Soft Gel Naproxen Formulation for High Drug Loading
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Solution Overview
Problem
Existing soft gel capsule formulations face challenges in achieving high concentrations of poorly soluble drugs like naproxen without increasing the capsule size, and require complex pH adjustment processes that can be corrosive and inefficient.
Innovation Solution
A formulation combining naproxen, naproxen sodium, polyethylene glycol, propylene glycol, povidone, and water, allowing for higher concentrations and adjustable pH without neutralization steps, ensuring compatibility with the capsule shell and improved bioavailability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If naproxen is formulated in traditional soft gel capsules using polyethylene glycol, then the capsule can be manufactured, but the solubility is insufficient to provide a reasonably sized capsule small enough to be comfortably administered
Solution Approach 1:
The patent changes the chemical parameters of the solvent system by introducing a eutectic mixture of polyethylene glycol and propylene glycol, which fundamentally alters the solubility characteristics. This parameter change enables higher naproxen concentration (up to 25% w/w) in a smaller volume, resolving the contradiction between capsule size and drug concentration
Solution Approach 2:
The invention uses a composite solvent system combining polyethylene glycol and propylene glycol in specific ratios to create a eutectic mixture. This composite material provides synergistic solubility enhancement that neither component achieves alone, allowing high naproxen loading in small capsule volumes
2Quantity of substance
If pH adjustment processes are used to enhance naproxen solubility, then solubility improves, but the process becomes complex and corrosive
Solution Approach 1:
The patent extracts and eliminates the pH adjustment step from the manufacturing process. By using the eutectic solvent system, naproxen achieves high solubility without requiring acidic or basic pH modification, thereby removing the complex and corrosive pH adjustment operations from the process
Solution Approach 2:
The invention replaces complex pH adjustment procedures with a simple, straightforward dissolution process using the eutectic solvent mixture. This simpler approach is more economical and avoids the need for additional chemicals and process steps
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 solution enables smaller, more stable, and safer capsules with enhanced bioavailability and pH adjustability, reducing manufacturing complexity and costs.
Implementation Method 1
a eutectic mixture of polyethylene glycol and propylene glycol
Implementation Method 2
The solvent systems provide for a highly concentrated solution capable of encapsulation into a small vessel
Data Source
AI summary
Disclosed are methods of using a naproxen fill formulation suitable for encapsulation into a soft gel dosage unit to treat inflammation and pain. Methods include administering naproxen to a subject in need thereof to treat pain and inflammation. Methods can include administering naproxen together with another medicament to a subject in need thereof to treat an additional condition such as a cough, cold, allergy, congestion, etc.