The Development and the Validation of a Novel Dissolution Method of Favipiravir Film-Coated Tablets

Göktuğ, Özge; Altaş, Ecem; Kayar, Gönül; Gökalp, Mine

doi:10.3390/scipharm90010003

Cited by 7 publications

(3 citation statements)

References 12 publications

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“…Because the results showed a better fit 36 , phosphate buffer medium (pH 6.8) is recommended as the optimal dissolution medium for level C IVIVC. These findings were consistent with results obtained by Göktuğ et al 37 who concluded that 900 mL of phosphate buffer (pH 6.8) maintained at 37.0±0.5°C is considered as proper dissolution medium for favipiravir tablets if using USP (apparatus II) at 50 rpm for 30 min. In vitro-in vivo correlations (IVIVCs) are generally practiced for modified-release (MR) formulations.…”

Section: Discussionsupporting

confidence: 92%

Does the Ethnic Difference Affect the Pharmacokinetics of Favipiravir? A Pharmacokinetic Study in Healthy Egyptian Volunteers and Development of Level C In-vitro In-vivo Correlation

2023

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Favipiravir is an antiviral drug used to treat influenza and is also being investigated for the treatment of SARS-CoV-2. Its pharmacokinetic profile varies depending on ethnic group. The present research examines the pharmacokinetic features of favipiravir in healthy male Egyptian volunteers. Another goal of this research is to determine the optimum dissolution testing conditions for immediate release tablets. In vitro dissolution testing was investigated for favipiravir tablets in three different pH media. The pharmacokinetic features of favipiravir were examined in 27 healthy male Egyptian volunteers. The parameter “AUC0-t” vs. percent dissolved was used to develop level C in vitro in vivo correlation (IVIVC) to set the optimum dissolution medium to achieve accurate dissolution profile for favipiravir (IR) tablets. The in vitro release results revealed significant difference among the three different dissolution media. The Pk parameters of twenty-seven human subjects showed mean value of Cpmax of 5966.45 ng/mL at median tmax of 0.75 h with AUC0-∞ equals 13325.54 ng.h/mL, showing half-life of 1.25 h. Level C IVIVC was developed successfully. It was concluded that Egyptian volunteers had comparable Pk values to American and Caucasian volunteers, however they were considerably different from Japanese subjects. AUC0-t vs. % dissolved was used to develop level C IVIVC to set the optimum dissolution medium. Phosphate buffer medium (pH 6.8) was found to be the optimum dissolution medium for in vitro dissolution testing for Favipiravir IR tablets.

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Section: Discussionsupporting

confidence: 92%

Does the Ethnic Difference Affect the Pharmacokinetics of Favipiravir? A Pharmacokinetic Study in Healthy Egyptian Volunteers and Development of Level C In-vitro In-vivo Correlation

2023

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“…Exposes the UV-Vis spectra of FVP. The scanned range between 200 to 400nM and two absorption bands appeared at 221 and 325nM [45][46]. The obtained results were in good agreement with electrochemical impedance measurements of graphene and G/In 2 O 3 composites, which give a high surface area along with better electron conduction.…”

Section: Sample Preparationsupporting

confidence: 69%

A novel sensor for antiviral drug Favipiravir in the treatment of COVID-19 designed by G/In 2 O 3 nanomaterial

Sanjeevagol¹,

Manjanna²,

Chaithra

2022

Preprint

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The world health organization (WHO) declared that the outbreak of SARS-CoV-2 constituted a public health emergency of international concern. Thus, accredited fevipiravir (FVP) was one of the potential drugs for the treatment of Covid-19 infected patients. Hence it is of interest to study the electrochemical behavior of FVP. We report the performance of a low-cost composite of graphene and indium oxide (G/In2O3) nanomaterial drop casted on pencil graphite electrode employed to detect FVP. The G/In2O3 was prepared by a simple precipitation method. The electrochemical study of FVP was carried out by using cyclic voltammetry (CV), differential pulse voltammetry (DPV) and chronoamperometry. The G/In2O3 modified electrode detects FVP well in Britton Robinson (BR) buffer pH of 7.2. The oxidation peak was observed at the potential range of 1.0 to 1.23 V (vs. Ag/AgCl). The linear range detection limit was estimated to be 10 µl to 70 µl. The calculated sensitivity is 17.49 µA µM-1 cm-2 and the limit of detection (LOD) and limit of quantification (LOQ) were found to be 3.0nM and 10.0nM. The fabricated cost-effective G/In2O3 electroactive biosensor was effectively employed to regulate FAV in urine and tablet samples with adequate repossession. The proposed sensor offers good selectivity, sensitivity and long-term stability.

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“…The general procedure to develop a dissolution method includes (1) understanding the properties of drug substance and drug product, (2) evaluating sink conditions, (3) optimizing the dissolution conditions, and (4) evaluating the dissolution profiles and finalizing the method conditions [14][15][16][17][18][19][20][21]. One-factor-at-a-time (OFAT) approach is commonly used for process and method optimization [22,23].…”

Section: Introductionmentioning

confidence: 99%

Discriminative Dissolution Method Development Through an aQbD Approach

Chen,

Wang,

McElderry

2023

AAPS PharmSciTech

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Using a one-factor-at-a-time approach for dissolution method and discrimination analysis can be time-consuming and may not yield the optimal and discriminative method. To address this, we have developed a two-stage workflow for the dissolution method development followed by demonstration of discrimination power through an analytical Quality by Design (aQbD) approach. In the first stage, an optimal dissolution method was achieved by determining the method operable design region (MODR) through a design of experiment study of the high-risk method-related parameters. In the second stage, we established a Formulation-Discrimination Correlation Diagram strategy to examine the method discrimination capability, through which one can determine the method discriminative design region (MDDR) and visualize the impact of each formulation parameter and their interactions on dissolution. The application of aQbD principles into a workflow provides a scientific-driven guidance for robust method development and demonstrating discrimination power for dissolution methods. Graphical Abstract

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The Development and the Validation of a Novel Dissolution Method of Favipiravir Film-Coated Tablets

Cited by 7 publications

References 12 publications

Does the Ethnic Difference Affect the Pharmacokinetics of Favipiravir? A Pharmacokinetic Study in Healthy Egyptian Volunteers and Development of Level C In-vitro In-vivo Correlation

Does the Ethnic Difference Affect the Pharmacokinetics of Favipiravir? A Pharmacokinetic Study in Healthy Egyptian Volunteers and Development of Level C In-vitro In-vivo Correlation

A novel sensor for antiviral drug Favipiravir in the treatment of COVID-19 designed by G/In 2 O 3 nanomaterial

Discriminative Dissolution Method Development Through an aQbD Approach

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