EP0538858A1
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EP
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Improved lyophilized ifosfamide compositions
Assignee: Bristol Myers Squibb Co
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Filing: 1992-10-22
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Granted: —
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Expires: 2012-10-22
Abstract
Abstract Improved lyophilizate compositions of ifosfamide comprising urea as the primary excipient and, optionally, mesna, are produced in a modified freeze-drying process to give products with increased heat stability and extended shelf storage life.
Inventors
- 👤 Robert Lee Alexander
- 👤 Robert Joseph Behme
- 👤 Joseph Arthur Scott
- 👤 Dana Brooke
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-23 05:37
CPC Classifications
A; A61; A61K; A61K31/00; A61K31/66; A61K31/665; A61K31/675; A61K47/00; A61K47/06; A61K47/16; A61K47/18; A61K9/00; A61K9/0012; A61K9/0019; A61K9/14; A61K9/19; A61P; A61P35/00
Claims Analysis
Total Claims: 10
Claim 1
Independent Claim
29 words
A lyophilizate composition having improved heat stability and shelf-life, the lyophilizate comprising from about 0.3 to 5 parts by weight of urea to each part by weight of ifosfamide.
Claim 2
Dependent Claim
23 words
A lyophilizate composition of claim 1 comprising about 0.8 to 1.5 parts by weight of urea to each part by weight of ifosfamide.
Claim 3
Dependent Claim
29 words
A lyophilizate composition of claim 1 or claim 2 further comprising about 0.1 to 1 part by weight of sodium 2-mercaptoethanesulfonate (mesna) to each part by weight of ifosfamide.
Claim 4
Dependent Claim
33 words
A dosage unit formulation comprising the lyophilizate composition of claim 1 in a container of sufficient size to allow reconstitution with diluent to give an intended solution of desired ifosfamide concentration for administration.
Claim 5
Dependent Claim
20 words
The dosage unit formulation of claim 4 wherein the lyophilizate composition comprises approximately 1g of ifosfamide and 1g of urea.
Claim 6
Dependent Claim
20 words
The dosage unit formulation of claim 4 wherein the lyophilizate composition comprises approximately 3g of ifosfamide and 3g of urea.
Claim 7
Dependent Claim
28 words
The dosage unit formulation of claim 5 or claim 6 wherein the lyophilizate compositions comprise from about 100 mg to 1g of mesna to each gram of ifosfamide.
Claim 8
Dependent Claim
80 words
A process for the preparation of a lyophilizate composition having improved heat stability and shelf-life, which comprises freezing an aqueous solution containing from about 0.3 to 5 parts by weight of an excipient consisting essentially of urea to each part by weight of ifosfamide, to a temperature of about -40°C and removing both nonadsorptively bound and adsorptively bound water by sublimation at a temperature between about -40°C and about +28°C and at a pressure between about 0.7 and 0.1 torr.
Claim 9
Dependent Claim
32 words
A process according to claim 12 wherein the aqueous solution to be frozen further comprises from about 0.1 to 1 part by weight of sodium-2-mercaptoethanesulfonate(mesna) to each part by weight of ifosfamide.
Claim 10
Dependent Claim
37 words
The dosage unit formulation of claim 5, claim 6 or claim 7 wherein said composition is reconstituted with about 20 ml of diluent (such as Water for Injection) per gram of ifosfamide to provide solution for administration.
References Cited (Backward Citations)
US4537883A
Cited
EP0334083A1
Cited
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