Interpretation of Percent Dissolved-Time Plots Derived from In Vitro Testing of Conventional Tablets and Capsules

Wagner, John G.

doi:10.1002/jps.2600581021

Cited by 413 publications

(160 citation statements)

References 25 publications

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“…To evaluate the release profiles of the formulations, several release profiles were tested, such as zero order, first order (21,22), Higuchi (23), Hixon-Crowell (24) and KorsmeyerPeppas (25). Mathematical models were fitted one at a time to individual dissolution data, using the SigmaPlot 11.0 (Systat software, USA) software.…”

Section: Release Kineticsmentioning

confidence: 99%

Formulation and pharmaceutical development of quetiapine fumarate sustained release matrix tablets using a QbD approach

et al. 2017

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The main objective of the present study was to apply QbD methodology in the development of once-a-day sustained release quetiapine tablets. The quality target product profile (QTPP) was defined after the pharmaceutical properties and kinetic release of the innovator product, Seroquel XR 200 mg. For the D-optimal experimental design, the level and ratio of matrix forming agents and the type of extragranular diluent were chosen as independent inputs, which represented critical formulation factors. The critical quality attributes (CQAs) studied were the cumulative percentages of quetiapine released after certain time intervals. After the analysis of the experimental design, optimal formulas and the design space were defined. Optimal formulas demonstrated zero-order release kinetics and a dissolution profile similar to the innovator product, with f 2 values of 74.53 and 83.74. It was concluded that the QbD approach allowed fast development of sustained release tablets with similar dissolution behavior as the innovator product.Keywords: quality by design, design of experiments, sustained release, hydrophilic matrix, quetiapineIn the past years, the main goal of antipsychotic drug development has been to develop molecules with higher efficacy and fewer side effects usually associated with the classic antipsychotic medications. The newly developed agents, called atypical antipsychotics, are successfully used in the treatment of both positive and negative symptoms of schizophrenia and are associated with fewer neurological and endocrine side effects compared to older medications (1). Quetiapine is a recently introduced atypical antipsychotic, which has an excellent risk/benefit ratio and is indicated as the first-line option for the treatment of psychotic disorder manifestations and schizophrenia (2). Quetiapine is available as fumarate salt in immediate as well as in sustained released formulations, the innovative product being Seroquel. The sustained release formulation was introduced several years ago and its primary objective is to release the drug slowly over an extended ALEXANDRU GAVAN

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Section: Release Kineticsmentioning

confidence: 99%

Formulation and pharmaceutical development of quetiapine fumarate sustained release matrix tablets using a QbD approach

et al. 2017

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“…The aliquots were further diluted suitably and analyzed at 332 nm using a Beckman DU-64 spectrophotometer. In order to analyze the furosemide release mechanism, the in vitro release data were fitted into various release equations and the following kinetic models (zero-order, first order [10], Higuchi [11], Korsemeyer and Peppas [12]). …”

Section: In-vitro Drug Release Studymentioning

confidence: 99%

Formulation and In Vitro Evaluation of Sunflower Oil Entrapped within Buoyant Beads of Furosemide

Bera¹,

Mandal²,

Bhowmik³

et al. 2009

Sci. Pharm.

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The purpose of the present study was to develop buoyant beads for the intragastric delivery of furosemide in order to evaluate the effect of incorporated sunflower oil on physiochemical properties of alginate beads. Sunflower oil entrapped buoyant alginate beads of furosemide were prepared by the emulsion-gelation technique. During the preparation of various batches of beads, the ratio of sunflower oil to water (v/v), the ratio of drug to polymer (w/w), were kept as variables at two levels; either high or low. Smooth, spherical beads with nominal weight variation were obtained. All batches of beads floated for 24 hours with a lag time of 5-10 min. The release of drug followed for 5 hours. Higuchi and first order kinetic modeling indicated a diffusion-controlled release of drug from the beads. The study also demonstrated the influence of sunflower oil on drug entrapment (81-95%) and in vitro release. A higher level of oil increased drug entrapment efficiency but retarded drug release rate as compared to a lower level of oil containing beads.

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“…The dissolution profiles of all the batches were fitted to zero order, first order, Higuchi, Hixon-Crowell (erosion) and Korsemeyer-Peppas to ascertain the kinetic modelling of drug release (Lazarus, Cooper, 1961;Wagner, 1969;Higuchi, 1963;Korsmeyer, Gurny, Peppas, 1983;Hixson, Crowell, 1931).…”

Section: Release Kineticsmentioning

confidence: 99%

Formulation of gastroretentive floating drug delivery system using hydrophilic polymers and its in vitro characterization

Meka

Dharmanlingam

Kolapalli

2014

Braz. J. Pharm. Sci.

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The aim of the present research is to formulate and evaluate the gastroretentive floating drug delivery system of antihypertensive drug, propranolol HCl. Gastroretentive floating tablets (GRFT) were prepared by using a synthetic hydrophilic polymer polyethylene oxide of different grades such as PEO WSR N-12 K and PEO 18 NF as release retarding polymers and calcium carbonate as gas generating agent. The GRFT were compressed by direct compression strategy and the tablets were evaluated for physicochemical properties, in vitro buoyancy, swelling studies, in vitro dissolution studies and release mechanism studies. From the dissolution and buoyancy studies, F 9 was selected as an optimized formulation. The optimized formulation followed zero order rate kinetics with non-Fickian diffusion mechanism. The optimized formulation was characterised with FTIR studies and observed no interaction between the drug and the polymers.Uniterms: Gastroretentive floating/ drug delivery system. Gastroretentive floating tablets/in vitro dissolution. Hydrophilic polymers/use in drug delivery system. Polyethylene oxide. Propranolol HCl/ delivery system. O objetivo da presente pesquisa é o de formular e avaliar o sistema de liberação de fármaco gastrorretentivo flutuante, contendo o anti-hipertensivo, cloridrato de propranolol. Comprimidos gastrorretentivo flutuantes (GRFT) foram preparados utilizando um polímero hidrofílico sintético, o óxido de polietileno, de diferentes graus, tais como GE WSR N-12 K e GE 18 NF, como polímeros de retardamento de liberação, e carbonato de cálcio, como agente gerador de gases. Os GRFT foram comprimidos por compressão direta e avaliados para determinação das propriedades físico-químicas, flutuabilidade in vitro, estudos de inchamento, de dissolução in vitro e de mecanismo de liberação. Dos testes de dissolução e de flutuabilidade, selecionou-se F 9 como formulação otimizada. A formulação otimizada seguiu cinética de ordem zero, com mecanismo de difusão não-Fickiano. Essa formulação foi caracterizada por estudos de FTIR, não se observando interação entre o fármaco e os polímeros.Unitermos: Retenção gástrica flutuante/sistema de liberação de fármaco. Comprimidos gastrorretentivo flutuante/dissolução in vitro. Polímeros hidrofílicos/uso em sistema de liberação de fármaco. Óxido de polietileno. Cloridrato de propranolol/ sistema de liberação.

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Interpretation of Percent Dissolved-Time Plots Derived from In Vitro Testing of Conventional Tablets and Capsules

Cited by 413 publications

References 25 publications

Formulation and pharmaceutical development of quetiapine fumarate sustained release matrix tablets using a QbD approach

Formulation and pharmaceutical development of quetiapine fumarate sustained release matrix tablets using a QbD approach

Formulation and In Vitro Evaluation of Sunflower Oil Entrapped within Buoyant Beads of Furosemide

Formulation of gastroretentive floating drug delivery system using hydrophilic polymers and its in vitro characterization

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