Adhering Antacid Lozenge for Fast Dissolution and Local Acid Neutralization
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Solution Overview
Problem
Existing treatments for gastro-esophageal reflux disease (GERD) using antacid tablets can cause undesirable side effects due to the neutralization of stomach acids, and existing adhering lozenges do not effectively deliver sparsely soluble active ingredients like antacids in therapeutically effective amounts.
Innovation Solution
Formulating oral adhering lozenges with a non-adhesive layer containing sparsely soluble antacids like calcium carbonate, combined with water-soluble bulking agents and compression binders, to release the antacid component in the mouth and throat, thereby neutralizing acid without significant stomach neutralization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If antacid tablets are swallowed to neutralize stomach acids, then acid reflux is reduced, but undesirable side effects occur due to excessive stomach neutralization
Solution Approach 1:
The lozenge is divided into two functional layers: a non-adhesive layer containing antacid particles and a soluble bulking agent layer. This segmentation allows the antacid to be delivered selectively to the mouth/throat region rather than being swallowed, thereby reducing unwanted stomach neutralization while maintaining acid reflux protection.
Solution Approach 2:
The soluble bulking agent acts as an intermediary carrier that facilitates the delivery of antacid particles to the mouth/throat region. The bulking agent dissolves in saliva, releasing the antacid particles at the desired location without allowing them to be swallowed, thus mediating between the antacid delivery system and the target site.
2Quantity of substance
If sparsely soluble antacids are used in adhering lozenges, then therapeutically effective amounts can be delivered, but the lozenge dissolves too slowly in saliva
Solution Approach 1:
The lozenge is segmented into a non-adhesive layer containing sparsely soluble antacid particles and a separate soluble bulking agent layer. This segmentation allows the sparsely soluble antacid to maintain its structural integrity for sustained release while the soluble bulking agent rapidly dissolves in saliva, providing the necessary dissolution speed without compromising the antacid delivery quantity.
Solution Approach 2:
The lozenge combines sparsely soluble antacid particles with a soluble bulking agent to create a composite structure. The composite material leverages the low solubility of the antacid for sustained delivery while the high solubility of the bulking agent ensures rapid initial dissolution, resolving the contradiction between delivery quantity and dissolution speed.
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
The lozenges effectively reduce GERD by releasing antacid in the mouth and throat, minimizing stomach neutralization and reducing side effects, while maintaining therapeutic efficacy.
Implementation Method 1
The lozenges begin to dissolve in the mouth upon contact with saliva to facilitate the release of the active ingredient
Implementation Method 2
when adhered inside the mouth, are effective to release an amount of antacid component that is effective to neutralize acid in the mouth and throat
Data Source
AI summary
An oral adhering lozenge including a sparsely water-soluble active ingredient is provided. In one aspect, an oral adhering lozenge having at least 5 milliequivalents (mEq) of acid neutralizing capacity is provided. The acid neutralization capacity may be achieved with at least 200 milligrams of a sparsely water-soluble antacid, such as calcium carbonate. To achieve a fast enough speed of dissolution with such a large quantity of sparsely water-soluble active ingredient, one or more water-soluble ingredients acting as a compression binder and/or bulking agent that dissolves quickly in water is included in an amount equal to greater than the sparsely soluble active ingredient in the non-adhesive layer.