Imatinib Powder Reconstitution Kit for Pediatric Cancer
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Solution Overview
Problem
Current imatinib tablets take a long time to disperse in water or apple juice, leaving residues and having a bitter taste, which can be unpalatable and inconvenient for patients, especially pediatric patients who may not have access to flavored beverages for administration, and lack dosage uniformity.
Innovation Solution
A pharmaceutical composition of imatinib or its pharmaceutically acceptable salt in powder form that can be reconstituted with a diluent just before administration, containing excipients like mannitol, hypromellose, sucralose, and forest berry flavor, eliminating the need for surfactants and stabilizers, and packaged in a dual-chamber kit for easy reconstitution and administration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If imatinib tablets are dispersed in water or apple juice, then the drug can be administered to patients unable to swallow tablets, but the tablets take a long time to disperse and leave residues
Solution Approach 1:
The patent transforms imatinib from tablet form to powder form, fundamentally changing the physical state parameter. This allows the drug to be reconstituted with diluent immediately before administration, achieving rapid dissolution without the prolonged dispersion time and residue issues associated with tablets.
Solution Approach 2:
The invention divides the pharmaceutical formulation into separate components: imatinib powder and diluent are provided separately and combined immediately before use. This segmentation allows each component to be optimized independently and ensures complete mixing without residue, resolving the dispersion time problem.
2Ease of operation
If imatinib tablets are dispersed in apple juice, then the bitter taste may be masked and patient compliance improved, but flavored beverages may not be available all the time
Solution Approach 1:
The patent creates a universal administration system where the imatinib powder can be reconstituted with various diluents including water, apple juice, or other beverages. This multi-functional approach eliminates dependence on specific flavored beverages while maintaining patient compliance through optional flavor masking.
Solution Approach 2:
The invention introduces diluent as an intermediary substance that facilitates drug administration. The diluent serves multiple functions: dissolving the powder, masking bitter taste when flavored (e.g., apple juice), and providing a versatile administration medium that can be selected based on patient preference and availability.
3Ease of operation
If imatinib tablets are dispersed in water, then administration is simple, but the bitter taste of imatinib remains unpalatable
Solution Approach 1:
The patent extracts the bitter taste problem by separating the drug substance from its traditional tablet formulation. The powder form allows complete dissolution in water without the bitter taste of undissolved tablet particles, while the option to use flavored diluents provides additional taste masking capability.
4Manufacturing precision
If liquid dosage forms of imatinib are prepared, then dosage uniformity is improved and administration difficulty is reduced, but the formulation becomes more complex
Solution Approach 1:
The patent applies preliminary action by pre-accurately weighing and mixing imatinib with excipients in powder form before use. This pre-preparation ensures precise dosage uniformity, while the simple two-component system (powder + diluent) maintains formulation simplicity despite the precision achieved.
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 ensures rapid reconstitution within minutes, improved patient compliance due to palatability and uniform dosage, and stability with minimal impurities, making it suitable for pediatric and adult cancer treatment.
Implementation Method 1
oral aqueous solution which essentially comprises viscosity regulating agent that is used to stabilize the active ingredient (i.e. Imatinib mesylate) or increase the viscosity of the oral solution
Data Source
AI summary
A pharmaceutical composition having imatinib or its pharmaceutically acceptable salt thereof and one or more pharmaceutical acceptable excipients in powder form, which can be reconstituted with a diluent just before administration. Also disclosed is a process for the preparation of the composition and its use in a method for the treatment of cancer in pediatric patients.