US2019046444A1PendingUtilityA1
A sterically stabilized carrier for subcutaneous, sublingual, and oral therapeutics, compositions and methods for treating a mammal
Est. expirySep 14, 2035(~9.1 yrs left)· nominal 20-yr term from priority
A61P 31/06A61K 31/58A61K 47/34A61P 29/00A61K 9/1271A61K 45/06A61K 31/573A61P 37/08A61K 9/127
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Claims
Abstract
Disclosed herein are pharmaceutical compositions and methods for oral, sublingual or subcutaneous administration comprising a sterically stabilized liposome carrier comprising: i) poly (ethylene glycol) distearoylphosphatidylethanolamine (PEG-DSPE); and ii) at least one of phosphatidylglycerol and phosphatidylcholine. Compositions and methods for treatment of food allergy and eosinophilic esophagitis are also described.
Claims
exact text as granted — not AI-modifiedWhat is claimed is:
1 . A method for treating eosinophilic esophagitis (EoE), comprising: administering to a subject in need thereof, a pharmaceutical composition comprising a therapeutically effective amount of at least one agent suitable for treating eosinophilic esophagitis, wherein the at least one agent is encapsulated in a liposome carrier.
2 . The method of claim 1 , wherein the liposome carrier comprises phosphatidylglycerol (PG), phosphatidylcholine (PC), phosphatidylethanolamine (PE), phosphatidylserine (PS), phosphatidylinositol (PI), or any combination or derivative thereof.
3 . The method of claim 1 or 2 , wherein the liposome carrier is a sterically stabilized liposome carrier.
4 . The method of claim 3 , wherein the sterically stabilized liposome carrier comprises poly (ethylene glycol) distearoylphosphatidylethanolamine (PEG-DSPE), PEG-dipalmitoylphosphatidylethanolamine (DPPE), PEG-di-C:15 PE, PEG-soy PE, or PEG-egg PE.
5 . The method of any one of claims 1 - 4 , wherein the administering is performed subcutaneously, sublingually, intranasally, or orally.
6 . The method of any one of claims 1 - 5 , wherein the at least one agent comprises a proton-pump inhibitor (PPI), a corticosteroid, or any combination, or derivative thereof.
7 . The method of claim 6 , wherein the proton-pump inhibitor comprises omeprazole, lansoprazole, dexlansoprazole, esomeprazole, pantoprazole, rabeprazole, ilaprazole, or any combination, or derivative thereof.
8 . The method of claim 6 , wherein the corticosteroid comprises budesonide, flunisolide, triamcinolone, beclomethasone, fluticasone, mometasone, dexamethasone, hydrocortisone, methylprednisolone, prednisone, cortisone, betamethasone, or any combination or derivative thereof.
9 . A method for inducing tolerance to an allergen in a subject in need thereof, comprising: administering to the subject, a pharmaceutical composition comprising a therapeutically effective amount of at least one agent suitable for treating an allergy, wherein the at least one agent is encapsulated in a sterically stabilized liposome carrier comprising: i) poly (ethylene glycol) distearoylphosphatidylethanolamine (PEG-DSPE); and ii) at least one of phosphatidylglycerol, phosphatidylcholine, or any combination or derivative thereof.
10 . The method of claim 9 , wherein the allergen is a food allergen.
11 . The method of any one of claims 1 - 10 , wherein said administering to the subject is performed less than about 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 or 14 times per week.
12 . The method of any one of claims 1 - 11 , wherein the pharmaceutical composition is administered to the subject about once per week.
13 . The method of any one of claims 1 - 12 , wherein the administering the pharmaceutical composition is performed orally, sublingually, buccally, by inhalation, or subcutaneously.
14 . The method of any one of claims 1 - 13 , wherein the pharmaceutical composition is provided as a lyophile.
15 . The method of claim 14 , wherein said lyophile is deposited on a filter paper.
16 . The method of claim 14 or 15 , wherein the lyophile is reconstituted prior to administering.
17 . The method of claim 16 , wherein the lyophile is reconstituted with an aqueous diluent.
18 . The method of claim 17 , wherein said aqueous diluent is selected from the group consisting of: distilled water, deionized water; sterile water; bacteriostatic water; and normal saline.
