Hydroxyurea Oral Suspension Stable at Room Temperature
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Solution Overview
Problem
Existing liquid formulations of Hydroxyurea for pediatric patients are not stable at room temperature, requiring refrigeration and compounding, which leads to dosing errors, adverse reactions, and increased costs.
Innovation Solution
A ready-to-use, room temperature stable oral suspension of Hydroxyurea formulated with excipients such as vegetable oil, antioxidants, and sweeteners, ensuring stability for at least three months without refrigeration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If Hydroxyurea is formulated as a liquid solution for pediatric patients, then ease of administration is improved, but stability at room temperature deteriorates
Solution Approach 1:
The patent changes the physical state parameter from aqueous solution to non-aqueous suspension, and modifies chemical composition by adding specific excipients (suspending agents, antioxidants, chelating agents) to achieve room temperature stability while maintaining ease of administration
Solution Approach 2:
The patent creates a composite formulation combining Hydroxyurea with multiple excipients including non-aqueous carriers, suspending agents, antioxidants, and chelating agents to achieve both stability and ease of administration simultaneously
2Stability of the object's composition
If Hydroxyurea is formulated as a solid dosage form (tablet or capsule), then stability is improved, but ease of administration deteriorates
Solution Approach 1:
The patent changes the dosage form parameter from solid (tablet/capsule) to liquid suspension, making it easier for pediatric patients to administer while maintaining stability through the use of non-aqueous carriers and stabilizing excipients
3Adaptability or versatility
If Hydroxyurea liquid solution is compounded in pharmacies, then availability is improved, but manufacturing precision deteriorates
Solution Approach 1:
The patent performs preliminary action by pre-formulating the precise concentration of Hydroxyurea (100 mg/ml) during manufacturing, eliminating the need for pharmacy compounding and ensuring accurate dosing while maintaining wide availability
Solution Approach 2:
The patent replaces the compounding process with a ready-to-use pre-formulated product that does not require preparation at the point of use, ensuring dosing accuracy while maintaining availability
4Stability of the object's composition
If Hydroxyurea requires refrigeration for storage, then stability is improved, but device complexity deteriorates
Solution Approach 1:
The patent changes the storage temperature parameter from refrigerated (2-8°C) to room temperature (25°C) by modifying the formulation to use non-aqueous carriers and adding antioxidants and chelating agents that prevent degradation at higher temperatures
Solution Approach 2:
The patent extracts the requirement for refrigeration by incorporating stabilizing excipients that enable room temperature storage, eliminating the need for complex cold chain storage and distribution infrastructure
Data Source
AI summary
The present invention provides a liquid composition comprising effective amount of Hydroxyurea for oral administration. The invention further discloses liquid formulation in form of ready to use oral suspension which remains stable at room temperature at the time of dispensing, storage and even after reopening of the container comprising the suspension. Also provided is a method of preparing the formulation and treating sickle cell anemia in pediatric patients.