treatment of excipients in Chinese Pharmacopoeia 2015 (hereinafter referred to as "new Pharmacopoeia") There are only two months left for the formal implementation of the new edition of Pharmacopoeia The attention of the industry to the new edition of Pharmacopoeia continues to be hot Most of the recent industry technical seminars talk about relevant contents Recently, at the 2015 freeze drying technical seminar sponsored by the Pharmaceutical Engineering Professional Committee of Guangdong Pharmaceutical Association, some experts in the industry reminded drug research and development personnel that they should pay attention to the collection guidance of excipients in the new pharmacopoeia and avoid using excipients deleted by the new pharmacopoeia It is emphasized that one of the most significant changes in the new edition of pharmacopoeia is that the appendix (general principles) and excipients are divided into four parts independently, and the standard level of medicinal excipients is improved Zhang Wei, secretary-general of the national pharmacopoeia commission, once said publicly that although the pharmaceutical excipients of the new pharmacopoeia increased by 105%, there is still a gap between the quality and standard level of the excipients and the international comparison It is important to keep up with the development trend of the International Pharmacopoeia and adopt new technologies and methods to ensure the safety and effectiveness of the drugs The improvement of the quality standard of pharmaceutical excipients will have a great impact on the quality and safety of preparations According to the published catalogue, 270 kinds of pharmaceutical excipients are included in the new pharmacopoeia, including 137 new ones, 97 revised ones and 2 not included According to Shi Yongjun, operation director of international pharmaceutical preparation network, the addition of Pharmacopoeia not only means that the 137 kinds of pharmaceutical excipients have "national standards", but also is a strong application support for enterprises interested in developing these varieties "The new edition of Pharmacopoeia has improved the construction of pharmacopoeia standard system, improved the requirements of quality control as a whole, further expanded the application of advanced and mature detection technology, greatly increased the varieties of pharmaceutical excipients, and tightened the quality requirements and safety control, further embodying the leading role and technical guidance role of China Pharmacopoeia." Liang Chaofeng, head of the preparation center of Guangzhou Pharmaceutical Research Institute, added that although the number of pharmaceutical excipients in the new pharmacopoeia has increased from 132 to 270 Species, but in terms of the number of varieties of pharmaceutical excipients, whether from the actual production of the pharmaceutical excipients used, need to monitor, or with the foreign advanced Pharmacopoeia of the pharmaceutical excipients ratio, China's pharmacopoeia of pharmaceutical excipients or very few At the 2015 freeze drying technology seminar, it was revealed that the future supplement is expected to continue to contain more varieties of pharmaceutical excipients What attracts the attention of the industry is that the new edition of Pharmacopoeia not only strengthens the control of safety indicators, but also gradually attaches importance to the evaluation of functional items, and increases the guiding principles of functional indicators research of pharmaceutical excipients Shi Yongjun pointed out that the increase of Pharmacopoeia functional indicators will guide enterprises to improve and upgrade the corresponding pharmaceutical excipients process, "to provide assistance for the improvement of the level of domestic generic drugs." Many industry insiders also believe that for pharmaceutical excipients, functional indicators can be said to be the core of product quality "Although the functional indicators of pharmaceutical excipients are not suitable to be included in the Pharmacopoeia as a mandatory standard due to various practical needs and other factors, they are not recognized as the compliance of pharmaceutical excipients." Professor Song Minxian, director of the technical promotion committee of pharmaceutical excipients of the National Pharmaceutical Technology Market Association, pointed out that in recent years, some pharmaceutical excipients enterprises have begun to study the pharmaceutical excipients with functional indicators as their characteristics, but they need the active guidance of pharmaceutical enterprises to form the trend of the industry However, the most concern of the participants was the classification requirements of the new pharmacopoeia for the quality of excipients according to different uses In consideration of the particularity of the injection dosage form, which can enter the body directly, absorb quickly and act quickly, the new pharmacopoeia puts forward stricter safety indexes for the auxiliary materials for injection, which can be understood " A business person attending the seminar said Song Minxian also believes that the market space for injection excipients newly included in the 2015 pharmacopoeia is quite large in the future It is worth noting that, in addition to "Shuanghuanglian for injection (freeze-drying)" included in the first part, the other freeze-drying varieties included in the new pharmacopoeia are all in the biological product categories of the third part At the seminar, many researchers also raised questions about freeze-drying of biological products "Corresponding freeze-drying equipment and process improvement is becoming more and more urgent," some participants said in private According to the regulations of the new edition of Pharmacopoeia on the subpackage and freeze-drying of biological products, the freeze-drying equipment and process shall be verified According to the different characteristics of the products, the appropriate freeze-drying process parameters shall be formulated and selected The freeze-drying process shall be verified according to the actual freeze-drying batch The freeze-drying process shall have automatic scanning records The whole freeze-drying process shall be strictly sterile "For the formulation development of biological products, it is important to focus on the addition and treatment of excipients." Dr Jeff schwegman, who has been engaged in the development of injection formulation technology for many years, reminded the seminar Although the impact of quality classification on pharmaceutical excipients industry will take some time to release, the classification of excipients' safety quality requirements and functional indicators according to different uses proposed by the new pharmacopoeia can reduce resource waste to a certain extent.