US6096331A
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Methods and compositions useful for administration of chemotherapeutic agents
Assignee: Abraxis Bioscience LLC
•
Filing: 1997-09-09
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Granted: 2000-08-01
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Expires: 2017-09-09
Abstract
Abstract In accordance with the present invention, there are provided compositions and methods useful for the in vivo delivery of a pharmaceutically active agent, wherein the agent is associated with a polymeric biocompatible material.
Inventors
- 👤 Neil P. Desai
- 👤 Patrick Soon-Shiong
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-29 16:53
CPC Classifications
A; A23; A23L; A23L33/00; A23L33/40; A61; A61K; A61K47/00; A61K47/50; A61K47/69; A61K47/6921; A61K47/6927; A61K49/00; A61K49/22; A61K49/222; A61K49/223; A61K49/226; A61K9/00; A61K9/0012; A61K9/0019; A61K9/0026; A61K9/48; A61K9/50; A61K9/5005; A61K9/5021; A61K9/5052; A61K9/51; A61K9/5107; A61K9/513; A61K9/5169; A61K9/5192; B; B82; B82Y; B82Y5/00; A61K9/10; A61K9/107; A61K9/1075; A61K9/14; A61K9/19
Claims Analysis
Total Claims: 70
Claim 1
Independent Claim
63 words
A method for the administration of a taxane to a subject in need thereof, said method comprising systemically administering a dose in the range of about 30 mg/m 2 to about 1000 mg/m 2 of said taxane to said subject in a pharmaceutically acceptable formulation substantially free of cremophor, over an administration time of less than 3 hours, without the use of premedication.
Claim 2
Independent Claim
63 words
A method for the administration of a taxane to a subject in need thereof, said method comprising systemically administering a dose in the range of about 30 mg/m 2 to about 1000 mg/m 2 of said taxane to said subject in a pharmaceutically acceptable formulation substantially free of cremophor, over an administration time of less than 3 hours, without the use of premedication.
Claim 3
Dependent Claim
15 words
The method of claim 1, wherein said dose is at least 135 mg/m 2 .
Claim 4
Dependent Claim
16 words
The method of claim 1, wherein said pharmaceutically acceptable formulation is administered as a bolus injection.
Claim 5
Dependent Claim
15 words
The method of claim 3, wherein said dose is at least 135 mg/m 2 .
Claim 6
Dependent Claim
14 words
The method of claim 1, wherein said administration period is less than 2 hours.
Claim 7
Dependent Claim
15 words
The method of claim 1, wherein said dose is at least 175 mg/m 2 .
Claim 8
Independent Claim
64 words
A method for the administration of a taxane to a subject in need thereof, said method comprising systemically administering a dose in the range of about 30 mg/m 2 to about 1000 mg/m 2 of said taxane to said subject in a pharmaceutically acceptable formulation substantially free of cremophor without the use of premedication, with a treatment cycle of no greater than 2 weeks.
Claim 9
Independent Claim
64 words
A method for the administration of a taxane to a subject in need thereof, said method comprising systemically administering a dose in the range of about 30 mg/m 2 to about 1000 mg/m 2 of said taxane to said subject in a pharmaceutically acceptable formulation substantially free of cremophor without the use of premedication, with a treatment cycle of no greater than 2 weeks.
Claim 10
Dependent Claim
15 words
The method of claim 7, wherein said dose is at least 135 mg/m 2 .
Claim 11
Dependent Claim
15 words
The method of claim 7, wherein said dose is at least 175 mg/m 2 .
Claim 12
Dependent Claim
14 words
The method of claim 7, wherein said administration period is less than 2 hours.
Claim 13
Dependent Claim
16 words
The method of claim 7, wherein said pharmaceutically acceptable formulation is administered as a bolus injection.
Claim 14
Dependent Claim
15 words
The method of claim 11, wherein said dose is at least 135 mg/m 2 .
Claim 15
Dependent Claim
15 words
The method of claim 11, wherein said dose is at least 175 mg/m 2 .
Claim 16
Dependent Claim
15 words
The method of claim 11, wherein said dose is at least 250 mg/m 2 .
Claim 17
Independent Claim
58 words
A method for reducing the hematologic toxicity of a taxane in a subject undergoing treatment with taxane, said method comprising systemically administering a dose in the range of about 30 mg/m 2 to about 1000 mg/m 2 of said taxane to said subject in a pharmaceutically acceptable formulation, wherein said pharmaceutically acceptable formulation is substantially free of cremophor.
Claim 18
Independent Claim
58 words
A method for reducing the hematologic toxicity of a taxane in a subject undergoing treatment with taxane, said method comprising systemically administering a dose in the range of about 30 mg/m 2 to about 1000 mg/m 2 of said taxane to said subject in a pharmaceutically acceptable formulation, wherein said pharmaceutically acceptable formulation is substantially free of cremophor.
Claim 19
Dependent Claim
13 words
The method of claim 15, wherein said pharmaceutically acceptable formulation further comprises albumin.
