Rapid formulation screening with a Multipart Microscale Fluid bed Powder processor.
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.
Kivikero
Niina
N
Industrial Pharmacy, University of Helsinki, Finland. niina.kivikero@helsinki.fi
Murtomaa
Matti
M
Antikainen
Osmo
O
Hatara
Juha
J
Juppo
Anne-Mari
AM
Sandler
Niklas
N
D001241:Aspirin / Q000737:chemistry*; D002482:Cellulose / Q000737:chemistry; D004339:Drug Compounding / Q000379:methods*; D005079:Excipients / Q000737:chemistry*; D007785:Lactose / Q000737:chemistry; D010316:Particle Size; D011205:Povidone / Q000737:chemistry; D011208:Powders; D012044:Regression Analysis; D013607:Tablets / Q000737:chemistry*
D005079:Excipients; D011208:Powders; D013607:Tablets; D002482:Cellulose; D011205:Povidone; D007785:Lactose; C109691:microcrystalline cellulose; D001241:Aspirin