KinetDS: An Open Source Software for Dissolution Test Data Analysis

Mendyk, Aleksander; Jachowicz, Renata; Fijorek, Kamil; Dorożyński, Przemysław; Kulinowski, Piotr; Polak, Sebastian

doi:10.14227/dt190112p6

Cited by 109 publications

(70 citation statements)

References 8 publications

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“…Drug release profiles were compared with a marketed extended-release product (MP) of THP using similarity factor (f 2 ). Drug release data were computed with free open source software KinetDS® [16] and DDSolver® [17]. Several mathematic models were applied to determine and describe the drug releases from nanoclay-based matrix i.e.…”

Section: Discussionmentioning

confidence: 99%

Drug Release Mechanism of Slightly Soluble Drug from Nanocomposite Matrix Formulated with Zeolite/ Hydrotalcite as Drug Carrier

Ainurofiq¹,

Choiri²

2015

Trop. J. Pharm Res

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Section: Discussionmentioning

confidence: 99%

Drug Release Mechanism of Slightly Soluble Drug from Nanocomposite Matrix Formulated with Zeolite/ Hydrotalcite as Drug Carrier

Ainurofiq¹,

Choiri²

2015

Trop. J. Pharm Res

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“…KinetDS software (20) was used for modeling the dissolution curve and establishing the possible time points, at which dissolution kinetics switch. Piecewise mode was employed with an approximation accuracy, i.e., a tolerance criterion, of 0.99 and nonlinear regression enabled.…”

Section: Methodsmentioning

confidence: 99%

The Relationship Between the Evolution of an Internal Structure and Drug Dissolution from Controlled-Release Matrix Tablets

et al. 2015

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Abstract. In the last decade, imaging has been introduced as a supplementary method to the dissolution tests, but a direct relationship of dissolution and imaging data has been almost completely overlooked. The purpose of this study was to assess the feasibility of relating magnetic resonance imaging (MRI) and dissolution data to elucidate dissolution profile features (i.e., kinetics, kinetics changes, and variability). Commercial, hydroxypropylmethyl cellulose-based quetiapine fumarate controlled-release matrix tablets were studied using the following two methods: (i) MRI inside the USP4 apparatus with subsequent machine learning-based image segmentation and (ii) dissolution testing with piecewise dissolution modeling. Obtained data were analyzed together using statistical data processing methods, including multiple linear regression. As a result, in this case, zeroth order release was found to be a consequence of internal structure evolution (interplay between region's areas-e.g., linear relationship between interface and core), which eventually resulted in core disappearance. Dry core disappearance had an impact on (i) changes in dissolution kinetics (from zeroth order to nonlinear) and (ii) an increase in variability of drug dissolution results. It can be concluded that it is feasible to parameterize changes in micro/meso morphology of hydrated, controlled release, swellable matrices using MRI to establish a causal relationship between the changes in morphology and drug dissolution. Presented results open new perspectives in practical application of combined MRI/dissolution to controlled-release drug products.

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“…Con estas variables se hizo la selección de los niveles de compresión en los cuales las tabletas cumplieron satisfactoria y simultáneamente los criterios en las tres pruebas [21]. Estos comprimidos se analizaron con respecto al contenido de principio activo y uniformidad del mismo y se compararon por medio del comportamiento de disolución [22].…”

Section: Compresión De La Mezclaunclassified

Efecto de la fuerza de compresión sobre los atributos críticos de calidad en tabletas de liberación inmediata de furosemida

Fonseca

López

2017

Rev. colomb. cienc. quim. farm.

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La furosemida es un fármaco poco soluble en agua (0,01825 mg/mL). Debido a su bajasolubilidad y baja permeabilidad, se ubica en la clase IV del Sistema de ClasificaciónBiofarmacéutica (BCS, por sus siglas en inglés). Se absorbe rápida pero incompletamenteen el tracto gastrointestinal (GI). Actualmente, este fármaco se comercializa entabletas, las que para su obtención deben ser sometidas a un proceso de compresión.La fuerza aplicada en dicha compresión puede influenciar algunas de las característicasde calidad del producto; por ello, la presente investigación estudia el efecto de lafuerza de compresión sobre los atributos críticos de calidad en el proceso de fabricación(dureza, friabilidad y desintegración) y en el producto terminado (uniformidadde dosificación y disolución) de comprimidos de furosemida. El efecto sobre la disoluciónse determinó por los factores de diferencia (f1) y de similitud (f2) de los perfilesde disolución y los parámetros de eficiencia de la disolución (ED) y tiempo medio dedisolución (TMD), los cuales se calcularon con el software académico kinetDS. Losresultados obtenidos permitieron definir el rango de la fuerza de compresión para elcual se obtuvo una ED superior al 85% y un TMD inferior a 7,5 min.

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KinetDS: An Open Source Software for Dissolution Test Data Analysis

Cited by 109 publications

References 8 publications

Drug Release Mechanism of Slightly Soluble Drug from Nanocomposite Matrix Formulated with Zeolite/ Hydrotalcite as Drug Carrier

Drug Release Mechanism of Slightly Soluble Drug from Nanocomposite Matrix Formulated with Zeolite/ Hydrotalcite as Drug Carrier

The Relationship Between the Evolution of an Internal Structure and Drug Dissolution from Controlled-Release Matrix Tablets

Efecto de la fuerza de compresión sobre los atributos críticos de calidad en tabletas de liberación inmediata de furosemida

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