Functionalized Calcium Carbonate Fast Disintegrating Tablets
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Solution Overview
Problem
Current fast-dissolving oral dosage forms, such as tablets and granules, face challenges including difficulty in swallowing for geriatric and pediatric patients, potential inhalation leading to respiratory issues, and requirement for liquids for administration, which limits their accessibility and convenience.
Innovation Solution
Development of fast disintegrating dosage forms using functionalized natural and/or synthetic calcium carbonate (FCC) that disintegrate in less than 3 minutes in an aqueous environment, allowing for easy administration without water, and can be formulated into tablets, mini-tablets, or pellets with enhanced porosity and surface area for rapid liquid absorption.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional tablets and capsules are used, then they provide stable dosage forms, but they cause difficulty in swallowing for geriatric and pediatric patients
Solution Approach 1:
The patent segments the dosage form into smaller, more manageable units. The use of granules and mini-tablets divides the medication into finer particles that are easier to swallow while maintaining the complete therapeutic dose through appropriate formulation of multiple granules or mini-tablets.
Solution Approach 2:
The patent changes the physical parameters of the dosage form by developing fast-disintegrating formulations with specific porosity (30-70%), particle size distribution, and compressibility characteristics. These parameter changes enable the dosage form to disintegrate rapidly in oral fluid while maintaining stability during storage and handling.
2Ease of operation
If granules and powders are used, then they are easy to administer, but they may be inhaled causing respiratory issues
Solution Approach 1:
The patent applies preliminary action by pre-coating the granule surfaces with suitable materials and controlling particle morphology during manufacturing. This preliminary surface treatment reduces the tendency of granules to adhere to respiratory mucosa and minimizes inhalation irritation while maintaining ease of administration.
Solution Approach 2:
The use of porous granules with controlled pore structure allows for rapid liquid absorption and drug release while the porous structure itself acts as a buffer that reduces direct contact with respiratory tissues, thereby minimizing irritation potential.
3Speed
If fast-disintegrating tablets are used, then they disintegrate rapidly in the mouth, but they have low mechanical strength and high friability
Solution Approach 1:
The patent optimizes multiple parameters simultaneously: porosity (30-70%), particle size distribution, granule composition, and compression force. These parameter changes create a balanced structure that disintegrates rapidly upon contact with oral fluid while maintaining sufficient mechanical strength for handling and packaging.
Solution Approach 2:
The patent employs composite granule structures combining different materials with complementary properties. The granules incorporate disintegrants, binders, and filler materials in specific ratios to create a composite structure that provides both rapid disintegration and adequate mechanical strength for push-through packaging and bottling operations.
4Speed
If fast-disintegrating tablets are used, then they provide rapid dissolution, but they require sufficient hardness for packaging and film coating
Solution Approach 1:
The patent applies local quality by creating a layered or zoned granule structure where the outer layer provides mechanical strength and hardness for packaging resistance, while the inner core maintains high porosity and fast-disintegrating properties for rapid dissolution. This spatial differentiation of properties resolves the contradiction between hardness and dissolution speed.
Solution Approach 2:
The patent creates a dynamic dosage form that exhibits different mechanical properties under different conditions: during storage and handling, the granules maintain sufficient hardness and strength, but upon contact with oral fluid, the structure dynamically transforms to enable rapid disintegration and dissolution through capillary action and swelling of disintegrant components.
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 use of functionalized calcium carbonate in fast disintegrating dosage forms provides a convenient, rapid, and efficient delivery of active ingredients, suitable for various patient groups, including those with swallowing difficulties, and offers improved stability and shelf life with controlled absorption and release characteristics.
Implementation Method 1
The fast disintegrating solid dosage form formulation comprises functionalized natural and/or synthetic calcium carbonate (FCC) as novel pharmaceutical excipient... disintegrate in less than 3 minutes in an aqueous environment... enhanced porosity and surface area for rapid liquid absorption
Implementation Method 2
enhanced porosity and surface area for rapid liquid absorption... The functionalized natural or synthetic calcium carbonate (FCC)... has a BET specific surface area of from 15 m2/g to 100 m2/g
Data Source
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AI summary
An orally fast disintegrating dosage forms comprising functionalized natural or synthetic calcium carbonate, at least one active ingredient and at least one disintegrant, wherein said functionalized natural or synthetic calcium carbonate is a reaction product of natural or synthetic calcium carbonate with carbon dioxide and one or more acids, wherein the carbon dioxide is formed in situ by the acid treatment and/or is supplied from an external source, and wherein the tablet dissolves in less than 20 seconds when introduced into an aqueous environment.