Dry powder coating technology for pharmaceutical solid dosage forms

药物固体剂型的干粉包衣技术

• 批准号: 355067-2007
• 负责人: Zhu, Jingxu(Jesse)
• 金额: $ 5.28万
• 依托单位: University of Western Ontario
• 依托单位国家: 加拿大
• 项目类别: Collaborative Research and Development Grants
• 财政年份: 2007
• 资助国家: 加拿大
• 起止时间: 2007-01-01 至 2008-12-31
• 项目状态: 已结题
• 来源: https://www.nserc-crsng.gc.ca/ase-oro/Details-Detailles_eng.asp?id=361691
• 关键词: Dry; powder; coating; technology; pharmaceutical

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.

通常需要对药物固体剂型（例如片剂和珠粒）进行包衣，以改善产品外观和可操作性、掩盖味道/气味、促进吞咽；提高患者依从性，保护产品免受潮湿和光照，并改变药物释放特性（肠溶或缓释）。  然而，几乎所有商业包衣工艺都是基于液体包衣技术，将包衣溶液/悬浮液喷雾到固体剂型上，然后液体蒸发在表面形成干燥的包衣膜。液体涂层最显着的缺点是在固化前加热大量空气以干燥液体的成本（资金和操作）非常高，并且需要清洁进气和排气。基于申请人为汽车和其他行业开发的专利超细粉末涂层技术，我们在早期NSERC-I2I项目中的初步研究表明，干粉涂层也可以直接应用于干粉涂层 药物剂型（片剂和珠粒），实现干粉包衣的优点（能耗少且环保）。拟议的研究是进一步改进这项技术，通过开发一系列适合干粉包衣的配方，通过优化操作条件，并将工艺放大到适合体外研究的半生产规模，使这项技术能够成功地应用于制药行业。申请人在粉末加工和处理（包括粉末包衣）方面拥有多年的经验。 UWO 的粒子技术研究中心以及通过最近的几项 CFI 拨款购买的大量设备将为拟议项目提供必要的基础设施。申请人还与支持公司建立了长期合作关系，该公司也支持了早期的121项目。