Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Capsules
Reexamination Certificate
2000-05-10
2001-09-04
Reamer, James H. (Department: 1614)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Capsules
C424S462000, C424S479000, C424S493000, C424S499000
Reexamination Certificate
active
06284269
ABSTRACT:
PATENT CLAIMS
1. Pharmaceutical composition comprising meloxicam as active ingredient, a cyclodextrin, a facultative oligosaccharide other than cyclodextrin, a facultative polysaccharide, one or more pharmaceutically acceptable additives selected from the group consisting of
surfactants,
hydrotropic agents,
alkalizing agents,
hydrocolloids and
polymers
and facultative excipients, carriers and/or auxiliary agents, wherein the pharmaceutical composition is obtainable by co-milling, co-grinding or co-kneading meloxicam in the presence of cyclodextrin as a pharmaceutically acceptable additive.
2. Composition according to claim
1
, obtainable by micronizing meloxicam in the presence of a pharmaceutically acceptable additive.
3. Composition according to claim
1
or
2
, obtainable by wet mechanical homogenization of its components in the presence of water, preferably in an amount of 5 to 50% by weight (based on the total weight of the composition).
4. Composition according to any of the preceding claims, characterized by microcrystalline cellulose and/or lactose and/or starch as oligo- or polysaccharide.
5. Composition according to any of the preceding claims, characterized by polyoxyethylene-sorbitan-mono-fatty acid, diethyleneglycol monoethylether and/or nonylphenol tetraethyleneglycol ether as surfactant.
6. Composition according to any of the preceding claims, characterized by an amount of 1 to 99 and preferably about 20% by weight of a hydrotropic agent (based on the total weight of the composition).
7. Composition according to any of the preceding claims, characterized by sodium glycinate, nicotinamide and/or methylglucamine as hydrotropic agent.
8. Composition according to any of the preceding claims, characterized by sodium carbonate, ammonium carbonate, sodium hydroxide, especially powdered sodium hydroxide, and/or sodium phosphate as alkalizing agent.
9. Composition according to any of the preceding claims, characterized by &bgr;-cyclodextrin hydrate (BCDx), 6-monoamino-beta-cyclodextrin (AMBCDx), gamma-cyclodextrin hydrate (GCDx), branched &bgr;-cyclodextrin, especially a branched &bgr;-cyclodextrin of the glycosyl/maltosyl substituted type or a &bgr;-cyclodextrin hydrate derivative, and/or hydroxypropyl-&bgr;-cyclodextrin as cyclodextrin, especially of a hydroxyalkylation degree in the range of 4.0 to 5.0.
10. Composition according to any of the preceding claims, characterized by methylcellulose-propylene-glycol ether, tris-hydroxymethylaminomethane, 2,6-diamino-hexanoic acid (D,L-lysine), mannitol, polyethyleneglycol, propyleneglycol, diethanolamine, ethyleneamine, monoethanolamine, triethanolamine, diisopropylamine, dibutylamine, pentylamine, sodium dodecylsulfate, methylglucamine, polyvinylpyrrolidone, cellulose ether, polyoxyethylene-polyoxypropylene-block-copolymers and/or nicotinamide as pharmaceutically acceptable additive.
11. Pharmaceutical composition comprising meloxicam as active ingredient, a cyclodextrin and a facultativen oligosaccharide or polysaccharide, water as aqueous vehicle, a co-solvent and facultative auxiliary agents, wherein the pharmaceutical composition is obtainable by micronizing meloxicam in the presence of the cyclodextrin, the facultative oligosaccharide or polysaccharide, water and a co-solvent as pharmaceutically acceptable additive.
12. Pharmaceutical composition comprising meloxicam as active ingredient, a cyclodextrin and a facultative oligosaccharide or polysaccharide, water as aqueous vehicle, a co-solvent and facultative auxiliary agents, obtainable by wet mechanical homogenization of its components in the presence of water, preferably in an amount of 5 to 50% by weight (based on the total weight of the composition).
13. Composition according to claim
11
or
12
, characterized by &bgr;-cyclodextrin hydrate (BCDx), 6-monoamino-beta-cyclodextrin (AMBCDx), gamma-cyclodextrin hydrate (GCDx), branched &bgr;-cyclodextrin, especially a branched &bgr;-cyclodextrin of the glycosyl/maltosyl substituted type or a &bgr;-cyclodextrin hydrate derivative, and/or hydroxypropyl-&bgr;-cyclodextrin as cyclodextrin, especially of a hydroxyalkylation degree in the range of 4.0 to 5.0.
14. Composition according to any of claims
11
to
13
, characterized by microcrystalline cellulose, lactose and/or starch as oligo- or polysaccharide.
15. Composition according to any of claims
11
to
14
, characterized by an amount of 0.1 to 25 and preferably about 5.0% by weight co-solvent (based on the amount of water or on the total weight of the composition).
16. Composition according to any of claims
11
to
15
, characterized by i-propanol, propyleneglycol, glycerol, polyethyleneglycol and/or ethanol as co-solvent.
17. Composition according to any of claims
11
to
16
, characterized by one ore more additional pharmaceutical acceptable additives selected from the group consisting of surfactants, hydrotropic agents, alkalizing agents, hydrocolloids and polymers, preferably selected from the group consisting of methylcellulose-propylene-glycol ether, tris-hydroxymethylaminomethane, 2,6-diamino-hexanoic acid (D,L-lysine), mannitol, polyethyleneglycol, propyleneglycol, diethanolamine, ethyleneamine, monoethanolamine, triethanolamine, diisopropylamine, dibutylamine, pentylamine, sodium carbonate, sodium dodecylsulfate, ammonium carbonate, sodium hydroxide, especially powdered sodium hydroxide, sodium phosphate, methylglucamine, polyvinylpyrrolidone, cellulose ether, polyoxyethylene-polyoxypropylene-block-copolymers and/or nicotinamide as pharmaceutically acceptable additive.
18. Composition according to any of claims
11
to
17
, characterized by an amount of 1 to 99 and preferably about 20% by weight of a hydrotropic agent (based on the total weight of the composition).
19. Composition according to any of the preceding claims for oral, rectal, transdermal, ophthalmic or parenteral administration.
20. Composition according to any of the preceding claims, characterized in that it is provided as tablet, effervescent tablet, sachet, aromatized effervescent sachet, tab, hydrogel, ophthalmic ointment, ophthalmic hydrogel or retal suppository.
21. Composition according to any of the preceding claims, characterized in that it is provided as controlled release tablet for oral application.
22. Composition according to claim
20
or
21
, characterized in that it is provided as multi-layer tablet, especially a two-layer tablet, wherein
one of the layers comprises meloxicam together with at least one pharmaceutically acceptable additive for rapid release and
another layer comprises meloxicam optionally with a usual controlled release agent.
REFERENCES:
patent: 5055306 (1991-10-01), Barry et al.
patent: 5427799 (1995-06-01), Valentine et al.
patent: 5840881 (1998-11-01), Uda et al.
patent: 5965163 (1999-10-01), Miller et al.
patent: 6068855 (2000-05-01), Leslie et al.
patent: 6093420 (2000-07-01), Baichwal
Lakemedelsverket, Summary of Product Characteristics, Mobic, Nov. 1995.
Freudensprung Brigitte
Klokkers Karin
Struengmann Andreas
Hexal AG
Pitney Hardin Kipp & Szuch LLP
Reamer James H.
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