Homogeneous coloring of tablet cores

Situation

• One of our customers developed 3 different dosages for 1 active pharmaceutical ingredient (API).
• Coating was avoided as the API was heat and moisture sensitive.
• Cores had to be colored to distinguish each dosage:
  • Light color shade (orange) for lower dosage – 5 mg
  • Medium color shade (pink) for dosage of 10 mg
  • Darker color shade (red) for higher dosage – 15 mg
• A primary objective was to achieve homogeneous core coloration.

Challenge

Demonstrated here using the example of the dark color shade for high dosage.

• Inhouse pigment co-sifting and milling process was tough and time consuming.
• Possibility of foreign material contamination due to co-sifting and milling process was identified as a risk.
• Agglomerated pigments showing up as darker spots on the tablet.
• Inhomogeneous tableting blend resulting in a mottled appearance of the tablet surface.
• Unacceptable appearance that could result in poor patient acceptance and raise questions regarding product quality.

Solution

BIOGRUND assisted the customer in improving the formulation.

Approach:

• Review of formulation ingredients
• Color matching
• Formulation adjustment was recommended by using the pigment premix TopMill® without changing the quantitative formulation.
• Performing direct compression trials

Comparison and results

How to use TopMill®

• The use is easy, fast & reliable.
• It should be blended with the rest of the tableting blend.
• An addition of 0.5 % – 5.0 % is recommended to achieve the desired color.
• This blend could be directly compressed.
• We could also develop TopMill® for a wet granulation process.
• Processing guideline is provided with samples.

See the full case study on Homogeneous coloring of tablet cores here

(click the picture to download the brochure)

Source: BIOGRUND, brochure Homogeneous coloring of tablet cores

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