Bioequivalence study of a fixed-dose combination of Dapagliflozin/ Vildagliptin Sustained Release tablets in healthy adult male subjects: A Randomized, Open-Label, Crossover Study

Joshi, Ameya; Birla, Ashish; Prasad, Ashish; Warrier, Sona

doi:10.22270/jddt.v12i6.5798

Cited by 3 publications

(2 citation statements)

References 7 publications

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“…In late 2022, the newer combination comprising of DPZ and VGT was made available in the Indian market. Fixed dose combination consisting of DPZ (10 mg) and VGT (100 mg) formulated as tablets (sustained release that aids people with keeping blood sugar levels in check when suffering from type 2 diabetes) (Joshi et al, 2022;Orme et al, 2014;Sen et al, 2022;1mg.com, 2023). Ultra violet (UV) spectrophotometry (Attimarad et al, 2023;Banik et al, 2015;Manasa et al, 2014;Mante et al, 2017;Sen et al, 2023), high-performance liquid chromatography (Deepan and Dhanaraju, 2018;Gundala et al, 2019;Mante et al, 2018;Usman et al, 2020;Vankalapati et al, 2022), and high-performance thin layer chromatography (Abdelrahman et al, 2020;Ahmed et al, 2020;Bendale et al, 2018;Patil et al, 2020;Suma et al, 2019) were only some of the analytical methods described in the literature for determining DPZ and VGT concentrations in single and mixed dosage forms.…”

Section: Preparation Of Standard Solutionmentioning

confidence: 99%

Various innovative UV spectroscopic methodologies for concurrent estimation of dapagliflozin and vildagliptin in combined tablet

Sen,

Khatariya,

Sen

et al. 2023

J Appl Pharm Sci

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Improved glycemic regulation in people with diabetes mellitus can be achieved with a fixed-dose combination (tablets) comprising dapagliflozin 10 mg and vildagliptin 100 mg. The proposed research suggests five spectrophotometric methodologies namely simultaneous equation, absorbance ratio, second derivative zero crossing, ratio difference, and first derivative of ratio spectra methods for the simultaneous assessment of the combined tablet that are straightforward, fast, easy, accurate, and reproducible. The concentration series for DPZ showed a strong linear correlation between 0.5 and 10 µg/ml for the first, second, third, and fourth methods and between 1 and 15 µg/ml for the fifth method. However, VGT displayed exceptional linear association in the sequence of 5-100 µg/ml for the first, second, third, and fourth methods; 10-150 µg/ml for the fifth method. The outcome of precision studies was evaluated in terms of % RSD, following International Conference on Harmonization guideline acceptable limits (˂2), which shows good repeatability, low intra, and interday variability, indicating an excellent precision of the developed methods. The outcome of recovery studies ranged from 96% to 103% for both the drug suggests the suitability of the proposed methods. Percentage recovery indicates that there was no interference from tablet excipients. Moreover, the low limit of detection and the limit of quantification values prove the sensitivity of the proposed methods. The projected methods were successfully applied for the quantitative determination of both drugs. Sample solutions were analyzed six times and experimental values were found to be within 98% and 101% for both the drugs. Proposed methods were compared with reported methods in terms of their name of methods, range, sensitivity, specificity, solvents used, and application. The proposed methods are found to be comparable with the reported methods and can cover up shortcomings and thus can be utilized as alternative methods for the simultaneous assessment of dapagliflozin and vildagliptin in the combined formulation.

