Pharmaceutical formulations of oxcarbazepine and methods for its preparation
OwnerSigal Blauinventor
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Abstract
The present invention provides a pharmaceutical composition comprising oxcarbazepine and at least one pharmaceutical excipient, wherein the oxcarbazepine in the composition has a broad particle size distribution and an enhanced oxcarbazepine dissolution rate. The broad particle size distribution of oxcarbazepine in the pharmaceutical composition is preferably a multi-modal oxcarbazepine particle size distribution.
Claims71
A pharmaceutical composition comprising,
- a) oxcarbazepine, and
- b) at least one pharmaceutical excipient,
- wherein the oxcarbazepine in the composition has a broad particle size distribution.
A method for preparing a pharmaceutical composition comprising oxcarbazepine having a multi-modal oxcarbazepine particle size distribution comprising the steps of;
- a) providing oxcarbazepine which comprises two or more populations of oxcarbazepine particles of different particle size distributions;
- b) providing at least one excipient;
- c) forming at least one granulate comprising at least one of said oxcarbazepine populations;
- and
- d) combining the granulated oxcarbazepine with any remaining ungranulated oxcarbazepine and at least one excipient.
A pharmaceutical composition comprising,
- a) spray —granulated oxcarbazepine;
- and
- b) at least one pharmaceutical excipient.
A method of preparing a granular composition comprising at least two populations of different oxcarbazepine particle sizes wherein at least one population of oxcarbazepine particles is spray granulated comprising the following steps of
- a) providing oxcarbazepine which comprises two or more populations of oxcarbazepine particles having different particle size distributions;
- b) preparing a dispersion of at least one population of oxcarbazepine particles forming at least one oxcarbazepine dispersion;
- c) spraying the oxcarbazepine dispersion onto one or more excipients forming at least one spray granulate;
- and
- d) mixing the at least one population of spray granulated oxcarbazepine particles with any remaining population of non-spray granulated oxcarbazepine particles, which together form an oxcarbazepine mixture of the total amount of oxcarbazepine in the composition.
A method of preparing a granular composition comprising at least two populations of different oxcarbazepine particle sizes wherein at least one population of oxcarbazepine particles is spray granulated comprising the following steps of
- a) providing oxcarbazepine which comprises two or more populations of oxcarbazepine particles having different particle size distributions;
- b) preparing a dispersion of at least one population of oxcarbazepine particles forming at least one oxcarbazepine dispersion;
- c) spraying the oxcarbazepine dispersion onto one or more excipients and at least one of the remaining populations of oxcarbazepine forming an oxcarbazepine spray granulate which contains at least two populations;
Dependencies are inferred from the claim text.