Indian Patents. 218792:A COMPOSITION COMPRISING A LIPOSOME OR LIPID COMPLEX AND AN ENTRAPPED ACTIVE PLATINUM COMPOUND AND A PROCESS FOR PRODUCING THE SAME

Title of Invention	A COMPOSITION COMPRISING A LIPOSOME OR LIPID COMPLEX AND AN ENTRAPPED ACTIVE PLATINUM COMPOUND AND A PROCESS FOR PRODUCING THE SAME
Abstract	The present invention relates to a composition comprising a liposome or lipid complex and an entrapped active platinum compound, the liposome or lipid complex containing one or more lipids, wherein the active platinum compound to lipid ratio is from 1:50 to 1:2 by weight. The invention also relates to a process for producing the same.

Full Text	[IJ The present invention relates to a composition comprising a liposome or lipid complex and an entrapped active platinum compound and a process for producing the same. WE CLAIM 1. A composition comprising a liposome or lipid complex and an entrapped active platinum compound, the liposome or lipid complex containing one or more lipids, wherein the active platinum compound to lipid ratio is from 1:50 to 1:2 by weight. 2. The composition as claimed in claim 1, wherein the active platinum compound to lipid ratio is from 1:50 to 1:5 by weight 3. The composition as claimed in claim 1, wherein the active platinum compound to lipid ratio is from 1:50 to 1:10 by weight. 4. The composition as claimed in claim 1, wherein the active platinum compound is cisplatin. 5. The composition as claimed in claim 1, wherein the active platinum compound to lipid ratio is 1:25 to 1:15 by weight. 6. The composition as claimed in claim 5, wherein the active platinum compound is cisplatin. 7. The composition as claimed in claim 6, wherein the one or more lipids comprise DPPC. 8. The composition as claimed in claim 7, wherein the one or more lipids comprise cholesterol. 9. The composition as claimed in claim 7, wherein the one or more lipids comprise 50-100 mol% DPPC and 0-50 mol% cholesterol. 10. The composition as claimed in claim 7, wherein the one or more lipids comprise 50-65 mol% DPPC and 35-50 mol% cholesterol. 11. A process for making the platinum composition as claimed in claim 1 comprising the steps of: (a) combining an active platinum compound produced by dissolving active platinum compound in a saline solution and a hydrophobic matrix carrying system; (b) establishing the mixture at a first temperature; and (c) thereafter establishing the mixture at a second temperature which second temperature is cooler than the first temperature; wherein the steps (b) and (c) are effective to increase the encapsulation of active platinum compound. 12. The process as claimed in claim 11, wherein it comprises repeating the steps (b) and (c) for a total of two or more cycles. 13. The process as claimed in claim 11, wherein the active platinum compound is cisplatin. 14. The process as claimed in claim 11, wherein the hydrophobic matrix carrying system comprises liposome or lipid complex-forming lipids. 15. The process as claimed in claim 14, wherein the one or more lipids comprise DPPC. 16. The process as claimed in claim 14, wherein the one or more lipids comprise cholesterol. 17. The process as claimed in claim II, wherein the hydrophobic matrix carrying system is produced by dissolving one or more lipids in ethanol to form a Hid solution and injecting the lipid solution into an aqueous medium containing active platinum compound. 18. The process as claimed in claim 11, wherein it comprises sequentially repeating the steps (b) and (c) for a total of three or more cycles. 19. The process as claimed in claim 18, wherein the step (c) comprises establishing the mixture at a temperature from -25 degrees Celsius to 25 degrees Celsius. 20. The process as claimed in claim 18, wherein step (c) comprises establishing the mixture at a temperature from -5 degree Celsius to 5 degrees Celsius. 21. The process as claimed in claim 18, wherein the step (b) comprises establishing the mixture at a temperature from 4 degrees Celsius to 70 degrees Celsius. 22. The process as claimed in claim 18, wherein the step (b) comprises establishing the mixture at a temperature from 45 degrees Celsius to 55 degrees Celsius. 23. The process as claimed in claim 11, wherein the temperature differential between steps (b) and (c) is 25 degrees Celsius or more. 24, The process as claimed in claim 23, wherein the temperature established in step (b) is 50 degrees Celsius or more. 25, The process as claimed in claim 11, wherein the temperature established in step (b) is 50 degrees Celsius or more. 26, The process as claimed in claim 11, wherein it comprises, after all of steps (b) and steps (c) have been completed: (d) removing un-entrapped active platinum compound by filtering through a membrane having a molecular weight cut-off selected to retain desired liposomes or lipid complexes and adding a liposome or lipid complex compatible liquid to wash out un-entrapped active platinum compound.

Full Text

[IJ The present invention relates to a composition comprising a liposome or lipid complex and an entrapped active platinum compound and a process for producing the same.

