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US3917812A Expired / Lapsed US ⏱️ 0.0 years remaining

Compositions and method for diagnosing diseases of the pancreas

Assignee: Roche Diagnostics GmbH
•
Filing: 1974-03-06
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Granted: 1975-11-04
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Expires: 1994-03-06
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Abstract

Abstract Diagnostic compositions containing fluorescein carboxylic acid esters comprising a hard gelatine capsule containing (a) a granulate and (b) an outer phase surrounding the granulate, wherein the granulate comprises a fluorescein carboxylic acid ester, sodium carboxymethylamylopectin, microcrystalline cellulose and polyvinylpyrrolidone and the outer phase comprises magnesium stearate, talc and lactose, provide particularly efficacious forms of administration of such fluorescein esters in the determination of pancreas enzymes.

Inventors

  • 👤 Heinrich Woog
  • 👤 Werner Rothe

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-07 22:54
CPC Classifications
A; A61; A61K; A61K49/00; A61K49/001; A61K49/0013; A61K49/0017; A61K49/0019; A61K49/0021; A61K49/0041; A61K49/0043; A61K49/005; A61K49/0052; A61K49/0063; A61K49/0069; A61K49/0089; A61K49/0091; A61K9/00; A61K9/48; A61K9/4808; A61K9/4841

Claims Analysis

Total Claims: 13
Claim 1
Independent Claim 73 words
DIAGNOISIT COMPOSITION CONTAINING FLUORESCEIN DILAURYL ESTER, WHICH COMPOSITION COMPRISES A HARD GELATINE CAPSULE CONTAINING (A) A GRANULATE AND (B) AN OUTER PHASE SURROUNDING THE GRANDULATE AND COATED THEREON, WHEREIN SAID GRANULATE COMPRISES 10 TO 63% OF SAID FLUORESCEIN DILAURYL ESTER, 6 TO 13% OF SODIUM CARBOCYMETHYLAMYLOPECTIN, 3 TO 7 % OF MICROCRYSTALLINE CELLOLOSE AND 8 TO 1, % OF POLYVINYLPYROLIDONE AND THE OUTER PHASE COMPRISES A MIXTURE OF MAGNESIUM STERATE, TALE AND LACTOSE.
Claim 2
Dependent Claim 73 words
DIAGNOISIT COMPOSITION CONTAINING FLUORESCEIN DILAURYL ESTER, WHICH COMPOSITION COMPRISES A HARD GELATINE CAPSULE CONTAINING (A) A GRANULATE AND (B) AN OUTER PHASE SURROUNDING THE GRANDULATE AND COATED THEREON, WHEREIN SAID GRANULATE COMPRISES 10 TO 63% OF SAID FLUORESCEIN DILAURYL ESTER, 6 TO 13% OF SODIUM CARBOCYMETHYLAMYLOPECTIN, 3 TO 7 % OF MICROCRYSTALLINE CELLOLOSE AND 8 TO 1, % OF POLYVINYLPYROLIDONE AND THE OUTER PHASE COMPRISES A MIXTURE OF MAGNESIUM STERATE, TALE AND LACTOSE.
Claim 3
Dependent Claim 20 words
The composition of claim 1 wherein the granulate also contains at least one of highly-dispersed silicic acid or calcium carbonate.
Claim 4
Dependent Claim 25 words
The composition of claim 1 wherein said outer phase additionally comprises at least one of microcrystalline cellulose, corn starch, highly-dispersed silicic acid or calcium carbonate.
Claim 5
Dependent Claim 23 words
The diagnostic composition of claim 1 wherein the fluorescein ester is contained in an amount of from 0.1 to 0.5 mM per capsule.
Claim 6
Dependent Claim 21 words
The diagnostic composition of claim 4 wherein the fluorescein ester is contained in an amount of about 0.25 mM per capsule.
Claim 7
Dependent Claim 32 words
The diagnostic composition of claim 1 wherein the granulate additionally contains a material selected from the group consisting of 0.3 to 0.5% silicic acid, 1 to 5% calcium carbonate and mixtures thereof.
Claim 8
Dependent Claim 25 words
the diagnostic composition of claim 1 wherein the outer phase contains 1 to 2% magnesium stearate, 1 to 4% talc, and 10 to 26% lactose.
Claim 9
Dependent Claim 43 words
The diagnostic composition of claim 1 wherein the outer phase additionally contains at least one material selected from the group consisting of 5 to 11% microcrystalline cellulose, 3 to 11% corn starch, 1 to 2% silicic acid and 1 to 2% calcium carbonate.
Claim 10
Dependent Claim 23 words
The diagnostic composition of claim 1 wherein the particle size of the granules of the granulate is from about 0.1 to 0.75 mm.
Claim 11
Dependent Claim 62 words
Process for the preparation of the diagnostic composition of claim 1 which process comprises preparing a granulate of said fluorescein dilauryl acid ester, sodium carboxymethylamylopectin, microcrystalline cellulose and polyvinylpyrrolidone; preparing an outer phase comprising magnesium stearate, talc and lactose; surrounding and coating said granulate with said outer phase; and placing the granulate coated with said outer phase into a hard gelatine capsule.
Claim 12
Dependent Claim 43 words
In the method of diagnosing diseases of the pancreas which comprises oral administration of fluorescein carboxylic acid esters and the determination of the fluorescein excreted in the urine, the improvement which comprises orally administering the fluorescein carboxylic aciD ester composition of claim 1.
Claim 13
Dependent Claim 28 words
The method of claim 11 wherein said composition is administered in a dosage of up to 175 mM of said fluorescein ester per capsule in unit dosage form.

References Cited (Backward Citations)

US2801203A Cited
US3079303A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1978-11-03 1979-05-05 1979-11-04 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1982-11-03 1983-05-05 1983-11-04 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 1986-11-03 1987-05-05 1987-11-04 $7700.00 Window Closed / Lapsed

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