Placebo Orodispersible Tablets with PEARLITOL® 200 SD Mannitol
Formulation Guideline

Placebo Orodispersible Tablets with PEARLITOL® 200 SD Mannitol

Placebo formulation for a directly compressible tutti frutti flavor orodispersible tablet (ODT)

Formula

% (By weight)

mg / tablet

PEARLITOL®  200 SD mannitol

87.15

1220.1

KOLLIDON® CL crospovidone (BASF)

7.50

105.0

Magnesium stearate

2.00

28.0

Anhydrous citric acid

1.00

14.0

Tutti frutti flavor

1.00

14.0

Tutti frutti Durarome flavor

1.00

14.0

Aspartame

0.30

4.2

Red Ponceau lake

0.05

0.7

Method

  1. In a mixer, mix PEARLITOL®  200 SD, crospovidone, flavors, coloring agent, anhydrous citric acid and aspartame for 20 minutes.
  2. Add magnesium stearate and mix for 5 minutes. 
  3. Compress the powder with 18 mm flat face bevel edge punches

Additional Comments

  • Tablet weight: 1400 mg
  • Tablet thickness: 5.15 mm
  • Tablet density: 1.058  g/cm3
  • Tablet hardness: 47 N

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.