Ibuprofen Soft Gelatin Capsule Rapid Release Formulation
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Solution Overview
Problem
Current soft gelatin capsules containing ibuprofen have a release rate and onset of pharmaceutical effect that is not quick enough, with a need for improved speed of action.
Innovation Solution
A composition for soft gelatin capsules comprising ibuprofen, polyvinylpyrrolidones, and polyethylene glycols in specific weight ratios, along with optional polyoxysorbitan esters and hydroxides, which enhances the solubilization of ibuprofen in simulated gastric fluid, allowing for rapid release.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If conventional soft gelatin capsules containing ibuprofen are used, then the capsule provides acceptable stability and ease of manufacture, but the release rate and onset of pharmaceutical effect are not quick enough
Solution Approach 1:
The patent changes the chemical parameters of the fill formulation by incorporating specific solvents (polyethylene glycol monoethyl ether, polyglycerol oleate) and alkaline agents (sodium hydroxide, potassium hydroxide) in optimized concentrations. These parameter changes create a more favorable chemical environment for rapid ibuprofen release while maintaining stability through controlled pH and solubility conditions.
Solution Approach 2:
The patent uses a composite fill formulation combining multiple components: ibuprofen (active ingredient), polyethylene glycol monoethyl ether (solvent), polyglycerol oleate (emulsifier), and alkaline agents (pH control). This composite system works synergistically to achieve both rapid release and stability, with each component contributing specific functional properties that collectively resolve the contradiction.
2Speed
If the solubility of ibuprofen is increased to achieve faster release, then the onset of action improves, but the complexity of the formulation increases
Solution Approach 1:
The patent introduces polyethylene glycol monoethyl ether and polyglycerol oleate as intermediary substances that facilitate the solubility of ibuprofen. These intermediaries act as mediators between the poorly water-soluble ibuprofen and the aqueous gastric environment, enabling rapid dissolution without requiring complex formulation systems or multiple processing steps.
Solution Approach 2:
The patent optimizes the concentration parameters of solvents and emulsifiers in the fill formulation to achieve maximum solubility enhancement at practical levels. By carefully controlling the amounts of polyethylene glycol monoethyl ether and polyglycerol oleate, the formulation achieves rapid ibuprofen release without excessive complexity in manufacturing or formulation development.
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 composition enables at least 5% of the ibuprofen dose to be solubilized within 5 minutes in simulated gastric fluid, significantly quicker than existing capsules, with improved stability and faster onset of action.
Implementation Method 1
the composition enhances the solubilization of ibuprofen in simulated gastric fluid, allowing for rapid release
Data Source
AI summary
The present invention relates to a composition for encapsulation in a soft gelatin shell which comprises ibuprofen, one or more polyvinyl pyrrolidones and one or more polyethylene glycols wherein the weight ratio of the ibuprofen to the one or more polyvinylpyrrolidones is from 2:1-15:1, the weight ratio of the ibuprofen to the one or more polyethylene glycols is from 1:1-5:1 and the weight ratio of the one or more polyethylene glycols to the one or more polyvinylpyrrolidones is 2:1-10:1.