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US4975281A Expired / Lapsed US ⏱️ 0.0 years remaining

Anti-ulcer composition

Assignee: ER Squibb and Sons LLC
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Filing: 1989-01-30
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Granted: 1990-12-04
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Expires: 2009-01-30
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Abstract

Abstract In accordance with the present invention a novel oral composition and method of using same for the treatment of ulcers and other gastrointestinal disorders is disclosed. The composition comprises an agent capable of forming an ulcer-adherent protective complex in an acid environment combined with one or more alkaline materials in a total amount sufficient to substantially prevent the formation of such a complex in the mouth and adherence of such a complex to the buccal mucosa.

Inventors

  • 👤 Richard J. Harwood
  • 👤 Edward V. Henry
  • 👤 Joseph S. Sonk
  • 👤 Luke T. H. Foo
  • 👤 Jay L. Rheingold
  • 👤 Robert C. deGroof

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-05 13:05
CPC Classifications
A; A61; A61K; A61K31/00; A61K31/33; A61K31/395; A61K31/41; A61K31/425; A61K9/00; A61K9/20; A61K9/2004; A61K9/2009; A61K31/70; A61K9/0012; A61K9/0053; A61K9/0056; A61K9/006; A61P; A61P1/00; A61P1/04; C; C07; C07C; C07C265/00; C07C265/14