Claim 20
Independent Claim
59 words
A method for reducing the cerebral or neurologic toxicity of taxane in a subject undergoing treatment with taxane, said method comprising systemically administering a dose in the range of about 30 mg/m 2 to about 1000 mg/m 2 of said taxane to said subject in a pharmaceutically acceptable formulation, wherein said pharmaceutically acceptable formulation is substantially free of cremophor.
Claim 21
Independent Claim
59 words
A method for reducing the cerebral or neurologic toxicity of taxane in a subject undergoing treatment with taxane, said method comprising systemically administering a dose in the range of about 30 mg/m 2 to about 1000 mg/m 2 of said taxane to said subject in a pharmaceutically acceptable formulation, wherein said pharmaceutically acceptable formulation is substantially free of cremophor.
Claim 22
Dependent Claim
13 words
The method of claim 17, wherein said pharmaceutically acceptable formulation further comprises albumin.
Claim 23
Independent Claim
56 words
A method for treatment of primary tumors in a subject by achieving high local concentration of taxane at the tumor site, said method comprising systemically administering a dose in the range of about 30 mg/m 2 to about 1000 mg/m 2 of said taxane to said subject in a pharmaceutically acceptable formulation substantially free of cremophor.
Claim 24
Independent Claim
56 words
A method for treatment of primary tumors in a subject by achieving high local concentration of taxane at the tumor site, said method comprising systemically administering a dose in the range of about 30 mg/m 2 to about 1000 mg/m 2 of said taxane to said subject in a pharmaceutically acceptable formulation substantially free of cremophor.
Claim 25
Dependent Claim
24 words
The method of claim 19, wherein said primary tumors are selected from cancers of prostate, testes, lung, kidney, pancreas, bone, spleen, liver or brain.
Claim 26
Dependent Claim
13 words
The method of claim 20, wherein said pharmaceutically acceptable formulation further comprises albumin.
Claim 27
Dependent Claim
53 words
A pharmaceutically acceptable formulation of taxane for treatment of primary tumors in a subject which achieves high local concentration of said taxane at the tumor site, said formulation being substantially free of cremophor and comprising taxane in a dose in the range of about 30 mg/m 2 to about 1000 mg/m 2 .
Claim 28
Dependent Claim
53 words
A pharmaceutically acceptable formulation of taxane for treatment of primary tumors in a subject which achieves high local concentration of said taxane at the tumor site, said formulation being substantially free of cremophor and comprising taxane in a dose in the range of about 30 mg/m 2 to about 1000 mg/m 2 .
Claim 29
Dependent Claim
24 words
The formulation of claim 22, wherein said primary tumors are selected from cancers of prostate, testes, lung, kidney, pancreas, bone, spleen, liver or brain.
Claim 30
Dependent Claim
8 words
The formulation of claim 22 further comprising albumin.
Claim 31
Dependent Claim
19 words
A pharmaceutically acceptable formulation of taxane according to claim 22, wherein said formulation shows reduced cerebral or neurologic toxicity.
Claim 32
Independent Claim
57 words
A method for treatment of metastatic tumors in a subject by achieving high local concentration of taxane at the site of metastases, said method comprising systemically administering a dose in the range of about 30 mg/m 2 to about 1000 mg/m 2 of said taxane to said subject in a pharmaceutically acceptable formulation substantially free of cremophor.
Claim 33
Independent Claim
57 words
A method for treatment of metastatic tumors in a subject by achieving high local concentration of taxane at the site of metastases, said method comprising systemically administering a dose in the range of about 30 mg/m 2 to about 1000 mg/m 2 of said taxane to said subject in a pharmaceutically acceptable formulation substantially free of cremophor.
Claim 34
Dependent Claim
18 words
The method of claim 26, wherein said site of metastases are selected from lung, bone, liver or brain.
Claim 35
Dependent Claim
13 words
The method of claim 26, wherein said pharmaceutically acceptable formulation further comprises albumin.
Claim 36
Independent Claim
46 words
A method for treatment of prostatic cancer in a subject by inducing a medical orchiectomy by administering a dose of taxane in the range of about 30 mg/m 2 to about 1000 mg/m 2 to said subject in a pharmaceutically acceptable formulation substantially free of cremophor.
Claim 37
Independent Claim
46 words
A method for treatment of prostatic cancer in a subject by inducing a medical orchiectomy by administering a dose of taxane in the range of about 30 mg/m 2 to about 1000 mg/m 2 to said subject in a pharmaceutically acceptable formulation substantially free of cremophor.
Claim 38
Dependent Claim
13 words
The method of claim 29, wherein said pharmaceutically acceptable formulation further comprises albumin.
Claim 39
Dependent Claim
42 words
A unit dosage form comprising a vessel containing a sufficient quantity of taxane to allow systemic administration at a dose in the range of about 30 mg/m 2 to about 1000 mg/m 2 over an administration period of less than 3 hours.