19 . The method of any of claims 1 - 18 , wherein said pharmaceutical composition further comprises a sugar.
20 . The method of claim 19 , wherein said sugar is selected from the group consisting of trehalose, glucose, sucrose, maltose, galactose, fructose, and arabinose.
21 . The method of any one of claims 1 - 20 , wherein the at least one agent comprises an allergen.
22 . The method of claim 21 , wherein the allergen is selected from the group consisting of proteins, plant products and animal products.
23 . The method of claim 21 or 22 , wherein the allergen is a protein.
24 . The method of any one of claims 21 - 23 , wherein the allergen is selected from the group consisting of whole peanut, peanut powder, peanut butter, derivatives and combinations thereof.
25 . The method of any one of claims 21 - 24 , wherein the allergen is derived from peanut, tree nut, egg, shellfish, soy, milk, gluten, or any combination thereof.
26 . The method of any one of claims 21 - 25 , wherein the allergen comprises a grass pollen allergen, a weed pollen allergen, an indoor allergen, a mold allergen, a tree pollen allergen, a stinging insect allergen, a food allergen, or any combination or derivative thereof.
27 . The method of any one of claims 1 - 26 , wherein the at least one agent comprises an allergy medication.
28 . The method of claim 27 , wherein the allergy medication comprises an antihistamine, a corticosteroid, a bronchodilator, a mast cell stabilizer, a leukotriene inhibitor, an anti-tuberculosis agent, a serine lung protease inhibitor, or any combination or derivative thereof.
29 . The method of claim 28 , wherein the antihistamine comprises a H 1 -antihistamine, H 2 -antihistamine, H 3 -antihistamine, H 4 -antihistamine, or any combination thereof.
30 . The method of claim 29 , wherein the H 1 -antihistamine comprises acrivastine, azelastine, bilastine, brompheniramine, buclizine, bromodiphenhydramine, carbinoxamine, chlorpromazine, cyclizine, chlorphenamine, chlorodiphenhydramine, clemastine, cyproheptadine, dexbrompheniramine, dexchlorpheniramine, dimenhydrinate, dimetindene, diphenhydramine, doxylamine, ebastine, embramine, fexofenadine, hydroxyzine, loratadine, meclozine, mirtazapine, olopatadine, orphenadrine, phenindamine, pheniramine, phenyltoloxamine, promethazine, quetiapine, rupatadine, tripelennamine, triprolidine, or any combination, or derivative thereof.
31 . The method of claim 28 , wherein the corticosteroid comprises budesonide, flunisolide, triamcinolone, beclomethasone, fluticasone, mometasone, dexamethasone, hydrocortisone, methylprednisolone, prednisone, cortisone, betamethasone, or any combination or derivative thereof.
32 . The method of claim 28 , wherein the bronchodilator comprises terbutaline, albuterol, ipatropium, pirbuterol, epinephrine, salmeterol, levalbuterol, formoterol, or any combination thereof.
33 . The method of claim 28 , wherein the mast cell stabilizer comprises cromoglicic acid.
34 . The method of claim 28 , wherein the leukotriene inhibitor comprises montelukast, zafirlukast, zileuton, or any combination or derivative thereof.
35 . The method of claim 28 , wherein the anti-tuberculosis agent comprises isoniazid, ethambutol, pyrazinamide, rifamycin, rifampin, rifabutine, linezolid, streptomycin, clarithromycin, amikacin, kanamycin, gentamicin, capreomycin, viomycin, enviomycin, ciprofloxacin, levofloxacin, moxifloxacin, ethionamide, prothionamide, cycloserine, terizidone, or any combination, or derivative thereof.
36 . The method of any one of claims 1 - 35 , wherein the pharmaceutical composition is substantially devoid of cholesterol.
37 . The method of any one of claims 1 - 36 , wherein the at least one agent comprises azelastine, theophylline, amikacin, gentamicin, tobramycin, rifabutin, rifapentine, sparfioxacin, ciprofloxacin, quinolones, azithromycin, erythromycin, or any combination or derivative thereof.
