Benzocaine Orally Disintegrating Tablet (ODT) made by direct compression
Published January 28, 2026
Benzocaine formulation demonstrating the excellent properties of PEARLITOL® Flash co-process mannitol starch as directly compressible excipient for orally disintegrating tablets.
Objective
Realize a formulation for orally disintegrating tablet made by direct compression. The tablet must present quick disintegration time and offer good stability of the API.
Formula
| Ingredient | Functionality of the ingredient | mg/tablet (Total weight: 500mg) | % by weight |
| Benzocaine | Active Ingredient | 30 | 6 |
| PEARLITOL® Flash | Direct compression filler-binder with disintegrant benefits | 462.5 | 92.5 |
| Magnesium stearate | Lubricant | 7.5 | 1.5 |
Method
In a mixer, mix the ingredients for 10 minutes.
Compress the powder with a 10 mm concave punch.
Additional comments
| Hardness | 100 N |
| Friability test | Passed |
| Disintegration time | 60s (in 200 mL of water) |
| API stability | Chemical inertness of PEARLITOL® Flash toward benzocaine, superior humidity stability in comparison to other ODT platforms (see reference article for more detail) |
| Tablet mass | 500 mg |
PEARLITOL® Flash is a co-processed mannitol starch specifically designed for direct compression with disintegrating properties. Distinctive physicochemical properties of co-processed mannitol starch make it an excellent excipient for orally disintegrating formulations as it gives short disintegration time together with high API stability. PEARLITOL® Flash is low hygroscopic and chemically stable. It brings a pleasant texture and a slightly sweet taste. PEARLITOL® Flash is EP/USP-NF/JP compliant.
Reference
Köllmer, M., Popescu, C., Manda, P., Zhou, L., Gemeinhart, R. A., Stability of Benzocaine Formulated in Commercial Oral Disintegrating Tablet Platforms, AAPS PharmSciTech 14, 1333-1340 (2013)
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.