Rapid development and optimization of tablet manufacturing using statistical tools.
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.
Fernández
Eutimio Gustavo
EG
Inorganic Chemistry Department, Center for Engineering and Chemical Researches, F Street, # 115 be/Ave 5th and Calzada, Havana 10400, Cuba. eutimiocu@yahoo.com
Cordero
Silvia
S
Benítez
Malvina
M
Perdomo
Iraelio
I
Morón
Yohandro
Y
Morales
Ada Esther
AE
Arce
Milagros Gaudencia
MG
Cuesta
Ernesto
E
Lugones
Juan
J
Fernández
Maritza
M
Gil
Arturo
A
Valdés
Rodolfo
R
Fernández
Mirna
M
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
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