Expertise on DC:

Example formulation Amlodipine tablets 5mg (as the besylate) with SuperTab® 30GR

Formulation

Component

mg / tablet

% w/w

Notes

Amlodipine besylate

6.94

2.78

   equivalent to 5mg Amlodipine

SuperTab® 30GR

234.32

93.72

Primojel®

7.50

3.00

Magnesium stearate

1.25

0.50

Total

250.0

100.0

 


Recommended Process

  1. Blend the Amlodipine with 25% of the SuperTab® 30GR and blend.
  2. Pass the preblend through a sieve.
  3. Blend with remaining SuperTab® 30GR and Primojel®.
  4. Add the magnesium stearate and blend for a further 2 minutes.
  5. Compress using 9mm round normal concave tooling using a compaction force of 7.5kN.

Measured properties

Tablet Core Property

Value

Mean weight (mg)

249.8

Weight Uniformity (% RSD)

0.48

Thickness (mm)

3.04

Crushing strength (N)

84.6

Friability (%)

0.12

Disintegration time (min:sec)

0:49

Mean assay (% label)

98.1

Content Uniformity (%RSD)

1.64

Dissolution (% after 15 mins)

98.0


Dissolution Profile




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