Chewable Gel Strength Control for Pediatric Compliance
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Solution Overview
Problem
Current pharmaceutical dosage forms, particularly for pediatric and geriatric populations, face challenges such as difficulty in swallowing, unpleasant taste, and inaccurate dosing, leading to poor compliance and suboptimal therapeutic outcomes.
Innovation Solution
A chewable composition with a gelling component providing cohesive gel strength up to 10,000 g, comprising sugar alcohols in excess of 50% w/w, and a low glycemic index, and excluding gelatin, designed to incorporate active pharmaceutical ingredients in a palatable and easily consumable format.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If chewable tablets are used to improve ease of administration for pediatric and geriatric patients, then swallowing difficulty is reduced, but the products become leathery or rubbery with poor mouthfeel and difficult to consume
Solution Approach 1:
The patent changes the physical-chemical parameters of the chewable composition by controlling gel strength (1,000-10,000 g), water content (5-50%), and sugar alcohol content (20-80% w/w) to achieve an optimal balance between ease of administration and acceptable texture. The gel strength is specifically controlled to be no more than 10,000 g to prevent the leathery texture while maintaining sufficient cohesion.
Solution Approach 2:
The patent uses composite materials combining gelatin or plant-based gelling agents with sugar alcohols (maltitol, sorbitol, xylitol, erythritol, mannitol, isomalt, lactitol, hydrogenated starch hydrolysates) and pharmaceutical active ingredients to create a chewable composition that provides both ease of administration and acceptable mouthfeel. This composite approach allows optimization of texture while maintaining therapeutic efficacy.
2Measurement precision
If chewable dosage forms are used to deliver accurate amounts of active ingredients, then dosing accuracy is improved, but the products become foul-tasting due to the bitter taste of APIs
Solution Approach 1:
The patent uses sugar alcohols as intermediary substances that serve dual functions: they provide the chewable texture and act as taste maskers to conceal the bitter taste of pharmaceutical active ingredients. The sugar alcohols (20-80% w/w) create a palatable matrix that delivers accurate dosing while making the product acceptable to children and sensitive patients.
Solution Approach 2:
The patent optimizes the concentration parameters of sugar alcohols (20-80% w/w) and gel strength (1,000-10,000 g) to create a chewable composition that maintains dosing accuracy while improving palatability. The specific parameter ranges ensure sufficient API content for accurate dosing while the sugar alcohol matrix masks the bitter taste.
3Object-affected harmful factors
If traditional solid dosage forms are used to minimize mouth contact, then taste issues are reduced, but swallowing difficulty increases for pediatric and geriatric populations
Solution Approach 1:
The patent segments the dosage form into small, manageable chewable units that can be easily handled and consumed by pediatric and geriatric patients. The chewable composition is divided into individual tablets or capsules containing specific amounts of API, making them easier to administer compared to large solid dosage forms while maintaining dosing accuracy.
Solution Approach 2:
The patent changes the physical parameters of the dosage form by controlling gel strength, water content, and sugar alcohol content to create a chewable composition that is easier to administer than traditional solids. The gel strength is controlled to no more than 10,000 g to ensure ease of chewing while maintaining sufficient structural integrity for accurate dosing.
4Ease of operation
If oral liquid dosage forms are used to improve ease of administration, then swallowing difficulty is reduced, but dosing precision is compromised and requires on-site measurement
Solution Approach 1:
The patent segments the liquid dosage into pre-measured chewable units, each containing a fixed amount of pharmaceutical active ingredient. This segmentation eliminates the need for on-site measurement while maintaining ease of administration, as each chewable unit represents a precise, pre-determined dose that can be easily consumed by pediatric and geriatric patients.
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 offers improved patient compliance and therapeutic efficacy by providing a palatable, easily administered, and accurately dosed medication, addressing the challenges of swallowing and taste issues in pediatric and geriatric patients.
Implementation Method 1
a gelling component in a sufficient amount to provide a cohesive gelled product
Implementation Method 2
the chewable composition has a gel strength up to 10,000 g, measured by pressing force test
Implementation Method 3
sugar alcohols in an amount of not less than 50% w/w
Implementation Method 4
a low glycemic index sugar component having a glycemic index of not more than 55
Data Source
AI summary
A chewable composition is provided. The composition includes a gelling component in a sufficient amount to provide a cohesive gelled product and not more than 1.5% w/w and an active pharmaceutical ingredient (API), wherein the chewable composition has a gel strength up to 10,000 g, measured by pressing force test.