Translucent Chewable Gel Formulation for Bitter API Masking
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Solution Overview
Problem
Existing chewable oral dosage forms, particularly gels, lack organoleptic properties, are difficult to manufacture on a large scale, fail to meet regulatory standards, and often have unpleasant tastes due to active pharmaceutical ingredients.
Innovation Solution
Formulating chewable gels with water insoluble or soluble active pharmaceutical ingredients complexed with cyclodextrins to create inclusion complexes, which minimize bitter taste and oral numbness, while using non-acidic antimicrobial agents and controlled pH to ensure manufacturability and regulatory compliance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If chewable gels contain active pharmaceutical ingredients with bitter taste, then the therapeutic effect is achieved, but the organoleptic properties deteriorate (unpleasant taste)
Solution Approach 1:
The patent employs taste-masking agents as intermediary substances that form complexes with bitter-tasting active pharmaceutical ingredients. These agents (such as cyclodextrins, polymers, or lipids) act as mediators between the drug and the patient's taste receptors, preventing direct contact and thus masking the unpleasant bitter taste while preserving the drug's therapeutic efficacy.
Solution Approach 2:
The patent modifies the physical and chemical parameters of the active pharmaceutical ingredient through various techniques including encapsulation in microcapsules, formation of inclusion complexes, or conversion to prodrugs. These parameter changes alter the taste profile and release characteristics of the drug, enabling effective delivery while improving organoleptic properties.
2Ease of manufacture
If chewable gels are formulated with traditional ingredients, then manufacturing is simpler, but regulatory compliance becomes difficult to achieve
Solution Approach 1:
The patent utilizes composite gel formulations combining multiple gelling agents (such as gelatin, pectin, carrageenan, or alginate) with specific ratios and formulations. These composite materials provide consistent rheological properties, structural integrity, and controlled drug release, meeting both manufacturing feasibility and stringent regulatory requirements for chewable gel dosage forms.
Solution Approach 2:
The patent employs multi-functional excipients and formulation components that simultaneously fulfill multiple requirements: structural support, drug solubility enhancement, taste masking, and regulatory compliance. This multi-functionality simplifies the manufacturing process while ensuring the product meets all necessary pharmaceutical standards.
3Illumination intensity
If chewable gels are made translucent, then aesthetic appeal improves, but manufacturing complexity increases
Solution Approach 1:
The patent achieves translucency by carefully controlling the molecular structure and concentration of gelling agents, adjusting the pH and ionic strength of the formulation, and selecting specific excipients with appropriate molecular weights. These parameter changes enable light transmission through the gel matrix without requiring complex manufacturing processes or additional additives.
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 translucent, commercially viable, and pharmaceutically suitable chewable gels that mask unpleasant tastes and sensations, maintaining product integrity and shelf life.
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.