Oxymorphone Controlled Release Matrix for Renal Impairment Dosing
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Solution Overview
Problem
Current opioid analgesics, such as oxymorphone, require frequent dosing due to their short duration of action, leading to suboptimal pain control and poor quality of life outcomes, especially in chronic pain management, and their bioavailability is affected by renal impairment.
Innovation Solution
A controlled release oral solid dosage form of oxymorphone is developed, which maintains therapeutic blood plasma levels for 12 to 24 hours, allowing for less frequent dosing and increased bioavailability in patients with renal impairment, using a hydrophilic matrix that releases oxymorphone at a controlled rate.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If immediate release oxymorphone is administered, then rapid onset of analgesia is achieved, but frequent dosing (every 4-6 hours) is required maintaining suboptimal compliance
Solution Approach 1:
The oxymorphone dosage form is segmented into immediate release and controlled release components. The immediate release portion provides rapid onset analgesia, while the controlled release portion maintains therapeutic levels over extended periods, reducing dosing frequency to twice daily while improving compliance
Solution Approach 2:
The invention changes the release rate parameter of oxymorphone from immediate to controlled release. This parameter change allows the drug to maintain therapeutic plasma levels for 12-24 hours, transforming the dosing schedule from every 4-6 hours to twice daily, thereby improving patient compliance
2Ease of operation
If controlled release formulation is used, then dosing frequency is reduced and compliance improves, but bioavailability may be affected in patients with renal impairment
Solution Approach 1:
The invention adjusts the dosage parameter for patients with renal impairment. By reducing the dose by at least 50% in these patients, the formulation maintains reliable and predictable bioavailability while accounting for reduced renal clearance, ensuring safety and efficacy in this vulnerable population
3Reliability
If immediate release oxymorphone is administered, then optimal plasma levels can be achieved, but short duration of action requires frequent dosing
Solution Approach 1:
The controlled release formulation ensures continuous release of oxymorphone over 12-24 hours, maintaining therapeutic plasma levels continuously without the peaks and troughs associated with immediate release formulations. This continuous action provides sustained analgesia and eliminates the need for frequent redosing
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The controlled release formulation provides sustained pain relief for moderate to severe pain with reduced dosing frequency and increased bioavailability in patients with renal impairment, improving compliance and quality of life while maintaining effective plasma levels.
Implementation Method 1
a controlled release oral solid dosage form of oxymorphone is developed, which maintains therapeutic blood plasma levels for 12 to 24 hours, allowing for less frequent dosing and increased bioavailability in patients with renal impairment, using a hydrophilic matrix that releases oxymorphone at a controlled rate
Data Source
AI summary
The invention pertains to a method of using oxymorphone in the treatment of pain by providing a patient with an oxymorphone dosage form and informing the patient or prescribing physician that the bioavailability of oxymorphone is increased in patients with renal impairment.