Flavored Capsule Banding Composition for Tamper Evidence
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Solution Overview
Problem
Pharmaceutical capsules with flavored bands face challenges in maintaining tamper evidence, as the addition of flavors and sweeteners compromises the tamper evidence capability, which is crucial for preventing misuse and ensuring compliance with regulatory standards.
Innovation Solution
A composition for the flavored banding portion of a two-part capsule, comprising at least 50 weight percent gelling agent, a surfactant, and a flavor system with a sweetener and flavor, where specific weight ratios between these components are maintained to ensure tamper evidence, including a gelling agent like gelatin and a surfactant such as polyoxyethylene sorbitan monooleate, and a sweetener like sucralose, to provide effective tamper evidence in compliance with 21 C.F.R. Section 211.132.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If flavors and sweeteners are added to the capsule band to increase acceptance, then the ease of operation is improved, but the tamper evidence capability deteriorates
Solution Approach 1:
The patent applies parameter changes by precisely controlling the composition ratios of the banding material. Specifically, it limits flavors to 1-50 wt%, sweeteners to 1-50 wt%, and surfactants to 1-10 wt% relative to the gelling agent, with the flavor-to-surfactant weight ratio maintained between 10:1 to 25:1. These parameter adjustments allow the band to provide acceptable flavor while maintaining sufficient structural integrity for tamper evidence functionality.
2Ease of operation
If a high concentration of flavor system is used to improve taste acceptance, then the ease of operation is improved, but the structural integrity of the band deteriorates
Solution Approach 1:
The patent resolves this contradiction through parameter changes by establishing specific concentration limits. The flavor system is limited to a maximum of 50 wt% of the total composition, while the gelling agent maintains a minimum of 50 wt%. This parameter control ensures that sufficient gelling agent remains to provide structural integrity while allowing adequate flavor concentration for patient acceptance.
Solution Approach 2:
The patent employs composite materials by combining multiple components in a specific formulation: gelling agent (50-95 wt%), flavor system (1-50 wt%), sweetener (1-50 wt%), and surfactant (1-10 wt%). This composite approach allows the band to simultaneously achieve structural requirements and sensory acceptance through the synergistic interaction of components at controlled ratios.
3Ease of operation
If surfactant concentration is increased to improve flavor delivery, then the ease of operation is improved, but the tamper evidence capability deteriorates
Solution Approach 1:
The patent applies parameter changes by controlling the surfactant concentration within specific ranges (1-10 wt% relative to gelling agent, or 0.2:1 to 2:1 ratio relative to sweetener). This parameter optimization allows sufficient surfactant to be present for effective flavor delivery while preventing excessive surfactant that would compromise the band's structural integrity and tamper evidence functionality.
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 composition effectively provides tamper evidence for the two-part capsule while incorporating flavors and sweeteners, ensuring the capsule meets regulatory requirements for tamper evidence, even when flavors and sweeteners are included, by maintaining specific ratios of gelling agent, surfactant, and flavor system components.
Implementation Method 1
the composition includes at least about 50 weight percent, on a dry basis, of a gelling agent
Implementation Method 2
a surfactant
Data Source
AI summary
The present disclosure relates to a composition suitable for a flavored banding portion of a tamper-evidence, two-part capsule and to the tamper-evident, two-part capsule having a flavored banding portion. The composition suitable for the flavored capsule banding portion includes a gelling agent, a surfactant, and a flavor system including a sweetener and a flavor configured to provide a capsule band that is effective to provide tamper evidence to a two-part capsule.