38 . A pharmaceutical composition comprising: a therapeutically effective amount of at least one agent for treating an allergy in a subject in need thereof, wherein the at least one agent is encapsulated in a sterically stabilized liposome carrier comprising: i) poly (ethylene glycol) distearoylphosphatidylethanolamine (PEG-DSPE); and ii) at least one of phosphatidylglycerol, phosphatidylcholine, or any combination or derivative thereof, and wherein said pharmaceutical composition is formulated for oral administration to said subject.
39 . A pharmaceutical composition comprising: a therapeutically effective amount of at least one agent for treating an allergy in a subject in need thereof, wherein the at least one agent is encapsulated in a sterically stabilized liposome carrier comprising: i) poly (ethylene glycol) distearoylphosphatidylethanolamine (PEG-DSPE); and ii) at least one of phosphatidylglycerol, phosphatidylcholine, or any combination or derivative thereof, and wherein said composition is formulated for subcutaneous administration to said subject.
40 . The pharmaceutical composition of claim 38 or 39 , wherein said composition comprises a lyophile.
41 . The pharmaceutical composition of claim 40 , wherein said lyophile is deposited on a filter paper.
42 . The pharmaceutical composition of claim 40 , wherein the lyophile is reconstituted prior to administration.
43 . The pharmaceutical composition of claim 42 , wherein the lyophile is reconstituted with an aqueous diluent.
44 . The pharmaceutical composition of claim 43 , wherein said aqueous diluent is selected from the group consisting of: distilled water, deionized water; sterile water; bacteriostatic water; and normal saline.
45 . The pharmaceutical composition of any of claims 38 - 44 , further comprising a sugar.
46 . The pharmaceutical composition of claim 45 , wherein said sugar is selected from the group consisting of trehalose, glucose, sucrose, maltose, galactose, fructose, and arabinose.
47 . The pharmaceutical composition of any of claims 38 - 46 , wherein the at least one agent comprises an allergen.
48 . The pharmaceutical composition of claim 47 , wherein the allergen is selected from the group consisting of food proteins, plant products and animal products.
49 . The pharmaceutical composition of claim 47 or 48 , wherein the allergen is a protein selected from the group consisting of peanut protein and tree nut protein.
50 . The pharmaceutical composition of any of claims 47 - 49 , wherein the allergen is selected from the group consisting of whole peanut, peanut powder, peanut butter, derivatives and combinations thereof.
51 . The pharmaceutical composition of any of claims 47 - 50 , wherein the allergen is selected from the group consisting of peanut, tree nut, egg, shellfish, soy, milk, gluten, and derivatives and combinations thereof.
52 . The pharmaceutical composition of any of claims 47 - 51 , wherein the allergen is selected from the group consisting of indoor allergen, mold allergen, stinging insect allergen, food allergen, derivatives and combinations thereof.
53 . The pharmaceutical composition of any one of claims 38 - 52 , wherein the composition further comprises cholesterol.
54 . The pharmaceutical composition of any one of claims 38 - 53 , wherein the at least one agent comprises an allergy medication selected from the group consisting of an antihistamine, a corticosteroid, a bronchodilator, a mast cell stabilizer, a leukotriene inhibitor, an anti-tuberculosis agent, an antibacterial agent, a serine lung protease inhibitor, and any combination and derivative thereof.
55 . The pharmaceutical composition of claim 54 , wherein the antihistamine comprises a H 1 -antihistamine, H 2 -antihistamine, H 3 -antihistamine, H 4 -antihistamine, or any combination thereof.
56 . The pharmaceutical composition of claim 55 , wherein the H 1 -antihistamine comprises acrivastine, azelastine, bilastine, brompheniramine, buclizine, bromodiphenhydramine, carbinoxamine, chlorpromazine, cyclizine, chlorphenamine, chlorodiphenhydramine, clemastine, cyproheptadine, dexbrompheniramine, dexchlorpheniramine, dimenhydrinate, dimetindene, diphenhydramine, doxylamine, ebastine, embramine, fexofenadine, hydroxyzine, loratadine, meclozine, mirtazapine, olopatadine, orphenadrine, phenindamine, pheniramine, phenyltoloxamine, promethazine, quetiapine, rupatadine, tripelennamine, triprolidine, or any combination or derivative thereof.