Claim 40
Dependent Claim
42 words
A unit dosage form comprising a vessel containing a sufficient quantity of taxane to allow systemic administration at a dose in the range of about 30 mg/m 2 to about 1000 mg/m 2 over an administration period of less than 3 hours.
Claim 41
Dependent Claim
26 words
A unit dosage form according to claim 31, wherein said taxane is administered as a non-aqueous formulation, wherein said non-aqueous formulation is substantially free of cremophor.
Claim 42
Dependent Claim
18 words
A unit dosage form according to claim 31, wherein said taxane is administered as a dry powder formulation.
Claim 43
Dependent Claim
25 words
A lyophilized taxane-containing formulation characterized by the ability to be reconstituted at concentrations greater than 1.3 mg/ml, and remaining stable for at least 3 days.
Claim 44
Dependent Claim
25 words
A lyophilized taxane-containing formulation characterized by the ability to be reconstituted at concentrations greater than 1.3 mg/ml, and remaining stable for at least 3 days.
Claim 45
Dependent Claim
23 words
A taxane-containing formulation suitable for administration using standard intravenous infusion tubing, wherein said taxane-containing formulation has a concentration of greater than 1.3 mg/ml.
Claim 46
Dependent Claim
23 words
A taxane-containing formulation suitable for administration using standard intravenous infusion tubing, wherein said taxane-containing formulation has a concentration of greater than 1.3 mg/ml.
Claim 47
Dependent Claim
31 words
A taxane-containing formulation suitable for delivery of a dose in the range of about 30 mg/m 2 to about 1000 mg/m 2 with an administration period of less than 3 hrs.
Claim 48
Dependent Claim
31 words
A taxane-containing formulation suitable for delivery of a dose in the range of about 30 mg/m 2 to about 1000 mg/m 2 with an administration period of less than 3 hrs.
Claim 49
Dependent Claim
15 words
A formulation according to claim 36 wherein said dose comprises about 250-300 mg/m 2 .
Claim 50
Dependent Claim
17 words
A formulation according to claim 31 wherein said dose is delivered in a volume of <200 ml.
Claim 51
Dependent Claim
37 words
A pharmaceutically acceptable formulation of taxane comprising in the range of about 30 mg/m 2 to about 1000 mg/m 2 of taxane, wherein said formulation is useful for the reduction of serum testosterone levels in a subject.
Claim 52
Dependent Claim
37 words
A pharmaceutically acceptable formulation of taxane comprising in the range of about 30 mg/m 2 to about 1000 mg/m 2 of taxane, wherein said formulation is useful for the reduction of serum testosterone levels in a subject.
Claim 53
Dependent Claim
21 words
The method of claim 1, wherein said dose is greater than 80 mg/m 2 and up to 700 mg/m 2 .
Claim 54
Dependent Claim
44 words
A unit dosage form according to claim 31, wherein said quantity of taxane is sufficient to allow systemic administration of a taxane dose of greater than 80 mg/m 2 and up to 700 mg/m 2 over an administration period of less than 3 hours.
Claim 55
Dependent Claim
22 words
A formulation according to claim 36, wherein said dose is greater than 80 mg/m 2 and up to 700 mg/m 2 .
Claim 56
Dependent Claim
12 words
The method of claim 1 wherein said formulation is free of cremophor.
Claim 57
Dependent Claim
12 words
The method of claim 7 wherein said formulation is free of cremophor.
Claim 58
Dependent Claim
12 words
The method of claim 15 wherein said formulation is free of cremophor.
Claim 59
Dependent Claim
12 words
The method of claim 17 wherein said formulation is free of cremophor.
Claim 60
Dependent Claim
12 words
The method of claim 18 wherein said formulation is free of cremophor.
Claim 61
Dependent Claim
12 words
The formulation of claim 22, wherein said formulation is free of cremophor.
Claim 62
Dependent Claim
12 words
The method of claim 26 wherein said formulation is free of cremopor.
Claim 63
Dependent Claim
12 words
The method of claim 29 wherein said formulation is free of cremophor.
Claim 64
Dependent Claim
15 words
The unit dosage form of claim 32 wherein said non-aqueous formulation is free of cremophor.
Claim 65
Dependent Claim
14 words
The method of claim 1, wherein said administration period is less than 1 hour.
Claim 66
Dependent Claim
14 words
The method of claim 7, wherein said administration period is less than 1 hour.
Claim 67
Dependent Claim
15 words
The method of claim 1, wherein said dose is at least 250 mg/m 2 .
Claim 68
Dependent Claim
15 words
The method of claim 7, wherein said dose is at least 250 mg/m 2 .
Claim 69
Dependent Claim
20 words
The method of claim 1, wherein said formulation is free of agents which aid recovery from hematologic toxicity of taxane.
Claim 70
Dependent Claim
20 words
The method of claim 7, wherein said formulation is free of agents which aid recovery from hematologic toxicity of taxane.
References Cited (Backward Citations)
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