Comparison of in vitro dissolution profiles by ANOVA-based, model-dependent and -independent methods

Yüksel, Nilüfer; Kanık, Arzu; Baykara, Tamer

doi:10.1016/s0378-5173(00)00554-8

Cited by 254 publications

(187 citation statements)

References 15 publications

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“…The dissolution profiles of the generic drug products A and B vs. reference were compared by model-independent,-dependent and analysis of variance (ANOVA)-based methods [12,17]. For modelindependent comparisons, the f2 similarity factor, mean dissolution time (MDT), and dissolution efficiency (DE) were calculated.…”

Section: Discussionmentioning

confidence: 99%

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Comparison of the Usp Apparatus 2 and 4 for Testing the in Vitro Release Performance of Ibuprofen Generic Suspensions

2017

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Objective: The aim of this study was the comparison of the in vitro release performance of ibuprofen generic suspensions and reference, based on the hydrodynamic environment generated by the flow-through cell method (USP Apparatus 4). Results were compared with those obtained by the use of the USP Apparatus 2. Methods:The Advil ® suspension (2 g/100 ml) and two generic formulations with the same dose were tested. Dissolution studies were carried out using a USP Apparatus 4 Sotax CE6 with 22.6 mm cells, laminar flow at 16 ml/min, and pH 7.2 phosphate buffer at 37.0±0.5 °C as dissolution medium. Ibuprofen was quantified spectrophotometrically at 222 nm. The in vitro release of the three drug products were studied using the USP Apparatus 2. The dissolution profiles of generic products were compared with the reference by model-independent, model-dependent, and analysis of variance (ANOVA)-based comparisons. Results:The dissolution profile of the generic product A was similar to the dissolution profile of reference, only with the use of the USP Apparatus 4. The f2 similarity factor was>50 and no significant differences were found with dissolution efficiency data (*P>0.05). Similar results were found with the comparison of t50% and t63.2% values. Similar dissolution profiles between generic product A and reference were also found with ANOVAbased comparisons. Conclusion:The flow-through cell method was adequate for study the in vitro release of ibuprofen suspensions. It is necessary to evaluate the in vivo performance of the drug products used in order to estimate the predictability of the proposed methodology.

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Section: Discussionmentioning

confidence: 99%

“…The model with the highest adjusted determination coefficient (R 2 adjusted) and the minimum Akaike information criterion (AIC) was chosen as the best fit model [17]. Data analysis was performed using the Excel add-in DDSolver.…”

Section: Discussionmentioning

confidence: 99%

Comparison of the Usp Apparatus 2 and 4 for Testing the in Vitro Release Performance of Ibuprofen Generic Suspensions

2017

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“…At each time of withdrawal, 5 ml of fresh medium was replaced into the dissolution flask, to maintain the sink condition. The release of the prepared gastro retentive formulations was compared with the theoretical release of the drug by calculating similarity and dissimilarity factor [27,28].…”

Section: Drug Release Studiesmentioning

confidence: 99%

Controlled-Release Effervescent Floating Matrix Tablets of Metformin Using Combination of Polymers

Patel

Shaikh

Patel

et al. 2016

Int J Pharm Pharm Sci

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Objective: It is always challenging to prepare the floating gastro retentive formulation of the high dose drug. The present research was aimed to prepare gastro retentive controlled release, matrix tablets of metformin, using the combination of different ionic, anionic and polyanionic polymers with HPMC.Methods: Formulations were prepared using sodium alginate, pullulan, kappa carrageenan, xanthan gum, poloxamer 68 in combination with HPMC K15M. All matrix tablets were prepared by direct compression method and evaluated for swelling, floating adhesive period and drug release.Results: All the tablets showed acceptable physicochemical properties. Statistical analyses of data revealed that tablets prepared using HPMC K15M and kappa carrageenan, formulation F2, is best in terms of showing excellent floating properties, extended adhesion periods and sustained drug release characteristics with similarity factor as 92 on comparison with the theoretical release of the drug. Conclusion:The combination of HPMC K15M and kappa carrageenan can be further optimized by applying the appropriate statistical design.

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“…The Weibull linear relationship was obtained by log-log plot of time versus -ln (1-m), where m is the cumulative fraction of drug dissolved over a time t (Manadas et al, 2002;Yukse et al, 2000).…”

Section: Dissolution Kineticsmentioning

confidence: 99%

In vitro dissolution kinetic for mycophenolic acid derivatives tablets

Costa¹,

Enéas²,

Miranda³

et al. 2013

Braz. J. Pharm. Sci.

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Mycophenolate mofetil (MMF) and mycophenolate sodium (MPS) are an ester and a salt of mycophenolic acid. They have different kinetic in vivo characteristics due to differences in molecular structures, physicochemical properties and formulations administered. In this study, dissolution profiles of reference products were tested in different media to evaluate the effect of pH, kinetic dissolution and the best statistical model that can be used to predict the release of both drugs. The drug release was determined by using a validated ultraviolet spectrophotometry method, λ 250 nm. The method showed to be selective, linear, precise and accurate for MMF in 0.1 M HCl and MPS in sodium phosphate buffer pH 6.8. Dissolution kinetics models of zero order, first order, Higuchi, Hixson-Crowell and Weibull were applied to data in order to select the best fit by linear regression. The regression parameters were estimated and the models were evaluated with the results of residuals and coefficient of determination. The residuals obtained from dissolution kinetics models were random, uncorrelated, and normally distributed with constant variance. The R 2 values (74.7% for MMF and 95.8% for MPS) demonstrated good ability of the Weibull regression to explain the variability and to predict the drugs' release.Uniterms: Mycophenolate sodium. Mycophenolate mofetil. Dissolution profiles. Weibull kinetics.Micofenolato de mofetila (MMF) e micofenolato sódico (MPS) são, respectivamente, éster e sal sódico do ácido micofenólico. Os fármacos possuem características farmacocinéticas distintas em função das diferenças na estrutura molecular, nas propriedades físico-químicas e nas formulações administradas. Neste trabalho, os perfis de dissolução dos medicamentos referências foram testados em diferentes meios de dissolução com o objetivo de avaliar o efeito da variação de pH, a cinética de dissolução e o modelo estatístico mais adequado para prever a dissolução dos fármacos. A liberação dos fármacos foi determinada com método validado por espectroscopia no ultravioleta, λ 250 nm. O método mostrou-se seletivo, linear, preciso e exato para dissolução de MMF em 0,1 M HCl e MPS em tampão fosfato pH 6,8. Os modelos cinéticos de dissolução de ordem zero, primeira ordem, Higuchi,

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Comparison of in vitro dissolution profiles by ANOVA-based, model-dependent and -independent methods

Cited by 254 publications

References 15 publications

Comparison of the Usp Apparatus 2 and 4 for Testing the in Vitro Release Performance of Ibuprofen Generic Suspensions

Comparison of the Usp Apparatus 2 and 4 for Testing the in Vitro Release Performance of Ibuprofen Generic Suspensions

Controlled-Release Effervescent Floating Matrix Tablets of Metformin Using Combination of Polymers

In vitro dissolution kinetic for mycophenolic acid derivatives tablets

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