Industrial Pharmacy

Author: China Medical Science Press
Publisher:
Publish Date: 2001-07-01
Features: This is the first industrial pharmacy undergraduate textbook in China, co-authored by renowned pharmacy experts such as Zhang Ruhua and Tu Xide. Unlike general pharmacy textbooks, this book appropriately increases content related to formulation technology, process design, quality control, and other aspects of formulation production. It also emphasizes the design and research of new dosage forms and formulations. This book does not cover the content of biopharmaceutics and pharmacokinetics. It is not only a textbook for pharmacy students and teachers but also has significant reference value for technical personnel engaged in pharmaceutical formulation production, research, and management.
Excerpt: After the founding of the People's Republic of China, the state formulated health work policies and strategies, and the pharmaceutical industry developed rapidly. At the 1950 National Pharmaceutical Industry Conference, it was determined that pharmaceutical production should be developed on the basis of self-reliance, in a planned and step-by-step manner. Formulation industry was developed on the premise of prioritizing the production of raw materials to solve the problem of "having no rice to cook." To adapt to the development of the pharmaceutical industry, pharmacy schools accelerated talent cultivation and established majors such as pharmaceutical production (mainly studying the research and production of raw materials, including antibiotics), pharmaceutical technology, and pharmaceutical analysis, among others. Textbooks such as Formulation Technology were also published. In 1956, the Drug Formulation Laboratory of the Shanghai Pharmaceutical Industry Research Institute was established, and national-level seminars on the production experience of injectables and tablets were held multiple times, promoting the rapid development of China's pharmaceutical industry (including the formulation industry). Since the reform and opening-up, the healthcare sector has ushered in a new spring. In the research of pharmaceutical excipients, several new materials were developed, such as the excellent surfactant poloxamer, fatty acid esters of sucrose, and semisynthetic fatty acid esters for suppository bases. In the development and application technology of excipients for oral solid dosage forms, activity was even more vibrant, with diluents such as microcrystalline cellulose, compressible starch, binders such as polyvinylpyrrolidone, sodium carboxymethyl starch, sodium hydroxyethyl cellulose, and hydroxypropyl methylcellulose, and disintegrants such as sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, and film-coating materials such as polyacrylic acid series products. Great progress has also been made in production technology and equipment. For example, microporous filters and polycarbonate filters compatible with them have been developed to significantly improve the quality of injectables. Multi-effect distilled water production equipment has been designed and manufactured to save energy and improve the quality of. More advanced sterilization equipment and technologies have been produced and applied, making the sterilization effect more reliable. In the production of oral solid dosage forms, new excipients have been widely promoted and applied, and micronization technology and other new technologies to improve drug dissolution have been adopted to improve product quality. In tablet production, fluidized bed spray granulation and high-speed agitation granulation technologies have been studied and adopted to improve product quality. Film-coating technology has been adopted, saving time and materials while improving product quality. New materials have also been widely used in the packaging of formulations. In addition, many advanced pharmaceutical equipment has been developed, such as high-speed automatic tablet presses, etc.
The research and development of new dosage forms have attracted high attention. In controlled (sustained) release formulations, reports have been made on the development of nearly all types of such dosage forms, and several varieties have been approved for production by the New Drug Approval Department of the Ministry of Health. Transdermal absorption delivery systems have several approved products, and research on targeted and localized delivery systems has also made significant progress, such as liposomes, microparticles, and nanocapsules. In recent years, some people have studied the combination of drugs with monoclonal antibodies to prepare active targeted formulations, while others have used iontophoresis to prepare transdermal delivery systems for macromolecular drugs, all of which have achieved encouraging progress.
Although research and production of pharmaceutical formulations have made great progress, they are still a relatively weak link in the pharmaceutical industry and have attracted attention to break the situation of large-scale imports of formulations. At the same time, it has been recognized that converting raw materials into appropriate dosage forms is a deep-processing process with high technical content and high added value. The quality of pharmaceutical formulations has a significant impact on efficacy. To promote the development of the formulation industry, pharmacy schools have restored and strengthened the pharmaceutical formulation major, with Industrial Pharmacy as the main professional course.
