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KMID : 1146920210510050555
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Journal of Pharmaceutical Investigation
2021 Volume.51 No. 5 p.555 ~ p.570
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Pharmaceutical application and development of fixed-dose combination: dosage form review
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Kim Dong-Wook
Weon Kwon-Yeon
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Abstract
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Background: Fixed dose combination (FDC) products are common in the treatment of various disease such as hypertension, diabetes, HIV and HCV, Pain, Respiratory disease for improving therapeutic efficacy and tolerability. They make it possible to combine more than two drug molecules with optimal doses, dosage form and optimize the treatment.
Area covered: This review provides discussions of the FDC application in variety of disease. various formulation technologies such as bilayer system, active film coating, co-crystal, multi-particulate system, Hot-melt co-extrusion, hot fusion method, spray drying and 3D-printing that consider characteristics of each active pharmaceutical ingredient (API) in FDC to maximize the benefits and overcome the challenges of developing FDC products.
Expert opinion: FDC has utilized as a promising dosage form to increase the oral absorption of drugs. From beneficial perspective, they offer efficacy and safety improvement, product exclusivity, patient compliance, medicinal cost reduction. while disadvantage perspectives such as a lack of dose flexibility, drug interaction, difference dosage regimen, dose difference and difference of physicochemical properties should be considered for the use of FDC, differences in individual drug characteristics, drug release profiles, therapeutic dose, and solubility should be considered for FDCs design and formulation.
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KEYWORD
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Fixed-dose, Combination, Osage form, Formulation, Compliance, Pharmaceutical approach
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