Long-Acting Growth Hormone Dosing With Weight Brackets
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Solution Overview
Problem
Current growth hormone treatments for children with growth hormone deficiency require daily injections, leading to noncompliance due to invasiveness, waste, and high costs, with long-acting formulations still generating significant waste and needing precise dose adjustments.
Innovation Solution
A bracketed dosage regimen for long-acting growth hormone formulations, where patients in specific weight brackets receive a fixed amount, minimizing waste and simplifying treatment by eliminating the need for precise dose calculations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If fixed weight-based dosing is used for long-acting growth hormone formulations, then dosing precision is improved, but device complexity and ease of operation deteriorate due to the need for precise dose calculations and adjustments
Solution Approach 1:
The patent segments the continuous weight-based dosing into discrete weight brackets (e.g., 10-20 kg, 20-30 kg, etc.), each associated with a fixed dose. This segmentation eliminates the need for precise calculations while maintaining dosing accuracy within each bracket, resolving the contradiction between dosing precision and ease of operation.
Solution Approach 2:
The patent changes the dosing parameter from continuous (exact weight-based calculation) to discrete (bracket-based fixed doses). By transforming the dosing approach from requiring precise weight measurement and calculation to using predefined weight ranges with fixed doses, it simultaneously maintains dosing precision and dramatically improves ease of operation.
2Measurement precision
If multiple dose adjustments are made as children grow, then dosing precision is improved, but loss of time and treatment complexity increase
Solution Approach 1:
The patent segments the growth and dosing process into discrete weight brackets that children progress through over time. Each bracket has a predetermined fixed dose, eliminating the need for frequent recalculations and adjustments. Children remain in each bracket until they grow into the next weight range, significantly reducing the time and complexity of dose adjustments while maintaining precision.
3Measurement precision
If daily injections are administered, then dosing precision is improved, but compliance deteriorates due to invasiveness and burden
Solution Approach 1:
The patent transforms the administration frequency from daily (every day) to periodic (less frequent, such as weekly or monthly injections). This periodic action maintains the precision of dose delivery while dramatically reducing the burden and invasiveness of treatment, thereby improving patient compliance and reliability of therapy continuation.
4Measurement precision
If precise dose calculations are required, then dosing precision is improved, but device complexity and ease of operation worsen
Solution Approach 1:
The patent segments the dosing system into predefined weight brackets with associated fixed doses. This segmentation allows the use of simple dosing devices (such as pens or syringes with fixed volume markings) rather than complex devices requiring calculation and precise measurement, thereby maintaining dosing accuracy while reducing device complexity.
Data Source
AI summary
The present invention relates a pharmaceutical formulation comprising a long-acting growth hormone for use in a method of treating growth hormone deficiency, wherein the long-acting growth hormone formulation is administered to a patient in a bracketed dosage regimen, to a multitude of unit dosage forms comprising a long-acting growth hormone formulation, wherein the unit dosage forms comprise increasing amounts of growth hormone equivalents and wherein the amount of growth hormone equivalents increases by at least 10% between one unit dosage form and the next higher dosage form; their use in a method of treating growth hormone deficiency and method of treating growth hormone deficiency in a bracketed dosing regimen.