Method of preparing an oral dosage form comprising fingolimod
Assigneeratiopharm GmbH
InventorsJana Paetz, Katrin Rimkus
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Abstract
The present invention relates to a method of preparing an intermediate containing fingolimod, a method of preparing granules containing fingolimod, a method of preparing an oral dosage form containing fingolimod and accordingly intermediates, granules and oral dosage forms obtainable by that method.
Claims18
A method of preparing an intermediate comprising (a) fingolimod and (b) one or more pharmaceutically acceptable excipients, comprising the steps of:
- (i) optionally mixing (a) fingolimod and (b) the excipient or the plurality of excipients,
- (ii) jointly comminuting (a) fingolimod and (b) the one or more excipients into intermediate particles such that 90 per cent by volume of all the resulting intermediate particles have a particle size of less than 250 μm and greater than 0.6 μm.
An intermediate comprising particles of (a) fingolimod and (b) one or more pharmaceutically acceptable excipients, wherein 90 per cent by volume of the particles have a particle size of less than 250 μm and greater than 0.6 μm.
Dependencies are inferred from the claim text.