Description
Technical Specifications
OxyContin is an oral solid dosage form containing oxycodone hydrochloride as its active pharmaceutical ingredient (API). The 80mg tablet is a high-strength formulation within the product line. Its defining technical feature is a patented controlled-release (CR) delivery system designed to provide a prolonged therapeutic effect. The tablet’s matrix is engineered to release oxycodone over an approximate 12-hour dosing interval through a combination of diffusion and erosion mechanisms, aiming to maintain stable plasma concentrations and reduce peak-to-trough fluctuations compared to immediate-release formulations. It is bioequivalent to corresponding total daily doses of immediate-release oxycodone administered every 6 hours. This formulation is indicated for the management of severe, around-the-clock pain requiring continuous, long-term opioid treatment in opioid-tolerant patients only. The tablet must be swallowed whole and must not be crushed, chewed, or dissolved, as this would disrupt the controlled-release mechanism, leading to the rapid release and absorption of a potentially fatal dose of oxycodone.
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Controlled-Release Mechanism: Utilizes a specialized polymer-based matrix to provide a biphasic release profile—an initial portion for prompt onset, followed by a prolonged release phase to sustain analgesic effect over 12 hours.
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Pharmacokinetic Profile: Designed to minimize the Cmax (peak plasma concentration) and Cmin (trough) variability, aiming for smoother plasma concentration-time curves compared to immediate-release opioids dosed multiple times per day.
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Opioid Tolerance Requirement: The 80mg dosage strength is specifically indicated for use only in opioid-tolerant patients. Tolerance is defined as taking at least 60 mg of oral oxycodone daily, 30 mg of oral oxyco/hydromorphone daily, 8 mg of oral hydromorphone daily, 25 mcg of transdermal fentanyl/hour, or an equianalgesic dose of another opioid for a minimum of one week.
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