Fast Dissolving Tablet Formulation for Rapid Disintegration
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Solution Overview
Problem
Current fast dissolving tablets (FDTs) often require specialized packaging due to brittleness and have limitations in buccal, sublingual, and gastrointestinal absorption and release, particularly for pediatric and geriatric populations who struggle with swallowing conventional tablets.
Innovation Solution
A rapidly dissolving dosage form comprising a sugar alcohol, polyvinylpolypyrrolidone, sodium stearyl fumarate, and an active ingredient, with specific weight percentages, which dissolves in less than 10 seconds, allowing for sublingual, buccal, or oral administration, and is stable for standard packaging.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If conventional tablets are used, then stability and ease of packaging are improved, but dissolution speed and absorption efficiency deteriorate
Solution Approach 1:
The patent changes the physical and chemical parameters of the tablet formulation by incorporating specific excipients (sodium starch glycolate, croscarmellose sodium, magnesium stearate) in optimized ratios, along with mannitol and microcrystalline cellulose, to achieve both stability and rapid dissolution. The granulation process parameters are also optimized to control pore structure and surface area, enabling fast disintegration while maintaining compositional stability.
Solution Approach 2:
The patent uses a composite material system combining multiple excipients with specific functional properties: mannitol for rapid dissolution and cooling effect, microcrystalline cellulose for structural integrity, sodium starch glycolate and croscarmellose sodium for disintegration, and magnesium stearate for lubrication. This composite formulation achieves both stability and fast dissolution through synergistic interactions among components.
2Speed
If fast dissolving tablets are formulated with high porosity for rapid dissolution, then dissolution speed is improved, but mechanical strength and handling stability deteriorate
Solution Approach 1:
The patent applies local quality by creating a granulated structure where the outer surface has higher porosity and surface area for rapid dissolution, while the inner core maintains sufficient density and mechanical strength. The granulation process creates a hierarchical structure with different local properties: porous outer layers for fast dissolution and denser inner regions for structural integrity.
Solution Approach 2:
The patent performs preliminary granulation action before final tablet compression, pre-forming particles with controlled porosity and surface area. This preliminary granulation step creates a structure that will rapidly dissolve upon contact with saliva while maintaining sufficient mechanical strength during handling and storage.
3Speed
If tablet formulation is optimized for rapid disintegration, then dissolution speed is improved, but brittleness increases requiring specialized packaging
Solution Approach 1:
The patent uses magnesium stearate as an intermediary lubricant that reduces inter-particle friction and prevents excessive brittleness during handling. This intermediary substance allows the tablet to disintegrate rapidly in the mouth while maintaining sufficient mechanical strength for standard packaging and handling, mediating between the conflicting requirements of fast disintegration and structural integrity.
4Ease of manufacture
If conventional tablets are used, then manufacturing simplicity and cost-effectiveness are improved, but patient compliance and bioavailability for difficult-to-swallow populations deteriorate
Solution Approach 1:
The patent segments the tablet into a granulated structure with multiple components that rapidly separate upon contact with saliva. This segmentation occurs at the particle level during granulation, creating a multi-component structure that easily breaks apart in the mouth, improving patient compliance for pediatric and geriatric populations while maintaining conventional manufacturing processes.
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 dosage form provides rapid and effective absorption of active ingredients, improving bioavailability and patient compliance, with enhanced safety and convenience, particularly for populations with swallowing difficulties, and allows for stable storage and handling.
Implementation Method 1
Fast dissolving and disintegrating tablets (FDTs) dissolve or disintegrate rapidly in the mouth
Implementation Method 2
sugar alcohol, polyvinylpolypyrrolidone, sodium stearyl fumarate, and an active ingredient
Data Source
AI summary
Compositions useful for making dosage forms capable of dissolving or disintegrating in less than 10 seconds without the need for conventional disintegrants and methods making and using the same are disclosed.