Phosphate-binding polymer and tablets using the same
First Claim
1. A tablet having a hardness of 6 KP or more which comprises:
- a. particles of a phosphate-binding polymer having an average particle size of no more than 400 microns, with at least 90% of the particles being occupied by particles no larger than 500 microns, and having a true specific gravity of 1.20-1.22 and a water content of 1-14%; and
b. at least one of crystalline cellulose or low substituted hydroxypropyl cellulose wherein the crystalline cellular or the low substituted hydroxypropyl cellulose or mixture thereof is present in an amount of at least 10% of the weight of the phosphate-binding polymer.
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Accused Products
Abstract
Disclosed are a phosphate-binding polymer having a true specific gravity of 1.18-1.24, tablets that solely consist of the particles of a phosphate-binding polymer having an average particle size of no more than 400 μm, with at least 90% being occupied by particles no larger than 500 μm, and having a true specific gravity of 1.18-1.24 and a water content of 1-14%, or tablets that contain both the particles and crystalline cellulose and/or low substituted hydroxypropyl cellulose, and a process for producing such tablets. The phosphate-binding polymer can be formulated as tablets either alone or in combination with specified additives. Whichever the case, the tablets have satisfactory hardness, contain the active ingredient in high proportion, have high phosphate-binding capability and exhibit rapid disintegrability in an acidic to neutral region while having little sensitivity to the strength of agitation. The tablets are excellent pharmaceutical preparations that undergo reduced variations in bioavailability in spite of movements within the digestive tracts and pH changes.
31 Citations
21 Claims
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1. A tablet having a hardness of 6 KP or more which comprises:
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a. particles of a phosphate-binding polymer having an average particle size of no more than 400 microns, with at least 90% of the particles being occupied by particles no larger than 500 microns, and having a true specific gravity of 1.20-1.22 and a water content of 1-14%; and
b. at least one of crystalline cellulose or low substituted hydroxypropyl cellulose wherein the crystalline cellular or the low substituted hydroxypropyl cellulose or mixture thereof is present in an amount of at least 10% of the weight of the phosphate-binding polymer. - View Dependent Claims (2, 3, 4, 5, 6, 15, 16, 17, 18, 20, 21)
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7. A process for producing a phosphate-binding polymer tablet having a hardness of 6 KP or more which comprises:
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a. grinding a phosphate-binding polymer having a true specific gravity of 1.20-1.22 into particles having an average particle size of no more than 400 microns, with at least 90% being occupied by particles no larger than 500 microns, said phosphate-binding polymer being either polyallylamine or obtained by crosslinking the same;
b. adjusting the phosphate-binding polymer particles to have a water content of 1-14%;
c. mixing the particles with at least one of crystalline cellulose or low substituted hydroxyproply cellulose, wherein the amount of the crystalline cellular, low substituted hydroxypropyl cellulose or mixture thereof is at least 10% by weight of phosphate binding polymer; and
d. compressing the mixture into tablets. - View Dependent Claims (8, 9, 10, 11, 12, 13, 14, 19)
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Specification