Ready-to-Use Parenteral Ibuprofen Phosphate Formulation for Plastic Storage
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Solution Overview
Problem
Existing parenteral Ibuprofen formulations require additional dilution steps and are not conveniently stored in plastic containers, lacking stability and ease of use.
Innovation Solution
A pharmaceutical composition comprising Ibuprofen and a phosphate buffer with a specific molar ratio and concentration, allowing for a ready-to-use formulation in a plastic container, which is stable and convenient for administration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If Ibuprofen formulations are prepared as concentrates requiring dilution, then the formulation can be stored in various containers, but additional dilution steps are required which reduce ease of operation
Solution Approach 1:
The patent applies preliminary action by pre-mixing Ibuprofen with phosphate buffer at optimal concentrations (15-25 mmol/l Ibuprofen with 0.5:1 to 0.7:1 molar ratio) during manufacturing, creating a ready-to-use formulation that eliminates the need for additional dilution steps at the point of administration. This pre-preparation resolves the contradiction by performing the mixing action in advance during production rather than requiring it during use.
2Stability of the object's composition
If higher amounts of phosphate buffer are used in Ibuprofen formulations, then stability is improved, but the formulation requires larger buffer amounts which increases quantity of substance
Solution Approach 1:
The patent applies parameter changes by optimizing the phosphate buffer concentration and molar ratio parameters to achieve the minimum effective amount (0.5:1 to 0.7:1 molar ratio) required for stability. By precisely controlling these parameters, the formulation achieves adequate stability with reduced buffer quantities compared to conventional formulations that use higher buffer amounts.
Solution Approach 2:
The patent applies partial action by using only the minimum necessary amount of phosphate buffer (0.5:1 to 0.7:1 molar ratio) required to achieve stability, rather than using excessive buffer amounts. This optimized approach provides sufficient stabilization while minimizing the quantity of buffer substance in the formulation.
3Stability of the object's composition
If excipients such as amino acids are added to Ibuprofen formulations, then solubility is improved, but adsorption to plastic container occurs which reduces purity
Solution Approach 1:
The patent applies the extraction principle by removing amino acid excipients from the formulation entirely, relying instead on the phosphate buffer system (0.5:1 to 0.7:1 molar ratio) to maintain solubility and stability. This elimination of problematic excipients resolves the adsorption issue with plastic containers while preserving the necessary solubility characteristics through the optimized phosphate buffer approach.
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 formulation is stable and easy to handle, providing a safe and convenient parenteral administration without the need for additional dilution, suitable for short-term pain and fever treatment.
Implementation Method 1
an Ibuprofen formulation comprising relatively low amounts of a phosphate buffer and relatively low ratios phosphate buffer to Ibuprofen is stable
Implementation Method 2
The composition of the invention does neither require large amounts of the buffer, nor does it require the presence of excipients (e.g. amino acids) that may cause adsorption to a plastic container
Data Source
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AI summary
The invention relates to pharmaceutical compositions for parenteral administration comprising a) Ibuprofen or a pharmaceutically acceptable salt thereof, and b) a phosphate buffer.