"Pump-controlled release tablets production process"
On March 1, 2003, a project evaluation meeting was held at Tsinghua University, organized by the Beijing Tsinghua Institute of Industrial Development Incubator and Peking Pharmaceutical Co., Ltd. The event focused on the successful completion of the "osmotic pump controlled release tablets" project, which aimed to develop a more efficient and stable drug delivery system. During the meeting, Peking Pharmaceutical presented their research report on the production technology of osmotic pump tablets, along with reports from the Beijing Pharmaceutical Inspection Institute, user experience feedback, scientific and technological review documents, and other key project materials. After thorough discussions, the expert panel highly praised the project's scientific achievements and its potential impact on the pharmaceutical industry.
Beijing Zhong Hui Pharmaceutical Co., Ltd. made significant progress in the development of osmotic pump technology by conducting in-depth research on various drugs with different physical and chemical properties. They established a comprehensive technology platform for osmotic pump preparation and developed the capability to produce a wide range of formulations. Notably, they optimized the use of high-suspension agents, swelling agents, solubilizers, and disintegrants, allowing for the creation of highly suspended single-agent osmotic pump tablets. This innovation simplified the manufacturing process, improved product quality control, and significantly reduced costs. The technology is unique, as no similar methods have been reported both domestically and internationally.
The company also successfully developed the first controlled-release formulation of a traditional Chinese medicine—Cyclovirobuxine D osmotic pump tablets—which can deliver the drug at a constant rate over 24 hours. In vivo studies showed that the drug concentration-time curve exhibited clear controlled release characteristics. Additionally, Beijing Zhong Hui introduced a new high-speed laser drilling machine, capable of achieving high drilling speed and penetration rates. This equipment supports both single- and double-sided drilling, enabling intelligent recognition for multi-pump tablet production, thus laying a solid foundation for large-scale manufacturing.
In September 2002, Beijing Zhong Hui obtained a new drug certificate and production approval from the State Drug Administration (SDA) for their salbutamol sulfate osmotic pump tablets. Currently, the company is constructing a controlled-release preparation production base in the Yongfeng High-tech Industrial Zone of Zhongguancun Science Park, with plans to complete the facility by June 2003. Once operational, this project will fill a critical gap in China’s osmotic pump technology sector and generate substantial social and economic benefits.
Experts highlighted that the "osmotic pump controlled release tablets production technology" project represents a major technical breakthrough with a high starting point and a systematic approach. The development of high-suspension single-chamber, single-layer osmotic pump technology for insoluble drugs has reached international standards. The high-speed laser drilling machine, a key piece of equipment in the production process, is among the best in China. Experts recommend that the government and investors provide further support to enhance the osmotic pump technology platform, especially in the context of traditional Chinese medicine. They also encourage deeper research into slow-controlled release formulations and the development of new materials to drive innovation in the pharmaceutical industry in Beijing.
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