Tabletting study for ODTs

In this joint tabletting study by Laboratoire Pierre Fabre and Roquette highlight some of the ODT production benefits of a new excipient.

Orally disintegrating tablets (ODTs) are dosage forms formulated in such a way as to improve a pharmaceutical
product’s in vivo oral disintegration and dissolution rates. In order to achieve rapid disintegration rates, the tablet formula must provide a high porosity, low density and low hardness. 

The most common preparation methods used to produce tablets are: moulding, lyophilisation, freeze-drying and direct compression.The basic approach of developing ODTs via direct compression involves the blending of a filler, superdisintegrant, a lubricant and an active pharmaceutical ingredient (API) and then compressing the mixture.

Mannitol is commonly used as a diluent or bulk excipient in the formulation of ODTs. A new generation of co-processed mannitol-based excipients has been developed by Roquette for the formulation of ODTs. For example, the latest – Pearlitol Flash – is a combination of mannitol and starch. Mannitol and starch are compliant with international pharmacopoeias and the combined ingredient is specifically designed to disintegrate rapidly, providing a smooth texture without the addition of superdisintegrant.

In the study presented here the physical properties of Pearlitol Flash were evaluated through a series of tests that revealed the impact of different compression parameters (pre compression and compression forces, tabletting speed) on tablet properties while using two different types of conventional tablet presses.

The materials used in this study were Pearlitol Flash (a combination of mannitol and starch from Roquette) and magnesium stearate as a lubricant (purchased from Bärlocher).

The powder properties, such as bulk and tapped density, angle of repose (using Hosokawa equipment), the flow rate through an orifice (using FloDex), the Hausner ratio and the Carr index, were all determined according to US Pharmacopeia (USP) and European Pharmacopeia (Ph. Eur) methods in order to characterise the physical properties of Pearlitol Flash.

Particle size distribution (sieving), loss on drying (IR method, Mettler LP16) and sorption of water (Dynamic Vapour of Sorption 20°C, DVS-1, Surface Measurement Systems LTD) were also evaluated. The Scanning Electron Microscopy (SEM) was performed using a Quanta 200FEG.

Reproduced courtesy of Manufacturing Chemist

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