Speckled Orally Disintegrating Tablets via Colored Granules
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Solution Overview
Problem
Orally Disintegrating Tablets (ODT) are difficult to identify due to their low hardness and limited visual differentiation from conventional tablets, posing challenges for elderly or visually impaired individuals, as existing identification methods like coating, printing, and embossing are not effective.
Innovation Solution
Incorporating colored granules of specific particle sizes and polyalcohols, such as mannitol, to create a speckled appearance on ODT, making them easily distinguishable by providing a visible pattern without affecting disintegration properties.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of information
If coating is used to identify tablets, then visual identification is improved, but disintegration time increases
Solution Approach 1:
The patent applies color changes by incorporating water-soluble colored granules (such as FD&C dyes) directly into the tablet matrix. These granules provide visual identification through their color while being completely soluble in water, thus not forming a coating layer that would delay disintegration. The colored granules dissolve along with the tablet, maintaining the required disintegration time of not more than 3 minutes.
2Loss of information
If printing is used to identify tablets, then visual identification is improved, but the technique requires smooth and shining tablet surface which ODT cannot provide
Solution Approach 1:
Instead of requiring a smooth and shining surface for printing, the patent uses water-soluble colored granules that can be incorporated into the tablet matrix during manufacturing. These granules provide visual identification through their color and distribution pattern within the tablet, eliminating the need for post-compression surface treatment and working well with the rough surface characteristic of ODT.
3Loss of information
If embossing is used to identify tablets, then visual identification is improved, but the dimension of characters is too small to be easily read
Solution Approach 1:
The patent uses water-soluble colored granules that can be distributed throughout the tablet to create visible color patterns, zones, or gradients. These color variations provide identification that is easily readable by the naked eye, overcoming the limitation of small embossed characters that are difficult for elderly or visually impaired patients to read.
4Loss of information
If colored ODT are prepared, then visual identification is improved, but the limited number of pharmaceutically acceptable colors make it difficult to obtain easily identifiable ODT
Solution Approach 1:
The patent utilizes water-soluble colored granules including FD&C dyes (red, yellow, blue, green, orange) and other pharmaceutically acceptable colorants. By incorporating these granules in different combinations, concentrations, and distribution patterns, the invention achieves diverse visual identification options while maintaining pharmaceutical acceptability and complete water solubility.
5Loss of information
If colored beads are incorporated to create speckled appearance, then visual identification is improved, but the beads must be soluble and dissolve as fast as the tablets
Solution Approach 1:
The patent incorporates water-soluble colored granules (such as FD&C dyes and other pharmaceutically acceptable colorants) that are completely soluble in water. These granules provide the desired speckled appearance and visual identification while dissolving at the same rate as the tablet matrix, ensuring no residue or staining remains after disintegration and meeting the solubility requirements for ODT.
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 speckled appearance enhances visual identification of ODT without altering their disintegration characteristics, ensuring easy recognition by users while maintaining the tablets' functionality and safety.
Implementation Method 1
colored granules of a water-soluble sugar
Implementation Method 2
granular particles of a polyalcohol. Specific examples of polyalcohols are sorbitol, mannitol, xylitol, etc.
Data Source
AI summary
Orally disintegrating tablets containing colored granules of a water-soluble sugar which give them a speckled appearance are described. The orally disintegrating tablets with speckled appearance are readily and easy identifiable by physicians, nurses and patients.