Precision-Granulation™ as an Alternative Fluid Bed Granulation Method

Paper by Celine Liew, Kim Walter, Anthony Wigmore, Albert Brzeczko and Paul WS Heng
Introduction
Fluid Bed Granulation and High Shear Granulation are presently the most important wet granulation techniques employed in the pharmaceutical industry. Precision-Granulation™, a new bottom spray method, is evaluated for comparison with the conventional granulation methods.
Objectives

1. To compare Precision-Granulation™ with Top Spray Fluid Bed Granulation and High Shear Granulation for tabletting.
2. To investigate the influence of four selected process variables, atomizing air pressure, column velocity, insert diameter and air cap area/opening, in Precision-Granulation™.
3. To prepare Acetaminophen granules by Precision-Granulation™ and Top Spray Fluid Bed Granulation.

Materials
Table 1- Formulations used in the granulation studies

Study	Part 1	Part 2	Part  1	Part 1	Part 3
Material	Formulation A1 (%)	Formulation A2 (%)	Formulation B (%)	Formulation C (%)	Formulation D (%)
Lactose 200M* (Pharmatose 200M, DMV)	88	88	-	-	-
Lactose 450M* (Pharmatose 450M, DMV)	-	-	88	-	-
Powdered sugar	-	-	-	88	-
Acetaminophen (Mallinckrodt)	-	-	-	-	88
Povidone / Polyvinyl pyrrolidone (aKollidon 30, BASF; bPlasdone K29/32, ISP)	5a	5b	5a	5a	5b
Microcrystalline cellulose (Avicel PH-101, FMC)	5	5	5	5	5
Crospovidone (Polyplasdone XL10, ISP)	2	2	2	2	2

*From DMV product literature:
- Lactose 200M - average particle size 0.040 mm; % <0.045 mm : 50-65
- Lactose 450M - average particle size 0.020 mm; % <0.045 mm : minimum 90
Schematic diagrams of components of the Precision Granulator™ and image of the MP-1™ with Precision-Granulation™ module.

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2. K.T. Walter, A Process for Granulation of a Particulate Material. European Patent 1064990 (2001).
3. T. Kawaguchi, H. Sunada, Y. Yonezawa, K. Danjo, M. Hasegawa, T. Makino, H. Sakamoto, K. Fujita, T. Tanino and H. Kokubo,Granulation of  Acetaminophen by a Rotating Fluidized-Bed Granulator, Pharm. Dev. Tech., 5(2), 141-151 (2000)