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Section: Preparation Of Standard Solutionmentioning

confidence: 99%

Various innovative UV spectroscopic methodologies for concurrent estimation of dapagliflozin and vildagliptin in combined tablet

Sen,

Khatariya,

Sen

et al. 2023

J Appl Pharm Sci

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“…This fixed‐dose combination (FDC) is available in tablet form (sustained release), containing DPZ (10 mg) and VGT (100 mg). The FDC tablets are designed to benefit individuals with type 2 diabetes in maintaining their blood sugar concentrations effectively [6–9].…”

Section: Introductionmentioning

confidence: 99%

Development and validation of high‐performance thin layer chromatographic method for concurrent estimation of dapagliflozin and vildagliptin in combined tablet

Sen,

Khatariya,

Sen

et al. 2023

Separation Science Plus

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Enhanced glycemic regulation in individuals with diabetes mellitus can be achieved using a fixed‐dose combination of dapagliflozin (10 mg) and vildagliptin (100 mg) in tablet. The primary objective of this research was to develop and validate a high‐performance thin layer chromatographic methodology for accurately measuring the quantities of dapagliflozin and vildagliptin in combined tablet formulation. The methodology involved using aluminum plates layered with silica gel 60F254, and the solvent system comprised of acetonitrile, benzene, and glacial acetic acid (9:1:2 v/v/v). Densitograms were scanned at a wavelength of 210 nm. The linearity of the procedure was established in the series of 200–2500 ng/band for dapagliflozin and 2000–25000 ng/band for vildagliptin, with correlation coefficients (r2) of 0.9931 and 0.9954, correspondingly. The method demonstrated good sensitivity, with detection limits of 21.07 ng/band for dapagliflozin and 154.97 ng/band for vildagliptin; quantification limits of 63.84 ng/band for dapagliflozin and 469.60 ng/band for vildagliptin. The methodology was found to be precise (% relative standard deviation of peak area <2) and accurate (recovery between 97% and 103%). Proposed method was found to be superior and capable of overcoming the shortcomings of previously reported methods for the assessment of dapagliflozin and vildagliptin in combined formulation.

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Vildagliptin Sustained-release and Dapagliflozin Fixed-dose Combination in the Management of Type 2 Diabetes Mellitus: A Comprehensive Review

Ghosh,

Mukhopadhyay,

Agrawal

et al. 2024

International Journal of Diabetes and Technology

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Type 2 diabetes mellitus (T2DM) is a complex disease with multiple pathophysiological defects and generally requires a combination of antidiabetic agents to achieve glycemic targets. In this context, a fixed-dose combination (FDC) of dipeptidyl peptidase-4 inhibitors vildagliptin sustained-release (SR) and a sodium-glucose cotransporter type 2 inhibitors dapagliflozin appear to be an attractive approach. There is a strong rationale for combining vildagliptin with dapagliflozin. They have complementary mechanisms of action that address several pathological pathways and are effective at all disease stages. Vildagliptin and dapagliflozin are generally well tolerated, with low hypoglycemia risk. Moreover, they exert beneficial pleiotropic actions on the cardiovascular system and kidneys, lower body weight, and blood pressure and reduce pill burden, providing an important option for managing a broad patient population. For Indian T2DM patients, who have a high prevalence of cardiometabolic risk factors, this combination would be an appropriate choice. Furthermore, the once-daily 100 mg SR dosage of vildagliptin meets the requirements for compliance and adherence. However, data on the vildagliptin SR and dapagliflozin FDC are limited. This review summarizes the available evidence and provides rational, practical guidance for the optimal clinical use of vildagliptin SR and dapagliflozin FDCs in T2DM patients.

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Bioequivalence study of a fixed-dose combination of Dapagliflozin/ Vildagliptin Sustained Release tablets in healthy adult male subjects: A Randomized, Open-Label, Crossover Study

Cited by 3 publications

References 7 publications

Various innovative UV spectroscopic methodologies for concurrent estimation of dapagliflozin and vildagliptin in combined tablet

Various innovative UV spectroscopic methodologies for concurrent estimation of dapagliflozin and vildagliptin in combined tablet

Development and validation of high‐performance thin layer chromatographic method for concurrent estimation of dapagliflozin and vildagliptin in combined tablet

Vildagliptin Sustained-release and Dapagliflozin Fixed-dose Combination in the Management of Type 2 Diabetes Mellitus: A Comprehensive Review

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