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New technology to manufacture crystalline micro-particles of APIs for use in pharmaceutical formulations

机译:制造用于药物制剂的晶体微粒的新技术

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A technology was developed to generate special particle size distributions of API's by crystallizing under synchronous input of mechanical energy within an efficient continuous process. The process was realized in a miniplant scale. The adjustment of the steady state particle size is achieved by controlling the equilibrium of mechanically induced particle size reduction and particle generation with crystal growth in the metastable zone. The transfer of mechanical energy to the crystal suspension is conducted by special inert compacts during stirring. The produced particles are characterized by very small size (d_(50) lower than 1 (mu)m), narrow PSD and higher stability than conventionally micronized products. The technology is very well suitable for particle design for e.g. pulmonary applications or very fast releasing drugs.
机译:通过在高效连续过程中,通过在机械能的同步输入下结晶来开发一种技术以产生API的特殊粒度分布。该过程以尖端规模实现。通过控制机械诱导的粒度降低和颗粒生成的晶体生长在亚稳地区中的晶体生成来实现稳态粒度的调节。在搅拌下,通过特殊的惰性块进行机械能对晶体悬浮液的转移。产生的颗粒的特征在于非常小的尺寸(D_(50)低于1(mu)m),窄的PSD和比常规微粉化产品更高的稳定性。该技术非常适合于例如粒子设计。肺应用或非常快速的释放药物。

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