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US4092428A Expired / Lapsed US ⏱️ 0.0 years remaining

Process of preparing stable prostaglandin E group-containing formulation

Assignee: Astellas Pharma Inc
•
Filing: 1977-03-07
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Granted: 1978-05-30
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Expires: 1997-03-07
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Abstract

Abstract There is provided a process of preparing a prostaglandin E group-containing formulation by adding to a prostaglandin E group at least one additive selected from the group consisting of thiol compound, a water-soluble high molecular weight compound, and a water-soluble salt of deoxycholic acid and then subjecting the mixture to lyophilization.

Inventors

  • 👤 Masuo Murakami
  • 👤 Shigemi Kawahara
  • 👤 Hiroitsu Kawata
  • 👤 Kiyoshi Okazaki
  • 👤 Jun Sekino
  • 👤 Hidemi Shimizu

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-05 04:23
CPC Classifications
C; C07; C07C; C07C405/00

Claims Analysis

Total Claims: 13
Claim 1
Independent Claim 83 words
A process of preparing a stable prostaglandin E-containing formulation which comprises adding to prostaglandin E 1 , E 2 or E 3 at least one member selected from the group consisting of an arginine salt, a lysine salt and an alkali metal salt of deoxycholic acid and subjecting the resulting mixture to lyophilization, said arginine salt, lysine salt or alkali metal salt of deoxycholic acid being present in an amount varying between 1 to 200 mg. per 0.05 mg. of said prostaglandin E.
Claim 2
Dependent Claim 83 words
A process of preparing a stable prostaglandin E-containing formulation which comprises adding to prostaglandin E 1 , E 2 or E 3 at least one member selected from the group consisting of an arginine salt, a lysine salt and an alkali metal salt of deoxycholic acid and subjecting the resulting mixture to lyophilization, said arginine salt, lysine salt or alkali metal salt of deoxycholic acid being present in an amount varying between 1 to 200 mg. per 0.05 mg. of said prostaglandin E.
Claim 3
Dependent Claim 41 words
A process as claimed in claim 1 wherein said prostaglandin E is a member selected from the group consisting of 16-methyl-prostaglandin E 2 , 3-methyl-prostaglandin E 2 . 3-16(R)-dimethyl-prostaglandin E 2 , 17-oxo-15-epi-prostaglandin E 2 , and 16(R)-hydroxy-prostaglandin E 2 .
Claim 4
Dependent Claim 40 words
A process as claimed in claim 1 wherein when said prostaglandin E is in a crystalline state, the crystals are dissolved in an organic solvent followed by removal of the solvent before the additive is added to said prostaglandin E.
Claim 5
Dependent Claim 16 words
A process as claimed in claim 3 wherein said organic solvent is ethanol or ethyl acetate.
Claim 6
Dependent Claim 16 words
A process as claimed in claim 1 wherein said prostaglandin E is a natural prostaglandin E.
Claim 7
Dependent Claim 16 words
A process as claimed in claim 1 wherein said prostaglandin E is a synthetic prostaglandin E.
Claim 8
Dependent Claim 32 words
A process according to claim 1 in which 5-100 mgs. of said arginine salt, lysine salt and alkali metal salts of deoxycholic acid are added to 0.05 mg. of said prostaglandin E.
Claim 9
Dependent Claim 76 words
A lyophilized pharmaceutical composition comprising as the active ingredient a therapeutically effective amount of prostaglandin E 1 , E 2 or E 3 and at least one member selected from the group consisting of an arginine salt, a lysine salt and alkali metal salts of deoxycholic acid, said arginine salt, lysine salt and alkali metal salts of deoxycholic acid being present in an amount from 1 to 200 mg. per 0.05 mg. of said prostaglandin E.
Claim 10
Dependent Claim 76 words
A lyophilized pharmaceutical composition comprising as the active ingredient a therapeutically effective amount of prostaglandin E 1 , E 2 or E 3 and at least one member selected from the group consisting of an arginine salt, a lysine salt and alkali metal salts of deoxycholic acid, said arginine salt, lysine salt and alkali metal salts of deoxycholic acid being present in an amount from 1 to 200 mg. per 0.05 mg. of said prostaglandin E.
Claim 11
Dependent Claim 42 words
A lyophilized pharmaceutical composition as claimed in claim 8 wherein said prostaglandin E is a member selected from the group consisting of 16-methyl-prostaglandin E 2 , 3-methyl-prostaglandin E 2 .3-16(R)-dimethyl-prostaglandin E 2 , 17-oxo-15-epi-prostaglandin E 2 , and 16(R)-hydroxy-prostaglandin E 2 .
Claim 12
Dependent Claim 18 words
A lyophilized pharmaceutical composition as claimed in claim 8 wherein said prostaglandin E is a natural prostaglandin E.
Claim 13
Dependent Claim 18 words
A lyophilized pharmaceutical composition as claimed in claim 8 wherein said prostaglandin E is a synthetic prostaglandin E.

References Cited (Backward Citations)

US3826823A Cited
US3954787A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1981-05-29 1981-11-28 1982-05-30 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1985-05-29 1985-11-28 1986-05-30 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 1989-05-29 1989-11-28 1990-05-30 $7700.00 Window Closed / Lapsed

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