57 . The pharmaceutical composition of claim 54 , wherein the corticosteroid comprises budesonide, flunisolide, triamcinolone, beclomethasone, fluticasone, mometasone, dexamethasone, hydrocortisone, methylprednisolone, prednisone, cortisone, betamethasone, or any combination or derivative thereof.
58 . The pharmaceutical composition of claim 54 , wherein the bronchodilator comprises terbutaline, albuterol, ipatropium, pirbuterol, epinephrine, salmeterol, levalbuterol, formoterol, or any combination or derivative thereof.
59 . The pharmaceutical composition of claim 54 , wherein the mast cell stabilizer comprises cromoglicic acid.
60 . The pharmaceutical composition of claim 54 , wherein the leukotriene inhibitor comprises montelukast, zafirlukast, zileuton, or any combination or derivative thereof.
61 . The pharmaceutical composition of claim 54 , wherein the anti-tuberculosis agent comprises isoniazid, ethambutol, pyrazinamide, rifamycin, rifampin, rifabutine, linezolid, streptomycin, clarithromycin, amikacin, kanamycin, gentamicin, capreomycin, viomycin, enviomycin, ciprofloxacin, levofloxacin, moxifloxacin, ethionamide, prothionamide, cycloserine, terizidone, or any combination or derivative thereof.
62 . The pharmaceutical composition of any of claims 38 - 61 , wherein the composition is substantially devoid of cholesterol.
63 . A pharmaceutical composition, comprising: a therapeutically effective amount of at least one agent suitable for treating eosinophilic esophagitis (EoE) in a subject in need thereof, wherein the at least one agent is encapsulated in a liposome carrier.
64 . The pharmaceutical composition of claim 63 , wherein the liposome carrier comprises phosphatidylglycerol (PG), phosphatidylcholine (PC), phosphatidylethanolamine (PE), phosphatidylserine (PS), phosphatidylinositol (PI), or any combination or derivative thereof.
65 . The pharmaceutical composition of claim 63 or 64 , wherein the liposome carrier is a sterically stabilized liposome carrier.
66 . The pharmaceutical composition of claim 65 , wherein the sterically stabilized liposome carrier comprises poly (ethylene glycol) distearoylphosphatidylethanolamine (PEG-DSPE), PEG-dipalmitoylphosphatidylethanolamine (DPPE), PEG-di-C:15 PE, PEG-soy PE, or PEG-egg PE.
67 . The pharmaceutical composition of any one of claims 63 - 66 , wherein said composition comprises a lyophile.
68 . The pharmaceutical composition of claim 67 , wherein said lyophile is deposited on a filter paper.
69 . The pharmaceutical composition of claim 67 , wherein the lyophile is reconstituted prior to administration.
70 . The pharmaceutical composition of claim 69 , wherein the lyophile is reconstituted with an aqueous diluent.
71 . The pharmaceutical composition of claim 70 , wherein said aqueous diluent is selected from the group consisting of: distilled water, deionized water; sterile water; bacteriostatic water; and normal saline.
72 . The pharmaceutical composition of any of claims 63 - 71 , wherein the pharmaceutical composition is suitable for subcutaneous, sublingual, or oral administration.
73 . The pharmaceutical composition of any of claims 63 - 72 , wherein the at least one agent comprises a proton-pump inhibitor (PPI), a corticosteroid, or any combination or derivative thereof.
74 . The pharmaceutical composition of claim 73 , wherein the proton-pump inhibitor comprises omeprazole, lansoprazole, dexlansoprazole, esomeprazole, pantoprazole, rabeprazole, ilaprazole, or any combination or derivative thereof.
75 . The pharmaceutical composition of claim 73 , wherein the corticosteroid comprises budesonide, flunisolide, triamcinolone, beclomethasone, fluticasone, mometasone, dexamethasone, hydrocortisone, methylprednisolone, prednisone, cortisone, betamethasone, or any combination or derivative thereof.
