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US4469684A Expired / Lapsed US ⏱️ 0.0 years remaining

Storage stable topical pharmaceutical composition containing zinc erythromycin and low dielectric solvents

Assignee: Procter and Gamble Co
•
Filing: 1982-10-15
•
Granted: 1984-09-04
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Expires: 2002-10-15
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Abstract

Abstract A storage stable topical pharmaceutical composition containing zinc erythromycin, particularly useful in the topical treatment of acne vulgaris, is disclosed. This composition contains a solvent having a dielectric constant, measured at 25 DEG C., of from about 5.5 to about 15, preferably from about 8 to about 12, such as t-butanol, to impart storage stability to the zinc erythromycin component. The composition may additionally contain particularly selected pharmaceutically-acceptable nitrogen-containing stabilizer components, such as diisopropanolamine.

Inventors

  • 👤 James E. Huggins
  • 👤 Mary L. Batt
  • 👤 William J. Kozarek

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-26 15:27
CPC Classifications
A; A61; A61K; A61K31/00; A61K31/70; A61K47/00; A61K47/06; A61K47/08; A61K47/10; A61K47/16; A61K47/18; A61K9/00; A61K9/0012; A61K9/0014; A61P; A61P17/00; A61P31/00; A61P31/04

Claims Analysis

Total Claims: 13
Claim 1
Independent Claim 56 words
A stable topical pharmaceutical composition comprising: (a) a safe and effective amount of zinc erythromycin comprising a mixture of a toxicologically-acceptable zinc salt and an erythromycin compound selected from the group consisting of erythromycin base, salts of erythromycin base with acids, and ester derivatives of erythromycin; and (b) from about 50% to about 99% of t-butanol.
Claim 2
Dependent Claim 56 words
A stable topical pharmaceutical composition comprising: (a) a safe and effective amount of zinc erythromycin comprising a mixture of a toxicologically-acceptable zinc salt and an erythromycin compound selected from the group consisting of erythromycin base, salts of erythromycin base with acids, and ester derivatives of erythromycin; and (b) from about 50% to about 99% of t-butanol.
Claim 3
Dependent Claim 17 words
A composition according to claim 1 which contains from about 0.3% to about 15% of component (a).
Claim 4
Dependent Claim 16 words
A composition according to claim 2 having a pH of from about 7 to about 10.
Claim 5
Dependent Claim 16 words
A composition according to claim 3 which contains from about 55% to about 80% of t-butanol.
Claim 6
Dependent Claim 45 words
A composition according to claim 3 which additionally contains from about 0.1% to about 10% of a pharmaceutically-acceptable stabilizer selected from the group consisting of diisopropanolamine, monoethanolamine, 2-amino-2-methyl-1-propanol, diethylamine, N,N-dimethylethanolamine, triethylamine, triethanolamine, cetyl pyridinium chloride, C 20 ammonium hexanoate, 1-dimethylamino-2-propanol, 3-dimethylamino-1-propanol, lecithin, and mixtures thereof.
Claim 7
Dependent Claim 18 words
A composition according to claim 5 which contains from about 0.5% to about 5% of the stabilizer component.
Claim 8
Dependent Claim 12 words
A composition according to claim 6 wherein the stabilizer component is diisopropanolamine.
Claim 9
Dependent Claim 19 words
A composition according to claim 6 which additionally contains from about 1% to about 45% of a pharmaceutically-acceptable cosolvent.
Claim 10
Dependent Claim 17 words
A composition according to claim 8 which contains from about 15% to about 35% of said cosolvent.
Claim 11
Dependent Claim 12 words
A composition according to claim 9 wherein the stabilizer component is diisopropanolamine.
Claim 12
Dependent Claim 12 words
A composition according to claim 10 wherein the cosolvent is diisopropyl sebacate.
Claim 13
Dependent Claim 18 words
A composition according to claim 11 wherein component is the reaction product of erythromycin base and zinc acetate.

References Cited (Backward Citations)

US3562806A Cited
US3472931A Cited
US3927197A Cited
US4006218A Cited
US4000263A Cited
FR2383667A1 Cited
US4261982A Cited
BE889327A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1987-09-04 1988-03-05 1988-09-04 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1991-09-04 1992-03-05 1992-09-04 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 1995-09-04 1996-03-05 1996-09-04 $7700.00 Window Closed / Lapsed

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