Nonaqueous Hydrocortisone Oral Liquids for Room-Temperature Stability
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Solution Overview
Problem
There is a need for a stable liquid formulation of hydrocortisone that can be administered orally, as many patients, particularly children and the elderly, have difficulty swallowing solid dosage forms, and current methods for preparing liquid formulations are inconsistent and unstable.
Innovation Solution
A nonaqueous liquid pharmaceutical composition of hydrocortisone or a pharmaceutically acceptable salt thereof, with a nonaqueous liquid carrier, containing less than 5% weight by weight of water, which remains stable for at least 3 months at room temperature and retains at least 95% of the initial hydrocortisone amount, using carriers like propylene glycol, glycerin, and polyethylene glycol, and optionally includes preservatives, antioxidants, and flavoring agents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If conventional liquid formulations of hydrocortisone are prepared using aqueous carriers, then the formulation is easier to manufacture and administer, but the stability of hydrocortisone deteriorates rapidly at room temperature
Solution Approach 1:
The patent changes the fundamental parameter of the liquid carrier from aqueous to nonaqueous (organic solvents like propylene glycol, glycerin, polyethylene glycol). This parameter change resolves the contradiction by providing a carrier that maintains hydrocortisone stability at room temperature while still allowing for practical liquid formulation preparation and administration.
2Ease of operation
If hydrocortisone is formulated as solid dosage forms (tablets), then the formulation is more stable and easier to manufacture, but patient compliance deteriorates due to difficulty swallowing
Solution Approach 1:
The patent changes the physical state parameter from solid to liquid formulation, and simultaneously changes the chemical environment from aqueous to nonaqueous carrier. This resolves the contradiction by providing a liquid form that is easier for patients to administer while maintaining stability through the nonaqueous carrier system.
3Stability of the object's composition
If preservatives and antioxidants are added to the liquid formulation, then the stability and shelf life are improved, but the formulation complexity increases
Solution Approach 1:
The nonaqueous carrier acts as an intermediary that inherently protects hydrocortisone from degradation without requiring additional preservatives. The organic solvent environment prevents microbial growth and chemical degradation, thus extending shelf life while avoiding the complexity of adding multiple excipients.
Data Source
AI summary
Provided herein are oral liquid formulations of hydrocortisone. Also provided herein are methods of making and using hydrocortisone oral liquid compositions for the treatment of certain diseases including endocrine disorders, rheumatic disorders, collagen diseases, dermatologic diseases, and others.