76 . The pharmaceutical composition of any of claims 63 - 75 , wherein the at least one agent comprises azelastine, theophylline, amikacin, gentamicin, tobramycin, rifabutin, rifapentine, sparfioxacin, ciprofloxacin, quinolones, azithromycin, erythromycin, or any combination or derivative thereof.
77 . A pharmaceutical composition, comprising: a therapeutically effective amount of at least one agent suitable for treating tuberculosis, wherein the at least one agent is encapsulated in a sterically stabilized liposome carrier comprising: i) poly (ethylene glycol) distearoylphosphatidylethanolamine (PEG-DSPE); and ii) at least one of phosphatidylglycerol, phosphatidylcholine, or any combination or derivative thereof.
78 . The pharmaceutical composition of claim 77 , wherein said composition comprises a lyophile.
79 . The pharmaceutical composition of claim 78 , wherein said lyophile is deposited on a filter paper.
80 . The pharmaceutical composition of claim 78 or 79 , wherein the lyophile is reconstituted prior to administration.
81 . The pharmaceutical composition of claim 80 , wherein the lyophile is reconstituted with an aqueous diluent.
82 . The pharmaceutical composition of claim 81 , wherein said aqueous diluent is selected from the group consisting of: distilled water, deionized water; sterile water; bacteriostatic water; and normal saline.
83 . The pharmaceutical composition of any one of claims 77 - 82 , wherein the pharmaceutical composition is suitable for subcutaneous, sublingual, or oral administration.
84 . The pharmaceutical composition of any one of claims 77 - 83 , wherein the at least one agent comprises isoniazid, rifampin, gangamycin, pyrazinamide, ethambutol, rifabutin, kanamycin, amikacin, capreomycin, streptomycin, levofloxacin, levofloxacin, ofloxacin, para-aminosalicylic acid, cycloserine, terizidone, ethionamide, protionamide, clofazimine, linezolid, amoxicillin/clavulanate, thioacetazone, imipenem/cilastatin, high dose isoniazid, clarithromycin, or any combination or derivative thereof.
85 . The pharmaceutical composition of any one of claims 38 - 84 , wherein the at least one agent comprises an antibody, derivative or fragment thereof.
86 . The pharmaceutical composition of claim 85 , wherein the antibody is an anti-IgE antibody.
87 . The pharmaceutical composition of any one of claims 38 - 86 , wherein the at least one agent comprises a monophosphoryl lipid A (MPL).
88 . The pharmaceutical composition of any one of claims 38 - 87 , wherein upon administration, the at least one agent is released from the liposome carrier in a pH sensitive manner.
89 . The pharmaceutical composition of any one of claims 38 - 87 , wherein upon administration, the at least one agent is released from the liposome carrier in a pH independent manner.
90 . The pharmaceutical composition of any one of claims 38 - 89 , wherein said sterically stabilized liposome carrier comprises a membrane portion, and wherein at least about 50%, about 60%, about 70% or about 75% of the at least one agent is displaced within the membrane portion of the liposome carrier at the time of said administration.
91 . The pharmaceutical composition of any one of claims 38 - 90 , wherein said sterically stabilized liposome carrier comprises an internal portion encompassed by a membrane portion, and wherein at least about 25%, about 50%, about 60%, about 75%, or about 80% of the at least one agent is in the internal portion of the liposome carrier.
92 . The pharmaceutical composition of any one of claims 38 - 91 , comprising at least about 60% phosphatidylglycerol, at least about 60% phosphatidylcholine, or at least about 60% combination of phosphatidylglycerol and phosphatidylcholine.
93 . The pharmaceutical composition of any one of claims 38 - 92 , wherein the pharmaceutical composition contains about 60% to about 99% phosphatidylcholine, phosphatidylglycerol, or combination thereof.
94 . The pharmaceutical composition of any one of claims 38 - 93 , wherein the pharmaceutical composition contains about 1% to about 5% PEG-DSPE.
95 . The pharmaceutical composition of any one of claims 38 - 94 , wherein the pharmaceutical composition contains about 1% to about 33% of the at least one agent.
96 . The pharmaceutical composition of any one of claims 38 - 95 , wherein the sterically stabilized liposome carrier is stable at about pH 3 to about pH 7 or at about pH 7 to about pH 10.
