Micronized Glucocorticoid Formulation for Rapid Mucosal Absorption
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Solution Overview
Problem
Current glucocorticoid pharmaceutical compositions are not suitable for acute emergency situations as they result in slow absorption into systemic circulation, require medical training for administration, and are challenging to administer outside medical settings, especially for unconscious patients or those unable to swallow.
Innovation Solution
Development of pharmaceutical compositions with substantially immediate release of glucocorticoids, achieving at least 60% release within 30 minutes and a serum level of 20% of Cmax within 20 minutes after mucosal administration, allowing self-administration by non-medically trained persons in non-medical settings.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If conventional glucocorticoid tablets are used, then they are easy to administer orally, but they result in slow absorption into systemic circulation with lag-time of 1-3 hours
Solution Approach 1:
The patent changes the physical and chemical parameters of the glucocorticoid formulation by using micronized particles (1-10 μm size range) and specific crystal forms, which dramatically increases dissolution rate and absorption speed, reducing time to therapeutic level from hours to minutes
Solution Approach 2:
The patent utilizes phase transition by converting glucocorticoid from conventional tablet form to rapidly dissolving oral formulation that transitions from solid to dissolved state quickly in oral fluids, enabling rapid mucosal absorption and systemic circulation
2Speed
If parenteral administration (IV/IM) is used, then fast onset of action is achieved, but it requires qualified personnel and medical settings
Solution Approach 1:
The patent enables self-service administration by designing a formulation that patients can administer themselves orally without medical training, eliminating the need for IV/IM injection skills while achieving comparable onset of action to parenteral routes
Solution Approach 2:
The patent replaces the mechanical injection system (needles, syringes, IV equipment) with an oral pharmaceutical composition that achieves similar therapeutic效果 through rapid dissolution and absorption, simplifying the administration system
3Ease of operation
If oral administration is used for unconscious patients, then it is simple to administer, but it requires the patient to be conscious and able to swallow
Solution Approach 1:
The patent creates a universal formulation that can be administered to both conscious and unconscious patients through multiple routes (oral, nasal, rectal, pulmonary), making the same pharmaceutical composition adaptable to different patient states and administration scenarios
4Reliability
If glucocorticoid serum level is increased rapidly, then acute adrenal crisis is treated effectively, but conventional formulations cannot achieve sufficient serum levels quickly enough
Solution Approach 1:
The patent segments the glucocorticoid into fine micronized particles (1-10 μm) that have vastly increased surface area to volume ratio, enabling rapid dissolution and absorption, and can be further segmented into inhalable particles or nasal spray droplets for different administration routes
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
Enables fast onset of glucocorticoid action, facilitating effective treatment of acute adrenal crises and other disorders without the need for medical personnel or specialized equipment, even in unconscious patients.
Implementation Method 1
a glucocorticoid serum level of a subject of at least 20% of Cmax is reached within 20 min after administration of the composition via a mucosa of the subject
Data Source
AI summary
The present invention relates to glucocorticoid-containing pharmaceutical compositions or kits for use in acute emergency situations where acute glucocorticoid therapy is required. Notably, the invention relates to pharmaceutical compositions and kits that are designed to be administered by non-medically trained persons outside a hospital or another medical or clinical setting. The invention also relates to a method for treating a disorder requiring acute glucocorticoid therapy by providing a fast onset of action of a glucocorticoid.