RXCIPIENTS® FM 1000 – A versatile excipient for orally disintegrating tablet (ODT) formulations

1. Introduction

Certain patient groups, specifically elderly and infant
patients, experience difficulties with swallowing oral
dosages of medication. Orally disintegrating tablets (ODTs) are one approach to ease the intake, helping patients to comply with their prescription plans.

A conventional disintegrant pulls water into the tablet and swells, resulting in the delamination of the tablet. Evonik new excipient RXCIPIENTS® FM 1000 boosts the function of the disintegrant, causing the tablet to breakdown into small particles rather than to just delaminate.

By adjusting the concentration of RXCIPIENTS® FM 1000 in combination with the disintegrant, formulators can target different disintegration times of the ODT.

RXCIPIENTS® FM1000 calcium silicate can thereby be combined with a broad range of other ingredients.

2. Mode of action and advantages

RXCIPIENTS® FM 1000 channels moisture to the disintegrant due to its hydrophobic nature. The disintegrant absorbs that moisture, swells and thereby breaks the tablet.

Typically, 5–15 wt.-% of RXCIPIENTS® FM 1000 are used in the formulation.

Advantages of using RXCIPIENTS® FM1000 include:

• Promotion of faster tablet disintegration, breaking the tablet down into easy to swallow fine particles
• Durability of tablets, with low friability even at low
  compression forces
• Support of bulk packing instead of expensive blister
  packing
• High level of flexibility in formulation due to compatibility
  with many different disintegrants and fillers

Mixing

• All components except magnesium stearate were passed through a sieve (840 µm)
• Mixing in a V blender for 10 min at 27 rpm
• Addition of magnesium stearate after passing through a sieve (400 µm)
• Mixing in V blender for 5 min at 27 rpm

Tabletting

• SMI – Piccola rotary press, Model 8
• Turret speed: 30 rpm
• Compression force: 5–9 kN
• Tablet diameter: 10 mm
• Tablet mass: 450 mg