Rapid formulation screening with a Multipart Microscale Fluid bed Powder processor.

Abstract:

:The aim of this study was to investigate early formulation screening in small scale with a miniaturized fluid bed device. Altogether eight different batches were granulated in a Multipart Microscale Fluid bed Powder processor (MMFP) with constant process conditions using electrostatic atomization. Atomization voltage and granulation liquid flow rate were kept constant. Acid acetylsalicylic was used as model active pharmaceutical ingredient (API), lactose monohydrate, microcrystalline cellulose and polyvinylpyrrolidone were used as excipients. Granule size distributions were measured with spatial filtering technique. Friability test was performed by spinning granules in the mixer with glass beads. Compressibility of the granules was evaluated by tableting and the breaking force of the tablets was measured. Multivariate analysis, namely partial least squares regression and multilinear regression were applied to the data. It was possible to generate granules of different compositions rapidly employing MMFP with electrostatic atomization fast and acquire reliable and logical results with only small amount of material. However, a major challenge was to find suitable analytical methods for such small batches.

journal_name

Pharm Dev Technol

authors

Kivikero N,Murtomaa M,Antikainen O,Hatara J,Juppo AM,Sandler N

doi

10.3109/10837451003739271

subject

Has Abstract

pub_date

2011-08-01 00:00:00

pages

358-66

issue

4

eissn

1083-7450

issn

1097-9867

journal_volume

16

pub_type

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