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  • The impact of roller compaction and tablet compression on physicomechanical properties of pharmaceutical excipients.

The impact of roller compaction and tablet compression on physicomechanical properties of pharmaceutical excipients.

Pharmaceutical development and technology (2013-08-15)
Raman Mahadevan Iyer, Shridhar Hegde, James Dinunzio, Dharmendra Singhal, Waseem Malick
摘要

Material properties play a significant role in pharmaceutical processing. The impact of roller compaction (RC) and tablet compression on solid fraction (SF), tensile strength (TS) and flexural modulus (FM) of Avicel DG [co-processed excipient with 75% microcrystalline cellulose (MCC) and 25% anhydrous dibasic calcium phosphate (DCPA)], lactose and 1:1 Mixture of the two was studied. Materials were roller compacted at different force and roller type and compressed into tablets over a range of compression pressures (CP). SF, TS and FM were determined for ribbons and tablets. Roller force was a significant variable affecting SF while roller type was not. Both SF and TS of tablets increased with CP with Avicel DG exhibiting greater TS than that of 1:1 Mixture while tablets of lactose had the lowest TS. The TS of tablets decreased exponentially with tablet porosity. Ribbon of Avicel DG had higher TS and lower SF than lactose and greater reworkability. This is attributed to plastic deformation of MCC resulting in high degree of bonding and fragmentation of DCPA that fills the void spaces during tablet compression. The lack of significant increase in SF and low tablet TS for lactose upon compression is likely due to its brittle fragmentation and some elastic recovery as shown by the high FM.

材料
货号
品牌
产品描述

Sigma-Aldrich
纤维素, microcrystalline, powder, 20 μm
Supelco
乳糖(无水), Pharmaceutical Secondary Standard; Certified Reference Material
Sigma-Aldrich
纤维素, fibers, (medium)
Sigma-Aldrich
纤维素, microcrystalline, powder
Supelco
Avicel® PH-101, ~50 μm particle size
Sigma-Aldrich
Sigmacell 纤维素, Type 20, 20 μm
Sigma-Aldrich
乳糖, tested according to Ph. Eur.
Sigma-Aldrich
α纤维素, powder
Sigma-Aldrich
磷酸钙 二元, 98.0-105.0%
Sigma-Aldrich
Avicel® PH-101, tested according to Ph. Eur.
Supelco
纤维素, powder, for column chromatography
Sigma-Aldrich
纤维素, colloidal, microcrystalline
Sigma-Aldrich
Sigmacell 纤维素, Type 101, Highly purified, fibers
USP
无水乳糖, United States Pharmacopeia (USP) Reference Standard
乳糖, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Sigmacell 纤维素, Type 50, 50 μm
Sigma-Aldrich
磷酸氢钙, meets USP testing specifications
Supelco
纤维素, DS-0, powder, suitable for thin layer chromatography (TLC)
Sigma-Aldrich
α纤维素, BioReagent, suitable for insect cell culture
Supelco
纤维素, acid washed, powder, for column chromatography
Supelco
纤维素, DFS-0, microcrystalline, suitable for thin layer chromatography (TLC)
Supelco
纤维素, acid washed, from spruce, for column chromatography