Method of manufacturing pharmaceutical compositions
AssigneeVifor Fresenius Medical Care Renal Pharma Ltd
InventorsLaurent Chofflon, Erik Philipp
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Abstract
The present invention relates to pharmaceutical composition, comprising certain phosphate binder particles having a certain particle size distribution, a process for the manufacture of the pharmaceutical composition and the use of sucroferric oxyhydroxide having a certain particle size distribution for the manufacture of a pharmaceutical composition.
Claims16
A method of manufacturing a pharmaceutical composition for oral administration, said method comprising:
- (i) combining sucroferric oxyhydroxide particles and at least one pharmaceutically acceptable excipient, wherein at least 80% by volume of the sucroferric oxyhydroxide particles have a particle size in the range of 4 μm to 200 μm and the d50 particle size distribution by volume of the sucroferric oxyhydroxide particles is in the range of 30 μm to 80 μm;
- and
- (ii) tableting the combined sucroferric oxyhydroxide particles and at least one pharmaceutically acceptable excipient from step (i) by compression;
- wherein the pharmaceutical composition is in the form of a chewable tablet;
- wherein the hardness of the chewable tablet is between 100 N to 200 N as measured according to the European Pharmacopoeia 01/2008:20908;
- wherein the weight of the chewable tablet is between 2000 mg and 3000 mg;
- and
- wherein the chewable tablet has a disintegration time of between 5 minutes and 18 minutes as measured according to the European Pharmacopoeia 04/2011:20901.
A method of manufacturing a pharmaceutical composition for oral administration, said method comprising:
- (i) combining sucroferric oxyhydroxide particles and at least one pharmaceutically acceptable excipient, wherein the d50 particle size distribution by volume of the sucroferric oxyhydroxide particles is in the range of 30 μm to 80 μm;
- and
- (ii) tableting the combined sucroferric oxyhydroxide particles and at least one pharmaceutically acceptable excipient from step (i) by compression;
- wherein the pharmaceutical composition is in the form of a chewable tablet;
- wherein the pharmaceutical composition comprises about 2500 mg of sucroferric oxyhydroxide;
- wherein the hardness of the chewable tablet is between 100 N to 200 N as measured according to the European Pharmacopoeia 01/2008:20908;
- and
- wherein the chewable tablet has a disintegration time of between 5 minutes and 18 minutes as measured according to the European Pharmacopoeia 04/2011:20901.
A method of manufacturing a pharmaceutical composition for oral administration, said method comprising:
- (i) combining sucroferric oxyhydroxide particles and at least one pharmaceutically acceptable excipient, wherein the d50 particle size distribution by volume of said sucroferric oxyhydroxide particles is in the range of 30 μm to 80 μm;
- and
- (ii) tableting the combined sucroferric oxyhydroxide particles and at least one pharmaceutically acceptable excipient from step (i) by compression;
- wherein the pharmaceutical composition is in the form of a chewable tablet;
- wherein the weight of the chewable tablet is between 2000 mg and 3000 mg;
- wherein the hardness of the chewable tablet is between 100 N to 200 N as measured according to the European Pharmacopoeia 01/2008:20908;
- wherein the chewable tablet has a disintegration time of between 5 minutes and 18 minutes as measured according to the European Pharmacopoeia 04/2011:20901;
- and
- wherein more than 80% of the total weight of the chewable tablet (by weight on a dry weight basis) is sucroferric oxyhydroxide.
Dependencies are inferred from the claim text.