97 . The pharmaceutical composition of any one of claims 38 - 96 , wherein the sterically stabilized liposome carrier has a gel-liquid crystalline phase transition temperature in a range from about −20° C. to about 44° C.
98 . A kit, comprising the pharmaceutical composition of any one of claims 38 - 97 .
99 . The kit of claim 98 , further comprising instructions for use of the pharmaceutical composition.
100 . A method for treating a subject in need thereof, comprising: administering the pharmaceutical composition of any one of claims 38 - 97 to the subject.
101 . The method of claim 100 , wherein the administering the pharmaceutical composition is performed subcutaneously, sublingually, or orally.
102 . The method of claim 100 or 101 , wherein the subject has a non-asthmatic allergy.
103 . The method of any one of claims 100 - 102 , wherein the subject has a food allergy.
104 . The method of any one of claims 100 - 103 , wherein the subject has eosinophilic esophagitis.
105 . The method of any one of claims 100 - 104 , wherein the pharmaceutical composition is administered to the subject less than about 7 times per week.
106 . The method of any one of claims 100 - 105 , wherein the pharmaceutical composition is administered to the subject about once per week.
107 . A method for treating tuberculosis, comprising: administering to a subject in need thereof, a pharmaceutical composition comprising a therapeutically effective amount of at least one agent suitable for treating tuberculosis, wherein the at least one agent is encapsulated in a sterically stabilized liposome carrier comprising: i) poly (ethylene glycol) distearoylphosphatidylethanolamine (PEG-DSPE); and ii) at least one of phosphatidylglycerol, phosphatidylcholine, or any combination or derivative thereof.
108 . The method of any one of claims 100 - 107 , wherein said composition comprises a lyophile.
109 . The method of claim 108 , wherein said lyophile is deposited on a filter paper.
110 . The method of claim 108 , wherein the lyophile is reconstituted prior to administration.
111 . The method of claim 110 , wherein the lyophile is reconstituted with an aqueous diluent.
112 . The method of claim 111 , wherein said aqueous diluent is selected from the group consisting of: distilled water, deionized water; sterile water; bacteriostatic water; and normal saline.
113 . The method of any one of claims 107 - 112 , wherein the administering the pharmaceutical composition is performed subcutaneously, sublingually, or orally.
114 . The method of any one of claims 107 - 113 , wherein the at least one agent comprises isoniazid, rifampin, gangamycin, pyrazinamide, ethambutol, rifabutin, kanamycin, amikacin, capreomycin, streptomycin, levofloxacin, levofloxacin, ofloxacin, para-aminosalicylic acid, cycloserine, terizidone, ethionamide, protionamide, clofazimine, linezolid, amoxicillin/clavulanate, thioacetazone, imipenem/cilastatin, high dose isoniazid, clarithromycin, or any combination or derivative thereof.
115 . The method of any one of claims 100 - 114 , wherein the at least one agent comprises an antibody, derivative or fragment thereof.
116 . The method of claim 115 , wherein the antibody is an anti-IgE antibody.
117 . The method of any one of claims 100 - 116 , wherein the at least one agent comprises a monophosphoryl lipid A (MPL).
118 . The method of any one of claims 100 - 117 , wherein the pharmaceutical composition is in powder, liquid, tablet, or capsule form.
119 . The method of any one of claims 100 - 118 , wherein the pharmaceutical composition is suspended in a solvent before administration.
120 . The method of any one of claims 100 - 119 , wherein at least about 75% of the at least one agent is in a membrane portion of the liposome carrier.
121 . The method of any one of claims 100 - 120 , wherein at least about 75% of the at least one agent is in an internal portion of the liposome carrier.
122 . The method of any one of claims 100 - 121 , wherein the pharmaceutical composition contains at least about 60% phosphatidylglycerol, phosphatidylcholine, or a combination thereof.
123 . The method of any one of claims 100 - 122 , wherein the pharmaceutical composition contains about 60% to about 99% phosphatidylglycerol, phosphatidylcholine, or a combination thereof.
