Particles for inhalation having sustained release properties
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IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61K-009/12
A61K-009/14
A61K-038/28
A61K-033/30
출원번호
UP-0822716
(2001-03-30)
등록번호
US-7678364
(2010-04-21)
발명자
/ 주소
Edwards, David A.
Hrkach, Jeffrey S.
출원인 / 주소
Alkermes, Inc.
대리인 / 주소
Elmore Patent Law Group, PC
인용정보
피인용 횟수 :
1인용 특허 :
138
초록▼
The invention generally relates to a method for pulmonary delivery of therapeutic, prophylactic and diagnostic agents to a patient wherein the agent is released in a sustained fashion, and to particles suitable for use in the method. In particular, the invention relates to a method for the pulmonary
The invention generally relates to a method for pulmonary delivery of therapeutic, prophylactic and diagnostic agents to a patient wherein the agent is released in a sustained fashion, and to particles suitable for use in the method. In particular, the invention relates to a method for the pulmonary delivery of a therapeutic, prophylactic or diagnostic agent comprising administering to the respiratory tract of a patient in need of treatment, prophylaxis or diagnosis an effective amount of particles comprising a multivalent metal cation which is complexed with a therapeutic, prophylactic or diagnostic agent or any combination thereof having a charge capable of complexing with the cation upon association with the agent, a pharmaceutically acceptable carrier and optionally, a multivalent metal cation-containing component wherein the total amount of multivalent metal cation present in the particles is more than 1% weight/weight of the total weight of the agent (% w/w). Release of the agent from the administered particles occurs in a sustained fashion.
대표청구항▼
What is claimed is: 1. A method of delivery to the pulmonary system comprising: administering to the respiratory tract of a patient in need of treatment, prophylaxis or diagnosis an effective amount of a dry powder comprising: a) a multivalent metal cation which is complexed with a therapeutic, pro
What is claimed is: 1. A method of delivery to the pulmonary system comprising: administering to the respiratory tract of a patient in need of treatment, prophylaxis or diagnosis an effective amount of a dry powder comprising: a) a multivalent metal cation which is complexed with a therapeutic, prophylactic or diagnostic agent; b) a pharmaceutically acceptable carrier; and c) a multivalent metal cation-containing component wherein the dry powder is spray-dried and has a total amount of multivalent metal cation which is about 10% w/w or more of the total weight of the agent, a tap density of about 0.4 g/cm3 or less, a median geometric diameter of between about 5 micrometers and about 30 micrometers and an aerodynamic diameter of from about 1 to about 5 microns. 2. The method of claim 1, wherein the biologically active agent is a protein. 3. The method of claim 2, wherein the protein is insulin. 4. The method of claim 2, wherein the multivalent metal cation is selected from Zn(II), Ca(II), Cu(II), Ni(II), Co(II), Fe(II), Ag(II), Mn(II), Mg(II) or Cd(II). 5. The method of claim 4, wherein the multivalent metal cation is Zn(II). 6. The method of claim 2, wherein the multivalent metal cation is present at about 3% w/w or more of the total weight of the agent. 7. The method of claim 2, wherein the multivalent metal cation is present at about 50% w/w or more of the total weight of the agent. 8. The method of claim 2, wherein complexation of the agent and multivalent metal cation comprises a metal coordination. 9. The method of claim 2, wherein the dry powder has a tap density about 0.1 g/cm3 or less. 10. The method of claim 2, wherein the dry powder has an aerodynamic diameter of from about 1 to about 3 microns. 11. The method of claim 2, wherein the dry powder has an aerodynamic diameter of from about 3 to about 5 microns. 12. The method of claim 2, wherein delivery to the pulmonary system includes delivery to the deep lung. 13. The method of claim 2, wherein delivery to the pulmonary system includes delivery to the central airways. 14. The method of claim 2, wherein delivery to the pulmonary system includes delivery to the upper airways. 15. The method of claim 2, wherein the dry powder further comprise a carboxylic acid. 16. The method of claim 15, wherein the carboxylic acid includes at least two carboxyl groups. 17. The method of claim 16, wherein the carboxylic acid is citric acid or a salt thereof. 18. The method of claim 2, wherein the dry powder further comprise an amino acid. 19. The method of claim 18, wherein the amino acid is hydrophobic. 20. The method of claim 19, wherein the hydrophobic amino acid is leucine, isoleucine, alanine, valine, phenylalanine or any combination thereof. 21. The method of claim 2 wherein the pharmaceutically acceptable carrier is a phospholipid. 22. The method of claim 21 wherein the phospholipid is a phosphatidic acid, a phosphatidylcholine, a phosphatidylalkanolamine, a phosphatidylethanolamine, a phosphatidylglycerol, a phosphatidylserine, a phosphatidylinositol or combinations thereof. 23. A method of delivery to the pulmonary system comprising: administering to the respiratory tract of a patient in need of treatment, prophylaxis or diagnosis an effective amount of a dry powder comprising: a) a protein which is complexed with zinc; b) a pharmaceutically acceptable carrier; and c) a multivalent metal cation-containing component wherein the dry powder is spray-dried and has a total amount of multivalent metal cation which is about 10% w/w or more of the total weight of the agent, a tap density of about 0.4 g/cm3 or less, a median geometric diameter of between about 5 micrometers and about 30 micrometers and an aerodynamic diameter of from about 1 to about 5 microns. 24. The method of claim 23, wherein the dry powder has a tap density about 0.1 g/cm3 or less. 25. The method of claim 23, wherein the pharmaceutically acceptable carrier is a phospholipid. 26. The method of claim 23 wherein the dry powder further comprises a carboxylic acid. 27. A composition for delivery to the pulmonary system comprising: administering to the respiratory tract of a patient in need of treatment, prophylaxis or diagnosis an effective amount of a dry powder comprising: a) a protein which is complexed with zinc; b) a pharmaceutically acceptable carrier; and c) a multivalent metal cation-containing component wherein the dry powder is spray-dried and has a total amount of multivalent metal cation which is about 10% w/w or more of the total weight of the agent, a tap density of about 0.4 g/cm3 or less, a median geometric diameter of between about 5 micrometers and about 30 micrometers and an aerodynamic diameter of from about 1 to about 5 microns. 28. The method of claim 27, wherein the dry powder has a tap density about 0.1 g/cm3 or less. 29. The method of claim 27, wherein the pharmaceutically acceptable carrier is a phospholipid. 30. The method of claim 27 wherein the dry powder further comprises a carboxylic acid.
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