Rasagiline formulations of improved content uniformity
AssigneeTeva Pharmaceutical Industries Ltd.
InventorTirza Peskin
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Abstract
Disclosed are pharmaceutical preparations of R(+)-N-propargyl-1-aminoindan salts having enhanced content uniformity, processes for preparation of the compositions, and their uses.
Claims27
A mixture of particles of a pharmaceutically acceptable salt of R(+)-N-propargyl-1-aminoindan, wherein more than 90% of the total amount by volume of R(+)-N-propargyl-1-aminoindan salt particles have a size of less than 250 microns.
The composition of 10, wherein the content uniformity is between 95% and 105%.
A process for preparing a composition which comprises reducing the particle size of a pharmaceutically acceptable salt of R(+)-N-propargyl-1-aminoindan to a particle size of less than 250 microns.
A process for preparing a solid composition comprising:
- a) subjecting a batch of particles of a pharmaceutically acceptable salt of R(+)-N-propargyl-1-aminoindan to comminution;
- b) admixing the product of step a) with a carrier to form a granulate;
- c) determining the blend uniformity of the granulate;
- and
- d) forming the composition from the granulate only if the blend uniformity of the granulate satisfies a predetermined criteria, so as to prepare the composition.
27-41. (canceled)
Dependencies are inferred from the claim text.