124 . The method of any one of claims 100 - 123 , wherein the pharmaceutical composition contains at least about 1% PEG-DSPE.
125 . The method of any one of claims 100 - 124 , wherein the pharmaceutical composition contains about 1% to about 5% PEG-DSPE.
126 . The method of any one of claims 100 - 125 , wherein the pharmaceutical composition comprises at least about 1% of the at least one agent.
127 . The method of any one of claims 100 - 126 , wherein the pharmaceutical composition contains about 1% to about 33% of the at least one agent.
128 . The method of any one of claims 100 - 127 , wherein the sterically stabilized liposome carrier is stable at about pH 7 to about pH 10.
129 . The method of any one of claims 100 - 128 , wherein the sterically stabilized liposome carrier is stable at about pH 3 to about 7.
130 . The method of any one of claims 100 - 129 , wherein the sterically stabilized liposome carrier has a gel-liquid crystalline phase transition temperature in a range from about −20° C. to about 44° C.
131 . The method of any one of claims 100 - 130 , wherein the pharmaceutical composition is administered to the subject less than about 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 or 14 times per week.
132 . The method of any one of claims 100 - 131 , wherein the pharmaceutical composition is administered to the subject about once per week.
133 . A method for treating inflammation in a subject in need thereof, comprising: administering subcutaneously, sublingually, or orally to said subject, an effective amount of a pharmaceutical composition comprising a sterically stabilized liposome comprising: i) poly (ethylene glycol) distearoylphosphatidylethanolamine (PEG-DSPE); and ii) at least one of phosphatidylglycerol, phosphatidylcholine, or any combination or derivative thereof.
134 . The method of claim 133 , wherein said composition comprises a lyophile.
135 . The method of claim 134 , wherein said lyophile is deposited on a filter paper.
136 . The method of claim 134 or 135 , wherein the lyophile is reconstituted prior to administration.
137 . The method of any claim 136 , wherein the lyophile is reconstituted with an aqueous diluent.
138 . The method of claim 137 , wherein said aqueous diluent is selected from the group consisting of: distilled water, deionized water; sterile water; bacteriostatic water; and normal saline.
139 . The method of any one of claims 133 - 138 , wherein the inflammation is associated with an allergy or a disease.
140 . The method of any one of claims 133 - 139 , wherein the sterically stabilized liposome carrier is stable at about pH 7 to about 10.
141 . The method of any one of claims 133 - 140 , wherein the sterically stabilized liposome carrier is stable at about pH 3 to about 7.
142 . The method of any one of claims 133 - 141 , wherein the sterically stabilized liposome carrier has a gel-liquid crystalline phase transition temperature in a range from −20° C. to 44° C.
143 . The method of any one of claims 133 - 142 , wherein the pharmaceutical composition is administered to the subject less than about 7 times per week.
144 . The method of any one of claims 133 - 143 , wherein the pharmaceutical composition is administered to the subject about once or about two times per week.
145 . The method of any one of claims 133 - 144 , wherein the pharmaceutical composition further comprises a therapeutically effective amount of at least one agent suitable for treating said allergy or disease.
146 . The method of claim 145 , wherein the at least one agent is a corticosteroid.
147 . The method of claim 146 , wherein the corticosteroid comprises budesonide, flunisolide, triamcinolone, beclomethasone, fluticasone, mometasone, dexamethasone, hydrocortisone, methylprednisolone, prednisone, cortisone, betamethasone, or any combination thereof.
148 . The method of any one of claims 145 - 147 , wherein the sterically stabilized liposome and the at least one agent suitable for treating said allergy or disease are administered concurrently.
149 . The method of any one of claims 145 - 147 , wherein the sterically stabilized liposome and the at least one agent suitable for treating said allergy or disease are administered sequentially.
150 . The method of claim 149 , wherein the sterically stabilized liposome and the at least one agent suitable for treating said allergy or disease are administered sequentially, and wherein the sterically stabilized liposome is administered first.
151 . The method of claim 149 , wherein the sterically stabilized liposome and the at least one agent suitable for treating said allergy or disease are administered sequentially, and wherein the at least one agent suitable for treating said allergy or disease is administered first.Join the waitlist — get patent alerts
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