Use of granular materials based on pyrogenically produced silicon dioxide in pharmaceutical compositions
First Claim
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1. A pharmaceutical composition comprising granular pyrogenically produced silicon dioxide, having void volumes, and at least one pharmaceutical active constituent, wherein the granular silicon dioxide has meso- and macropores, a mean grain diameter of 10 to 120 μ
- m and a BET surface of 40 to 400 m2/g, determination according to DIN 66 131 using nitrogen, wherein the mesopores account for 10 to 80% of the total volume and the particle size distribution of the granular material is 80 vol. % greater than 8 μ
m and 80% less than 96 μ
m and the proportion of the pores less than 5 μ
m be at most 5% referred to the total pore volume.
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Abstract
The use of granular materials based on pyrogenically produced silicon dioxide in pharmaceutical compositions, the pharmaceutical compositions per se, as well as an adsorbate consisting of the granular material and at least one further substance selected from pharmaceutical active constituents and auxiliary substances, and the production of such adsorbates, are described.
109 Citations
8 Claims
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1. A pharmaceutical composition comprising granular pyrogenically produced silicon dioxide, having void volumes, and at least one pharmaceutical active constituent, wherein the granular silicon dioxide has meso- and macropores, a mean grain diameter of 10 to 120 μ
- m and a BET surface of 40 to 400 m2/g, determination according to DIN 66 131 using nitrogen, wherein the mesopores account for 10 to 80% of the total volume and the particle size distribution of the granular material is 80 vol. % greater than 8 μ
m and 80% less than 96 μ
m and the proportion of the pores less than 5 μ
m be at most 5% referred to the total pore volume. - View Dependent Claims (2, 3, 4)
- m and a BET surface of 40 to 400 m2/g, determination according to DIN 66 131 using nitrogen, wherein the mesopores account for 10 to 80% of the total volume and the particle size distribution of the granular material is 80 vol. % greater than 8 μ
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5. An adsorbate comprising granular pyrogenically produced silicon dioxide, having void volumes, and absorbed on a surface and/or incorporated within the void volumes, at least one further substance selected from pharmaceutical active constituents and auxiliary substances, wherein the granular silicon dioxide has meso- and macropores, a mean grain diameter of 10 to 120 μ
- m and a BET surface of 40 to 400 m2/g, determination according to DIN 66 131 using nitrogen and the mesopores account for 10 to 80% of the total volume and the particle size distribution of the granular material is 80 vol. % greater than 8 μ
m and 80% less than 96 μ
m and the proportion of the pores less than 5 μ
m be at most 5% referred to the total pore volume, and wherein the adsorbate is prepared by forming a mixture by melting the substance(s) to be adsorbed, selected from pharmaceutical active constituents and auxiliary substances, or dissolving or dispersing the substance in a solvent;
adsorbing the substance(s) by mixing the granular pyrogenically produced silicon dioxide with the mixture; and
removing the solvent, when present. - View Dependent Claims (6, 7)
- m and a BET surface of 40 to 400 m2/g, determination according to DIN 66 131 using nitrogen and the mesopores account for 10 to 80% of the total volume and the particle size distribution of the granular material is 80 vol. % greater than 8 μ
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8. Process for the production of an adsorbate, comprising the following steps:
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(a) forming a mixture by melting the substance(s) to be adsorbed, selected from pharmaceutical active constituents and auxiliary substances, or by dissolving or dispersing the substance(s) in a solvent; (b) adsorbing the substance(s) by mixing the granular pyrogenically produced silicon dioxide, having meso and macro pores, a mean grain diameter of 10 to 120 μ
m and a BET surface of 40 to 400 m2/g, determination according to DIN 66 131 using nitrogen, and the mesopores account for 10 to 80% of the total volume and the particle size distribution of the granular material is 80 vol. % greater than 8 pm and 80% less than 96 μ
m and the proportion of the pores less than 5 μ
m be at most 5% referred to the total pore volume, with the mixture from step (a) under conditions where no dust or electrostatic charge is formed; and(c) removing the solvent, when present.
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Specification