Fast Dissolving Dosage Form Using Starch Matrix
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Solution Overview
Problem
Current fast dissolving dosage forms face challenges such as high production costs, complex manufacturing processes, and physical integrity issues due to the use of mammalian-derived gelatin, which also has a bland taste and viscosity problems, and alternatives like starch can cause particulate feel and are expensive.
Innovation Solution
A fast dissolving solid dosage form comprising a biologically active material and a matrix forming agent, preferably sodium carboxymethylcellulose, amylopectin, and mannitol, which rapidly dissolves in the oral cavity without substantial gelatin or starch, using a freeze-drying process to enhance manufacturing efficiency and reduce costs.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If gelatin is used as a matrix forming agent in fast dissolving dosage forms, then the dosage form gains strength and prevents cracking, but it results in bland taste requiring sweeteners and flavours, increases viscosity over time, and causes processing difficulties
Solution Approach 1:
The patent replaces gelatin with starch-based materials that are inexpensive, readily available, and provide sufficient strength for fast dissolving dosage forms without the taste and viscosity problems of gelatin. The starch matrix is designed to dissolve completely in the oral cavity, providing the necessary structural support only during handling and storage.
Solution Approach 2:
The patent modifies the physical and chemical parameters of the matrix forming agent by using starch and its derivatives (such as pregelatinized starch, hydroxypropyl starch) instead of gelatin. This parameter change eliminates the need for sweeteners and flavours to mask taste, and prevents viscosity increase over time while maintaining adequate mechanical strength.
2Speed
If freeze drying process is used to prepare fast dissolving dosage forms, then the product rapidly dissolves in water or oral cavity, but the physical integrity of the structure is poor and production costs are high due to lengthy cycles
Solution Approach 1:
The patent applies preliminary action by pre-gelatinizing or pre-modifying the starch before forming the dosage form. This preliminary treatment creates a matrix that is pre-configured for rapid dissolution without requiring lengthy freeze drying cycles, thereby reducing manufacturing time and complexity while maintaining fast dissolution performance.
Solution Approach 2:
The patent changes the physical state and structural parameters of the starch matrix through modification processes (such as pregelatinization, cross-linking, or granulation) to achieve rapid dissolution. These parameter changes allow the dosage form to dissolve quickly without relying on the complex and time-consuming freeze drying process, thus reducing production costs and manufacturing complexity.
3Object-generated harmful factors
If starch is used as an alternative to gelatin, then the taste problems are avoided, but it causes particulate feel in the mouth and is expensive
Solution Approach 1:
The patent uses composite materials by combining starch with other excipients such as binders, disintegrants, and fillers to create a matrix that eliminates the particulate feel in the mouth. The composite formulation maintains the taste advantages of starch while adding components that ensure smooth dissolution and patient acceptance, and the overall cost remains competitive due to the low base cost of starch.
Solution Approach 2:
The patent modifies the particle size, morphology, and surface properties of the starch through processing techniques (such as micronization, granulation, or surface coating) to eliminate the particulate feel in the oral cavity. These parameter changes make the starch-based dosage form smooth and pleasant to use, improving patient acceptance while maintaining the cost advantages of starch over gelatin.
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 achieves rapid dissolution and absorption, avoiding the drawbacks of gelatin and starch, with improved taste and reduced production costs, suitable for various biologically active materials including pharmaceuticals and veterinary use.
Implementation Method 1
combining at least one matrix-forming agent with a biologically active material to form a homogeneous mixture and then freeze drying the mixture to prepare the solid dosage form
Data Source
AI summary
There is provided a fast dissolving solid dosage form adapted for the release of a biologically active material in the oral cavity wherein the dosage form comprises at least one biologically active material, and at least one matrix forming agent, wherein the dosage form substantially dissolves in the oral cavity. A method of producing the same and a kit comprising the same are also provided.