title: Predictive model for tensile strength of pharmaceutical tablets based on local hardness measurements.
abstract: In the pharmaceutical field, tablets are the most common dosage forms for oral administration. During the manufacture of tablets, measures are taken to assure that they possess a suitable mechanical strength to avoid crumbling or breaking when handling while ensuring disintegration after administration. Accordingly, the tensile strength is an essential parameter to consider. In the present study, microscopic hardness and macroscopic tensile strength of binary tablets made from microcrystalline cellulose and caffeine in various proportions were measured. A relationship between these two mechanical properties was found for binary mixture. The proposed model was based on two physical measurements easily reachable: hardness and tablet density. Constants were determined from the two extreme compositions of this given system. This model was validated with experimental results, and a comparison was made with the one developed by Wu et al. (2005). Both models are relevant for this studied system. Nonetheless, with this model, the tablet tensile strength can be connected with a tablet characteristic at microscopic scale in which porosity is not needed.
authors.affiliation: Université de Lyon, F-69622 Lyon, France; Université Lyon 1, Villeurbanne, CNRS, UMR5007, Laboratoire d'Automatique et de Génie des Procédés (LAGEP), CPE-Lyon, 43 bd du 11 Novembre 1918, 69622 Villeurbanne Cedex, France.
authors.forename: Audrey
authors.initials: A
authors.lastname: Juban
authors.affiliation: Université de Lyon, LTDS UMR CNRS 5513, Ecole Centrale de Lyon, 36 avenue Guy de Collongue, 69134 ECULLY cedex, France.
authors.forename: Cécile
authors.initials: C
authors.lastname: Nouguier-Lehon
authors.affiliation: Université de Lyon, F-69622 Lyon, France; Université Lyon 1, Villeurbanne, CNRS, UMR5007, Laboratoire d'Automatique et de Génie des Procédés (LAGEP), CPE-Lyon, 43 bd du 11 Novembre 1918, 69622 Villeurbanne Cedex, France.
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Briancon
authors.affiliation: Université de Lyon, LTDS UMR CNRS 5513, Ecole Centrale de Lyon, 36 avenue Guy de Collongue, 69134 ECULLY cedex, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Hoc
authors.affiliation: Université de Lyon, F-69622 Lyon, France; Université Lyon 1, Villeurbanne, CNRS, UMR5007, Laboratoire d'Automatique et de Génie des Procédés (LAGEP), CPE-Lyon, 43 bd du 11 Novembre 1918, 69622 Villeurbanne Cedex, France; Université Paris Saclay, CentraleSupélec, Laboratoire de Génie des Procédés et Matériaux (LGPM), EA 4038, Grande Voie des Vignes, 92295 Châtenay-Malabry, France. Electronic address: francois.puel@centralesupelec.fr.
authors.forename: François
authors.initials: F
authors.lastname: Puel
mesh_terms: D002110:Caffeine / Q000737:chemistry; D002482:Cellulose / Q000737:chemistry; D004339:Drug Compounding / Q000379:methods; D005079:Excipients / Q000737:chemistry; D006244:Hardness; D008956:Models, Chemical; D016062:Porosity; D013607:Tablets / Q000737:chemistry*; D013678:Technology, Pharmaceutical / Q000379:methods; D013718:Tensile Strength
chemical_list: D005079:Excipients; D013607:Tablets; D002110:Caffeine; D002482:Cellulose; C109691:microcrystalline cellulose
keywords: Caffeine (PubChem CID: 2519); Diametral compression test; Direct compression; Microcrystalline cellulose (PubChem CID: 14055602); Nanoindentation; Powder mixture; Predictive model; Tablet tensile strength