Dry powder coating technology for pharmaceutical solid dosage forms

通常需要药物固体剂型如片剂和珠粒的包衣，以改善产品外观和可吸收性，掩盖味道/气味，使吞咽顺畅;增加患者依从性，保护产品免受水分和光线的影响，并改变药物释放特性（肠释放或持续释放）。 然而，几乎所有的商业包衣工艺都是基于液体包衣技术，利用该技术，将包衣溶液/悬浮液喷雾到固体剂型上，然后液体蒸发以在表面上形成干燥的包衣膜。液体涂料最大的缺点是成本很高（资本和操作）加热大量空气以在固化之前干燥液体的要求以及清洁进气和排气的要求。基于申请人开发的用于汽车和其他工业的专利超细粉末涂层技术，我们在较早的NSERC-I2 I项目下的初步研究表明，干粉包衣也可以直接应用于干燥的药物剂型（片剂和珠粒），以实现干粉包衣的优点（能耗低，环境友好）。拟开展的研究旨在通过开发一系列适用于干粉包衣的配方、优化操作条件以及将工艺放大至适用于体外研究的半生产规模，进一步改进该技术，以便该技术能够成功应用于制药行业。申请人在粉末加工和处理（包括粉末包衣）方面拥有多年经验。UWO的粒子技术研究中心和通过最近几次CFI赠款购买的大量设备将为拟议项目提供必要的基础设施。申请人与支持公司也有长期的合作关系，该公司也支持早期的121项目。

Coating of pharmaceutical solid dosage forms such as tablets and beads are often required in order to improve product appearance and handle-ability, mask taste/odor, smoothen swallowing; increase patient compliance, protect product from moisture and light, and modify drug release characteristics (enteric or sustained release).  However, almost all commercial coating processes are based on liquid coating technology, with which a coating solution/suspension is sprayed onto the solid dosage forms and then the liquid gets evaporated to form a dry coating film on the surface. The most significantdisadvantage of liquid coating is the very high cost (capital and operation) of heating the large quantity of air for drying the liquid before curing and the requirements of cleaning both the intake as well as outgoing air.Based on a patented ultrafine powder coating technology developed by the applicant for the automobile and other industries, our preliminary study under an earlier NSERC-I2I project has shown that dry powder coating can also be applied directly on dry pharmaceutical dosage forms (tablets and beads), to realize the benefits of dry powder coating (less energy consumption and environmentally-friendly). The proposed research is to further improve on this technology, by developing a series of suitable formulations for dry powder coating, by optimizing the operating conditions, and by scaling up the process to a semi-production scale suitable for in-vitro studies, so that this technology can be successfully applied in the pharmaceutical industry.The applicant has had many years of experience in powder processing and handling, including powder coating. The Particle Technology Research Centre at UWO and the large amount of equipment purchased through several recent CFI grants will provide the necessary infrastructure for the proposed project. The applicant also has a long collaborating relationship with the support company who also supported the earlier 121 project.