Core Particle Granules With Fine-Mist Granulation for Faster Drug Coating
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Solution Overview
Problem
Conventional methods for producing drug-containing granules, such as layering, require long manufacturing times and can lead to increased exposure of the drug substance to air, facilitating oxidation.
Innovation Solution
A method involving spraying granulation liquid with a mist diameter smaller than the core particle size onto a mixture of drug substance and core particle, using a stirring or rotating fluidized bed granulation process, to produce granules with the drug substance arranged on the core particle surface.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional layering method is used to prepare drug-containing granules, then uniform drug distribution is achieved, but manufacturing time is excessively long
Solution Approach 1:
The invention changes the particle size parameter of the granulation liquid mist to be smaller than the core particle size, which fundamentally alters the granulation mechanism from conventional layering to a faster deposition process. This parameter change enables the granulation liquid to rapidly deposit drug substance on core particles without requiring prolonged exposure times, thus reducing manufacturing time while maintaining uniform drug distribution.
2Manufacturing precision
If conventional layering method is used, then drug substance is evenly coated, but exposure time to air is increased causing oxidation
Solution Approach 1:
The invention employs a rapid granulation process where the granulation liquid mist is sprayed onto core particles and drug substance deposition occurs quickly in a fluidized bed environment. This rushing through the granulation process minimizes the time drug substance is exposed to air, thereby reducing oxidation while still achieving even coating through the mist deposition mechanism.
3Productivity
If granulation liquid with larger droplet size is used, then coating efficiency is improved, but particle size uniformity deteriorates
Solution Approach 1:
The invention creates local quality differences by using granulation liquid mist with specific particle size characteristics that are smaller than the core particles. This localized control of droplet size ensures that the granulation liquid can penetrate and coat individual core particles uniformly without creating aggregation or size variation, thus maintaining particle size uniformity while achieving efficient coating.
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 method reduces production time to about 30 minutes to 1 hour, compared to several hours to 1 day, and minimizes drug substance oxidation by reducing exposure time, allowing for the production of spherical or substantially spherical granules.
Implementation Method 1
spraying granulation liquid having a mist diameter (D50) not more than a particle size (D50) of the core particle on a mixture containing a drug substance and the core particle to granulate the mixture
Implementation Method 2
granulated by a stirring granulation method or a rotating fluidized bed granulation method
Data Source
AI summary
A method for producing granules containing a core particle by using a general granulation method is provided. Granules containing a core particle produced by the method are provided. In addition, a pharmaceutical composition and preparation containing the granules containing the core particle are provided. The granulation method according to an embodiment of the present invention granulates by splaying granulation liquid having a mist diameter (D50) not more than the particle size (D50) of the core particle on a mixture containing a drug substance and a core particle. The granulation liquid may be water. The particle size of the core particle (D50) may be larger than the particle size (D50) of the drug substance.