Core-Particle Drug Granulation With Fine-Mist Spraying
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Solution Overview
Problem
Conventional methods for producing drug-containing granules, such as those described in Japanese laid-open patent publication No. 2015-218322, suffer from long manufacturing times due to the spraying of drug solutions onto core particles, which can lead to increased exposure and oxidation of the drug substance.
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 particles, using a stirring or rotating fluidized bed granulation process, to produce granules containing a core particle more efficiently.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a solution in which a drug is dissolved or dispersed in a solvent is sprayed onto core particles to form layering granules, then the drug substance layer is formed on the core particle surface, but the manufacturing time becomes long
Solution Approach 1:
The invention changes the physical state parameter of the granulation liquid from a solution (dissolved or dispersed drug in solvent) to a mist state. By controlling the mist diameter (D50) to be not more than the particle size (D50) of the core particle, the granulation process achieves faster drying and granule formation, significantly reducing manufacturing time while still forming a uniform drug substance layer on the core particle surface.
2Manufacturing precision
If a solution in which a drug is dissolved or dispersed in a solvent is sprayed onto core particles, then the drug layer is formed, but the drug substance exposure and oxidation increase
Solution Approach 1:
The invention changes the granulation liquid from a solution state to a mist state with controlled particle size. This parameter change enables rapid evaporation and drying during the granulation process, reducing the time the drug substance is exposed to the environment and thereby minimizing oxidation and other harmful effects while still achieving uniform drug layer formation on the core particles.
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 granules with a core particle in a significantly shorter time, reducing drug substance exposure and oxidation, and enables the formation of spherical or substantially spherical granules with a drug substance layer on the core particle.
Implementation Method 1
spraying granulation liquid having a mist diameter (D50) not more than a particle size (D50) of the core particle
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 spraying 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.