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US4486412A Expired / Lapsed US ⏱️ 0.0 years remaining

Encapsulated antacid dispersions

Assignee: Patheon Softgels Inc
•
Filing: 1983-03-15
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Granted: 1984-12-04
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Expires: 2003-03-15
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Abstract

Abstract Pharmaceutical unit dosage forms comprising dispersions of basic salts in a carrier mixture comprising polyalkylene glycols and a C 2 -C 5 polyol encapsulated in soft gelatin capsules are prepared without deleteriously affecting the stability of the capsules.

Inventors

  • 👤 Dilip Shah
  • 👤 Lionel Borkan
  • 👤 Ira R. Berry

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 16:03
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/48; A61K9/4841; A61K9/4866; A61K33/00; A61K33/06; A61K9/4858

Claims Analysis

Total Claims: 27
Claim 1
Independent Claim 67 words
A pharmaceutical unit dosage form comprising a soft gelatin capsule containing a dispersion of particles of a pharmaceutially-effective amount of a basic salt in a substantially water-free liquid carrier comprising a mixture of polyalkylene glycol and a C 2 -C 5 polyol; said carrier being present in an amount effective to coat the particles of the salt and thereby render them substantially non-reactive with said gelatin capsule.
Claim 2
Dependent Claim 67 words
A pharmaceutical unit dosage form comprising a soft gelatin capsule containing a dispersion of particles of a pharmaceutially-effective amount of a basic salt in a substantially water-free liquid carrier comprising a mixture of polyalkylene glycol and a C 2 -C 5 polyol; said carrier being present in an amount effective to coat the particles of the salt and thereby render them substantially non-reactive with said gelatin capsule.
Claim 3
Dependent Claim 24 words
The unit dosage form of claim 1 wherein the basic salt is selected from the group consisting of aluminum, magnesium, sodium and calcium salts.
Claim 4
Dependent Claim 43 words
The unit dosage form of claim 2 wherein the basic salt is selected from the group consisting of magnesium phosphate, magnesium hydroxide, magnesium oxide, magnesium carbonate, aluminum hydroxide, dihydroxy aluminum sodium carbonate, magaldrate, dihydroxy aluminum aminoacetate, sodium bicarbonate, calcium carbonate and mixtures thereof.
Claim 5
Dependent Claim 22 words
The unit dosage form of claim 1 wherein the polyalkylene glycol comprises a polyethylene gylcol and wherein the polyol comprises propylene glycol.
Claim 6
Dependent Claim 24 words
The unit dosage form of claim 4 wherein the polyalkylene glycol comprises a mixture of a liquid polyethylene glycol and a waxy polyethylene glycol.
Claim 7
Dependent Claim 29 words
The unit dosage form of claim 5 wherein the polyalkylene glycol comrpsies a mixture of polyethylene glycol 400 and polyethylene glycol 3350 in a weight ratio of about 15-40:1.
Claim 8
Dependent Claim 28 words
The unit dosage form of claim 3 wherein the dispersion comprises about 20-60% by weight of the basic salt, about 20-80% polyethylene glycol and about 0.2-10% propylene glycol.
Claim 9
Dependent Claim 25 words
The unit dosage form of claim 7 wherein the dispersion further comprises an effective amount of no more than about 5% by weight of polysorbate.
Claim 10
Dependent Claim 40 words
The unit dosage form of claim 8 wherein the basic salt is a mixture of aluminum hydroxide and magnesium hydroxide, the polyethylene glycol is a mixture of polyethylene glycol 400 and polyethylene glycol 3350 and the polysorbate is polysorbate 80.
Claim 11
Dependent Claim 15 words
The unit dosage form of claim 9 further comprising an effective flatulence-relieving amount of simethicone.
Claim 12
Dependent Claim 29 words
The unit dosage form of claim 7 wherein the basic salt is calcium carbonate and the polyethylene glycol is a mixture of polyethylene glycol 400 and polyethylene glycol 3350.
Claim 13
Dependent Claim 27 words
The unit dosage form of claim 6 wherein the basic salt is selected from the group consisting of calcium carbonate, magnesium hydroxide, aluminum hydroxide and mixtures thereof.
