US2017100420A1PendingUtilityA1

Sustained release of antiinfectives

69
Assignee: INSMED INCPriority: Oct 29, 2002Filed: Oct 20, 2016Published: Apr 13, 2017
Est. expiryOct 29, 2022(expired)· nominal 20-yr term from priority
Inventors:Lawrence BoniBrian S. Miller
A61K 31/7036A61K 9/0073A61K 9/127Y10S977/907Y10S977/906A61K 31/407A61K 9/0078A61P 31/00Y10S977/773A61K 31/496A61K 31/545A61K 9/48Y02A50/30
69
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Claims

Abstract

Provided, among other things, is a method of treating or ameliorating pulmonary infection in a cystic fibrosis patient comprising pulmonary administration of an effective amount of a liposomal/complexed antiinfective to the patient, wherein the (i) administrated amount is 50% or less of the comparative free drug amount, or (ii) the dosing is once a day or less, or (iii) both.

Claims

exact text as granted — not AI-modified
1 .- 25 . (canceled) 
     
     
         26 . A liposomal aminoglycoside formulation comprising an aminoglycoside or salt thereof encapsulated in liposomes, wherein the lipid component of the liposomes consists of a sterol and a phosphatidylcholine, and the weight ratio of the lipid component to aminoglycoside is less than 2.5 (lipid component) to 1 (aminoglycoside). 
     
     
         27 . The liposomal aminoglycoside formulation of  claim 26 , wherein the aminoglycoside is streptomycin, gentamicin, tobramycin, amikacin, netilmicin or kanamycin, or a salt thereof. 
     
     
         29 . The liposomal aminoglycoside formulation of  claim 26 , wherein the aminoglycoside is tobramycin, or a salt thereof. 
     
     
         30 . The liposomal aminoglycoside formulation of  claim 26 , wherein the aminoglycoside is amikacin, or a salt thereof. 
     
     
         31 . The liposomal aminoglycoside formulation of  claim 30 , wherein the aminoglycoside or salt thereof is amikacin sulfate. 
     
     
         32 . The liposomal aminoglycoside formulation of  claim 26 , wherein the phosphatidylcholine is selected from the group consisting of egg phosphatidylcholine (EPC), soy phosphatidylcholine (SPC), hydrogenated egg phosphatidylcholine (HEPC), hydrogenated soy phosphatidylcholine (HSPC), dipalmitoyl phosphatidylcholine (DPPC), dioleoyl phosphatidylcholine (DOPC), dimyristoyl phosphatidylcholine (DMPC), distearoyl phosphatidylcholine (DSPC), palmitoylstearoyl phosphatidylcholine (PSPC), and mixtures thereof. 
     
     
         33 . The liposomal aminoglycoside formulation of  claim 26 , wherein the phosphatidylcholine is DPPC. 
     
     
         34 . The liposomal aminoglycoside formulation of  claim 26 , wherein the sterol is cholesterol. 
     
     
         35 . The liposomal aminoglycoside formulation of  claim 26 , wherein the sterol is cholesterol and the phosphatidylcholine is DPPC. 
     
     
         36 . The liposomal aminoglycoside formulation of  claim 30 , wherein the sterol is cholesterol and the phosphatidylcholine is DPPC. 
     
     
         37 . The liposomal aminoglycoside formulation of  claim 31 , wherein the sterol is cholesterol and the phosphatidylcholine is DPPC. 
     
     
         38 . The liposomal aminoglycoside formulation of  claim 36 , wherein the cholesterol and DPPC are present at a mole ratio of 1:1. 
     
     
         39 . The liposomal aminoglycoside formulation of  claim 37 , wherein the cholesterol and DPPC are present at a mole ratio of 1:1. 
     
     
         40 . A method of treating a mycobacterial infection in the lungs of a patient in need thereof, comprising administering to the lungs of the patient an effective amount of a liposomal aminoglycoside formulation, wherein the liposomal aminoglycoside formulation comprises an aminoglycoside or a salt thereof encapsulated in liposomes, wherein the lipid component of the liposomes consists of a sterol and a phosphatidylcholine, and the weight ratio of the lipid component to aminoglycoside is less than 2.5 (lipid component) to 1 (aminoglycoside). 
     
     
         41 . The method of  claim 40 , wherein the patient is a cystic fibrosis patient. 
     
