Aspirin oral tablet formulation for direct compression
Directly compressible formulation of aspirin oral tablets using MICROCEL® MC-101 microcrystalline cellulose (MCC) as filler-binder and SOLUTAB® A croscarmellose sodium as superdisintegrant
Objective
Develop a prototype formulation for aspirin tablets demonstrating the desirable tabletability of MICROCEL® MC-101 microcrystalline cellulose as a filler-binder and SOLUTAB® A croscarmellose sodium as a superdisintegrant.
Formula
Ingredient |
Functionality of the ingredient |
mg/tablet |
% by weight |
Aspirin |
Active ingredient |
500.0 |
83.33 |
MICROCEL® MC-101 microcrystalline cellulose |
Filler-binder |
78.4 |
13.07 |
SOLUTAB® A croscarmellose sodium |
Superdisintegrant |
4.8 |
0.80 |
Talc |
Glidant |
12.0 |
2.00 |
Silicon dioxide |
Glidant |
4.8 |
0.80 |
Method
1. Screen the ingredients to remove any clumps.
2. In a mixer, blend MICROCEL® MC-101, aspirin and the silicon dioxide for 20 minutes.
3. Add the talc and SOLUTAB® A, and mix for not more than 5 minutes.
4. Compress the powder with a 12 mm diameter concave punch.
Additional comments
Tablet hardness |
80 N |
Tablet disintegration time |
15 s |
Tablet friability |
0.6 % |
Tablet mass |
600 mg |
Active ingredient content |
500 mg/tablet |
Tablet dissolution |
> 95 % in 30 min |
Comment on Roquette product benefits
MICROCEL® microcrystalline cellulose is used as a filler-binder in various oral dosage forms in both pharmaceutical and nutraceutical applications due to its capacity to provide high tablet hardness. Roquette offers a large range of MICROCEL® in order to meet different formulation and process requirements such as direct compression and wet granulation.
SOLUTAB® A croscarmellose sodium is a superdisintegrant for swallowable and orally dispersible tablets, hard capsules, blends, granules and pellets premix. It is flexible as it is adapted to wet and dry granulation or direct compression processes.
MICROCEL® MC-101 and SOLUTAB® A are EP/USP-NF compliant.
® Registered trademark(s) of Roquette Frères.
MICROCEL® is a registered trademark in Benelux, Brazil, Canada, Chile, France, Germany, Italy, Mexico, the United Kingdom, and the United States of America and is pending in other countries or regions.
Disclaimer
This formula is a guideline for recommended use of our products; it does not imply consent to their use in violation of existing patent(s).
These details are for information only, and we believe them to be reliable.