US4537883A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Lyophilized cyclophosphamide
Assignee: Mead Johnson and Co LLC
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Filing: 1984-03-13
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Granted: 1985-08-27
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Expires: 2004-03-13
Abstract
Abstract A lyophilized pharmaceutical solid composition containing cyclophosphamide for reconstitution with water to provide a solution for oral or parenteral administration. This lyophilized cyclophosphamide solid composition demonstrates improved stability, solubility characteristics and enhanced appearance compared with currently available dry powder pre-mix compositions of cyclophosphamide. The lyophilized solid composition contains about 20 parts by weight of cyclophosphamide, about 11/4-2 parts by weight of water and from about 10-85 parts by weight of excipient which is comprised mainly of mannitol. Processes for making the composition are disclosed.
Inventors
- 👤 Robert L. Alexander
- 👤 Robert J. Bequette
- 👤 Terry T. Kensler
- 👤 Joseph A. Scott
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 12:19
CPC Classifications
A; A61; A61K; A61K47/00; A61K47/06; A61K47/26; A61K31/00; A61K31/66; A61K31/675; A61K9/00; A61K9/0012; A61K9/0019; A61K9/14; A61K9/19
Claims Analysis
Total Claims: 17
Claim 1
Independent Claim
43 words
A hydrated lyophilizate composition with improved stability, superior solubility characteristics and enhanced appearance comprising about 20 parts by weight of cyclophosphamide, taken as the anhydride, about 11/4-2 parts by weight of water and from about 10 to 85 parts by weight of mannitol.
Claim 2
Dependent Claim
43 words
A hydrated lyophilizate composition with improved stability, superior solubility characteristics and enhanced appearance comprising about 20 parts by weight of cyclophosphamide, taken as the anhydride, about 11/4-2 parts by weight of water and from about 10 to 85 parts by weight of mannitol.
Claim 3
Dependent Claim
37 words
The hydrated lyophilizate composition of claim 1 comprising about 20 parts by weight of cyclophosphamide, taken as the anhydride, about 11/4-2 parts by weight of water and from about 10 to 40 parts by weight of mannitol.
Claim 4
Dependent Claim
36 words
The hydrated lyophilizate of claim 1 comprising about 20 parts by weight of cyclophosphamide, taken as the anhydride, about 11/4-2 parts by weight of water and from about 10 to 20 parts by weight of mannitol.
Claim 5
Dependent Claim
34 words
The hydrated lyophilizate composition of claim 1 comprising about 20 parts by weight of cyclophosphamide, taken as the anhydride, about 11/4-2 parts by weight of water and about 15 parts by weight of mannitol.
Claim 6
Dependent Claim
37 words
The hydrated lyophilizate composition of claim 1 comprising about 20 parts by weight of cyclophosphamide, taken as the anhydride, about 11/2 parts by weight of water and from about 10 to 40 parts by weight of mannitol.
Claim 7
Dependent Claim
40 words
A single dose formulation comprising the hydrated lyophilizate composition of claim 4 in a single dose vial container means of sufficient size to allow reconstitution with water to give an intended volume of solution of desired cyclophosphamide concentration for administration.
Claim 8
Dependent Claim
28 words
The single dose form of claim 6 wherein the hydrated lyophilizate composition comprises approximately 100 mg cyclophosphamide, taken as the anhydride, 75 mg mannitol and 7 mg water.
Claim 9
Dependent Claim
21 words
The single dose of claim 7 wherein said composition is reconstituted with 5 mL of water to provide solution for administration.
Claim 10
Dependent Claim
28 words
The single dose form of claim 6 wherein the hydrated lyophilizate composition comprises approximately 200 mg cyclophosphamide, taken as the anhydride, 150 mg mannitol and 14 mg water.
Claim 11
Dependent Claim
21 words
The single dose of claim 9 wherein said composition is reconstituted with 10 mL of water to provide solution for administration.
Claim 12
Dependent Claim
28 words
The single dose form of claim 6 wherein the hydrated lyophilizate composition comprises approximately 500 mg cyclophosphamide, taken as the anhydride, 375 mg mannitol and 35 mg water.
Claim 13
Dependent Claim
21 words
The single dose of claim 11 wherein said composition is reconstituted with 25 mL of water to provide solution for administration.
Claim 14
Dependent Claim
28 words
The single dose form of claim 6 wherein the hydrated lyophilizate composition comprises approximately 1,000 mg cyclophosphamide, taken as the anhydride, 750 mg mannitol and 70 mg water.
Claim 15
Dependent Claim
21 words
The single dose of claim 13 wherein said composition is reconstituted with 50 ml of water to provide solution for administration.
Claim 16
Dependent Claim
28 words
The single dose form of claim 6 wherein the hydrated lyophilizate composition comprises approximately 2,000 mg cyclophosphamide, taken as the anhydride, 1,500 mg mannitol and 140 mg water.
Claim 17
Dependent Claim
21 words
The single dose of claim 15 wherein said composition is reconstituted with 100 mL of water to provide solution for administration.
References Cited (Backward Citations)
US3018302A
Cited
US3732340A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1988-08-26 | 1989-02-25 | 1989-08-27 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1992-08-26 | 1993-02-25 | 1993-08-27 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1996-08-26 | 1997-02-25 | 1997-08-27 | $7700.00 | Window Closed / Lapsed |