     
         42 . The method of  claim 40 , wherein the aminoglycoside is streptomycin, gentamicin, tobramycin, amikacin, netilmicin or kanamycin, or a salt thereof. 
     
     
         43 . The method of  claim 40 , wherein the aminoglycoside is tobramycin, or a salt thereof. 
     
     
         44 . The method of  claim 40 , wherein the aminoglycoside is amikacin, or a salt thereof. 
     
     
         45 . The method of  claim 44 , wherein the aminoglycoside or salt thereof is amikacin sulfate. 
     
     
         46 . The method of claim40, wherein the phosphatidylcholine is selected from the group consisting of egg phosphatidylcholine (EPC), soy phosphatidylcholine (SPC), hydrogenated egg phosphatidylcholine (HEPC), hydrogenated soy phosphatidylcholine (HSPC), dipalmitoyl phosphatidylcholine (DPPC), dioleoyl phosphatidylcholine (DOPC), dimyristoyl phosphatidylcholine (DMPC), distearoyl phosphatidylcholine (DSPC), palmitoylstearoyl phosphatidylcholine (PSPC), and mixtures thereof. 
     
     
         47 . The method of  claim 40 , wherein the phosphatidylcholine is DPPC. 
     
     
         48 . The method of  claim 40 , wherein the sterol is cholesterol. 
     
     
         49 . The method of  claim 40 , wherein the sterol is cholesterol and the phosphatidylcholine is DPPC. 
     
     
         50 . The method of  claim 44 , wherein the sterol is cholesterol and the phosphatidylcholine is DPPC. 
     
     
         51 . The method of  claim 45 , wherein the sterol is cholesterol and the phosphatidylcholine is DPPC. 
     
     
         52 . The method of  claim 50 , wherein the cholesterol and DPPC are present at a mole ratio of 1:1. 
     
     
         53 . The method of  claim 51 , wherein the cholesterol and DPPC are present at a mole ratio of 1:1. 
     
     
         54 . The method of  claim 40 , wherein administering to the lungs of the patient comprises inhalation administration via a nebulizer at a dosing schedule of once a day or less. 
     
     
         55 . The method of  claim 45 , wherein administering to the lungs of the patient comprises inhalation administration via a nebulizer at a dosing schedule of once a day or less. 
     
     
         56 . The method of  claim 49 , wherein administering to the lungs of the patient comprises inhalation administration via a nebulizer at a dosing schedule of once a day or less. 
     
     
         57 . The method of  claim 50 , wherein administering to the lungs of the patient comprises inhalation administration via a nebulizer at a dosing schedule of once a day or less. 
     
     
         58 . The method of  claim 51 , wherein administering to the lungs of the patient comprises inhalation administration via a nebulizer at a dosing schedule of once a day or less. 
     
     
         59 . The method of  claim 52 , wherein administering to the lungs of the patient comprises inhalation administration via a nebulizer at a dosing schedule of once a day or less. 
     
     
         60 . The method of  claim 53 , wherein administering to the lungs of the patient comprises inhalation administration via a nebulizer at a dosing schedule of once a day or less. 
     
     
         61 . The method of  claim 40 , wherein the mycobacterial infection is a  M. avium  complex  M. avium  and  M. intracellulare ) infection. 
     
     
         62 . The method of  claim 44 , wherein the mycobacterial infection is a  M. avium  complex  M. avium  and  M. intracellulare ) infection. 
     
     
         63 . The method of  claim 54 , wherein the mycobacterial infection is a  M. avium  complex  M. avium  and  M. intracellulare ) infection. 
     
     
         64 . The method of  claim 55 , wherein the mycobacterial infection is a  M. avium  complex  M. avium  and  M. intracellulare ) infection. 
     
     
         65 . The method of  claim 56 , wherein the mycobacterial infection is a  M. avium  complex  M. avium  and  M. intracellulare ) infection. 
     
     
         66 . The method of  claim 57 , wherein the mycobacterial infection is a  M. avium  complex  M. avium  and  M. intracellulare ) infection. 
     
     
         67 . The method of  claim 58 , wherein the mycobacterial infection is a  M. avium  complex  M. avium  and  M. intracellulare ) infection. 
     
     
         68 . The method of  claim 59 , wherein the mycobacterial infection is a  M. avium  complex  M. avium  and  M. intracellulare ) infection. 
     
     
         69 . The method of  claim 60 , wherein the mycobacterial infection is a  M. avium  complex  M. avium  and  M. intracellulare ) infection. 
     
