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US 2008/0175908 A1Published application
Tablet-in-tablet compositions
AssigneeWyeth
InventorsXiuying Liu, John Kresevic, Nizamuddin Baksh, Robin Enever
Life of this patent
Estimating the term…
Abstract
The present invention is directed to tablet-in-tablet compositions comprising one or more estrogens in a first layer and a therapeutic agent in a second layer, and processes for their preparation
Claims109
A tablet-in-tablet composition comprising:
- a) a core tablet comprising:
- one or more estrogens;
- a core filler/diluent component comprising from about 30% to about 85% by weight of said core tablet;
- a core filler/binder component comprising from about 1% to about 30% by weight of said core tablet;
- a core hydrophilic gel-forming polymer component comprising from about 1% to about 40% by weight of said core tablet;
- and
- optionally, a core lubricant component comprising from about 0.01% to about 2% by weight of said core tablet;
- and
- b) a compressed outer tablet layer comprising:
- one or more therapeutic agents selected from the group consisting of selective estrogen receptor modulators and progestational agents;
- an outer layer filler/diluent component comprising from about 10% to about 80% by weight of said compressed outer tablet layer;
- an outer layer filler/binder component comprising from about 1% to about 60% by weight of said compressed outer tablet layer;
- an outer layer hydrophilic gel-forming polymer component comprising from about 1% to about 70% by weight of said compressed outer tablet layer;
- optionally, an antioxidant component comprising from about 0.01% to about 4% by weight of said compressed outer tablet layer;
- and
- optionally, an outer layer lubricant component comprising from about 0.01% to about 2% by weight of said compressed outer tablet layer.
13 more elements
A tablet-in-tablet composition comprising:
- a) a core tablet comprising:
- one or more estrogens;
- a core filler/diluent component comprising from about 30% to about 85% by weight by weight of said core tablet;
- a core filler/binder component comprising from about 1% to about 30% by weight of said core tablet;
- a core hydrophilic gel-forming polymer component comprising from about 1% to about 40% by weight of said core tablet;
- and
- optionally, a core lubricant component comprising from about 0.01% to about 2% by weight of said core tablet;
- and
- b) a compressed outer tablet layer comprising:
- one or more therapeutic agents selected from the group consisting of selective estrogen receptor modulators and progestational agents;
- a pharmaceutically acceptable carrier component comprising from about 60% to about 99.9% by weight of said compressed outer tablet layer, wherein said pharmaceutically acceptable carrier component optionally comprises one or more of an outer layer filler/diluent component, an outer layer filler/binder component, and an outer layer hydrophilic gel-forming polymer component;
- optionally, an outer layer lubricant component comprising from about 0.01% to about 2% by weight of said compressed outer tablet layer;
- and
- optionally, an antioxidant component comprising from about 0.01% to about 4% by weight of said compressed outer tablet layer.
11 more elements
A tablet-in-tablet composition comprising:
- a) a core tablet comprising:
- one or more estrogens;
- a core filler/diluent component comprising from about 30% to about 85% by weight by weight of said core tablet;
- a core filler/binder component comprising from about 1% to about 30% by weight of said core tablet;
- a core hydrophilic gel-forming polymer component comprising from about 1% to about 40% by weight of said core tablet;
- and
- optionally, a core lubricant component comprising from about 0.01% 10 to about 2% by weight of said core tablet;
- and
- b) a compressed outer tablet layer comprising:
- one or more therapeutic agents selected from the group consisting of selective estrogen receptor modulators and progestational agents;
- an outer layer filler/diluent component comprising from about 25% to about 65% by weight of said compressed outer tablet layer;
- an outer layer filler/binder component comprising from about 20% to about 50% by weight of said compressed outer tablet layer;
- a disintegrant component comprising from about 2% to about 15% by weight of said compressed outer tablet layer;
- optionally, an outer layer wetting agent component comprising from about 0.01% to about 4% of said compressed outer tablet layer;
- optionally, an outer layer lubricant component comprising from about 0.01% to about 2% by weight of said compressed outer tablet layer;
- and
- optionally, an antioxidant component comprising from about 0.01% to about 4% by weight of said compressed outer tablet layer.
