Benzocaine Orally Disintegrating Tablet (ODT) made by direct compression
Formulation Guideline

Benzocaine Orally Disintegrating Tablet (ODT) made by direct compression

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

  1. In a mixer, mix the ingredients for 10 minutes.

  2. 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.

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