WE CLAIM
1. A composition comprising a liposome or lipid complex and an entrapped active platinum compound, the liposome or lipid complex containing one or more lipids, wherein the active platinum compound to lipid ratio is from 1:50 to 1:2 by weight.
2. The composition as claimed in claim 1, wherein the active platinum compound to lipid ratio is from 1:50 to 1:5 by weight
3. The composition as claimed in claim 1, wherein the active platinum compound to lipid ratio is from 1:50 to 1:10 by weight.
4. The composition as claimed in claim 1, wherein the active platinum compound is
cisplatin.
5. The composition as claimed in claim 1, wherein the active platinum compound to lipid ratio is 1:25 to 1:15 by weight.
6. The composition as claimed in claim 5, wherein the active platinum compound is cisplatin.
7. The composition as claimed in claim 6, wherein the one or more lipids comprise DPPC.
8. The composition as claimed in claim 7, wherein the one or more lipids comprise cholesterol.

9. The composition as claimed in claim 7, wherein the one or more lipids comprise
50-100 mol% DPPC and 0-50 mol% cholesterol.
10. The composition as claimed in claim 7, wherein the one or more lipids comprise 50-65 mol% DPPC and 35-50 mol% cholesterol.
11. A process for making the platinum composition as claimed in claim 1 comprising the steps of:

(a) combining an active platinum compound produced by dissolving active platinum compound in a saline solution and a hydrophobic matrix carrying system;
(b) establishing the mixture at a first temperature; and
(c) thereafter establishing the mixture at a second temperature which second
temperature is cooler than the first temperature;
wherein the steps (b) and (c) are effective to increase the encapsulation of active platinum compound.
12. The process as claimed in claim 11, wherein it comprises repeating the steps (b) and (c) for a total of two or more cycles.
13. The process as claimed in claim 11, wherein the active platinum compound is cisplatin.
14. The process as claimed in claim 11, wherein the hydrophobic matrix carrying system comprises liposome or lipid complex-forming lipids.
15. The process as claimed in claim 14, wherein the one or more lipids comprise DPPC.

16. The process as claimed in claim 14, wherein the one or more lipids comprise cholesterol.
17. The process as claimed in claim II, wherein the hydrophobic matrix carrying system is produced by dissolving one or more lipids in ethanol to form a Hid solution and injecting the lipid solution into an aqueous medium containing active platinum compound.
18. The process as claimed in claim 11, wherein it comprises sequentially repeating the steps (b) and (c) for a total of three or more cycles.
19. The process as claimed in claim 18, wherein the step (c) comprises establishing the mixture at a temperature from -25 degrees Celsius to 25 degrees Celsius.
20. The process as claimed in claim 18, wherein step (c) comprises establishing the mixture at a temperature from -5 degree Celsius to 5 degrees Celsius.
21. The process as claimed in claim 18, wherein the step (b) comprises establishing the mixture at a temperature from 4 degrees Celsius to 70 degrees Celsius.
22. The process as claimed in claim 18, wherein the step (b) comprises establishing the mixture at a temperature from 45 degrees Celsius to 55 degrees Celsius.
23. The process as claimed in claim 11, wherein the temperature differential between steps (b) and (c) is 25 degrees Celsius or more.

24, The process as claimed in claim 23, wherein the temperature established in step
(b) is 50 degrees Celsius or more.
25, The process as claimed in claim 11, wherein the temperature established in step
(b) is 50 degrees Celsius or more.
26, The process as claimed in claim 11, wherein it comprises, after all of steps (b) and
steps (c) have been completed:
(d) removing un-entrapped active platinum compound by filtering through a membrane having a molecular weight cut-off selected to retain desired liposomes or lipid complexes and adding a liposome or lipid complex compatible liquid to wash out un-entrapped active platinum compound.

Documents:

301-chenp-2005 abstract-duplicate.pdf

301-chenp-2005 abstract.pdf

301-chenp-2005 claims-duplicate.pdf

301-chenp-2005 claims.pdf

301-chenp-2005 correspondence-others.pdf

301-chenp-2005 correspondence-po.pdf

301-chenp-2005 description (complete)-duplicate.pdf

301-chenp-2005 description (complete).pdf

301-chenp-2005 drawings.pdf

301-chenp-2005 form-1.pdf

301-chenp-2005 form-18.pdf

301-chenp-2005 form-26.pdf

301-chenp-2005 form-3.pdf

301-chenp-2005 form-5.pdf

301-chenp-2005 pct.pdf

301-chenp-2005 petition.pdf

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Patent Number

218792

Indian Patent Application Number

301/CHENP/2005

PG Journal Number

21/2008

Publication Date

23-May-2008

Grant Date

16-Apr-2008

Date of Filing

02-Mar-2005

Name of Patentee

TRANSAVE, INC

Applicant Address

11 Deer Park Drive, Suite 117, Monmouth Junction, NJ 08852-1923,

Inventors:

#	Inventor's Name	Inventor's Address
1	LEE, Jin	46 McElroy Lane, Belle Mead, NJ 08502,
2	MILLER, Brian, S	20 Guilford Lane, Mercerville, NJ 08619,
3	WU, Fangjun	74 E. McClellan Avenue, Livingston, NJ 07039,
4	BONI, Lawrence, T	40 Cummings Road, Monmouth Junction, NJ 08852,

PCT International Classification Number

A61K 9/127

PCT International Application Number

PCT/US2003/024350

PCT International Filing date

2003-08-04

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1	60/400,875	2002-08-02	U.S.A.