title: Physico-Mechanical Properties of Coprocessed Excipient MicroceLac® 100 by DM(3) Approach.
abstract: OBJECTIVE
  To determine the effect of relative humidity (RH) and hydroxypropyl methylcellulose (HPMC) on the physico-mechanical properties of coprocessed MacroceLac(®) 100 using 'DM(3)' approach.
  
  
  METHODS
  Effects of RH and 5% w/w HPMC on MacroceLac(®) 100 Compressibility Index (CI) and tablet mechanical strength (TMS) were evaluated by 'DM(3)'. The 'DM(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(®) 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(®) 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(®)100 > MicroceLac(®)100-HPMC (p < 0.0001). MANOVA showed PBM's and PBM-HPMC's TMS values were lower than MicroceLac(®)100 and MicroceLac(®)100-HPMC (p < 0.0001). PLS showed that % RH, HPMC, and several molecular properties significantly affected CI and TMS.
  
  
  CONCLUSIONS
  Significant MicroceLac(®)100 changes occurred with % RH exposure affecting performance attributes. HPMC physical addition did not prevent molecular or macroscopic matrix changes.
authors.affiliation: College of Pharmacy & Health Sciences, Campbell University, Buies Creek, North Carolina, 27506, USA. haware@campbell.edu.
authors.forename: Rahul V
authors.initials: RV
authors.lastname: Haware
authors.affiliation: College of Pharmacy & Health Sciences, Campbell University, Buies Creek, North Carolina, 27506, USA.
authors.forename: Joseph P
authors.initials: JP
authors.lastname: Kancharla
authors.affiliation: College of Pharmacy & Health Sciences, Campbell University, Buies Creek, North Carolina, 27506, USA.
authors.forename: Aishwarya K
authors.initials: AK
authors.lastname: Udupa
authors.affiliation: Pharmaceutical Education & Research Center (PERC), Campbell University, Buies Creek, North Carolina, 27506, USA.
authors.forename: Scott
authors.initials: S
authors.lastname: Staton
authors.affiliation: College of Pharmacy & Health Sciences, Campbell University, Buies Creek, North Carolina, 27506, USA.|Pharmaceutical Education & Research Center (PERC), Campbell University, Buies Creek, North Carolina, 27506, USA.
authors.forename: Mali R
authors.initials: MR
authors.lastname: Gupta
authors.affiliation: College of Pharmacy & Health Sciences, Campbell University, Buies Creek, North Carolina, 27506, USA.
authors.forename: Antoine
authors.initials: A
authors.lastname: Al-Achi
authors.affiliation: College of Pharmacy & Health Sciences, Campbell University, Buies Creek, North Carolina, 27506, USA.
authors.forename: William C
authors.initials: WC
authors.lastname: Stagner
mesh_terms: D002482:Cellulose / Q000737:chemistry*; D003460:Crystallization; D004339:Drug Compounding / Q000379:methods*; D005079:Excipients / Q000737:chemistry*; D065347:Hypromellose Derivatives / Q000737:chemistry*; D007785:Lactose / Q000737:chemistry*; D008956:Models, Chemical; D015999:Multivariate Analysis; D025341:Principal Component Analysis; D012107:Research Design; D013499:Surface Properties; D013607:Tablets / Q000737:chemistry* / Q000592:standards; D013718:Tensile Strength; D014867:Water / Q000737:chemistry
chemical_list: D005079:Excipients; D013607:Tablets; D014867:Water; D065347:Hypromellose Derivatives; D002482:Cellulose; D007785:Lactose; C109691:microcrystalline cellulose
keywords: DM3; coprocessed excipient; design of experiments; factorial design; macroscopic properties; molecular properties; multivariate analysis; multivariate analysis of variance (MANOVA); partial least squares (PLS); principal component analysis (PCA); stability