Effect of Various Alcohols on Intestinal Net Water Flux and Theophylline Absorption in Rats

Houston, J. Brian; Levy, Gerhard

doi:10.1002/jps.2600640406

Cited by 8 publications

(1 citation statement)

References 3 publications

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“…Ethanol has been shown to affect glucose and water transport (20). Houston and Levy reported that various alcohols increased net water flux with concomitant increase in theophylline absorption from solution in rats (21). The results of all of these investigations although conducted in several solvents that are not often used in solid dosage forms suggest that excipients in pharmaceutical preparations can not only affect permeability and solubility, but also membrane partitioning.…”

Section: Introductionmentioning

confidence: 99%

Scientific Perspectives on Extending the Provision for Waivers of In vivo Bioavailability and Bioequivalence Studies for Drug Products Containing High Solubility-Low Permeability Drugs (BCS-Class 3)

Stavchansky

2008

AAPS J

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Abstract. Recently, there has been increased interest in extending the provision for waivers of in vivo bioavailability and bioequivalence (BA-BE) studies that appeared in the guidance published by the Food and Drug Administration (FDA) (1) to pharmaceutical products containing Class 3 drugs (High solubility-Low Permeability). The extension of the Biopharmaceutics Classification System (BCS) to Class 3 drugs is meritorious because of its impact on public health policy considerations. The rate limiting step in the absorption of Class 3 drugs is the permeability through the intestinal membrane. This commentary will focus its attention on the scientific considerations which need to be examined to assess the risk and the benefit prior to granting a waiver of in vivo bioavailability and/or bioequivalence studies for Class 3 drugs. It will examine the forces affecting the interconnectivity of the neuronal, immunological and hormonal systems in the gastrointestinal tract that may affect its permeability and functionality. It will also challenge the assumption that in vitro dissolution and in vitro permeability studies in tissue cultures in the presence and absence of excipients are good predictors for in vivo dissolution and in vivo permeability which are at the heart of the BCS.

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Section: Introductionmentioning

confidence: 99%

Scientific Perspectives on Extending the Provision for Waivers of In vivo Bioavailability and Bioequivalence Studies for Drug Products Containing High Solubility-Low Permeability Drugs (BCS-Class 3)

Stavchansky

2008

AAPS J

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Pharmaceutical Sciences—1975: Literature Review of Pharmaceutics II∆∆Editor’s note: Part I of this article appeared in the July 1976 issue of the Journal of Pharmaceutical Sciences

Goodhart¹,

Eichman

1976

Journal of Pharmaceutical Sciences

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Effects of Short and Medium Chain Fatty Acids on Absorption of Lipophilic Drugs from Perfused Rat Intestine

Ghisafe

Hayton

1978

Journal of Pharmaceutical Sciences

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Effect of Various Alcohols on Intestinal Net Water Flux and Theophylline Absorption in Rats

Cited by 8 publications

References 3 publications

Scientific Perspectives on Extending the Provision for Waivers of In vivo Bioavailability and Bioequivalence Studies for Drug Products Containing High Solubility-Low Permeability Drugs (BCS-Class 3)

Scientific Perspectives on Extending the Provision for Waivers of In vivo Bioavailability and Bioequivalence Studies for Drug Products Containing High Solubility-Low Permeability Drugs (BCS-Class 3)

Pharmaceutical Sciences—1975: Literature Review of Pharmaceutics II∆∆Editor’s note: Part I of this article appeared in the July 1976 issue of the Journal of Pharmaceutical Sciences

Effects of Short and Medium Chain Fatty Acids on Absorption of Lipophilic Drugs from Perfused Rat Intestine

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