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Three Characteristics of the Production of Pharmaceutical Intermediates

2020-12-17
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The various products between the production of raw materials are pharmaceutical intermediates, and the synthesis of pharmaceuticals has a strong dependence on the intermediates. Pharmaceutical intermediates are important raw materials for the production of APIs and belong to the category of chemical products. The production plant does not require GMP certification. And its production has a certain degree of particularity. In terms of site selection, layout planning and plant design, it is necessary to strictly follow GMP related requirements. Different from the general chemical production process, the pharmaceutical intermediate production process has the characteristics of miniaturization, single batch intermittent and multifunctionality.

Miniaturization

The production of pharmaceutical intermediates has the characteristics of miniaturization. The characteristics of miniaturization are that the reactor is small, the raw materials are few and the requirements are accurate, especially the liquid materials that are added during the reaction, the amount required is small and needs to be controlled. For example, the common hydrogenation reaction process in the production of pharmaceutical intermediates is a small-scale batch reaction, which mainly includes the feeding process, the replacement process, the reaction process, the pressure relief process after the reaction, and the discharge process. Hydrogen, solid materials and liquid materials are all hydrogenation reaction process materials. The general process is to first add solid and liquid materials, and then add hydrogen under a certain pressure for reaction. During the feeding process, solid and liquid materials other than hydrogen need to be reacted. The addition of liquid materials is controlled, which is also a fine chemical process.

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At present, large pharmaceutical companies are more focused on improving their core competitiveness, focusing on drug R&D and sales. In order to shorten the cycle of new drug R&D and reduce the cost of new drug R&D, they often outsource custom production of intermediates. Some companies provide customized intermediate synthesis services. . Medicilon provides customized synthesis services for intermediates, which can synthesize reference compounds, intermediates, candidate drugs, impurities and metabolites and other small molecule chemical substances for customers. The scale can range from milligrams to kilograms (including GMP quality). The team is proficient in new route design and route optimization, relying on proficient problem solving skills and a high success rate of projects.

Single Batch Intermittent

The general chemical production process is mostly continuous production. The difference is that the production process of pharmaceutical intermediates is mostly single batch intermittent, usually frequent single batch production, which requires repeated pre-processing and post-processing, and These processes need to meet the requirements of the “Good Manufacturing Practice for Drugs”. In the continuous process, the raw materials continuously pass through a set of special equipment, each equipment is in steady state operation and only performs a specific processing task, and the product is output in a continuous flow mode. Intermittent production means that the raw materials are processed in accordance with the prescribed processing sequence and operating conditions, and the products are output in a limited amount. The nature of batch processes is dynamic, and operating conditions and product quality will change over time.

Multifunctional

The reactor in the production of pharmaceutical intermediates usually requires multi-step reactions or multiple processes, requiring different temperature control or pressure control at different stages. In order to complete the precise control of these processes, it is necessary to consider the characteristics of satisfying a wide range of adjustments when designing control schemes and instrument selection.

The pharmaceutical industry currently dominates the batch process using batch reactors. The reactor with agitator used in this method is suitable for most of the unit operations in the pharmaceutical industry, such as reaction, extraction, distillation and crystallization, etc. The design of batch processes requires more decisions. The continuous processing method provides a more predictable zoom path and some additional operational advantages. These advantages have enabled more and more pharmaceutical companies to apply continuous processing as a new method to the actual production process of pharmaceutical intermediates and active pharmaceutical ingredients.

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