ArticleEuropean journal of drug metabolism and pharmacokinetics2024
Development, Physicochemical Characteristics and Pharmacokinetics of a New Sustained-Release Bilayer Tablet Formulation of Tramadol with an Immediate-Release Component for Twice-Daily Administration.
Article in European journal of drug metabolism and pharmacokinetics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Who cites it
6 citing papers in PubMed, 8 citations in OpenAlex.
- Phase III study of bilayer sustained-release tramadol tablets in patients with cancer pain: a double-blind parallel-group, non-inferiority study with immediate-release tramadol capsules as an active comparator.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023Trial
- Polymer-Gated Bilayer Buccoadhesive Tablets for Biphasic Release of Indomethacin: Balancing Dissolution and Mucoadhesion.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Pharmacokinetics and Tissue Distribution of Fluorescently Labeled Neoagarotetraose in Mice.Pharmaceutics · 2026Article
- New Technique for Tramadol Dose Accuracy: Are Dosing Pumps the Solution?Pharmaceuticals (Basel, Switzerland) · 2026Review
- The Relationship Between Treatment Satisfaction and Medication Understanding Among Patients Taking a Novel Oral Pain Reliever: A Questionnaire-Based Cross-Sectional Study.Pain and therapy · 2025Article
- Article
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7 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveThere are some potential concerns about the currently marketed solid oral dosage forms of tramadol, including decreased adherence to immediate-release (IR) formulations due to the high number of doses taken each day and the slow rise in the blood tramadol concentration after administration of sustained-release (SR) formulations, which may not achieve a rapid analgesic effect. To overcome these potential concerns, a twice-daily double-layered tablet formulation of tramadol comprising IR and SR layers was developed. This article reports studies that assessed its physicochemical and pharmacokinetic properties.
methodsDissolution tests of five bilayer tablet formulations (designated tablets A-E) and pharmacokinetic studies of tablets A and B were conducted to investigate the appropriate ratio of the IR/SR layers in the double-layered tablet. Additionally, pharmacokinetic studies of three finished dosage formulations (tablets C-E) were performed in healthy adult males to investigate the effect of food intake on drug absorption.
resultsAdjusting the excipients and tramadol content in the IR and SR layers of tablets A-E altered their dissolution profiles in a manner that could be predicted based on their compositions. The IR layer was released within 15 min, and the SR layer was slowly released over 10 h. In the pharmacokinetic study, the time to maximum plasma concentration (t
conclusionsTo address the potential concerns regarding existing formulations of tramadol, a twice-daily, extended-release bilayer formulation of tramadol consisting of an IR and SR layer was developed. Pharmacokinetic studies confirmed that the plasma tramadol concentration increased quickly after administration and was maintained over a long period of time.
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