Oral Fixed-Dose Combination Pharmaceutical Products: Industrial Manufacturing Versus Personalized 3D Printing
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EXPERT REVIEW
Oral Fixed-Dose Combination Pharmaceutical Products: Industrial Manufacturing Versus Personalized 3D Printing Raquel Fernández-García 1 & María Prada 1 & Francisco Bolás-Fernández 2 & M. Paloma Ballesteros 1,3 & Dolores R. Serrano 1,3
Received: 31 March 2020 / Accepted: 26 May 2020 # Springer Science+Business Media, LLC, part of Springer Nature 2020
ABSTRACT 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
* Dolores R. Serrano [email protected] 1
Departamento de Farmacia Galénica y Tecnología Alimentaria, Facultad de Farmacia, Universidad Complutense de Madrid, Plaza Ramón y Cajal, s/n., 28040 Madrid, Spain
2
Departamento de Microbiología y Parasitología, Facultad de Farmacia, Universidad Complutense de Madrid, Plaza Ramón y Cajal, s/n., 28040 Madrid, Spain
3
Instituto Universitario de Farmacia Industrial (IUFI), Facultad de Farmacia, Universidad Complutense de Madrid, Plaza Ramón y Cajal, s/n., 28040 Madrid, Spain
techniques will be compared with 3D printing manufacturing of FDCs.
KEY WORDS Fixed-dose combination . FDC . HIV . hepatitis C virus . antimicrobials . spray coating . hot-melt extrusion . 3D printing
INTRODUCTION Fixed-dose combination (FDC) is the term used in pharmaceutical technology to describe the combination of drugs, which includes at least two active pharmaceutical ingredients (APIs) combined in a single dosage form, manufactured and distributed as a fixed-dose product (1,2). FDCs are well-known in antimicrobial therapy as they are widely used in highly active antiretroviral therapy (HAART) in patients infected with the human immunodeficiency virus (HIV) but also, in last few years, in direct-acting antiviral agents (DAAs) utilized in patients infected with hepatitis C (HVC) (3). FDCs are also commer
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