Levan Inulin Matrix for Fast Dissolving Tablets
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Solution Overview
Problem
Existing fast dissolving pharmaceutical dosage forms are fragile and brittle, making them difficult to handle and pack, and they often disintegrate prematurely before administration.
Innovation Solution
A pharmaceutical composition comprising an open matrix network of levan and inulin, which provides high tensile strength for handling and rapid disintegration upon contact with an aqueous medium or saliva, allowing for easy removal from packaging and quick dissolution within seconds.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If a fast dissolving dosage form is made with a matrix of mannitol and fish gelatin (or other carriers), then the drug can be released in the oral cavity, but the dosage form becomes fragile and brittle with limited physical strength
Solution Approach 1:
The patent changes the chemical composition parameters of the matrix by using levan and inulin instead of conventional carriers like mannitol and fish gelatin. This parameter change results in a matrix that maintains both fast dissolution properties and high tensile strength, resolving the contradiction between dissolution speed and mechanical strength.
Solution Approach 2:
The patent employs a composite matrix system using levan and inulin together. This composite material approach creates a synergistic effect where the combination of these two polysaccharides provides both the required mechanical strength for handling and the fast disintegration properties needed for oral dissolution.
2Ease of manufacture
If the dosage form is made with conventional carriers, then the drug can be delivered, but the dosage form cannot withstand pressure and is difficult to pack and unpack
Solution Approach 1:
By changing the matrix composition to levan and inulin, the patent improves the pressure resistance and mechanical integrity of the dosage form. This enables the tablets to withstand packaging and unpacking operations without disintegrating, while still maintaining ease of manufacture through conventional lyophilization processes.
3Strength
If the matrix has high tensile strength for handling, then the composition can be removed from packaging without damage, but it may not disintegrate rapidly in the oral cavity
Solution Approach 1:
The patent applies local quality by creating an open matrix network structure where the levan and inulin form a porous framework. This structure provides tensile strength for handling while the open pores allow rapid penetration and disintegration by saliva, achieving both mechanical integrity and fast dissolution locally within the matrix structure.
Solution Approach 2:
The patent utilizes a porous open matrix network formed by levan and inulin. The porosity of this matrix allows saliva to rapidly penetrate and disintegrate the tablet in the oral cavity, while the overall network structure maintains sufficient tensile strength for handling and packaging. The porous structure resolves the contradiction between strength and disintegration speed.
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 achieves a balance of tensile strength and rapid disintegration, enabling handling like conventional tablets while ensuring the active ingredient is released quickly in the oral cavity, with at least 80% disintegration occurring within 30 seconds, typically within 10 seconds.
Implementation Method 1
the matrix rapidly disintegrating upon contact with an aqueous solution or with saliva
Implementation Method 2
a rapid dissolution in an aqueous medium or in saliva
Implementation Method 3
Fast dissolving dosage forms of the invention have relatively high tensile strength
Data Source
AI summary
The subject invention is directed to a pharmaceutical composition comprising an open matrix network carrying a pharmaceutically active ingredient, wherein the open matrix network comprises both the polysaccharides levan and inulin.