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Green Process Concepts for the Pharmaceutical Industry

机译：制药行业的绿色工艺概念

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Process concepts for producing drug particles using supercritical carbon dioxide (scCO_2) as an antisolvent and for substrate coating employing scCO_2 as the fluidizing medium and antisolvent are described. Particle micronization with scCO_2 allows for reproducible crystal formation with the potential for increased surface area and dissolution rates. Coating with scCO_2 allows the use of traditional organic-soluble coatings with complete solvent recovery and virtually no atmospheric emissions. For formation of drug nanoparticles, an ultrasonic nozzle that employs scCO_2 as the energizing medium is used to form droplets of the drug-laden solution. The scCO_2 also selectively extracts the solvent from the droplets, precipitating the drug. Submicron particles of hydrocortisone and ibuprofen (600 nanometers or less) formed in this manner are presented. Advantages include the production of virtually solvent-free drug particles in a narrow size range. For particle coating, scCO_2 is used to fluidize the core substrate particles. The scCO_2 also removes the solvent from the coating solution sprayed on the substrates, thereby precipitating the coating. This coating process expands the range of substrate/coating combinations possible with the conventional air-suspension Wurster coater, making it feasible to coat water-soluble substrates with solutes sprayed from organic solutions.
机译：描述了使用超临界二氧化碳（scCO_2）作为抗溶剂生产药物颗粒以及使用scCO_2作为流化介质和抗溶剂进行底物涂层的工艺概念。用scCO_2进行微粒微粉化可形成可重现的晶体，并具有增加表面积和溶解速率的潜力。使用scCO_2涂层可以使用传统的有机可溶性涂层，并具有完全的溶剂回收功能，并且几乎没有大气排放。为了形成药物纳米颗粒，使用采用scCO_2作为激励介质的超声喷嘴来形成载药溶液的液滴。 scCO_2还可以从液滴中选择性地提取溶剂，从而使药物沉淀。介绍了以此方式形成的氢化可的松和布洛芬的亚微米颗粒（600纳米或更小）。优势包括在狭窄的尺寸范围内生产几乎无溶剂的药物颗粒。对于颗粒涂层，scCO_2用于流化核心基材颗粒。 scCO_2还从喷涂在基材上的涂料溶液中除去溶剂，从而使涂料沉淀。这种涂布工艺扩大了传统空气悬浮Wurster涂布机可能的基材/涂料组合的范围，从而使从有机溶液中喷出的溶质涂布水溶性基材成为可能。

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