Claim 14
Independent Claim 75 words
A method for alleviating the symptoms of excessive gastic acidity comprising orally administering a soft gelatin capsule containing a dispersion comprising an amount of a pharmaceutically-effective amount of an antacid basic salt sufficient to neutralize at least about 5 mEq of hydrochloric acid and a substantially water-free liquid carrier comprising a mixture of polyalkylene glycol and a C 2 -C 5 polyol effective to substantially inhibit degradation of the gelatin capsule by the basic salt.
Claim 15
Independent Claim 75 words
A method for alleviating the symptoms of excessive gastic acidity comprising orally administering a soft gelatin capsule containing a dispersion comprising an amount of a pharmaceutically-effective amount of an antacid basic salt sufficient to neutralize at least about 5 mEq of hydrochloric acid and a substantially water-free liquid carrier comprising a mixture of polyalkylene glycol and a C 2 -C 5 polyol effective to substantially inhibit degradation of the gelatin capsule by the basic salt.
Claim 16
Dependent Claim 11 words
The method of claim 13 wherein the polyol comprises propylene glycol.
Claim 17
Dependent Claim 41 words
The method of claim 14 wherein the basic salt is selected from the group consisting of the salts of magnesium, calcium, sodium, aluminum and mixtures thereof and is present in an amount sufficient to neutralize about 5-25 mEq of hydrochloric acid.
Claim 18
Dependent Claim 42 words
The method of claim 14 wherein the polyalkylene glycol is a mixture of a liquid polyethylene glycol having a molecular weight in the range of about 100-700 and a waxy polyethylene glycol having a molecular weight in the range of about 800-9000.
Claim 19
Dependent Claim 20 words
The method of claim 16 wherein the weight ratio of liquid polyethylene glycol to waxy polyethylene glycol is about 20-35:1.
Claim 20
Dependent Claim 24 words
The method claim 15 wherein the basic salt is selected from the group consisting of magnesium hydroxide, aluminum hydroxide, calcium carbonate and mixtures thereof.
Claim 21
Dependent Claim 42 words
The method of claim 18 wherein the basic salt comprises calcium carbonate and the polyalkylene glycol comprises about 20-80% by weight of the dispersion of a mixture of polyethylene glycol 400 and polyethylene glycol 3350 in a ratio of about 15-40:1, respectively.
Claim 22
Dependent Claim 49 words
The method of claim 18 wherein the basic salt comprises a mixture of aluminum hydroxide and magnesium hydroxide and the polyalkylene glycol comprises about 20-80% by weight of the dispersion of a mixture of polyethylene glycol 400 and polyethylene glycol 3350 in a weight ratio of about 20-35:1, respectively.
Claim 23
Dependent Claim 17 words
The method of claim 19 wherein the propylene glycol comprises about 0.2-10% by weight of the dispersion.
Claim 24
Dependent Claim 17 words
The method of claim 20 wherein the propylene glycol comprises about 0.2-10% by weight of the dispersion.
Claim 25
Dependent Claim 23 words
The method of claim 20 wherein the dispersion further comprises an effective amount of no more than about 5% by weight of polysorbate.
Claim 26
Dependent Claim 21 words
The method of claim 19 wherein the dispersion further comprises an effective amount of no more than about 5% of simethicone.
Claim 27
Dependent Claim 30 words
A method of administering a pharmaceutically-effective amount of a basic salt to a patient comprising the oral, buccal, rectal or vaginal administration of the unit dosage form of claim 1.

References Cited (Backward Citations)

US3767794A Cited
US3843778A Cited
US4198391A Cited
US4088750A Cited
US4002718A Cited
US4067960A Cited
US4150110A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1987-12-04 1988-06-04 1988-12-04 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1991-12-04 1992-06-04 1992-12-04 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 1995-12-04 1996-06-04 1996-12-04 $7700.00 Window Closed / Lapsed

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