Bioequivalence study of carbamazepine tablets: In vitro/in vivo correlation

Jung, Hyo-Rin; Milán, R.C.; Girard, M; León, Francisco; Montoya, Mark A.

doi:10.1016/s0378-5173(97)04910-7

Cited by 31 publications

(26 citation statements)

References 14 publications

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“…This criterion makes aspirin a good candidate for IV-IVC study (Amidon et al, 1997;Young et al, 1997). Good correlations between various dissolution and bioavailability parameters of some drugs have been documented (Gadalla et al, 1986;Wood et al, 1990;Hussein and Friedman, 1990;Derendarf et al, 1983; Jung et al, 1997;Abuzarur-aloul et al, 1998). However, in some cases, no good correlation could be obtained as reported by some investigators (Amamar and Khalil, 1993;Khan et al, 2009).…”

Section: Introductionmentioning

confidence: 62%

In vitro-in vivo correlation of four commercial brands of aspirin tablets marketed in Nigeria

Bamigbola¹,

Ibrahim²,

Attama³

et al. 2011

Afr. J. Pharm. Pharmacol.

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The study investigated the possibility of developing an in vitro -in vivo correlation for four commercial brands of aspirin tablets using USPXXI rotating basket apparatus and urinary excretion profiles from eight human volunteers. Various dissolution and pharmacokinetic parameters were obtained for all the brands. Significant rank order correlations were observed between all the in vitro dissolution parameters such as percent dissolved at 30 min, dissolution rate constants (k) and time for 50% dissolution (DT 50% ) and all the in vivo bioavailability parameters such as cumulative amount excreted up to 8 h (E 8 ), maximum excretion rate (dE/dt) max and time for maximum excretion rate (T max ). However, no correlation could be established between the cumulative amount excreted up to 24 h (E 24 ) and any of the in vitro dissolution parameters. Moreover, statistical analysis showed no significant inter-subject variation among the subjects that participated in the experiments.

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Section: Introductionmentioning

confidence: 62%

In vitro-in vivo correlation of four commercial brands of aspirin tablets marketed in Nigeria

Bamigbola¹,

Ibrahim²,

Attama³

et al. 2011

Afr. J. Pharm. Pharmacol.

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“…The main mean parameters (T max , C max and AUC 0Àt ) obtained in RBA studies using plasma as the monitoring fluid [20][21][22][23] and in the present salivary RBA study, were correlated with the percentage of CBZ dissolved in vitro at 30 min. Thirty minutes was chosen as the sampling time since it was the only time used in all the cited articles.…”

Section: In Vitro-in Vivo Correlationsmentioning

confidence: 99%

“…Four previously published series of RBA studies for immediate release CBZ products using plasma as a biological matrix, involving 14 formulations, were analysed [20][21][22][23]. The use of the same commercial brand as the reference product and the same in vitro dissolution method, enabled us to assess whether saliva could be a surrogate of plasma, or furthermore, more useful for bioavailability/bioequivalence purposes.…”

Section: Introductionmentioning

confidence: 99%

The use of saliva as a biological fluid in relative bioavailability studies: comparison and correlation with plasma results

Ruiz

Conforti

Fagiolino

et al. 2010

Biopharm & Drug Disp

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The aim of the present study was to present new evidence supporting the use of saliva as a biological fluid in relative bioavailability studies. Carbamazepine was chosen as a model drug because of its suitability for salivary therapeutic drug monitoring and its well-documented plasma bioavailability. A relative bioavailability study of four different immediate release carbamazepine products was performed. Stimulated saliva samples were collected by chewing on parafilm wax and by the spitting method. In vitro dissolution testing of formulations, using 900 ml of 1% sodium lauryl sulphate in water, was also carried out. The in vitro-in vivo correlations obtained in this salivary study were consistent with previous correlations assessed using plasma. These results support the suitability of saliva as the biological fluid in relative bioavailability studies.

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“…The use of a 'snapshot medium' as pro-posed by Jantratid et al to simulate both gastric and intestinal fluids during different stages after a meal consumption has some potential drawbacks, including several 'snapshot' dissolution media being needed to reflect changes in the aspirate compositions during digestion in the small intestine [47]. Despite these drawbacks, they make dissolution testing more physiologically relevant and can be used in predicting formulation performance and food effects in vivo [47,81,82].…”

Section: Dissolution Mediamentioning

confidence: 99%

Drug release from matrix tablets: physiological parameters and the effect of food

Nokhodchi

Asare-Addo

2014

Expert Opinion on Drug Delivery

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Introduction: As dissolution plays an important and vital role in the drug-delivery process of oral solid dosage forms, it is, therefore, essential to critically evaluate the parameters that can affect this process. Areas covered:The consumption of food as well as the physiological environment and properties of the gastrointestinal tract, such as its volume and composition of fluid, the fluid hydrodynamics, properties of the intestinal membrane, drug dose and solubility, pK a , diffusion coefficient, permeability and particle size, all affect drug dissolution and absorption rate. There are several dissolution approaches that have been developed to address the conditions as experienced in the in vivo environment, as the traditional dissolution being a quality control method is not biorelevant and as such do not always produce meaningful data. This review also describes the development of a systematic way that differentiates between robust and non-robust formulations by varying the effects of agitation and ionic strength through the use of the automated United States Pharmacopeia type III Bio-Dis apparatus. Expert opinion:With the improved understanding of the physiological parameters that can affect the oral bioperformance of dosage forms, strides have, therefore, been made in making dissolution testing methods more bio-logically based with the view of obtaining more in vitro--in vivo correlations.Keywords: agitation rate, biodissolution, drug release, effect of food, hydrophilic matrices, ionic strength Highlights -Understanding all the physiological parameters can serve as a basis for designing dissolution testing methods and systems that can more fully represent the gastrointestinal (GI) tract in humans and allow more in vitro-in vivo (IVIVC) correlations to be obtained thereby improving the oral bioperformance of dosage forms.-Simulation of GI conditions is essential to adequately predict the in vivo behaviour of drug formulations.-The choice of appropriate media for in vitro tests is crucial to their ability to correctly forecast the food effect in pharmacokinetic studies.-Several methods of dissolution testing have been conducted and are still ongoing that seek to further understand and develop media and dissolution methods to better represent the in vivo conditions and to aid in the better prediction of in vivo drug release.-Systematic change of agitation method and ionic strength evaluation may be used as additional tools in allowing for the identification of potential fed and fasted effects on drug release from hydrophilic matrices in the drive for developing dissolution methodologies that are more relevant in helping to achieve more IVIVC.

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Bioequivalence study of carbamazepine tablets: In vitro/in vivo correlation

Cited by 31 publications

References 14 publications

In vitro-in vivo correlation of four commercial brands of aspirin tablets marketed in Nigeria

In vitro-in vivo correlation of four commercial brands of aspirin tablets marketed in Nigeria

The use of saliva as a biological fluid in relative bioavailability studies: comparison and correlation with plasma results

Drug release from matrix tablets: physiological parameters and the effect of food

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