Quality by Design (QbD) approach to optimize the formulation of a bilayer combination tablet (Telmiduo®) manufactured via high shear wet granulation.
Int J Pharm
; 534(1-2): 144-158, 2017 Dec 20.
Article
en En
| MEDLINE
| ID: mdl-29031980
A bilayer tablet, which consisted of telmisartan and amlodipine besylate, was formulated based on a Quality by Design (QbD) approach. The control and response factors were determined based on primary knowledge and the target values of the control tablet (Twynsta®). A D-optimal mixture design was used to obtain the optimal formulations in terms of D-mannitol, crospovidone, and MCC for the telmisartan layer, and CCM-Na, PVP K25, and Prosolv for the amlodipine layer. The quantitative effects of the different formulation factors on the response factors were accurately predicted using the equations of best fit and a strong linearity was observed between the predicted and actual values of the response factors. The optimized bilayer tablet was obtained using a numeric optimization technique and was characterized compared with a control (Twynsta®) by using various physical evaluations and in vivo pharmacokinetic parameters. The physical stability of Telmiduo® was greater than that of Twynsta® owing to the improvement of formulation factors. The in vivo pharmacokinetic parameters suggested that Telmiduo® might have pharmaceutical equivalence and bioequivalence with Twynsta®. Therefore, the bilayer tablet that consisted of telmisartan and amlodipine besylate could be produced using a more economical and simpler method than that used to produce Twynsta®. Moreover, the suitability of QbD for effective product development in the pharmaceutical industry was shown.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Comprimidos
/
Bencimidazoles
/
Benzoatos
/
Amlodipino
Tipo de estudio:
Prognostic_studies
/
Risk_factors_studies
Límite:
Animals
Idioma:
En
Revista:
Int J Pharm
Año:
2017
Tipo del documento:
Article
Pais de publicación:
Países Bajos