Compositions and methods for enhanced mucosal delivery of peptide YY and methods for treating and preventing obesity
First Claim
1. A PYY composition comprised of a solubilizing agent, a chelating agent, L-α
- -phosphatidylcholine didecanoyl (DDPC) and a PYY peptide wherein the PYY peptide is comprised of the amino acid sequence of SEQ ID NO;
2.
7 Assignments
0 Petitions
Accused Products
Abstract
Pharmaceutical compositions and methods are described comprising at least one peptide YY compound and one or more intranasal delivery-enhancing agents for enhanced nasal mucosal delivery of the peptide YY, for treating a variety of diseases and conditions in mammalian subjects, including obesity. In one aspect, the intranasal delivery formulations and methods provide enhanced delivery of peptide YY to the blood plasma or central nervous system (CNS) tissue or fluid, for example, by yielding a peak concentration (Cmax) of the peptide YY in the blood plasma or CNS tissue or fluid of the subject that is 20% or greater compared to a peak concentration of the peptide YY in the blood plasma or CNS tissue or fluid of the subject following administration to the subject of a same concentration or dose of the peptide YY to the subject by subcutaneous injection.
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Citations
19 Claims
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1. A PYY composition comprised of a solubilizing agent, a chelating agent, L-α
- -phosphatidylcholine didecanoyl (DDPC) and a PYY peptide wherein the PYY peptide is comprised of the amino acid sequence of SEQ ID NO;
2. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
- -phosphatidylcholine didecanoyl (DDPC) and a PYY peptide wherein the PYY peptide is comprised of the amino acid sequence of SEQ ID NO;
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9. A PYY composition comprised of methyl-β
- -cyclodextrin, EDTA, L-α
-phosphatidylcholine didecanoyl (DDPC) and a PYY peptide wherein the PYY peptide is comprised of the amino acid sequence of SEQ ID NO;
2.
- -cyclodextrin, EDTA, L-α
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10. A PYY composition comprised of water, a buffer, methyl-β
- -cyclodextrin, EDTA, L-α
-phosphatidylcholine didecanoyl (DDPC) and PYY(3-36) (SEQ ID NO;
2), wherein the formulation has a pH from about 4.0 to about 5.0. - View Dependent Claims (11, 12, 13)
- -cyclodextrin, EDTA, L-α
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14. A PYY composition comprised of water, chlorobutanol, a buffer, methyl-β
- -cyclodextrin, EDTA, L-α
-phosphatidylcholine didecanoyl (DDPC) and PYY(3-36) (SEQ ID NO;
2), wherein the formulation has a pH from about 4.0 to about 5.0.
- -cyclodextrin, EDTA, L-α
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15. A PYY composition comprised of water, benzalkonium chloride, a buffer, methyl-β
- -cyclodextrin, EDTA, L-α
-phosphatidylcholine didecanoyl (DDPC) and PYY(3-36) (SEQ ID NO;
2), wherein the formulation has a pH from about 4.0 to about 5.0.
- -cyclodextrin, EDTA, L-α
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16. A PYY composition comprised of water, chlorobutanol at a concentration of 5 mg/ml, a buffer, methyl-β
- -cyclodextrin at a concentration of about 45 mg/ml, EDTA at a concentration of about 1 mg/ml, L-α
-phosphatidylcholine didecanoyl (DDPC) at a concentration of about 1 mg/ml and PYY(3-36) (SEQ ID NO;
2) at a concentration of about 1 mg/ml, wherein the formulation has a pH from about 4.0 to about 5.0.
- -cyclodextrin at a concentration of about 45 mg/ml, EDTA at a concentration of about 1 mg/ml, L-α
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17. A PYY composition comprised of water, chlorobutanol at a concentration of 5 mg/ml, a buffer, methyl-β
- -cyclodextrin at a concentration of about 45 mg/ml, EDTA at a concentration of about 1 mg/ml, L-α
-phosphatidylcholine didecanoyl (DDPC) at a concentration of about 1 mg/ml and PYY(3-36) (SEQ ID NO;
2) at a concentration of about 15 mg/ml, wherein the formulation has a pH from about 4.0 to about 5.0.
- -cyclodextrin at a concentration of about 45 mg/ml, EDTA at a concentration of about 1 mg/ml, L-α
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18. A kit for treatment of a mammalian subject comprising a stable pharmaceutical composition comprised of PYY(3-36) (SEQ ID NO:
- 2), L-α
-phosphatidylcholine didecanoyl and a solubilizing agent selected from the group consisting of a cyclodextrin, hydroxypropyl-β
-cyclodextrin, sulfobutylether-β
-cyclodextrin and methyl-β
-cyclodextrin.
- 2), L-α
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19. A kit for treatment of a mammalian subject comprising a stable pharmaceutical composition comprised of PYY(3-36) (SEQ ID NO:
- 2), a solubilizing agent, and an L-α
-phosphatidylcholine didecanoyl.
- 2), a solubilizing agent, and an L-α
Specification
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- Resources
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Current AssigneeMdrna Inc. (Adhera Therapeutics, Inc.)
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Original AssigneeNastech Pharmaceutical Company Inc. (Adhera Therapeutics, Inc.)
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InventorsQuay, Steven C
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Primary Examiner(s)Weber; Jon
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Assistant Examiner(s)Kosson; Rosanne
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Application NumberUS10/322,266Publication NumberTime in Patent Office1,498 DaysField of Search514/12, 530/324, 530/303US Class Current514/4.8CPC Class CodesA61K 38/1709 from mammalsA61K 9/0043 NoseA61P 3/04 Anorexiants; Antiobesity ag...
