Translucent Chewable Gel with Cyclodextrin Complex
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Solution Overview
Problem
Existing chewable oral dosage forms are difficult to manufacture on a large scale and fail to consistently meet regulatory standards, often having unpleasant tastes and textures due to unmaskable bitter or numbing active pharmaceutical ingredients.
Innovation Solution
The development of translucent chewable gels that incorporate water insoluble or soluble active pharmaceutical ingredients complexed with cyclodextrins, which form inclusion complexes, minimizing bitter tastes and numbing sensations, and using a formulation that includes gelling agents, buffering agents, and non-acidic antimicrobial agents to ensure commercial viability and regulatory compliance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If chewable gels include active pharmaceutical ingredients with bitter taste, then the therapeutic effect is achieved, but the patient acceptance and organoleptic properties deteriorate
Solution Approach 1:
The patent employs taste-masking agents as intermediary substances that form complexes with bitter-tasting active pharmaceutical ingredients. These agents act as mediators between the API and the patient's taste buds, preventing direct contact and perception of bitterness while allowing the API to maintain its therapeutic function. Specific taste-masking agents mentioned include cyclodextrins, polyvinylpyrrolidone, and various polymers that can complex with bitter compounds.
Solution Approach 2:
The invention extracts or separates the bitter-tasting API from the immediate contact zone with taste buds by incorporating it into a gel matrix and complexing it with taste-masking agents. This effectively removes the harmful bitter taste property from the patient's perception while retaining the API's therapeutic presence in the dosage form.
2Productivity
If chewable gels use traditional manufacturing methods, then production can be initiated, but manufacturing difficulty and inconsistency with regulatory standards increase
Solution Approach 1:
The patent modifies critical manufacturing parameters including pH control (maintaining pH 2-7), water activity control (aw 0.60-0.85), and temperature parameters during processing. These parameter changes enable consistent production that meets regulatory standards while maintaining manufacturing feasibility. The gel formulation parameters are specifically optimized to ensure reproducibility and compliance.
Solution Approach 2:
The gel matrix serves multiple functions simultaneously: it provides structural integrity for manufacturability, controls drug release, masks bitter tastes, and ensures regulatory compliance. This multi-functionality simplifies the manufacturing process by consolidating several requirements into a single formulation system rather than requiring separate components for each function.
3Reliability
If chewable gels include water insoluble active pharmaceutical ingredients, then the therapeutic effect is achieved, but the taste masking becomes more difficult
Solution Approach 1:
The patent creates a composite dosage form combining the water-insoluble API with taste-masking agents and gel matrix materials. This composite structure ensures the insoluble API is properly dispersed and complexed within the gel, preventing direct taste perception while maintaining therapeutic availability. The composite nature allows simultaneous achievement of solubility requirements for effectiveness and taste masking.
Solution Approach 2:
Taste-masking agents serve as intermediaries between water-insoluble APIs and the aqueous gel environment, facilitating both solubilization/complexation for taste masking and maintaining the API's therapeutic properties. The intermediaries enable the insoluble API to function effectively while being shielded from taste buds.
4Object-affected harmful factors
If chewable gels aim for pleasant taste and texture, then patient acceptance improves, but manufacturing complexity and regulatory compliance difficulty increase
Solution Approach 1:
The gel formulation uses multi-functional ingredients that simultaneously provide pleasant taste, appropriate texture, and regulatory compliance. For example, specific gelling agents provide both texture and structural integrity, while taste-masking agents provide both flavor masking and stability. This reduces the need for separate components for each function.
Solution Approach 2:
The patent employs composite gel formulations combining multiple ingredients in specific ratios to achieve desirable organoleptic properties while ensuring manufacturability and compliance. The composite nature allows optimization of taste, texture, and stability together rather than as separate concerns.
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 pharmaceutically suitable, commercially viable, and consistently meet regulatory standards, offering improved taste and texture while maintaining the bioavailability of active ingredients, with enhanced stability 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.