Reckitt Benckiser Healthcare (uk) Limited

Avida Medical Limited

Reckitt Benckiser Healthcare

Robert Arthur Sherry

Tracey Jane Rhoades

Frederick Raymond Higton

John Gerard Barfield

Weng Sam Tang

Richard James Dring

Nicholas David Edinborough

Philip Thomas Hewitt

Jacqueline Marie Boot

A formulation having excellent gastric protection properties comprises an active pharmaceutical ingredient and a waxy compound, dispersed in a pharmaceutically acceptable oily carrier. The formulation presents a palatable and stable oral dosage form which is particularly suitable for acid-sensitive active pharmaceutical ingredients, and which is also suitable for active pharmaceutical ingredients which are liable to cause stomach irritation.

Formulation

A compressed tablet composition comprising: a granular component comprising a plurality of solidified melt granules of a non-steroidal anti-inflammatory drug (NSAID) having a melting point in the range 30-300&#xb0; C. and incorporating a disintegrant uniformly dispersed therein; characterised in that the granules comprise a continuous phase of said non-steroidal anti-inflammatory drug and further characterised in that the tablet composition comprises silicon dioxide present in an amount of 0.05-5.0% by weight of the composition. Preferably, the composition also contains an extra-granular component comprising the silicon dioxide and a lubricant. Further preferably the NSAID is ibuprofen which has a melting point in the range 75-77&#xb0; C. Optionally the melting process can be carried out in an extruder. Tablets containing advantageous processing properties and dissolution characteristics are obtained.

Compressed tablet formulation comprising non-steroidal anti-inflammatory drugs and methods

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Nottingham, United Kingdom

Robert Arthur Sherry