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Cryo-crystallization under a partial anti-solvent environment as a facile technology for dry powder inhalation development

机译：在部分抗溶剂环境下冷冻结晶作为干粉吸入发育的容易技术

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摘要

Industrial research in the field of dry powder inhalation (DPI) technology is still confined to the micronization of active pharmaceutical ingredients (APIs). Earlier studies have identified triboelectric charge as the main reason for the reduced efficiency of most of the marketed formulations. The physical instability of the micronized product aggravates the situation. Direct conversion of an API into an inhalable dry crystal, without applying an attritional force, would be a solution for many issues such as loss of crystallinity or metal contamination of the final product. In this work, Isoniazid (INH) (an anti-TB drug) was converted to inhalable particles using cryo-crystallization under a partial anti-solvent environment. The crystals were dried using a lyophilization technique and furthermore, the powder was characterized. PXRD studies showed that a new polymorph was evolved by the proposed technique. Since lyophilization is a closed method, microbial contamination can also be avoided through this method. Accelerated stability studies at 40 degrees C with 75% relative humidity indicated that the newly formed crystals had similar stability to that of the raw material (the API).
机译：干粉吸入（DPI）技术领域的工业研究仍然限于活性药物成分（API）的微粉化。早期的研究已经确定了摩擦电荷作为大多数营销制剂效率降低的主要原因。微粉化产品的身体不稳定加剧了这种情况。将API的直接转化为可吸入的干燥晶体，而不施加滑动力，是许多问题的解决方案，例如最终产品的结晶度或金属污染物的损失。在这项工作中，在部分抗溶剂环境下使用低温结晶转化为可吸入颗粒的异噻唑（INH）（抗TB药物）。使用冻干技术干燥晶体，此外，表征粉末。 PXRD研究表明，通过所提出的技术演化了新的多晶型物。由于冻干是一种封闭的方法，因此也可以通过该方法避免微生物污染。在40℃下加速稳定性研究，具有75％的相对湿度表明，新形成的晶体对原料（API）的稳定性相似。

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  • 来源
    《RSC Advances》 |2015年第89期|共8页
  • 作者

    Vadakkan Mithun Varghese; Kumar G. S. Vinod;

  • 作者单位

    Rajiv Gandhi Ctr Biotechnol Chem Biol Nano Drug Delivery Syst Thiruvananthapuram 695014 India;

    Rajiv Gandhi Ctr Biotechnol Chem Biol Nano Drug Delivery Syst Thiruvananthapuram 695014 India;

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  • 正文语种 eng
  • 中图分类 化学;
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