title: Rapid development and optimization of tablet manufacturing using statistical tools.
abstract: The purpose of this paper was to develop a statistical methodology to optimize tablet manufacturing considering drug chemical and physical properties applying a crossed experimental design. The assessed model drug was dried ferrous sulphate and the variables were the hardness and the relative proportions of three excipients, binder, filler and disintegrant. Granule properties were modeled as a function of excipient proportions and tablet parameters were defined by the excipient proportion and hardness. The desirability function was applied to achieve optimal values for excipient proportions and hardness. In conclusion, crossed experimental design using hardness as the only process variable is an efficient strategy to quickly determine the optimal design process for tablet manufacturing. This method can be applied for any tablet manufacturing method.
authors.affiliation: Inorganic Chemistry Department, Center for Engineering and Chemical Researches, F Street, # 115 be/Ave 5th and Calzada, Havana 10400, Cuba. eutimiocu@yahoo.com
authors.forename: Eutimio Gustavo
authors.initials: EG
authors.lastname: Fernández
authors.forename: Silvia
authors.initials: S
authors.lastname: Cordero
authors.forename: Malvina
authors.initials: M
authors.lastname: Benítez
authors.forename: Iraelio
authors.initials: I
authors.lastname: Perdomo
authors.forename: Yohandro
authors.initials: Y
authors.lastname: Morón
authors.forename: Ada Esther
authors.initials: AE
authors.lastname: Morales
authors.forename: Milagros Gaudencia
authors.initials: MG
authors.lastname: Arce
authors.forename: Ernesto
authors.initials: E
authors.lastname: Cuesta
authors.forename: Juan
authors.initials: J
authors.lastname: Lugones
authors.forename: Maritza
authors.initials: M
authors.lastname: Fernández
authors.forename: Arturo
authors.initials: A
authors.lastname: Gil
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Valdés
authors.forename: Mirna
authors.initials: M
authors.lastname: Fernández
mesh_terms: D002482:Cellulose / Q000737:chemistry; D002626:Chemistry, Pharmaceutical; D005079:Excipients / Q000737:chemistry*; D005296:Ferrous Compounds / Q000737:chemistry*; D006244:Hardness; D015233:Models, Statistical; D010316:Particle Size; D011205:Povidone / Q000737:chemistry; D011208:Powders; D013213:Starch / Q000031:analogs & derivatives / Q000737:chemistry; D013229:Stearic Acids / Q000737:chemistry; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods*; D013997:Time Factors
chemical_list: D005079:Excipients; D005296:Ferrous Compounds; D011208:Powders; D013229:Stearic Acids; D013607:Tablets; C020748:ferrous sulfate; C031183:stearic acid; D002482:Cellulose; D013213:Starch; C048390:sodium starch glycolate; D011205:Povidone; C109691:microcrystalline cellulose