Physico-Mechanical Properties of Coprocessed Excipient MicroceLac^sup ^ 100 by DM^sup 3^ Approach

Purpose To determine the effect of relative humidity (RH) and hydroxypropyl methylcellulose (HPMC) on the physico-mechanical properties of coprocessed MacroceLac^sup ^ 100 using 'DM^sup 3^' approach. Methods Effects of RH and 5% w/w HPMC on MacroceLac^sup ^ 100 Compressibility Index (CI) a...

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Bibliographic Details
Published in:Pharmaceutical research 2015-11, Vol.32 (11), p.3618
Main Authors: Haware, Rahul V, Kancharla, Joseph P, Udupa, Aishwarya K, Staton, Scott, Gupta, Mali R, Al-achi, Antoine, Stagner, William C
Format: Article
Language:English
Subjects:
Humidity
Matrix
Mechanical properties
Pharmaceutical sciences
Online Access:Get full text
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Summary:Purpose To determine the effect of relative humidity (RH) and hydroxypropyl methylcellulose (HPMC) on the physico-mechanical properties of coprocessed MacroceLac^sup ^ 100 using 'DM^sup 3^' approach. Methods Effects of RH and 5% w/w HPMC on MacroceLac^sup ^ 100 Compressibility Index (CI) and tablet mechanical strength (TMS) were evaluated by 'DM^sup 3^'. The 'DM^sup 3^' approach evaluates material properties by combining 'design of experiments', material's 'macroscopic' properties, 'molecular' properties, and 'multivariate analysis' tools. A 4X4 full-factorial experimental design was used to study the relationship of MacroceLac^sup ^ 100 molecular properties (moisture content, dehydration, crystallization, fusion enthalpy, and moisture uptake) and macroscopic particle size and shape on CI and TMS. A physical binary mixture (PBM) of similar composition to MacroceLac^sup ^ 100 was also evaluated. Multivariate analysis of variance (MANOVA), principle component analysis, and partial least squares (PLS) were used to analyze the data. Results MANOVA CI ranking was: PBM-HPMC > PBM > MicroceLac^sup ^100 > MicroceLac^sup ^100-HPMC (p
ISSN:0724-8741
1573-904X
DOI:10.1007/s11095-015-1721-3