PhEq_bootstrap: Open-Source Software for the Simulation of f2 Distribution in Cases of Large Variability in Dissolution Profiles

Mendyk, Aleksander; Pacławski, Adam; Szlęk, Jakub; Jachowicz, Renata

doi:10.14227/dt200113p13

Cited by 21 publications

(22 citation statements)

References 1 publication

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“…Bootstrap of f 2 generates a new population of dissolution profiles through random samples with replacement from 12 units of the test and reference batches, respectively [28, 29]. It is possible to assess the similarity of dissolution profiles with large variability if the data populations are identically distributed.…”

Section: Resultsmentioning

confidence: 99%

Evaluation of the DDSolver Software Applications

Zuo

Gao

Bou‐Chacra

et al. 2014

BioMed Research International

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When a new oral dosage form is developed, its dissolution behavior must be quantitatively analyzed. Dissolution analysis involves a comparison of the dissolution profiles and the application of mathematical models to describe the drug release pattern. This report aims to assess the application of the DDSolver, an Excel add-in software package, which is designed to analyze data obtained from dissolution experiments. The data used in this report were chosen from two dissolution studies. The results of the DDSolver analysis were compared with those obtained using an Excel worksheet. The comparisons among three different products obtained similarity factors (f 2) of 23.21, 46.66, and 17.91 using both DDSolver and the Excel worksheet. The results differed when DDSolver and Excel were used to calculate the release exponent “n” in the Korsmeyer-Peppas model. Performing routine quantitative analysis proved to be much easier using the DDSolver program than an Excel spreadsheet. The use of the DDSolver program reduced the calculation time and has the potential to omit calculation errors, thus making this software package a convenient tool for dissolution comparison.

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Section: Resultsmentioning

confidence: 99%

Evaluation of the DDSolver Software Applications

Zuo

Gao

Bou‐Chacra

et al. 2014

BioMed Research International

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“…It was found that both mini-tablets containing either 37.5 % w/w or 62.5% w/w co-adsorbate formulations showed nearly identical release profiles due to the similarity of excipients used in the formulations. The F2 similarity factor value for comparison between the two mini-tablet formulations was >50 and the F2 bootstrap values was confirmed as 72.13 indicating a high degree of similarity between the dissolution profiles [24,25]. Both formulations achieved approximately 100±2.74% drug release after 15 mins which were slightly better than the release from 1:5:5 co-adsorbate mentioned before.…”

Section: Dissolution Of Glc From the Prepared Mini-tabletsmentioning

confidence: 87%

“…Calculations of f2 values were based on comparisons between the dissolution profiles for pure GLC, adsorbates, co-adsorbates and mini-tablet formulations. The degree of similarity between dissolution profiles was also confirmed by calculating the f2 values based on the bootstrap statistical approach using the PhEq_bootstrap v 1.2 software (number of bootstraps = 5000 and Confidence Interval = 90%) [25].…”

Section: In Vitro Dissolution Studiesmentioning

confidence: 97%

“…The F2 similarity factor values for 1:5 adsorbate and 1:5:5 co-adsorbate vs untreated GLC were < 50 and the F2 bootstrap values were confirmed as 20.42 and 3.31 respectively. Both indicate no degree of similarity between the dissolution profiles [24,25]. The order of drug release was as the following: co-adsorbates > loaded mixtures (adsorbates) > physical mixtures.…”

Section: Dsc Studymentioning

confidence: 99%

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Glibenclamide Mini-tablets with an Enhanced Pharmacokinetic and Pharmacodynamic Performance

et al. 2018

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In an attempt to decrease the dose, anticipated side effects, and the cost of production of glibenclamide, GLC, a potent oral hypoglycemic drug, the enhancement of the dissolution and hence the oral bioavailability were investigated. Adsorption and co-adsorption techniques using carriers having a very large surface area and surface active agents were utilized to enhance the drug dissolution. Moreover, the Langmuir adsorption isotherms were constructed to identify the type and mechanism of adsorption. The optimized formulation showing the highest in vitro release was compressed into mini-tablet to facilitate drug administration to elderly patients and those having swallowing difficulties. The produced mini-tablets were tested for their mechanical strength and in vitro release pattern. In addition, the pharmacodynamic and pharmacokinetic studies in New Zealand rabbits were performed using the optimized mini-tablet formulation. Mini-tablets containing GLC co-adsorbate with Pluronic F-68 and Laponite RD showed 100 ± 1.88% of GLC released after 20 min. Pharmacodynamic studies in rabbits revealed significantly higher (p ≤ 0.05) hypoglycemic effect with the optimized mini-tablets at a lower GLC dose compared to mini-tablets containing the commercial GLC dose. Moreover, pharmacokinetic analysis showed significantly higher (p ≤ 0.05) AUC, C, and shorter T. The optimized mini-tablet formulation showed 1.5-fold enhancement of the oral bioavailability compared to mini-tablets containing untreated GLC. It could be concluded that the co-adsorption technique successfully enhanced the oral bioavailability of GLC. Furthermore, the produced mini-tablets have a higher oral bioavailability with a lower GLC dose, which could offer economic benefit for industry as well as acceptability for patients.

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“…9,13) All data points until average dissolutions of both reference and generic products that reached 85% were used according to FDA recommendations. The datasets of dissolution profiles were created by random sampling of individual dissolution rates at each time point in the original data.…”

Section: Methodsmentioning

confidence: 99%

Comparison of Dissolution Similarity Assessment Methods for Products with Large Variations: <i>f</i><sub>2</sub> Statistics and Model-Independent Multivariate Confidence Region Procedure for Dissolution Profiles of Multiple Oral Products

Yoshida¹,

Shibata²,

Izutsu³

et al. 2017

Biological & Pharmaceutical Bulletin

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2 statistics defined in the MHLW guidelines (MHLW f 2 method) and two different Method B procedures, including a bootstrap method applied with f 2 statistics (BS method) and a multivariate analysis method using the Mahalanobis distance (MV method). The MHLW f 2 and BS methods provided similar dissolution similarities between reference and generic products. Although a small difference in the similarity assessment may be due to the decrease in the lower confidence interval for expected f 2 values derived from the large variation in individual dissolution rates, the MV method provided results different from those obtained through MHLW f 2 and BS methods. Analysis of actual dissolution data for products with large individual variations would provide valuable information towards an enhanced understanding of these methods and their possible incorporation in the MHLW guidelines.

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PhEq_bootstrap: Open-Source Software for the Simulation of f2 Distribution in Cases of Large Variability in Dissolution Profiles

Cited by 21 publications

References 1 publication

Evaluation of the DDSolver Software Applications

Evaluation of the DDSolver Software Applications

Glibenclamide Mini-tablets with an Enhanced Pharmacokinetic and Pharmacodynamic Performance

Comparison of Dissolution Similarity Assessment Methods for Products with Large Variations: <i>f</i><sub>2</sub> Statistics and Model-Independent Multivariate Confidence Region Procedure for Dissolution Profiles of Multiple Oral Products

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