Recently, the State Pharmacopoeia Commission released t […]
Recently, the State Pharmacopoeia Commission released the "General Rules for Capsules (Hollow Capsules)" (Draft for Comment) (hereinafter referred to as the "General Principles of Capsules") to solicit opinions from the society. As an oral preparation carrier, the hollow capsule uses more than 200 billion tablets each year. It is one of the important pharmaceutical excipients used in oral solid preparations. Its quality and safety are directly related to drug safety. Hollow capsules, as non-monocomponent reprocessed pharmaceutical excipients, are crucial to the quality of the product during its production and processing, and directly affect the quality of the preparation. The "Capsule General Principles" drafted this time fully embodies the concept of "quality control of the entire production process", which is the same for pharmaceutical excipients and medicines. The following features can be seen in the draft of the consultation.
First, emphasize the whole process of quality control
"General of Capsules" emphasizes quality control throughout the entire production process, including raw materials used in production, production processes, production environment, formulation aids, sterilization processes, quality control, product batching, packaging, storage, transportation and other factors affecting product quality. And the links have corresponding technical standards. The production of hollow capsules is no longer based solely on product inspection standards, but is controlled through the entire process to ensure product quality, minimize the risk introduced during the production process, and comprehensively improve the intrinsic quality of the product. This also indicates that the quality inspection of hollow capsules not only serves as a basis for the product to meet quality requirements, but also pays more attention to strict control and supervision of the entire production process. This will undoubtedly put higher requirements on the production and quality control of hollow capsules. The quality of products will be more assured and the use of pharmaceutical companies will be more assured.
Second, reflect the standard and forward-looking pharmacopoeia standards
The "General of Capsules" covers not only gelatin-derived capsules but also specifications for production of hollow capsules of non-animal origin. Although gelatin-free hollow capsules of animal origin are widely used in capsule preparations, with the development of capsule production technology, the emergence of non-animal-derived hollow capsules such as hypromellose, pullulan, hydroxypropyl starch, etc. The capsules made from film-forming materials, the State Pharmacopoeia Commission, combined with the current development and application of various types of hollow capsules in formulation development, regulate the preparation and quality control of various types of hollow capsules, thereby ensuring the quality of hollow capsules for formulations, fully embodying the "China Pharmacopoeia" technical standards of the normative and forward-looking role.
Third, to strengthen the entire process of production traceability
The "Capsule General" regulates the source of capsules and requires that the film-forming materials prepared from different raw materials be defined. For animal-derived gelatin capsules, it must be clarified whether the source of the animal is porcine, bovine or mixed sources. The non-animal source requires a clear clarification of the plant-based source used for its preparation. Based on film-forming materials from different sources, targeted risk control will be strengthened. In response to the problem of batch-wise confusion in preparation of hollow capsules, General Principles propose the principle of capsule batching. The purpose is to trace the entire process of capsule production, ensure product consistency and traceability, and strictly control the key risks of the production process.
Fourth, strictly control the use of capsule auxiliary materials
The auxiliary materials that may be used in the production of hollow capsules, in particular the specific requirements for the standard use of antibacterial agents, pigments and inks. The “General Rules for Capsules” explicitly states that the use of these excipients is discouraged and that the guidance requirements are clearly set forth; for use, strict limits are placed on the amount and type of use.
V. Exploring and Establishing Standards and Formulating New Mechanisms
The drafting unit of “Capsule General” involves industry associations, national drug inspection agencies, and research institutes. It forms a new working mechanism that integrates national standards of production, study, and research. It also encourages related companies to participate in standard setting, and improves the rationality and operability of standard formulation. Sex.
"Capsule General" is the first draft of the general technical requirements for pharmaceutical excipients issued by the National Pharmacopoeia Commission on the Internet under the framework of the preparation of the 2020 Pharmacopoeia. At present, the foreign pharmacopoeia has not yet published such a general rule of technology. In terms of technical specifications for hollow capsules, the Chinese pharmacopoeia standards have taken the lead in the international arena. It is believed that the formulation and implementation of the General Regulations will play a technical role in comprehensively regulating the production, quality, and supervision of hollow capsules, as well as the implementation of the current joint review, approval and approval system for APIs, pharmaceutical excipients, drug packaging materials and pharmaceutical preparations. Support function.