     
         70 . A method of treating a Pseudomonas aeruginosa infection in the lungs of a patient in need thereof, comprising administering to the lungs of the patient an effective amount of a liposomal aminoglycoside formulation, wherein the liposomal aminoglycoside formulation comprises an aminoglycoside or a salt thereof encapsulated in liposomes, wherein the lipid component of the liposomes consists of a sterol and a phosphatidylcholine, and the weight ratio of the lipid component to aminoglycoside is less than 2.5 (lipid component) to 1 (aminoglycoside). 
     
     
         71 . The method of  claim 70 , wherein the patient is a cystic fibrosis patient. 
     
     
         72 . The method of  claim 70 , wherein the aminoglycoside is streptomycin, gentamicin, tobramycin, amikacin, netilmicin or kanamycin, or a salt thereof. 
     
     
         73 . The method of  claim 70 , wherein the aminoglycoside is tobramycin, or a salt thereof. 
     
     
         74 . The method of  claim 70 , wherein the aminoglycoside is amikacin, or a salt thereof. 
     
     
         75 . The method of  claim 74 , wherein the aminoglycoside or salt thereof is amikacin sulfate. 
     
     
         76 . The method of  claim 70 , wherein the phosphatidylcholine is selected from the group consisting of egg phosphatidylcholine (EPC), soy phosphatidylcholine (SPC), hydrogenated egg phosphatidylcholine (HEPC), hydrogenated soy phosphatidylcholine (HSPC), dipalmitoyl phosphatidylcholine (DPPC), dioleoyl phosphatidylcholine (DOPC), dimyristoyl phosphatidylcholine (DMPC), distearoyl phosphatidylcholine (DSPC), palmitoylstearoyl phosphatidylcholine (PSPC), and mixtures thereof. 
     
     
         77 . The method of  claim 70 , wherein the phosphatidylcholine is DPPC. 
     
     
         78 . The method of  claim 70 , wherein the sterol is cholesterol. 
     
     
         79 . The method of  claim 70 , wherein the sterol is cholesterol and the phosphatidylcholine is DPPC. 
     
     
         80 . The method of  claim 74 , wherein the sterol is cholesterol and the phosphatidylcholine is DPPC. 
     
     
         81 . The method of  claim 75 , wherein the sterol is cholesterol and the phosphatidylcholine is DPPC. 
     
     
         82 . The method of  claim 79 , wherein the DPPC and cholesterol have a mole ratio of about 1:1. 
     
     
         83 . The method of  claim 80 , wherein the DPPC and cholesterol have a mole ratio of about 1:1. 
     
     
         84 . The method of  claim 81 , wherein the DPPC and cholesterol have a mole ratio of about 1:1. 
     
     
         85 . The method of  claim 79 , wherein the administering to the lungs of the patient comprises inhalation administration via a nebulizer at a dosing schedule of once a day or less. 
     
     
         86 . The method of  claim 80 , wherein the administering to the lungs of the patient comprises inhalation administration via a nebulizer at a dosing schedule of once a day or less. 
     
     
         87 . The method of  claim 81 , wherein the administering to the lungs of the patient comprises inhalation administration via a nebulizer at a dosing schedule of once a day or less. 
     
     
         88 . The method of  claim 70 , wherein the  Pseudomonas aeruginosa  infection is a chronic  Pseudomonas aeruginosa  infection. 
     
     
         89 . The method of  claim 79 , wherein the  Pseudomonas aeruginosa  infection is a chronic  Pseudomonas aeruginosa  infection. 
     
     
         90 . The method of  claim 80 , wherein the  Pseudomonas aeruginosa  infection is a chronic  Pseudomonas aeruginosa  infection. 
     
     
         91 . The method of  claim 81 , wherein the  Pseudomonas aeruginosa  infection is a chronic  Pseudomonas aeruginosa  infection. 
     
     
         92 . The method of  claim 85 , wherein the  Pseudomonas aeruginosa  infection is a chronic  Pseudomonas aeruginosa  infection. 
     
     
         93 . The method of  claim 86 , wherein the  Pseudomonas aeruginosa  infection is a chronic  Pseudomonas aeruginosa  infection. 
     
     
         94 . The method of  claim 87 , wherein the  Pseudomonas aeruginosa  infection is a chronic  Pseudomonas aeruginosa  infection.

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