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US5213810A Expired / Lapsed US ⏱️ 0.0 years remaining

Stable compositions for parenteral administration and method of making same

Assignee: Wyeth Holdings LLC
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Filing: 1990-03-30
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Granted: 1993-05-25
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Expires: 2010-03-30
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Abstract

Abstract The invention relates to certain stable microsphere compositions suitable for parenteral administration containing a fat or wax or mixture thereof; a biologically active protein, peptide or polypeptide; and an oil, semi-soft fat, fatty acid derivative or mixture thereof. The invention also relates to a method of making the microsphere compositions.

Inventors

  • 👤 William Steber

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-04 20:08
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/48; A61K38/00; A61K38/16; A61K38/17; A61K38/22; A61K38/27; A61K9/14; A61K9/16; A61K9/1605; A61K9/1617

Claims Analysis

Total Claims: 24
Claim 1
Independent Claim 66 words
A improved process for preparing a microsphere composition having the steps of melt blending a fat or wax or mixture thereof, and a biologically active protein, peptide or polypeptide to form a blend and prilling said blend to form said microsphere composition, the improvement which comprises admixing about 1% to 30% of an oil, semi-soft fat, fatty acid derivative or mixture thereof before prilling said blend.
Claim 2
Dependent Claim 66 words
A improved process for preparing a microsphere composition having the steps of melt blending a fat or wax or mixture thereof, and a biologically active protein, peptide or polypeptide to form a blend and prilling said blend to form said microsphere composition, the improvement which comprises admixing about 1% to 30% of an oil, semi-soft fat, fatty acid derivative or mixture thereof before prilling said blend.
Claim 3
Dependent Claim 35 words
The process according to claim 1 wherein the blend comprises about 30% to 95% of the fat or wax or mixture thereof and about 2% to 70% of the biologically active protein peptide or polypeptide.
Claim 4
Dependent Claim 18 words
The process according to claim 2 wherein the biologically active protein is bovine, porcine or avian growth hormone.
Claim 5
Dependent Claim 19 words
The process according to claim 3 wherein the blend comprises about 5% to 20% of a neutral triglycerol oil.
Claim 6
Dependent Claim 21 words
The process according to claim 1 which further comprises suspending the microsphere composition in a pharmaceutically and pharmacologically acceptable liquid vehicle.
Claim 7
Dependent Claim 18 words
The process according to claim 5 wherein the vehicle is an aqueous buffered system or an oil system.
Claim 8
Dependent Claim 12 words
A microsphere composition prepared in accordance with the process of claim 1.
Claim 9
Dependent Claim 37 words
A improved microsphere composition having fat or wax or mixture thereof and a biologically active protein, peptide or polypeptide, the improvement comprising about 1% to 30% of an oil, semi-soft fat, fatty acid derivative or mixture thereof.
Claim 10
Dependent Claim 37 words
A improved microsphere composition having fat or wax or mixture thereof and a biologically active protein, peptide or polypeptide, the improvement comprising about 1% to 30% of an oil, semi-soft fat, fatty acid derivative or mixture thereof.
Claim 11
Dependent Claim 36 words
The microsphere composition according to claim 8 wherein the composition comprises about 30% to 95% of the fat or wax or mixture thereof and about 2% to 70% of the biologically active protein peptide or polypeptide.
Claim 12
Dependent Claim 19 words
The microsphere composition according to claim 9 wherein the biologically active protein is bovine, porcine or avian growth hormone.
Claim 13
Dependent Claim 26 words
The microsphere composition according to claim 10 wherein the oil is a neutral triglyceride oil and the composition comprises about 5% to 20% of the oil.
Claim 14
Dependent Claim 51 words
A microsphere composition for parenteral administration comprising on a weight basis about 30% to 95% of a fat or wax or mixture thereof; about 2% to 70% of a biologically active protein, peptide or polypeptide; and about 1% to 30% of an oil, semi-soft fat, fatty acid derivative or mixture thereof.
Claim 15
Dependent Claim 51 words
A microsphere composition for parenteral administration comprising on a weight basis about 30% to 95% of a fat or wax or mixture thereof; about 2% to 70% of a biologically active protein, peptide or polypeptide; and about 1% to 30% of an oil, semi-soft fat, fatty acid derivative or mixture thereof.
Claim 16
Dependent Claim 15 words
The microsphere composition according to claim 12 comprising about 5% to 20% of the oil.
Claim 17
Dependent Claim 19 words
The microsphere composition according to claim 12 wherein the biologically active protein is bovine, porcine or avian growth hormone.
Claim 18
Dependent Claim 15 words
The microsphere composition according to claim 14 wherein the oil is a neutral triglycerol oil.
Claim 19
Dependent Claim 21 words
The microsphere composition according to claim 2 for parenteral administration and slow release in a pharmaceutically and pharmacologically acceptable liquid vehicle.
Claim 20
Dependent Claim 19 words
The microsphere composition according to claim 16 wherein the vehicle is an aqueous buffered system or an oil system.
Claim 21
Dependent Claim 59 words
A process for preparing a microsphere composition which comprises: melt blending on a weight basis about 30% to 95% of a fat or wax or mixture thereof, about 2% to 70% of a biologically active protein, peptide or polypeptide and about 1% to 30% of an oil to form a blend; and prilling said blend to form said composition.
Claim 22
Dependent Claim 59 words
A process for preparing a microsphere composition which comprises: melt blending on a weight basis about 30% to 95% of a fat or wax or mixture thereof, about 2% to 70% of a biologically active protein, peptide or polypeptide and about 1% to 30% of an oil to form a blend; and prilling said blend to form said composition.
Claim 23
Dependent Claim 16 words
The process according to claim 18 wherein the blend comprises 5% to 20% of the oil.
Claim 24
Dependent Claim 26 words
The process according to claim 19 wherein the oil is a neutral triglycerol oil and the biologically active protein is bovine, porcine or avian growth hormone.

References Cited (Backward Citations)

US3147187A Cited
US4483847A Cited
US4666839A Cited
US4452775A Cited
US4568559A Cited
US4568536A Cited
US4696914A Cited
US4837381A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1996-05-24 1996-11-23 1997-05-25 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2000-05-24 2000-11-23 2001-05-25 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2004-05-24 2004-11-23 2005-05-25 $7700.00 Window Closed / Lapsed

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