14 more elements
A process for producing a tablet-in-tablet composition comprising:
- compressing a first solid mixture to form a core tablet;
- and
- compressing a second solid mixture onto said core tablet to form a compressed outer tablet layer;
- wherein:
- (a) said first solid mixture comprises:
- one or more estrogens;
- a first solid mixture filler/diluent component comprising from about 30% to about 85% by weight of said first solid mixture;
- a first solid mixture filler/binder component comprising from about 1% to about 30% by weight of said first solid mixture;
- a first solid mixture hydrophilic gel-forming polymer component comprising from about 1% to about 40% by weight of said first solid mixture;
- and
- optionally, a first solid mixture lubricant component comprising from about 0.01% to about 2% by weight of said first solid mixture;
- and
- (b) said second solid mixture comprises:
- one or more therapeutic agents selected from the group consisting of selective estrogen receptor modulator and a progestational agent;
- a second solid mixture filler/diluent component comprising from about 10% to about 80% by weight of said second solid mixture;
- a second solid mixture filler/binder component comprising from about 1% to about 70% by weight of said second solid mixture;
- a second solid mixture hydrophilic gel-forming polymer component comprising from about 1% to about 60% of said compressed outer tablet layer;
- optionally, a second solid mixture antioxidant component comprising from about 0.01% to about 4% of said second solid mixture;
- and
- optionally, a second solid mixture lubricant component comprising from about 0.01% to about 2% of said second solid mixture.
17 more elements
A process for producing a tablet-in-tablet composition comprising:
- compressing a first solid mixture to form a core tablet;
- and
- compressing a second solid mixture onto said core tablet to form a compressed outer tablet layer;
- wherein:
- a) said first solid mixture comprises:
- one or more estrogens;
- a first solid mixture filler/diluent component comprising from about 30% to about 85% by weight by weight of said core tablet;
- a first solid mixture filler/binder component comprising from about 1% to about 30% by weight of said core tablet;
- a first solid mixture hydrophilic gel-forming polymer component comprising from about 1% to about 40% by weight of said core tablet;
- and
- optionally, a first solid mixture lubricant component comprising from about 0.01% to about 2% by weight of said core tablet;
- and
- b) said second solid mixture comprises:
- one or more therapeutic agents selected from the group consisting of selective estrogen receptor modulators and progestational agents;
- a pharmaceutically acceptable carrier component comprising from about 60% to about 99.9% by weight of said compressed outer tablet layer, wherein said outer pharmaceutically acceptable carrier component optionally comprises one or more of a second solid mixture filler/diluent component, a second solid mixture filler/binder component, and a second solid mixture hydrophilic gel-forming polymer component;
- optionally, a second solid mixture lubricant component comprising from about 0.01% to about 2% by weight of said compressed outer tablet layer;
- and
- optionally, a second solid mixture antioxidant component comprising from about 0.01% to about 4% by weight of said compressed outer tablet layer.
15 more elements
A process for producing a tablet-in-tablet composition comprising:
- compressing a first solid mixture to form a core tablet;
- and
- compressing a second solid mixture onto said core tablet to form a compressed outer tablet layer;
- wherein:
- a) said first solid mixture comprises:
- one or more estrogens;
- a first solid mixture filler/diluent component comprising from about 30% to about 85% by weight by weight of said core tablet;
- a first solid mixture filler/binder component comprising from about 1% to about 30% by weight of said core tablet;
- a first solid mixture hydrophilic gel-forming polymer component comprising from about 1% to about 40% by weight of said core tablet;
- and
- optionally, a first solid mixture lubricant component comprising from about 0.01% to about 2% by weight of said core tablet;
- and
- b) said second solid mixture comprises:
- one or more therapeutic agents selected from the group consisting of selective estrogen receptor modulators and progestational agents;
- a second solid mixture filler/diluent component comprising from about 25% to about 65% by weight of said compressed outer tablet layer;
- a second solid mixture filler/binder component comprising from about 20% to about 50% by weight of said compressed outer tablet layer;
- a second solid mixture disintegrant component comprising from about 2% to about 15% by weight of said compressed outer tablet layer;
- optionally, a second solid mixture wetting agent component comprising from about 0.01% to about 4% of said compressed outer tablet layer;
- optionally, a second solid mixture lubricant component comprising from about 0.01% to about 2% by weight of said compressed outer tablet layer;
- and
- optionally, a second solid mixture antioxidant component comprising from about 0.01% to about 4% by weight of said compressed outer tablet layer.
18 more elements
Dependencies are inferred from the claim text.