Departamento de Farmacia Galénica y Tecnología Alimentaria, Facultad de Farmacia, Universidad Complutense de Madrid, Plaza Ramón y Cajal, s/n., 28040, Madrid, Spain.
Departamento de Microbiología y Parasitología, Facultad de Farmacia, Universidad Complutense de Madrid, Plaza Ramón y Cajal, s/n., 28040, Madrid, Spain.
Pharm Res. 2020 Jun 17;37(7):132. doi: 10.1007/s11095-020-02847-3.
Fixed-dose combination (FDC) products containing at least two different active pharmaceutical ingredients are designed to treat more effectively different pathologies as they have demonstrated to enhance patient compliance. However, the combination of multiple drugs within the same dosage form can bring many physicochemical and pharmacodynamic interactions. The manufacturing process of FDC products can be challenging, especially when it is required to achieve different drug release profiles within the same dosage form to overcome physicochemical drug interactions. Monolithic, multiple-layer, and multiparticulate systems are the most common type of FDCs. Currently, the main manufacturing techniques utilized in industrial pharmaceutical companies rely on the use of combined wet and dry granulation, hot-melt extrusion coupled with spray coating, and compression of bilayered tablets. Nowadays, personalized medicines are gaining importance in clinical settings and 3D printing is taking a highlighted role in the manufacturing of complex and personalized 3D solid dosage forms that could not be manufactured using conventional techniques. In this review, it will be discussed in detail current marketed FDC products and their application in several diseases with an especial focus on antimicrobial drugs. Current industrial conventional techniques will be compared with 3D printing manufacturing of FDCs. Graphical Abstract.
固定剂量组合（FDC）产品含有至少两种不同的活性药物成分，旨在更有效地治疗不同的疾病，因为它们已被证明可以提高患者的依从性。然而，将多种药物组合在同一剂型中会带来许多物理化学和药效学相互作用。FDC 产品的制造过程具有挑战性，特别是当需要在同一剂型中实现不同的药物释放曲线以克服物理化学药物相互作用时。整体式、多层式和多颗粒系统是最常见的 FDC 类型。目前，工业制药公司中使用的主要制造技术依赖于联合湿法制粒和干法制粒、热熔挤出与喷雾包衣、双层片剂压缩。如今，个性化药物在临床环境中越来越重要，3D 打印在制造复杂和个性化的 3D 固体剂型方面发挥着突出的作用，这些剂型无法使用传统技术制造。本文详细讨论了当前市售的 FDC 产品及其在几种疾病中的应用，特别关注了抗菌药物。本文还将比较当前工业常规技术与 FDC 的 3D 打印制造。
