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Published on: May 12, 2017
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Novel, lean and environment-friendly granulation method: Green fluidized bed granulation (GFBG).
Hiroshi Takasaki1, Atsushi Sakurai1, Takuma Katayama1
1Nippon Boehringer Ingelheim Co, Ltd, 6-7-5 Minatojima Chuou-ku, Kobe, Hyogo 650-0047, Japan.
International Journal of Pharmaceutics
|December 21, 2018
Summary
Green fluidized bed granulation (GFBG) offers a faster, eco-friendly alternative for pharmaceutical manufacturing. This granulation method produces high-quality tablets with excellent disintegration and wetting properties, surpassing traditional techniques.
Area of Science:
- Pharmaceutical Technology
- Materials Science
- Chemical Engineering
Background:
- Traditional granulation methods like fluidized bed granulation (FBG) and high-shear granulation (HSG) are energy-intensive and time-consuming.
- Moisture activated dry granulation (MADG) offers an alternative but can be further optimized.
- There is a need for efficient, environmentally friendly granulation techniques in pharmaceutical manufacturing.
Purpose of the Study:
- To evaluate the manufacturability and properties of granules and tablets produced by Green Fluidized Bed Granulation (GFBG).
- To compare GFBG against Moisture Activated Dry Granulation (MADG), Fluidized Bed Granulation (FBG), and High-Shear Granulation (HSG).
- To assess the energy efficiency and environmental impact of GFBG.
Main Methods:
- GFBG process involving mixing and spraying in a fluidized bed granulator without heating.
- Comparative analysis of process time, machine requirements, and scale-up feasibility.
- Characterization of granule flowability using Hausner ratio (HR).
- Evaluation of tablet properties including mass variability, tensile strength, disintegration time, wettability, and porosity.
Main Results:
- GFBG demonstrated significantly shorter process times (<20 min for 700g scale) and reduced machine requirements compared to FBG and HSG.
- GFBG granules exhibited excellent flowability (HR = 1.30) with no tablet mass variability issues.
- Tablets produced via GFBG showed high tensile strength (>1.5 MPa) even at low compression forces and the fastest disintegration times.
- GFBG tablets displayed 3.6 times higher capillary wetting than FBG tablets, correlating with faster disintegration.
Conclusions:
- GFBG is a highly efficient and environmentally friendly granulation technology.
- GFBG offers superior manufacturability, granule flowability, and tablet properties, including rapid disintegration.
- The enhanced wettability of GFBG tablets contributes to their faster disintegration, making it a promising alternative to conventional methods.
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