In vitro/in vivo correlations of dissolution data of carbamazepine immediate release tablets with pharmacokinetic data obtained in healthy volunteers

Lake, O. A.; Olling, M.; Barends, D. M.

doi:10.1016/s0939-6411(99)00016-8

Cited by 49 publications

(30 citation statements)

References 9 publications

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“…Several studies support the validity of this approach, since good correlations between in vitro and in vivo data for CBZ have been established, both at a Level C [20,21,36] and at a Level A, point by point [22,37,38]. Moreover, Level A correlations were found using the same dissolution media that was used in the present study.…”

Section: Discussionsupporting

confidence: 80%

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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Section: Discussionsupporting

confidence: 80%

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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show abstract

“…In 1988, a clinical failure was reported for Tegretol ® tablets (carbamazepine), likely due to the polymorphic phase transition from the anhydrous to the dihydrate form (Lee et al, 2011). Moreover, there are several reports of variability in the dissolution profile of commercially available carbamazepine tablets (Davidson, 1994;Meyer et al, 1992Meyer et al, , 1998Al-Zein et al, 1999;Lake et al, 1999;Mittapalli et al, 2008).…”

Section: Carbamazepinementioning

confidence: 99%

Polymorphism: an evaluation of the potential risk to the quality of drug products from the Farmácia Popular Rede Própria

Santos

Reis

Jacon

et al. 2014

Braz. J. Pharm. Sci.

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Polymorphism in solids is a common phenomenon in drugs, which can lead to compromised quality due to changes in their physicochemical properties, particularly solubility, and, therefore, reduce bioavailability. Herein, a bibliographic survey was performed based on key issues and studies related to polymorphism in active pharmaceutical ingredient (APIs) present in medications from the Farmácia Popular Rede Própria. Polymorphism must be controlled to prevent possible ineffective therapy and/or improper dosage. Few mandatory tests for the identification and control of polymorphism in medications are currently available, which can result in serious public health concerns.Uniterms: Polymorphism. Medicines/quality control. Medicines/solubility. Medicines/bioavailability.O polimorfismo em sólidos é um fenômeno frequente em fármacos e pode levar a problemas na qualidade dos medicamentos por alterar suas propriedades físico-químicas, em especial a solubilidade e, consequentemente, a biodisponibilidade. Nesse trabalho realizou-se levantamento bibliográfico sobre os principais estudos e problemas relacionados ao polimorfismo em fármacos presentes nos medicamentos disponibilizados pela Farmácia Popular do Brasil. O polimorfismo deve ser controlado a fim de evitar possível ineficácia terapêutica e/ou dosagem inapropriada dos medicamentos. Destacamos que são poucos os ensaios obrigatórios para identificação e controle desse fenômeno em medicamentos, o que pode acarretar grande problema de saúde pública. Unitermos:Polimorfismo. Medicamentos/controle de qualidade. Medicamentos/solubilidade. Medicamentos/biodisponibilidade.

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“…be adjusted in retrospect,so that dissolution test results may correspond to in vivo outcome (14)(15)(16). Thus,in practice,the experimental conditions,including the use of different apparatus,are adjusted to achieve the desired outcome.…”

Section: Percent Drug Release Profiles Of Three Immediate-release Cmentioning

confidence: 99%

Developing Discriminatory Drug Dissolution Tests and Profiles: Some Thoughts for Consideration on the Concept and Its Interpretation

Qureshi¹

2006

Dissolution Technol.

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In vitro/in vivo correlations of dissolution data of carbamazepine immediate release tablets with pharmacokinetic data obtained in healthy volunteers

Cited by 49 publications

References 9 publications

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

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

Polymorphism: an evaluation of the potential risk to the quality of drug products from the Farmácia Popular Rede Própria

Developing Discriminatory Drug Dissolution Tests and Profiles: Some Thoughts for Consideration on the Concept and Its Interpretation

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