Formulation development and pharmacokinetic evaluation of enteric-coated dexrabeprazole tablets

Lee, Tae Jin; Kim, Dohyun; Kim, Jae Cheon; Ro, Si Won; Na, Dong Hee

doi:10.1007/s40005-022-00602-x

Cited by 6 publications

(2 citation statements)

References 24 publications

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“…The in vitro dissolution pattern of SOL from the DCTs was evaluated using the USP Paddle 2 method (VK750D, Varian, Huntington Beach, CA, USA) [ 23 ]. Simulated gastric fluid (pH 1.2), sodium acetate buffer (pH 4.0), simulated intestinal fluid (pH 6.8), and distilled water were used as the dissolution media.…”

Section: Methodsmentioning

confidence: 99%

Novel Bioequivalent Tablet of Solifenacin Succinate Prepared Using Direct Compression Technique for Improved Chemical Stability

Kim

Jeong

et al. 2023

Pharmaceutics

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We designed a bioequivalent tablet form of solifenacin succinate (SOL) with an improved storage stability using a direct compression (DC) technique. An optimal direct compressed tablet (DCT) containing an active substance (10 mg), lactose monohydrate, and silicified microcrystalline cellulose as diluents, crospovidone as a disintegrant, and hydrophilic fumed silica as an anti-coning agent was constructed by evaluating the drug content uniformity, mechanical properties, and in vitro dissolution. The physicochemical and mechanical properties of the DCT were as follows: drug content 100.1 ± 0.7%, disintegration time of 6.7 min, over 95% release within 30 min in dissolution media (pH 1.2, 4.0, 6.8, and distilled water), hardness > 107.8 N, and friability ~0.11%. The SOL-loaded tablet fabricated via DC showed an improved stability at 40 °C and RH 75%, exhibiting markedly reduced degradation products compared to those fabricated using ethanol or water-based wet granulation or a marketed product (Vesicare®, Astellas Pharma). Moreover, in a bioequivalence study in healthy subjects (n = 24), the optimized DCT offered a pharmacokinetic profile comparable to that of the marketed product, with no statistical differences in the pharmacokinetic parameters. The 90% CIs for the geometric mean ratios of the test to the reference formulation for the area under the curve and the maximum drug concentration in plasma were 0.98–1.05 and 0.98–1.07, respectively, and satisfied the FDA regulatory criteria for bioequivalence. Thus, we conclude that DCT is a beneficial oral dosage form of SOL with an improved chemical stability.

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Section: Methodsmentioning

confidence: 99%

Novel Bioequivalent Tablet of Solifenacin Succinate Prepared Using Direct Compression Technique for Improved Chemical Stability

Kim

Jeong

et al. 2023

Pharmaceutics

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“…The average plasma pharmacokinetic parameters, including the area under the curve from time 0 extrapolated to infinity (AUC inf ) and the terminal half-life (t 1/2 ), were determined using a non-compartment model (WinNonlin Ver. 3.1; Certara, Inc., Princeton, NJ, USA) [ 43 ]. The peak time (T max ) and maximal concentration (C max ) were obtained directly from the observed plasma concentration-time profiles.…”

Section: Methodsmentioning

confidence: 99%

A High-Performance Liquid Chromatography with Photodiode Array Detection Method for Simultaneous Determination of Three Compounds Isolated from Wikstroemia ganpi: Assessment of the Effects on Cytochrome P450-Mediated Metabolism In Vitro and In Vivo

Keem,

Seo,

Kim

et al. 2023

Nutrients

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In natural products, the content and quality of the marker components differ depending on the part, production area, collection period, and extraction method; therefore, a standardized analysis method is required to obtain consistent results. This study developed a simultaneous analysis method for three marker components (7-methoxylutolin-5-O-glucoseide, pilloin 5-O-β-d-glucopyranoside, rutarensin) isolated and purified from Wikstroemia ganpi (W. ganpi). Simultaneous analysis was performed using high-performance liquid chromatography with photodiode array detection (HPLC-PDA) method that was validated according to the International Council for Harmonisation (ICH) guidelines. The developed analytical method exhibited linearity (r2 > 0.999), detection limits (0.72–3.34 μg/mL), and quantification limits (2.19–10.22 μg/mL). The relative standard deviation (RSD) value of intra- and inter-day precisions was less than 1.68%, and analyte recoveries (93.42–117.55%; RSD < 1.86%) were validated according to the analytical procedures, and all parameters were within the allowable range. Quantitative analysis of the three marker components from W. ganpi MeOH extract (WGM) showed 7-methoxylutolin-5-O-glucoseide with the highest content (51.81 mg/g). The inhibitory effects of WGM on cytochrome P450 (CYP) substrate drugs were further investigated. The in vitro study revealed that WGM inhibited the CYP3A-mediated metabolism of buspirone and that 7-methoxylutolin-5-O-glucoseide and pilloin 5-O-β-d-glucopyranoside inhibited the metabolism of buspirone with IC50 values of 2.73 and 18.7 μM, respectively. However, a single oral dose of WGM did not have significant effects on the pharmacokinetics of buspirone in rats, suggesting that WGM cannot function as an inhibitor of CYP3A-mediated metabolism in vivo.

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Formulation and in vitro/in vivo characterization of a fixed-dose combination tablet of dapagliflozin and rosuvastatin

An,

Kim,

Kim

et al. 2024

J. Pharm. Investig.

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Formulation development and pharmacokinetic evaluation of enteric-coated dexrabeprazole tablets

Cited by 6 publications

References 24 publications

Novel Bioequivalent Tablet of Solifenacin Succinate Prepared Using Direct Compression Technique for Improved Chemical Stability

Novel Bioequivalent Tablet of Solifenacin Succinate Prepared Using Direct Compression Technique for Improved Chemical Stability

A High-Performance Liquid Chromatography with Photodiode Array Detection Method for Simultaneous Determination of Three Compounds Isolated from Wikstroemia ganpi: Assessment of the Effects on Cytochrome P450-Mediated Metabolism In Vitro and In Vivo

Formulation and in vitro/in vivo characterization of a fixed-dose combination tablet of dapagliflozin and rosuvastatin

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