Orally Disintegrating Tablet Hardness via HPC Granulation
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Solution Overview
Problem
The development of orally disintegrating tablets faces a challenge in achieving both rapid disintegration and adequate hardness, as high hardness is required to prevent breakage during handling, while rapid disintegration is necessary for ease of use, particularly for the elderly and young children.
Innovation Solution
The method involves fluid bed granulation using a granulation liquid with hydroxypropyl cellulose (HPC) having a viscosity of 150 mPa·s to 400 mPa·s, which is sprayed onto additives, ensuring a content of 0.2 wt% to 5 wt% HPC in the tablet, combined with a sweetener and other excipients, to create a tablet with adequate hardness and rapid disintegration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If the tablet hardness is increased to prevent breakage during handling, then the tablet strength is improved, but the disintegration time increases and rapid disintegration is compromised
Solution Approach 1:
The patent applies parameter changes by carefully controlling the viscosity of the granulation liquid (150-400 mPa·s) and the content of hydroxypropyl cellulose (0.2-5 wt%). These parameter optimizations enable the formation of granules with adequate hardness while preserving rapid disintegration properties, resolving the contradiction between tablet strength and disintegration speed.
2Strength
If hydroxypropyl cellulose with higher viscosity is used to increase tablet hardness, then the tablet strength is improved, but the ease of manufacture deteriorates due to handling difficulties
Solution Approach 1:
The patent optimizes the viscosity parameter of hydroxypropyl cellulose to a specific range (150-400 mPa·s). This parameter change balances the competing requirements: the viscosity is high enough to provide adequate tablet hardness but low enough to ensure easy handling and uniform spraying during granulation, thus resolving the contradiction between tablet strength and ease of manufacture.
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
This approach allows for the production of orally disintegrating tablets with sufficient hardness to prevent breakage during handling while maintaining rapid disintegration times, as demonstrated by the use of HPC-M in Examples 1 to 5, achieving both properties effectively.
Implementation Method 1
performing fluid bed granulation while spraying or dropping a liquid including hydroxypropyl cellulose having a viscosity in a 2% aqueous solution at 20° C. of 150 mPa·s or more and 400 mPa·s or less on additives
Data Source
AI summary
A method for manufacturing an orally disintegrating tablet, in which adequate hardness for preventing breakage of the tablet during transport or handling by a medical practitioner or a patient is provided while rapid disintegration is maintained. The method for manufacturing an orally disintegrating tablet according to an embodiment of the present invention comprises spraying or dropping a liquid including hydroxypropyl cellulose having a viscosity in a 2% aqueous solution at 20° C. of 150 mPa·s or more and 400 mPa·s on additives, and performing fluid bed granulation. The liquid including hydroxypropyl cellulose may be sprayed or dropped on the additives so that the content of the hydroxypropyl cellulose with respect to 100 wt % of the orally disintegrating tablet is 0.2 wt % to 5 wt %.