Section 3: Regulations on Pharmaceutical Formulations
1. Pharmacopoeia and Other Drug Standards
1. Overview
A pharmacopoeia is a legal code in a country that records drug standards and specifications. Pharmacopoeias are generally compiled, published, and enforced by national pharmacopoeia committees and governments, and their provisions are legally binding. Pharmacopoeias include those effective, low-side-effect, and stable commonly used drugs and their formulations, specifying their quality standards, such as content, melting point, identification, and the limits of possible impurities, as well as the methods and reagents for testing. In the formulation section, standards and inspection methods for various dosage forms are also specified. The production, inspection, supply, and application of drugs (including formulations) must all be based on pharmacopoeia standards. Products that do not comply with pharmacopoeia regulations are counterfeit or substandard drugs. Therefore, strict implementation of the pharmacopoeia can ensure the safety and efficacy of pharmaceutical products. A country's pharmacopoeia can reflect, to some extent, the level of its pharmaceutical production and science and technology. Due to the continuous development of science and technology, new drugs and new formulations constantly appear, and the quality requirements for drugs and formulations are also continuously improved. New inspection methods will be established accordingly, so pharmacopoeias should be revised regularly. Some pharmacopoeias are revised every five years, and the criteria for selecting varieties are also different. Due to the rapid development of the pharmaceutical industry, supplementary editions are often printed before the publication of new editions to facilitate the timely application of new drugs and formulations in medical and preventive care. Supplementary editions have the same nature as the pharmacopoeia.
2. Pharmacopoeia of the People's Republic of China
The Pharmacopoeia of the People's Republic of China is abbreviated as the Chinese Pharmacopoeia. The 1953 edition was promulgated in 1953. The 1963 edition was promulgated in 1963, in line with the Party's policy on traditional Chinese medicine, and the 1963 pharmacopoeia was divided into two parts: Part I for traditional Chinese medicine and Part II for chemical drugs, antibiotics, biological products, and their formulations. Subsequent editions such as the 1977, 1985, 1990, and 1995 editions continued to be divided into two parts as the 1963 edition but included continuously updated varieties and increasingly scientific inspection items and methods. The 1995 edition of the Chinese Pharmacopoeia imposed stricter standards on formulations. For example, in the disintegration test for tablets, except for enteric-coated tablets, no barriers are allowed; the disintegration test for gastric-soluble film-coated tablets can be determined in 0.1 mol/L hydrochloric acid; a disintegration test method for effervescent tablets was added; for the first time, standards and inspection methods for melting time limits of suppositories and vaginal tablets were specified in this edition; regarding dissolution test methods for oral solid dosage forms, there were few changes, but the number of varieties requiring dissolution testing was increased from 44 in the 1990 edition to 128; the new edition also defined the terms for controlled-release and sustained-release formulations, modified the inspection methods and standards for enteric-coated formulations requiring dissolution testing, and so on. The specific requirements for varieties included in the Chinese Pharmacopoeia are: medical needs, clinical common use, definite efficacy, good quality, low side effects, varieties that China can industrialize and control or test the quality of with standards.
3. Foreign Pharmacopoeias
According to incomplete statistics, nearly 40 countries have compiled national pharmacopoeias, and in addition, there are three regional pharmacopoeias and the International Pharmacopoeia compiled by the World Health Organization (WHO). Currently, the United States Pharmacopeia has been published to the 23rd edition and is compiled with the United States National Formulary. The United States Pharmacopeia and the United States National Formulary are revised every five years, with several supplements between each edition. The latest version of the British Pharmacopoeia is the 1993 edition. Other pharmacopoeias, such as the Japanese Pharmacopoeia, the German Pharmacopoeia, the French Pharmacopoeia, and so on.