PTERIDINE DERIVATIVES FOR TREATING RESPIRATORY DISEASE

التفاصيل البيبلوغرافية
العنوان: PTERIDINE DERIVATIVES FOR TREATING RESPIRATORY DISEASE
Document Number: 20110166149
تاريخ النشر: July 7, 2011
Appl. No: 12/866665
Application Filed: February 06, 2009
مستخلص: The invention provides methods and compositions for treating asthma and/or COPD. For example, provided herein are compositions that include a kinase inhibiting agent such as 6,7-bis(3-hydroxyphenyl)-pteridine-2,4-diamine or pharmaceutically acceptable salts thereof; and a surfactant.
Inventors: Dellamary, Luis A. (San Marcos, CA, US); Martin, Michael B. (San Marcos, CA, US)
Assignees: TARGEGEN INC. (San Diego, CA, US)
Claim: 1. A method for targeting delivery of a pharmaceutical kinase inhibitor composition to the respiratory tract of a patient in need thereof, comprising: administering to the patient a therapeutically effective amount of pharmaceutically acceptable composition suitable for direct delivery to the respiratory tract comprising: (a) from about 0.00001 to about 10% w/v of a kinase inhibiting agent selected from: 6,7-bis(3-hydroxyphenyl)-pteridine-2,4-diamine or pharmaceutically acceptable salts thereof; and (b) from about 0.00001 to about 10% w/v of a surfactant, wherein the administration results in the drug being predominantly delivered to a mucosal surface of the respiratory tract of the patient and results in a minimal plasma concentration of the kinase inhibiting agent in the patient.
Claim: 2. The method of claim 1, wherein the pharmaceutically acceptable composition further comprises an aqueous based solvent.
Claim: 3. The method of claim 1, wherein the plasma concentration of the agent in the patient is less than about 10 ng/mL within about two hours after administration.
Claim: 4. The method of claim 1, wherein the plasma concentration of the agent is less than about 2 ng/mL.
Claim: 5. The method of claim 1, wherein the surfactant is selected from one or more of: tyloxapol, poloxamer 188, poloxamer 407, Tween™ 80, phosphatidylcholine, phosphatides, or phosphatidyl glycerols.
Claim: 6. The method of claim 1, wherein the surfactant is tyloxapol.
Claim: 7. A composition suitable for administrating by inhalation or nasally, comprising: a) an active agent represented formula I: [chemical expression included] wherein: each of Z2 and Z4 is C, each of Z1, Z3, Z5, and Z6 is N; each X is NH2; each Y is independently selected from a group consisting of —ORd, —NRd2, —SRd, and —OPO3H2, wherein Rd is selected from a group consisting of H, lower alkyl, aryl, and —(CH2)2NH(CH2CH3); or each Y is independently selected from a group consisting of alkyl, substituted alkyl, aryl, substituted aryl, and halogen, wherein said substituents are selected from a group consisting of halogen, —ORe, —NR2—SRe, and —P(O)(OH)2, wherein Re is selected from a group consisting of —H, lower alkyl, and aryl; or each Y is independently selected from a group consisting of CH2glycinyl, CH2NHethoxy, CH2NHCH2alkyl, CH2NHCH2t-Bu, CH2NHCH2aryl, and CH2NHCH2substituted aryl; or when n is 2, each Y is taken together to form a fused aromatic ring system; and m and n are each independently 1 to 4, or pharmaceutically acceptable salts thereof; and b) a surfactant.
Claim: 8. The composition of claim 7, comprising: a) about 0.00001% w/v to about 20% w/v of 6,7-bis(3-hydroxyphenyl)-pteridine-2,4-diamine or pharmaceutically acceptable salts thereof; b) about 0.00001% w/v to about 6% w/v of a surfactant; and c) water sufficient to make 100% w/v.
Claim: 9. The composition of claim 7, wherein the surfactant is selected from one or more of: tyloxapol, poloxamer 188, poloxamer 407, Tween™ 80, phosphatidylcholine, phosphatides, and phosphatidyl glycerols.
Claim: 10. The composition of claim 7, wherein the surfactant is tyloxapol.
Claim: 11. The composition of claim 7, wherein the composition is in the form of a nebulized aerosol or a powder.
Claim: 12. The composition of claim 8, wherein the composition, when administered to a patient as a nebulized aerosol or dry powder, results in a lung tissue concentration in the patient of at least about 10 ng/g of 6,7-bis(3-hydroxyphenyl)-pteridine-2,4-diamine or pharmaceutically acceptable salts thereof about 15 minutes after administration.
Claim: 13. The composition of claim 8, wherein the composition, when administered to a patient as a nebulized aerosol or dry powder, results in a plasma concentration in the patient of less than about 5 ng/mL about 15 minutes after administration.
Claim: 14. A method of treating asthma or COPD of a patient in need thereof comprising: administering by inhalation to the patient a composition comprising a therapeutically effective amount of the active agent 6,7-bis(3-hydroxyphenyl)-pteridine-2,4-diamine or pharmaceutically acceptable salts thereof and a surfactant, thereby delivering to the mucus membranes of the lungs of the patient a pharmaceutically effective amount of the active agent.
Claim: 15. The method of claim 14 wherein the method of treating COPD is a method of treating emphysema.
Claim: 16. The method of claim 14, wherein the method of treating COPD is a method of treating chronic bronchitis.
Claim: 17. The method of claim 14, wherein the surfactant is selected from one or more of: tyloxapol, poloxamer 188, poloxamer 407, Tween™ 80, phosphatidylcholine, phosphatides, and phophatidyl glycerols.
Claim: 18. The method of claim 14, wherein the surfactant is tyloxapol.
Claim: 19. A kit for treating a respiratory disease, the kit comprising (a) a composition comprising 6,7-bis(3-hydroxyphenyl)-pteridine-2,4-diamine or pharmaceutically acceptable salts thereof, and a non-ionic surfactant, in a sealed container, and (b) a label indicating administration by inhalation or nasally.
Claim: 20. The kit of claim 19, wherein the composition comprises 0.05 mg to 40 mg of 6,7-bis(3-hydroxyphenyl)-pteridine-2,4-diamine or pharmaceutically acceptable salts thereof.
Current U.S. Class: 514/249
Current International Class: 61; 61; 61; 61
رقم الانضمام: edspap.20110166149
قاعدة البيانات: USPTO Patent Applications