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Merck
  • 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
摘要

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.

材料
货号
品牌
产品描述

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