Influence of Alcohol on the Release of Tramadol from 24-h Controlled-Release Formulations During In Vitro Dissolution Experiments

Traynor, Matthew J.; Brown, Marc; Pannala, Ananth Sekher; Beck, Peter; Martin, Gregory P.

doi:10.1080/03639040801929240

Cited by 34 publications

(19 citation statements)

References 8 publications

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“…Opioid abuse and addiction are serious medical and social problems. Oral controlled‐release formulations of opioids including tramadol have been reported to possess a potential risk for abuse and overdosing due to dose dumping caused by uncontrolled release of drugs when co‐ingested with alcohol [54] . Transdermal delivery decreases the possible abuse and overdosing potential of tramadol by not only avoiding peak and trough plasma concentrations but also reducing the risk of dose dumping observed in oral controlled release formulations [11,12] .…”

Section: Discussionmentioning

confidence: 99%

“…Oral controlled-release formulations of opioids including tramadol have been reported to possess a potential risk for abuse and overdosing due to dose dumping caused by uncontrolled release of drugs when co-ingested with alcohol. [54] Transdermal delivery decreases the possible abuse and overdosing potential of tramadol by not only avoiding peak and trough plasma concentrations but also reducing the risk of dose dumping observed in oral controlled release formulations. [11,12] The present study demonstrates that anodal iontophoresis can control skin permeation flux of tramadol in a current-dependent manner and deliver therapeutic amounts of tramadol.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

In-vitro and in-vivo transdermal iontophoretic delivery of tramadol, a centrally acting analgesic

Takasuga¹,

Yamamoto²,

Mafune³

et al. 2011

Journal of Pharmacy and Pharmacology

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

In-vitro and in-vivo transdermal iontophoretic delivery of tramadol, a centrally acting analgesic

Takasuga¹,

Yamamoto²,

Mafune³

et al. 2011

Journal of Pharmacy and Pharmacology

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“…Thus, there is the potential for concomitant use of an ER opioid formulation and alcohol that can lead to rapid release of the opioid (known as dose dumping) and possible overdose [5]. Recently, concerns have been raised in the scientific and regulatory arenas over the potential for alcohol-induced dose dumping with ER opioid formulations [6, 7], and this concern has led to the withdrawal of one controlled-release formulation of hydromorphone [5]. …”

Section: Introductionmentioning

confidence: 99%

Assessment of Alcohol-Induced Dose Dumping with a Hydrocodone Bitartrate Extended-Release Tablet Formulated with CIMA® Abuse Deterrence Technology

et al. 2015

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BackgroundGreater drug content requirements for extended-release (ER) opioids necessitate greater protection against dose dumping. Hydrocodone ER employs the CIMA® Abuse-Deterrence Technology platform, which provides resistance against rapid release of the active moiety when the tablet is manipulated or taken with alcohol.ObjectiveAssess effects of alcohol on hydrocodone ER pharmacokinetics.Study DesignOpen-label, crossover (January 25–April 30, 2010).SettingSingle center.ParticipantsForty healthy adults.InterventionSubjects received all four treatments in a randomized manner (separated by a minimum 5-day washout): hydrocodone ER 15 mg with 240 mL water and 240 mL orange juice containing 4, 20, and 40 % alcohol in a fasted state. Naltrexone was administered to minimize opioid-related adverse events.Main Outcome MeasureEffect of alcohol on pharmacokinetics of hydrocodone ER assessed by comparing systemic exposure [maximum plasma drug concentration (Cmax) and area under the plasma drug concentration-versus-time curve from time 0 to infinity (AUC0–∞)] after administration with alcohol or with water.ResultsGeometric means ratios of hydrocodone ER with 4, 20, and 40 % alcohol relative to water were 1.05, 1.09, and 1.14, respectively, for Cmax and 1.07, 1.13, and 1.17, respectively, for AUC0–∞. All 90 % confidence intervals for these geometric means ratios fell within the limits of 0.8 and 1.25. Increasing alcohol concentrations did not notably affect systemic exposure but were associated with increased adverse events.ConclusionsHydrocodone ER tablets were resistant to dose dumping when administered with alcohol in healthy subjects based on similar systemic exposures observed across all treatments.

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“…Potassium phosphate buffer (50 mM) pH 6.8 (700 ml) was selected as medium according to previously reported studies concerning tramadol release [26,27]. For each batch 3 tablets were tested and drug release was monitored spectrophotometrically at 271 nm (UV-1800, Shimadzu Corporation, JP) for a period of 4 hours.…”

Section: Dissolution Testingmentioning

confidence: 99%

Dextran and its potential use as tablet excipient

et al. 2015

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Dextrans are a class of carbohydrate polymers extensively applied in pharmaceutical applications, particularly as drug conjugate macromolecular carriers or drug delivery systems. These polysaccharides enable the stability of the therapeutics to be improved and for them to be delivered in a controlled manner, via either the parenteral and oral routes. In the latter case, due to their gel forming ability they may have potential as hydrophilic matrix tablets for sustained drug release.In this paper, we investigated the behaviour of different molecular weight (1, 40, 500 and 2300 kDa) dextrans as tabletting excipients. Powder particle size and hygroscopic studies have been reported, together with tabletability, tablet stability and tablet swelling. Moreover we use tramadol as model compound to evaluate the ability of dextrans to control drug dissolution. The results suggest that dextrans with lower molecular weights may be a promising excipient to be used as filler for immediate release tablets, due to their good tabletability and fast dissolution rate, while dextrans with higher molecular weights could be an efficient disintegrant due to their swelling ability.3

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Influence of Alcohol on the Release of Tramadol from 24-h Controlled-Release Formulations During In Vitro Dissolution Experiments

Cited by 34 publications

References 8 publications

In-vitro and in-vivo transdermal iontophoretic delivery of tramadol, a centrally acting analgesic

In-vitro and in-vivo transdermal iontophoretic delivery of tramadol, a centrally acting analgesic

Assessment of Alcohol-Induced Dose Dumping with a Hydrocodone Bitartrate Extended-Release Tablet Formulated with CIMA® Abuse Deterrence Technology

Dextran and its potential use as tablet excipient

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