The Milky Way: paediatric milk-based dispersible tablets prepared by direct compression - a proof-of-concept study

Area of Science:

• Pharmaceutical Sciences
• Paediatric Drug Delivery

Background:

• The World Health Organization recommends dispersible tablets as the preferred paediatric formulation.
• Improving the acceptability of oral medications for children is a significant challenge in paediatric pharmacotherapy.

Purpose of the Study:

• To investigate the potential of milk-based dispersible tablets as an acceptable paediatric formulation.
• To explore the impact of milk content and compression force on tablet properties.

Main Methods:

• Formulation of milk-based dispersible tablets using various milk powders and infant formulae.
• Design-of-experiments approach to study the influence of milk type and content on tablet friability, crushing strength, and disintegration time.
• Compaction simulation to assess the effect of compression force on tablet properties.

Main Results:

• Increased milk content led to longer disintegration times.
• Compression force significantly influenced the disintegration time of the model formulation.
• Milk content and compression force were identified as key determinants of tablet disintegration.

Conclusions:

• Up to 30% milk can be incorporated into 200 mg, 10-mm flat-faced placebo tablets via direct compression.
• These tablets disintegrate within 3 minutes in a realistic volume of water (5-10 ml) for paediatric administration.
• The milk-based platform can accommodate up to 30% of an active pharmaceutical ingredient, such as caffeine citrate.