Claims Analysis

Total Claims: 28
Claim 1
Independent Claim 68 words
A pharmaceutical composition comprising a therapeutically effective amount of an agent capable of forming an ulcer-adherent protective complex in an acid environment, and one or more alkaline materials in a total amount sufficient to provide between about 0.5 and 10 milliequivalents of acid neutralizing capacity, whereby formation of said complex in the area of the mouth and adherence of said complex to the buccal mucosa are substantially prevented.
Claim 2
Dependent Claim 68 words
A pharmaceutical composition comprising a therapeutically effective amount of an agent capable of forming an ulcer-adherent protective complex in an acid environment, and one or more alkaline materials in a total amount sufficient to provide between about 0.5 and 10 milliequivalents of acid neutralizing capacity, whereby formation of said complex in the area of the mouth and adherence of said complex to the buccal mucosa are substantially prevented.
Claim 3
Dependent Claim 11 words
The pharmaceutical composition of claim 1 wherein said agent is sucralfate.
Claim 4
Dependent Claim 34 words
The pharmaceutical composition of claim 1 wherein said alkaline materials are present in an amount sufficient to provide acid neutralizing capacity in the range greater than about 0.5 and less than about 5 milliequivalents.
Claim 5
Dependent Claim 77 words
A chewable tablet formulation for an agent capable of forming an ulcer-adherent protective complex in an acid environment, which formulation comprises a therapeutically effective amount of said agent, and one or more alkaline materials in a total amount sufficient to provide between about 0.5 and 10 milliequivalents of acid neutralizing capacity in a pharmaceutically acceptable carrier comprising one or more ingredients selected from sugar, sweeteners, natural and artificial flavors, flavor enhancers, diluents, diluent/sweetness enhancers, lubricants and preservatives.
Claim 6
Dependent Claim 77 words
A chewable tablet formulation for an agent capable of forming an ulcer-adherent protective complex in an acid environment, which formulation comprises a therapeutically effective amount of said agent, and one or more alkaline materials in a total amount sufficient to provide between about 0.5 and 10 milliequivalents of acid neutralizing capacity in a pharmaceutically acceptable carrier comprising one or more ingredients selected from sugar, sweeteners, natural and artificial flavors, flavor enhancers, diluents, diluent/sweetness enhancers, lubricants and preservatives.
Claim 7
Dependent Claim 12 words
The chewable tablet formulation of claim 4 wherein said agent is sucralfate.
Claim 8
Dependent Claim 28 words
The chewable tablet formulation of claim 4 wherein said alkaline materials are present in an amount sufficient to provide about 5 or less milliequivalents of acid neutralizing capacity.
Claim 9
Dependent Claim 36 words
The chewable tablet formulation of claim 4 wherein said one or more alkaline materials are selected from magnesium hydroxide, aluminum hydroxide, sodium bicarbonate, magaldrate, calcium carbonate, hydrotalcite, dihydroxy aluminum sodium carbonate, magnesium oxide and magnesium trisilicate.
Claim 10
Dependent Claim 89 words
The chewable tablet formulation of claim 4 comprising up to 30 percent by weight each of one or more diluent/sweetness enhancers provided that the total diluent/sweetness enhancers are not more than 60 percent by weight of said formulation; up to 50 percent by weight of one or more sugars; up to about 10 percent by weight of one or more artificial and natural flavors; up to about 5 percent by weight of one or more sweeteners; and, up to about 5 percent by weight of one or more lubricants.
Claim 11
Dependent Claim 26 words
The chewable tablet formulation of claim 8 wherein said one or more diluent/sweetness enhancers are selected from mannitol, sorbitol, xylitol, aspartame, lycasin, glycerin and ammoniated glycyrhizin.
Claim 12
Dependent Claim 32 words
The chewable tablet formulation of claim 8 wherein said one or more lubricants are selected from magnesium stearate, stearic acid, talc, calcium stearate, sodium stearate, sterotex, sodium stearyl fumarate, stearowet and carbowax.
Claim 13
Dependent Claim 96 words
A chewable tablet formulation comprising a therapeutically effective amount of sucralfate; one or more alkaline materials in a total amount sufficient to provide between about 0.5 and 10 milliequivalents of acid neutralizing capacity; between about 10 and 20 percent by weight of sorbitol; between about 10 and 20 percent by weight of mannitol; between about 20 and 30 percent by weight of sugar; between about 0.1 and 1.5 percent by weight of natural and artificial flavors; less than about 1 percent by weight of sweeteners; and between about 1 and 2 percent by weight of lubricants.
Claim 14
Dependent Claim 96 words
A chewable tablet formulation comprising a therapeutically effective amount of sucralfate; one or more alkaline materials in a total amount sufficient to provide between about 0.5 and 10 milliequivalents of acid neutralizing capacity; between about 10 and 20 percent by weight of sorbitol; between about 10 and 20 percent by weight of mannitol; between about 20 and 30 percent by weight of sugar; between about 0.1 and 1.5 percent by weight of natural and artificial flavors; less than about 1 percent by weight of sweeteners; and between about 1 and 2 percent by weight of lubricants.
Claim 15
Dependent Claim 38 words
The chewable tablet formulation of claim 11 wherein said one or more alkaline materials are present in an amount sufficient to provide acid neutralizing capacity in the range greater than about 0.5 and less than about 5 milliequivalents.
Claim 16
Dependent Claim 36 words
The chewable tablet formulation of claim 11 wherein said one or more alkaline materials are selected from magnesium hydroxide, aluminum hydroxide, sodium bicarbonate, magaldrate, calcium carbonate, hydrotalcite, dihydroxy aluminum sodium carbonate, magnesium oxide and magnesium trisilicate.
Claim 17
Dependent Claim 14 words
The chewable tablet formulation of claim 13 wherein said alkaline material is magnesium hydroxide.
Claim 18
Dependent Claim 89 words
In a method for the treatment of stomach ulcers, duodenal ulcers or regurgitational esophagitis, which comprises administering to a patient in need thereof a therapeutically effective amount of an agent capable of forming an ulcer-adherent protective complex; the improvement comprising combining said agent with one or more alkaline materials in a total amount sufficient to provide between about 0.5 and 10 milliequivalents of acid neutralizing capacity, whereby formation of said complex in the area of the mouth and adherence of said complex to the buccal mucosa are substantially prevented.
Claim 19
Dependent Claim 89 words
In a method for the treatment of stomach ulcers, duodenal ulcers or regurgitational esophagitis, which comprises administering to a patient in need thereof a therapeutically effective amount of an agent capable of forming an ulcer-adherent protective complex; the improvement comprising combining said agent with one or more alkaline materials in a total amount sufficient to provide between about 0.5 and 10 milliequivalents of acid neutralizing capacity, whereby formation of said complex in the area of the mouth and adherence of said complex to the buccal mucosa are substantially prevented.
Claim 20
Dependent Claim 10 words
The method of claim 15 wherein said agent is sucralfate.
Claim 21
Dependent Claim 36 words
The method of claim 15 wherein said one or more alkaline materials are present in an amount sufficient to provide acid neutralizing capacity in the range greater than about 0.5 and less than about 5 milliequivalents.
Claim 22
Dependent Claim 34 words
The method of claim 15 wherein said one or more alkaline materials are selected from magnesium hydroxide, aluminum hydroxide, sodium bicarbonate, magaldrate, calcium carbonate, hydrotalcite, dihydroxy aluminum sodium carbonate, magnesium oxide and magnesium trisilicate.
Claim 23
Dependent Claim 48 words
The method of claim 15 wherein said combination of said agent and said one or more alkaline materials is in the form of a chewable tablet further including one or more ingredients selected from sugar, sweeteners, natural and artificial flavors, flavor enhancers, diluents, diluent/sweetness enhancers, lubricants and preservatives.
Claim 24
Dependent Claim 100 words
The method of claim 19 wherein, in addition to said agent and said alkaline materials, said chewable tablet comprises up to 30 percent by weight each of one or more diluent/sweetness enhancers provided that the total diluent/sweetness enhancers are not more than 60 percent by weight of said formulation; up to 50 percent by weight of one or more sugars; up to about 10 percent by weight of one or more artificial and natural flavors; up to about 5 percent by weight of one or more sweeteners; and, up to about 5 percent by weight of one or more lubricants.
Claim 25
Dependent Claim 24 words
The method of claim 20 wherein said one or more diluent/sweetness enhancers are selected from mannitol, sorbitol, xylitol, aspartame, lycasin, glycerin and ammoniated glycyrhizin.
Claim 26
Dependent Claim 30 words
The method of claim 20 wherein said one or more lubricants are selected from magnesium stearate, stearic acid, talc, calcium stearate, sodium stearate, sterotex, sodium stearyl fumarate, stearowet and carbowax.
Claim 27
Dependent Claim 30 words
A method of treating symptoms of upset stomach or dyspepsia comprising administering to a patient in need thereof a therapeutically effective amount of a chewable tablet formulation of claim 4.
Claim 28
Dependent Claim 26 words
A method of treating hiatal hernia comprising administering to a patient in need thereof a therapeutically effective amount of a chewable tablet formulation of claim 4.

References Cited (Backward Citations)

US3432489A Cited
US4668665A Cited
US4676984A Cited
EP0245855A2 Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1993-12-03 1994-06-04 1994-12-04 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1997-12-03 1998-06-04 1998-12-04 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2001-12-03 2002-06-04 2002-12-04 $7700.00 Window Closed / Lapsed

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