title: Investigation and modelling approach of the mechanical properties of compacts made with binary mixtures of pharmaceutical excipients.
abstract: Three pharmaceutical excipients (microcrystalline cellulose, lactose, anhydrous calcium phosphate) and their binary mixtures were compacted to form compacts of various mean porosities. Some mechanical properties (Young's modulus, tensile strength and Brinell hardness) were studied on these compacts. The mechanical properties of the binary mixtures were not proportional to the mixture composition expressed in mass. More, for all the properties, a negative deviation was always observed from this linear relationship. In reference to a composition percolation phenomenon, critical mass fractions were detected from the graph mechanical property vs. mass composition of a mixture. The results obtained with Brinell hardness differed from the results of the Young's modulus and the tensile strength, i.e. the most plastic material in the binary mixture controlled the mixture behaviour. Secondly, a predictive model based on a statistical approach was proposed for the Young's modulus and the tensile strength. The validity of this model was verified on experimental data, and an interaction parameter used to characterize the affinity of the two compounds was calculated. Finally, the X-ray tomography technique was applied to the compacts of cellulose/phosphate mixtures to obtain cross-sections images of the compacts. The analysis of the cross-sections images allowed explaining the no linear relationship of the different mechanical properties results observed on these binary mixtures.
authors.affiliation: Centre d'études Pharmaceutiques de l'Université Paris XI, Châtenay-Malabry, France.
authors.forename: V
authors.initials: V
authors.lastname: Busignies
authors.forename: B
authors.initials: B
authors.lastname: Leclerc
authors.forename: P
authors.initials: P
authors.lastname: Porion
authors.forename: P
authors.initials: P
authors.lastname: Evesque
authors.forename: G
authors.initials: G
authors.lastname: Couarraze
authors.forename: P
authors.initials: P
authors.lastname: Tchoreloff
mesh_terms: D002482:Cellulose / Q000737:chemistry; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D004339:Drug Compounding; D015195:Drug Design; D005079:Excipients / Q000737:chemistry; D008956:Models, Chemical; D008962:Models, Theoretical; D011208:Powders; D013314:Stress, Mechanical; D013607:Tablets / Q000737:chemistry*; D013678:Technology, Pharmaceutical / Q000379:methods*; D013718:Tensile Strength; D014057:Tomography, X-Ray Computed / Q000379:methods; D014965:X-Rays
chemical_list: D005079:Excipients; D011208:Powders; D013607:Tablets; D002482:Cellulose; C109691:microcrystalline cellulose