TY - JOUR
T1 - A mesoporous silica based platform to enable tablet formulations of low dose drugs by direct compression
AU - Sun, Wei Jhe
AU - Aburub, Aktham
AU - Sun, Changquan Calvin
PY - 2018/3/25
Y1 - 2018/3/25
N2 - Achieving adequate content uniformity (CU) is a significant challenge in the development and manufacturing of low dose oral tablets. Using four model active pharmaceutical ingredients (APIs), we show that loading APIs into a grade of mesoporous silica, Aeroperl®, is effective for achieving excellent CU. All APIs in the Aeroperl® composites were amorphous. After six months under accelerated stability conditions, the drug-Aeoperl composites exhibited good physical stability for all four APIs. The performance of Aeroperl®-based formulations was robust since their good CU and manufacturability were insensitive to model APIs. In addition, the dissolution rate of composite-based formulations was higher than corresponding physical mixtures. Overall, the Aeroperl®-based platform formulation is a promising approach for successfully developing low dose oral tablet products.
AB - Achieving adequate content uniformity (CU) is a significant challenge in the development and manufacturing of low dose oral tablets. Using four model active pharmaceutical ingredients (APIs), we show that loading APIs into a grade of mesoporous silica, Aeroperl®, is effective for achieving excellent CU. All APIs in the Aeroperl® composites were amorphous. After six months under accelerated stability conditions, the drug-Aeoperl composites exhibited good physical stability for all four APIs. The performance of Aeroperl®-based formulations was robust since their good CU and manufacturability were insensitive to model APIs. In addition, the dissolution rate of composite-based formulations was higher than corresponding physical mixtures. Overall, the Aeroperl®-based platform formulation is a promising approach for successfully developing low dose oral tablet products.
KW - Aeroperl®
KW - Amorphous
KW - Neusilin®
KW - Particle engineering
KW - Stability
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U2 - 10.1016/j.ijpharm.2018.01.049
DO - 10.1016/j.ijpharm.2018.01.049
M3 - Article
C2 - 29414125
AN - SCOPUS:85041643249
VL - 539
SP - 184
EP - 189
JO - International Journal of Pharmaceutics
JF - International Journal of Pharmaceutics
SN - 0378-5173
IS - 1-2
ER -