Multiparticulate Technologies for Fixed-Dose Combinations

Caldwell, W. Brett; Kaushal, Aditya Mohan

doi:10.1007/978-1-4939-7012-4_7

Cited by 4 publications

(6 citation statements)

References 39 publications

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“…A single-pill combination, known as FDC, is a system formulated to deliver two or more active pharmaceutical ingredients as one unit. These products are increasing and represent an important segment of the global pharmaceutical market ( Kaushal, 2017 ). The number of FDC approvals significantly increased in the 2000 s and represents an important segment of the global pharmaceutical market ( Hao et al, 2015 , Kaushal, 2017 ).…”

Section: Introductionmentioning

confidence: 99%

“…These products are increasing and represent an important segment of the global pharmaceutical market ( Kaushal, 2017 ). The number of FDC approvals significantly increased in the 2000 s and represents an important segment of the global pharmaceutical market ( Hao et al, 2015 , Kaushal, 2017 ). Formulation of FD multidrug therapy may give a synergistic and sustained therapeutic effect associated with positive therapeutic outcomes, greater efficacy, safety improvement, and fewer side effects compared to a single maximum dose.…”

Section: Introductionmentioning

confidence: 99%

“…Multi-drug therapy can be formulated using different technologies, including monolithic, multilayer, multi-particulate, or 3D-printing systems, depending on the compatibilities between the active constituents and the dissolution profile for each ( Kaushal, 2017 ).…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Apixaban and clopidogrel in a fixed-dose combination: Formulation and in vitro evaluation

Al-Shami,

Naseef,

Kanaze

2024

Saudi Pharmaceutical Journal

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Apixaban and clopidogrel in a fixed-dose combination: Formulation and in vitro evaluation

Al-Shami,

Naseef,

Kanaze

2024

Saudi Pharmaceutical Journal

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“…A Single pill combination, known as FDC, is a system formulated to deliver two or more active pharmaceutical ingredients as one unit. These products are increasing and represent an important segment of the global pharmaceutical market 40 . The number of FDC approvals signi cantly increased in the 2000s and represents an important segment of the global pharmaceutical market 40,41 .…”

Section: Introductionmentioning

confidence: 99%

“…These products are increasing and represent an important segment of the global pharmaceutical market 40 . The number of FDC approvals signi cantly increased in the 2000s and represents an important segment of the global pharmaceutical market 40,41 . Formulation of FD multidrug therapy may give a synergistic and sustained therapeutic effect associated with positive therapeutic outcomes, greater e cacy, safety improvement, and fewer side effects compared to a single maximum dose.…”

Section: Introductionmentioning

confidence: 99%

Apixaban and Clopidogrel in a fixed-dose combination: Formulation and in vitro evaluation

Al-Shami

Naseef

Kanaze

2023

Preprint

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Fixed-dose combination (FDC) products represent a novel, safe, and cost-effective formulation. Combined use of anticoagulant and antiplatelet medications is common among comorbid cardiovascular patients. This study aimed to formulate FDC tablets for Apixaban and Clopidogrel, as prophylaxis and treatment of thrombo-embolic events. FDC tablets were developed by combining small tablets of Immediate-Release (IR) Clopidogrel 75 mg and Extend-Release (ER) Apixaban 5 mg through direct compression and wet granulation. Particularly, Apixaban tablets were developed using design expert software, and various types and concentrations of polymers were entered. For Clopidogrel tablets, various diluents were used to develop the formulation. Then, the dissolution profile for each formula was studied. Finally, the optimized formulations were encapsulated within hard gelatin capsules. Apixaban formulation followed zero-order with super case Ⅱ transport mechanism as the dominant mechanism of drug release. The Apixaban drug release rate was affected by the type and concentration of the polymers in the formulation (P < 0.05). As the HPMC concentration was increased, Apixaban release was retarded. For, Clopidogrel, the formulated tablets with spray-dried lactose filler and sodium stearyl fumarate lubricant were found to be stable with good properties. In conclusion, the optimum formulation yielded IR of Clopidogrel and ER of Apixaban for 24 hours with the desired in vitro drug dissolution.

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Oral Fixed-Dose Combination Pharmaceutical Products: Industrial Manufacturing Versus Personalized 3D Printing

et al. 2020

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Multiparticulate Technologies for Fixed-Dose Combinations

Cited by 4 publications

References 39 publications

Apixaban and clopidogrel in a fixed-dose combination: Formulation and in vitro evaluation

Apixaban and clopidogrel in a fixed-dose combination: Formulation and in vitro evaluation

Apixaban and Clopidogrel in a fixed-dose combination: Formulation and in vitro evaluation

Oral Fixed-Dose Combination Pharmaceutical Products: Industrial Manufacturing Versus Personalized 3D Printing

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