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  • A novel approach to determine solid fraction using a laser-based direct volume measurement device.

A novel approach to determine solid fraction using a laser-based direct volume measurement device.

Pharmaceutical development and technology (2013-08-13)
Raman Mahadevan Iyer, Shridhar Hegde, Dharmendra Singhal, Waseem Malick
ABSTRACT

Material properties play a significant role in pharmaceutical processing. In the present study, a novel approach is used to determine solid fraction (SF) based on a direct measurement (DM) of the apparent volume of a sample. The sample was scanned with low intensity laser beams that integrate the sample thickness across the surface (area) and quantitate the apparent volume. The SF by DM method was compared against that obtained by volume displacement (VD) and manual measurement methods. SF was determined by all three methods for formulations of Avicel DG, lactose and a 1:1 mixture of the two. The results from DM method and variability were comparable to that obtained by VD method. The manual method provided lower and more variable results. The DM method was able to differentiate between SF of different ribbon and tablet formulations and at varying force levels. Tracking SF of compacts during tablet development can help in setting acceptable specifications and to understand material deformation behavior during compression. Further, the results of the study indicate that the DM method using laser scan technique was suitable for routine testing of SF of roller compacted ribbons and compressed tablets.

MATERIALS
Product Number
Brand
Product Description

Supelco
Avicel® PH-101, ~50 μm particle size
Sigma-Aldrich
α-Cellulose, powder
Sigma-Aldrich
Sigmacell Cellulose, Type 20, 20 μm
Sigma-Aldrich
Sigmacell Cellulose, Type 50, 50 μm
Sigma-Aldrich
Sigmacell Cellulose, Type 101, Highly purified, fibers
Sigma-Aldrich
α-Cellulose, BioReagent, suitable for insect cell culture
USP
Anhydrous lactose, United States Pharmacopeia (USP) Reference Standard
Supelco
Lactose, Anhydrous, Pharmaceutical Secondary Standard; Certified Reference Material
Sigma-Aldrich
Cellulose, microcrystalline, powder, 20 μm
Sigma-Aldrich
Avicel® PH-101, tested according to Ph. Eur.
Supelco
Cellulose, powder, for column chromatography
Sigma-Aldrich
Lactose, tested according to Ph. Eur.
Supelco
Cellulose, acid washed, from spruce, for column chromatography
Sigma-Aldrich
Cellulose, colloidal, microcrystalline
Sigma-Aldrich
Cellulose, microcrystalline, powder
Sigma-Aldrich
Cellulose, fibers, (medium)
Supelco
Cellulose, acid washed, powder, for column chromatography
Supelco
Cellulose, DS-0, powder, suitable for thin layer chromatography (TLC)
Supelco
Cellulose, DFS-0, microcrystalline, suitable for thin layer chromatography (TLC)
Lactose (anhydrous), European Pharmacopoeia (EP) Reference Standard