Validation and application of a stability-indicating HPLC method for the in vitro determination of gastric and intestinal stability of venlafaxine

Asafu-Adjaye, Ebenezer B.; Faustino, Patrick J.; Tawakkul, Mobin A.; Anderson, Lawrence W.; Yu, Lawrence X.; Kwon, Hyojong; Volpe, Donna A.

doi:10.1016/j.jpba.2006.12.035

Cited by 51 publications

(37 citation statements)

References 20 publications

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“…Asafu-Adjaye et al [41] studied the stability of venlafaxine in gastrointestinal tract. Their study suggested that venlafaxine would be stable in gastrointestinal tract, and venlafaxine loss might take place by membrane permeation rather than a gastrointestinal degradation process.…”

Section: Release Performance Of Venlafaxine From Ca-pla-msn In Simulamentioning

confidence: 99%

Poly(lactic acid)-coated mesoporous silica nanosphere for controlled release of venlafaxine

Tang

Slowing

Huang

et al. 2011

Journal of Colloid and Interface Science

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Section: Release Performance Of Venlafaxine From Ca-pla-msn In Simulamentioning

confidence: 99%

Poly(lactic acid)-coated mesoporous silica nanosphere for controlled release of venlafaxine

Tang

Slowing

Huang

et al. 2011

Journal of Colloid and Interface Science

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“…Another study has shown that fluoxetine will have significant losses at room temperature (in plasma, aqueous and methanolic solutions) but will be stable at -20 and 5°C [61]. Venlafaxine has been studied in chemically simulated gastric and intestinal fluids, with no changes in concentration [62], however this does not give any indication about putrefactive stability, as digestive bacteria were not added.…”

Section: Anti-depressant Drugsmentioning

confidence: 99%

The influence of putrefaction and sample storage on post-mortem toxicology results

Butzbach

2009

Forensic Sci Med Pathol

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There are numerous biochemical and biological processes that occur after death that may have a significant influence on post-mortem drug concentrations. These processes may render the quantification of particular drugs unreliable, or even result in drugs being undetectable in some instances, despite the use of several methods. Problems may occur with changes in the drug concentration via bacterial degradation, residual tissue enzymatic activity, or via post-mortem redistribution from tissues of a higher to a lower concentration. Many analytical techniques can suffer from interferences due to co-extracted putrefactive compounds that mask or alter the way a drug is detected, depending on the analytical technique utilised. The following paper reviews problems associated with post-mortem drug concentration changes, and the significance of microbial influences during the post-mortem interval and sample storage.

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“…The Food and Drug Administration (FDA) has recommended stability studies of 1 h in SGF and 3 h in SIF at 378 to assist the BCS (Biopharmaceutical Classification System) of drugs for immediate release of solid dosage forms. Significant degradation ( > 5%) of a drug could suggest potential instability in the GI tract [31]. In drug discovery, stability information in SGF and SIF are useful to select compounds for in vivo oral dosing, guide structural modification, diagnose poor oral bioavailability, prioritize chemical series, and evaluate formulations for improving GI stability.…”

Section: Stability In Gastrointestinalmentioning

confidence: 99%

“…The compound was stable in SGF and had less than 5% degradation in SIF. This suggested that the drug loss in the GI tract was due to low membrane permeation rather than a degradation process [31].…”

Section: Stability In Gastrointestinalmentioning

confidence: 99%

Stability Challenges in Drug Discovery

Kerns

2009

Chemistry & Biodiversity

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Stability is one of the most important properties of drug candidates. Instable compounds can lead to false positive high-throughput screening (HTS) hits, incorrect bioassay results, erroneous structure-activity relationships (SAR), low oral bioavailability, drug withdrawal, toxic reactions from degradation products, and difficult formulation development. Screening of stability has been implemented early in drug discovery to identify labile chemotypes and guide structural modification. The most commonly applied stability studies in drug discovery are stability-pH profile, stability in gastrointestinal fluids, stability in bioassay media, excipient compatibility, and prodrug screening. The strategy enhances the quality of drug development candidates and reduces the risks.

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Validation and application of a stability-indicating HPLC method for the in vitro determination of gastric and intestinal stability of venlafaxine

Cited by 51 publications

References 20 publications

Poly(lactic acid)-coated mesoporous silica nanosphere for controlled release of venlafaxine

Poly(lactic acid)-coated mesoporous silica nanosphere for controlled release of venlafaxine

The influence of putrefaction and sample storage on post-mortem toxicology results

Stability Challenges in Drug Discovery

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