Particle size control
AssigneeBial - Portela & Ca, S.A.
InventorsTeófilo Vasconcelos, Domenico Russo, Ana Rita Gonçalves Da Cruz Ramos Pires, Sonia Maria Correia Dias
Life of this patent
Estimating the term…
Abstract
The present invention relates to micronised pharmaceutical products of crystalline opicapone with a percentage number of sheaf agglomerates less than or equal to 30%. The invention also relates to methods of production of these micronised pharmaceutical products and their use in improving bioavailability of opicapone in the treatment of Parkinson's disease. Furthermore, the invention provides methods for calculating the primary particle size distribution and agglomerate content of such products.
Claims30
A pharmaceutical product consisting essentially of crystalline opicapone having the following primary particle size distribution:
- D10 (maximum distance) greater than or equal to 5 μm;
- D50 (maximum distance) of 10 to 70 μm;
- and
- D90 (maximum distance) less than or equal to 250 μm;
- and the following agglomerate distribution:
- % number of sheaf agglomerates less than or equal to 30%.
A method of manufacturing a pharmaceutical product comprising the following steps:
- a) micronising a product consisting essentially of crystalline opicapone;
- b) determining the primary particle size distribution and the % number of sheaf agglomerates for the crystalline opicapone in the micronized product;
- c) retaining micronized product consisting essentially of crystalline opicapone having the following primary particle size distribution:
- D10 (maximum distance) greater than or equal to 5 μm;
- D50 (maximum distance) of 10 to 70 μm;
- and
- D90 (maximum distance) less than or equal to 250 μm;
- and the following agglomerate distribution:
- % number of sheaf agglomerates less than or equal to 30%;
- and
- d) if necessary, repeating steps a) to c) on micronized product consisting essentially of crystalline opicapone which does not have the primary particle size and agglomerate distributions defined in step c) above.
(canceled)
(canceled)
(canceled)
(canceled)
Dependencies are inferred from the claim text.