Urea Powder Composition for Hyponatremia Management
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Solution Overview
Problem
Existing oral urea compositions for treating hyponatremia face challenges such as clumping and sticking during manufacturing and packaging, susceptibility to caking during storage, and undesirable organoleptic properties, making them difficult to administer effectively.
Innovation Solution
A powder composition comprising 60-80 wt% urea, 4-15 wt% maltodextrine, and 2-10 wt% calcium silicate with a particle size distribution of 3-7 microns, which prevents clumping and improves palatability, is developed. The calcium silicate is specifically chosen to have a mean particle diameter between 3.0 and 7.0 microns, with less than 10% of particles outside this range, and maltodextrine levels are increased to greater than 7% by weight to enhance stability and taste.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If oral urea compositions are formulated to deliver clinically beneficial amounts of urea, then the therapeutic effectiveness is improved, but the organoleptic properties deteriorate due to bitter taste
Solution Approach 1:
The patent modifies the chemical composition parameters by incorporating specific ratios of sodium bicarbonate (2-10 wt%), citric acid (1-5 wt%), and sucrose (50-200 wt%) to counteract the bitter taste of urea while maintaining the required 10g urea dose for therapeutic effectiveness
Solution Approach 2:
The patent creates a composite powder composition combining urea with multiple excipients (sodium bicarbonate, citric acid, sucrose, and optional flavors) to achieve both therapeutic efficacy and acceptable organoleptic properties in a single formulation
2Ease of operation
If sodium bicarbonate and citric acid are combined to reduce bitter taste, then the organoleptic properties are improved, but the composition stability deteriorates due to reaction between the components
Solution Approach 1:
The patent performs preliminary action by controlling the particle size of calcium silicate (3-7 microns) and optimizing the formulation composition before packaging to prevent clumping and degradation, ensuring the composition remains stable during storage while maintaining improved taste properties
3Ease of operation
If urea powder is packaged for oral administration, then the ease of administration is improved, but the manufacturing process deteriorates due to clumping and sticking during packaging
Solution Approach 1:
The patent introduces calcium silicate as an intermediary anti-caking agent that prevents direct contact and adhesion between urea particles and packaging surfaces, eliminating clumping and sticking problems during the packaging process while maintaining ease of administration
Solution Approach 2:
The patent optimizes physical parameters including calcium silicate particle size (3-7 microns) and formulation composition to prevent clumping during manufacturing and packaging, ensuring both ease of manufacture and administration
4Duration of action of stationary object
If urea compositions are stored for extended periods, then the availability for treatment is improved, but the product quality deteriorates due to caking
Solution Approach 1:
The patent uses calcium silicate as a long-term protective intermediary that prevents caking during extended storage periods, maintaining product quality and usability throughout the shelf life while ensuring continuous availability for treatment
Solution Approach 2:
The patent performs preliminary action by optimizing the formulation composition and particle size distribution before storage to prevent caking, ensuring the product remains stable and usable throughout the intended storage period
Data Source
AI summary
The present invention involves novel urea compositions for oral administration, that are useful for treatment or management of hyponatremia. Also disclosed are novel methods of making the urea compositions.