Translucent Chewable Gels with Inclusion Complexes for Taste Masking
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Solution Overview
Problem
Existing chewable oral dosage forms, particularly gels, face challenges in manufacturing on a large scale while maintaining pleasant taste and adhering to regulatory standards, especially when incorporating active pharmaceutical ingredients with bitter tastes or causing oral numbness.
Innovation Solution
Formulating translucent chewable gels through the creation of inclusion complexes between active pharmaceutical ingredients and complexing agents, such as cyclodextrins, to mask bitter tastes and oral numbness, while using non-acidic antimicrobial agents and controlled pH to ensure commercial viability and regulatory compliance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If chewable gels are formulated with active pharmaceutical ingredients that have bitter tastes, then the therapeutic efficacy is improved, but the patient acceptance and organoleptic properties deteriorate
Solution Approach 1:
The patent employs taste-masking agents and flavoring compounds as intermediaries between the bitter active pharmaceutical ingredient and the patient's taste receptors. These agents form a protective layer or complex with the bitter compound, preventing direct contact with taste buds while allowing the active ingredient to remain therapeutically effective.
Solution Approach 2:
The patent modifies the physical and chemical parameters of the active pharmaceutical ingredient through formulation techniques such as encapsulation, salt formation, or complexation. These parameter changes alter the taste profile while maintaining the drug's pharmacological activity, transforming an unacceptable bitter taste into an acceptable flavor.
2Productivity
If chewable gels are manufactured on a large scale, then the productivity is improved, but the manufacturing complexity and regulatory compliance difficulty increase
Solution Approach 1:
The patent divides the manufacturing process into distinct modular stages including pre-formulation, formulation, molding, and quality control. Each stage can be independently optimized and controlled, making large-scale manufacturing more manageable and compliant with regulatory requirements while maintaining high productivity.
Solution Approach 2:
The patent develops a universal formulation platform and manufacturing process that can accommodate multiple active pharmaceutical ingredients and dosage requirements. This multi-functional approach allows the same manufacturing system to produce various chewable gel products, reducing overall complexity while enabling large-scale production.
3Object-affected harmful factors
If chewable gels are made translucent and pleasant tasting, then the patient acceptance is improved, but the manufacturing difficulty increases
Solution Approach 1:
The patent uses composite material systems combining gelling agents, plasticizers, flavoring compounds, and colorants in specific ratios and arrangements. These composite formulations achieve the desired translucent appearance and pleasant taste while maintaining manufacturability through established processing techniques and standardized ingredient combinations.
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 solution results in chewable gels that are commercially viable, pharmaceutically suitable, and effectively mask bitter tastes and oral numbness, ensuring consistent quality and compliance with regulatory standards.
Implementation Method 1
The water insoluble active pharmaceutical ingredient and the complexing agent are complexed in the form of an inclusion complex
Data Source
AI summary
One aspect of the present invention concerns compositions and methods of manufacturing translucent chewable gels that are pharmaceutically suitable for oral administration. The chewable gels includes an active pharmaceutical ingredient and a complexing agent. The active pharmaceutical ingredient has a bitter taste. The active pharmaceutical ingredient and the complexing agent are complexed in the form of an inclusion complex. The chewable gels are substantially devoid of bitter taste and/or a tendency to cause oral numbness when chewed.