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Details for Patent: 7,417,022

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Details for Patent: 7,417,022

Title:Compounds and compositions for delivering active agents
Abstract: Modified amino acid compounds useful in the delivery of active agents are provided. Methods of administration and preparation are provided as well.
Inventor(s): Leone-Bay; Andrea (Ridgefield, CT), Milstein; Sam J. (Larchmont, NY), Sarubbi; Donald J. (Bolton, MA), Leipold; Harry (Elmsford, NY)
Assignee: MHR Institutional Partners IIA LP (New York, NY)
Filing Date:Apr 11, 2005
Application Number:11/104,173
Claims:1. A pharmacological composition comprising: (A) parathyroid hormone; and (B) at least one carrier compound having the formula 2-HO--Ar--CONR.sup.8--R.sup.7--COOH wherein Ar is a substituted or unsubstituted phenyl or naphthyl; R.sup.7 is selected from the group consisting of C.sub.4 to C.sub.20 alkyl, C.sub.4 to C.sub.20 alkenyl, phenyl, naphthyl, (C.sub.1 to C.sub.10 alkyl) phenyl, (C.sub.1 to C.sub.10 alkenyl)phenyl, (C.sub.1 to C.sub.10 alkyl) naphthyl, (C.sub.1 to C.sub.10 alkenyl)naphthyl, phenyl (C.sub.1 to C.sub.10 alkyl), phenyl (C.sub.1 to C.sub.10 alkenyl), naphthyl (C.sub.1 to C.sub.10 alkyl), and naphthyl (C.sub.1 to C.sub.10 alkenyl); R.sup.8 is selected from the group consisting of hydrogen, C.sub.1 to C.sub.4 alkyl, C.sub.1 to C.sub.4 alkenyl, hydroxy, and C.sub.1 to C.sub.4 alkoxy; R.sup.7 is optionally substituted with C.sub.1 to C.sub.4 alkyl, C.sub.1 to C.sub.4 alkenyl, C.sub.1 to C.sub.4 alkoxy, --OH, --SH and --CO.sub.2R.sup.9 any combination thereof; R.sup.9 is hydrogen, C.sub.1 to C.sub.4 alkyl or C.sub.1 to C.sub.4 alkenyl; R.sup.7 is optionally interrupted by oxygen, nitrogen, sulfur or any combination thereof; with the proviso that the compounds are not substituted with an amino group in the position alpha to the acid group; or salts thereof.

2. The composition according to claim 1, wherein R.sup.7 is C.sub.4 to C.sub.20 alkyl.

3. The composition according to claim 1, wherein R.sup.7 is C.sub.5 to C.sub.20 alkyl.

4. The composition according to claim 1 wherein the carrier has the formula ##STR00067## or a salt thereof.

5. The composition according to claim 1 wherein said carrier is a compound selected from the group consisting of ##STR00068## ##STR00069## or salts thereof.

6. The composition according to claim 1 wherein the carrier is a compound selected from the group consisting of TABLE-US-00009 A ##STR00070## Compound n m X LII 1 0 2-OH LIII 3 0 2,6-dihydroxy LIV 2 0 2-OH LVI 2 0 2,6-dihydroxy

or salts thereof.

7. The composition according to claim 1 wherein the carrier is a compound selected from the group consisting of TABLE-US-00010 G ##STR00071## Compound n m X CXI 6 0 2-OH CXIX 9 0 2-OH

or salts thereof.

8. The composition according to claim 1, wherein said carrier has the formula ##STR00072## or a salt thereof.

9. The composition according to claim 1 wherein the carrier has the formula ##STR00073## or a salt thereof.

10. A dosage unit form comprising (A) a pharmacological composition according to claim 1; and (B) (a) an excipient, (b) a diluent, (c) a disintegrant, (d) a lubricant, (e) a plasticizer, (f) a colorant, (g) a dosing vehicle, or (h) any combination thereof.

11. A dosage unit form according to claim 10, comprising a tablet, a capsule, or a liquid.

12. A dosage unit form according to claim 11, wherein said dosing vehicle is selected from the group consisting of water, 1,2-propane diol, ethanol or any combination thereof.

13. A method for administering parathyroid hormone to a mammal in need of said agent, said method comprising administering orally to said mammal a composition as defined in claim 1.

14. A method for preparing a pharmacological composition, said method comprising mixing: (A) parathyroid hormone; (B) at least one carrier compound according to claim 1; and (C) optionally a dosing vehicle.

15. A method for administering parathyroid hormone to an animal in need thereof, said method comprising administering orally to said mammal a composition as defined in claim 1.
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