Multicomponent Gummy Dosage Form with Hydrocolloid Shell and Viscous Core
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Solution Overview
Problem
Conventional oral dosage forms, such as chewable gummies, face challenges in delivering active pharmaceutical ingredients (APIs) due to high thermal stress during manufacturing, leading to chemical and physical degradation, and the need for overages, which is not feasible for APIs, especially those with safety and regulatory concerns, limiting their suitability for delivering APIs effectively and consistently.
Innovation Solution
The development of multicomponent dosage forms comprising a hydrocolloid system as a shell surrounding a viscous fluid core, where the active ingredient is incorporated in the core, allowing for stable storage and improved palatability, with the core and shell having distinct properties to maintain active ingredient stability and control throughout the manufacturing process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If active ingredients are incorporated into gummy dosage forms during the initial compounding step prior to cooking, then the active ingredients can be included in the formulation, but the high thermal stress of the cooking process causes significant chemical and physical degradation of the active ingredients
Solution Approach 1:
The gummy dosage form is divided into two distinct components: a shell portion containing the active ingredient and a separate filling portion. This segmentation allows the active ingredient to be protected from thermal degradation by placing it in the shell that sets first, while the filling is added later without exposing the active ingredient to high thermal stress during mixing.
Solution Approach 2:
The shell portion is prepared and set beforehand with the active ingredient incorporated, creating a stable matrix that protects the active ingredient. This preliminary action allows the active ingredient to be incorporated before the high-temperature cooking step, as the shell sets at lower temperatures, thereby preventing thermal degradation.
2Quantity of substance
If overages are used to offset losses due to degradation during manufacturing, then active ingredient content can be maintained, but this practice is not feasible for APIs with safety and regulatory concerns
Solution Approach 1:
By segmenting the dosage form into shell and filling portions, the active ingredient is confined to the shell where it can be precisely controlled during manufacturing. This allows for accurate dosing without requiring overages, as the active ingredient is protected from degradation by the controlled setting of the shell portion before filling is added.
3Ease of manufacture
If the viscosity of the cooked mixture is reduced to enable retrospective addition of active ingredients, then active ingredients can be added after cooking, but the viscosity is generally too high to enable this
Solution Approach 1:
The formulation is segmented into shell and filling portions with different viscosity characteristics. The shell portion has lower viscosity during preparation to allow active ingredient incorporation, while the filling portion can be added separately after the shell sets, avoiding the need to reduce the viscosity of the entire cooked mixture.
4Ease of operation
If conventional gummy dosage forms are used for delivering APIs, then palatability and chewability are improved, but the limited number of active ingredients compatible with the gummy platform restricts application
Solution Approach 1:
The gummy dosage form is segmented into a shell portion that provides the palatable, chewable base with active ingredients, and a filling portion that can accommodate a wide variety of additional active ingredients. This segmentation increases versatility by allowing different combinations of APIs in the filling while maintaining the palatability of the shell.
Solution Approach 2:
The shell portion serves multiple functions: it provides the palatable gummy base, incorporates heat-sensitive active ingredients, and acts as a container for the filling portion. This multi-functionality allows the same shell structure to support various combinations of APIs, increasing the adaptability of the gummy platform.
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
This approach provides a stable and palatable delivery system for APIs, minimizing degradation and ensuring consistent quality, while allowing for the controlled release of active ingredients, enhancing compliance and safety, particularly suitable for children and geriatric adults.
Implementation Method 1
a first component that is a hydrocolloid system comprising about 70% to about 94% w/w of one or more hydrophilic bulking agents, about 1% to about 20% w/w of one or more hydrophilic, long-chain polymers
Data Source
Figure 1~6
AI summary
The present disclosure provides oral, chewable dosage forms that are suitable for delivery of one or more active ingredients to a consumer, particularly a human individual. The dosage forms can be configured as multicomponent compositions formed of a first component including a gummy composition, at least one further component including a composition that is different from the gummy composition, and an active ingredient. The gummy composition and the second composition can be co-deposited to form multicomponent dosage forms wherein a gummy shell at least partially surrounds a core that is solid or liquid at standard temperature.