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Particle size effect on the performance of Active Pharmaceutical Ingredient

Writer:Jinan WinnerSource:Jinan Winner Number of visits: Date:2016-04-14

1) API market condition overview:

 the pharmaceutical industry is divided into the pharmaceutical business and pharmaceutical manufacturing, pharmaceutical manufacturing subdivided into chemical raw materials manufacturing, chemicals manufacturing, medicine manufacture, Chinese medicine processing, biological and biochemical products manufacturing and hygiene materials and medical supplies manufacturing and other categories. Among them, chemical raw materials manufacturing and chemicals manufacturing belongs to the chemical and pharmaceutical industries.


Chemical and pharmaceutical industry is  downstream industry of the basic chemical industry and fine chemical industry. Complete chemical and pharmaceutical production value chain consists of basic chemical raw materials, pharmaceutical intermediates, chemical raw materials and chemical agents and other production processes. Among them, chemical raw materials is the main raw material for the production of chemicals, mainly by chemical synthesis of pharmaceutical active ingredients prepared, but the patient still can not directly use, still need further processed into drugs, namely preparations.



Pharmaceutical Industry overall sales revenue grew 19.27% , and gross profit increased by 16.83%  in 2012. Industry revenue and profit growth compared with the same period in 2011 has slowed, but growth is still relatively robust. Chemical raw materials sales revenue grew 13.03%, gross profit increased by 6.59%, and the second half of 2012 year on year growth rebounded drug. 2013 is also expected to maintain a moderate growth.



In the global market of  Active Pharmaceutical Ingredient,except for that the patent API formed monopoly supply- demand structure, chemical raw materials market is a fully competitive market. Meanwhile, with the development of the global pharmaceutical industry, the transfer of generic drugs as well as the proportion of consumption increased drug production patterns, more and more international manufacturers preparations to take drug outsourcing of production, from raw materials procurement that is developing the drug manufacturers and drug manufacturers needed for the production of pharmaceutical raw materials. In the global API market these trends influence, China, India, Brazil and Russia as the representative of emerging markets growing number of drug substances and drug manufacturers to participate in the international drug supply and demand system.

As the world's largest drug producing and exporting county, China raw material drug companies will not only be ready to face competition from other domestic companies, but also bear the raw material drug companies of similar products competitive pressures from abroad,  competition is becoming increasingly fierce.



 Particle size requirements of API production

 the drug absorption speed in the body is determined by the speed of dissolving, solid drug preparation before being absorbed, must disintegrate and dissolve then transfer into the solution process, if the drug is hardly released from the formulation or medicine dissolved speed is extremely slow, then the drug absorption rate of the formulation must be have problem. on the other hand,  pharmacological effects of some drugs are violent, security index is small, If the dissolution rate is too fast, may have significant adverse reactions, time of maintaining the efficacy will be shortened, in this case, the dissolution rate of the drug formulation should be controlled. The speed and extent of drug dissolved in a solvent called dissolution,  tablet is a common one of oral dosage formulation , its dissolution is related to c raw materials, auxiliary materials,composition of  prescription, particle size distribution, particle hardness  and the process conditions etc. In drug production, its size is an essential indicator. According to different requirements of tablet dissolution, particle size of the drug should be controlled in different size segments, in order to maximize efficacy.



2) Winner3003 Laser particle size analyzer application in production

Jinan Jiqun Pharmaceutical Technology Co., Ltd. is a high-tech zones in Jinan City, "5150 Talents" enterprises, a leading high-tech modern enterprise, is a professional engaged in drug research and development, technology transfer, technical advice of the modern high-tech enterprises. Chairman Suxian Bin, who is Cambridge University PhD in organic chemistry; engaged in organic synthesis methodology, total synthesis, chemical biology research of natural products and the creation of new drugs, has a solid academic background and rich research experience; in core international chemical journals published SCI papers.


They choose Winner3003 dry laser particle size analyzer for drug research and development  to particle size, the dissolution of the tablet developed to ensure the maximization of efficacy.



2) The Prospect of Laser Particle Meter


Laser diffraction is currently the most advanced particle size analysis method, when the particles pass through the laser beam, scattering light of every particle illuminating parallel arranged on different scattering angle detector,  the light strength of the detector formed scattering spectra, scattering spectrum is inverse into particle size distribution by computer.The former process is to obtain scattering spectrum of the particle groups, information is transmitted in parallel the speed of light, so fast test; the latter process is MIE scattering theory, computer numerically serial completed, so the test is accurate.


Pharmaceutical industries, including pharmaceutical manufacturing and pharmaceutical business, the overall industry in a rising stage, the industry continued to maintain a growth trend. Laser particle size analyzer for its excellent performance and easy operation will be more widely used in the pharmaceutical industry.

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