Group of Manufacturing and Materials, Department of Pharmacy, University of Copenhagen, Universitetsparken 2, 2100, Copenhagen, Denmark.
School of Pharmacy, University College London, 29-39 Brunswick Square, London, WC1N 1AX, UK.
AAPS PharmSciTech. 2019 Feb 26;20(3):127. doi: 10.1208/s12249-019-1341-z.
Development of new product design principles is crucial for obtaining pharmaceutical products with controlled functionality. Four different molds were designed using a computer-aided design (CAD) software and 3D printed with polylactic acid (PLA). A hydroxypropyl methylcellulose (HPMC) and polyethylene glycol (PEG)-based formulation containing indomethacin as the active pharmaceutical ingredient (API) was casted into the molds. Each mold produced a tablet that was designed to disintegrate into a defined number of sections (2, 4, and 6). This was achieved by incorporating break lines (regions that were significantly thinner than the remainder of the tablet) to control the disintegration process. Disintegration and drug release from these designed tablets was contrasted with a casted tablet without break lines. Disintegration studies confirmed that the casted tablets disintegrated according to their design. Drug-release studies meanwhile demonstrated that tablets with a greater number of sections released the API at a faster rate than those with fewer sections; for example, the 6-sectioned tablet released the API at twice the rate of the tablet without any break lines. It is expected that by using this concept, it would be possible to produce tablets with a designed disintegration profile, which could potentially allow the tailoring of the drug release.
开发新的产品设计原则对于获得具有控制功能的药物产品至关重要。使用计算机辅助设计 (CAD) 软件设计了四个不同的模具,并使用聚乳酸 (PLA) 进行 3D 打印。将含有吲哚美辛作为活性药物成分 (API) 的羟丙基甲基纤维素 (HPMC) 和聚乙二醇 (PEG) 基配方浇铸到模具中。每个模具都生产出一种片剂,设计为可分解成规定数量的部分(2、4 和 6)。通过在片剂上加入断裂线(比片剂其余部分薄得多的区域)来控制分解过程,从而实现了这一点。对这些设计片剂的崩解和药物释放与没有断裂线的浇铸片剂进行了对比。崩解研究证实,浇铸片剂按照其设计进行崩解。药物释放研究同时表明,具有更多部分的片剂比具有较少部分的片剂更快地释放 API;例如,6 部分片剂的 API 释放速度是没有任何断裂线的片剂的两倍。预计通过使用这种概念,可以生产出具有设计崩解特性的片剂,这可能允许定制药物释放。