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Details for Patent: 6,346,242

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Details for Patent: 6,346,242

Title: Compounds and compositions for delivering active agents
Abstract:The present invention provides a compound having the formula ##STR1## or a salt thereof which facilitates the delivery of active agents. Compositions and dosage unit forms comprising the compound of the present invention and at least one active agent, such as a peptide, mucopolysaccharide, carbohydrate, or a lipid, are also provided. Methods of administration and preparation of the compounds and compositions of the invention are provided as well.
Inventor(s): Leone-Bay; Andrea (Ridgefield, CT), Ho; Koc-Kan (Monmouth Junction, NJ), Sarubbi; Donald J. (Carmel, NY), Milstein; Sam J. (Larchmont, NY)
Assignee: Emishpere Technologies, Inc. (Tarrytown, NY)
Filing Date:Feb 08, 2000
Application Number:09/499,958
Claims:1. A composition comprising:

(A) at least one active agent; and

(B) a compound having the following formula ##STR68##

or a salt thereof.

2. A composition as defined in claim 1, wherein said active agent is selected from the group consisting of a biologically active agent, a chemically active agent, and a combination thereof.

3. A composition as defined in claim 2, wherein said biologically active agent comprises at least one peptide, hormone, polysaccharide, mucopolysaccharide, carbohydrate, or lipid.

4. The composition as defined in claim 3, wherein said biologically active agent is selected from the group consisting of human growth hormone, bovine growth hormone, growth hormone-releasing hormone, an interferon, interleukin-1, interleukin-II, insulin, heparin, low molecular weight heparin, calcitonin, erythropoietin, atrial naturetic factor, an antigen, a monoclonal antibody, somatostatin, adrenocorticotropin, gonadotropin releasing hormone, oxytocin, vasopressin, cromolyn sodium, vancomycin, parathyroid hormone, desferrioxamine, an anti-microbial agent, an anti-fungal agent, and any combination thereof.

5. A composition as defined in claim 4, wherein said biologically active agent comprises an interferon, interleukin-II, insulin, heparin, low molecular weight heparin, calcitonin, oxytocin, vasopressin, vancomycin, DFO, parathyroid hormone, or a combination thereof.

6. A composition as defined in claim 2, wherein said biologically active agent comprises parathyroid hormone.

7. A composition as defined in claim 2, wherein said biologically active agent comprises recombinant human growth hormone.

8. A composition as defined on claim 2, wherein said biologically active agent comprises interferon.

9. A composition as defined in claim 2, wherein said biologically active agent comprises heparin.

10. A composition as defined in claim 2, wherein said biologically active agent comprises low molecular weight heparin.

11. A dosage unit form comprising:

(A) a composition as defined in 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.

12. The dosage unit form as defined in claim 11, wherein said active agent is selected from the group consisting of a biologically active agent, a chemically active agent, and a combination thereof.

13. The dosage unit form as defined in claim 12, wherein said biologically active agent comprises at least one peptide, hormone, polysaccharide, mucopolysaccharide, carbohydrate, or lipid.

14. The dosage unit form as defined in claim 13, wherein said biologically active agent is selected from the group consisting of human growth hormone, bovine growth hormone, growth hormone-releasing hormone, an interferon, interleukin-1, interleukin-II, insulin, heparin, low molecular weight heparin, calcitonin, erythropoietin, atrial naturetic factor, an antigen, a monoclonal antibody, somatostatin, adrenocorticotropin, gonadotropin releasing hormone, oxytocin, vasopressin, cromolyn sodium, vancomycin, parathyroid hormone, desferrioxamine, an anti-microbial agent, an anti-fungal agent, and any combination thereof.

15. A dosage unit form as defined in claim 14, wherein said biologically active agent comprises an interferon, interleukin-II, insulin, heparin, low molecular weight heparin, calcitonin, oxytocin, vasopressin, vancomycin, DFO, parathyroid hormone, or a combination thereof.

16. A dosage unit form as defined in claim 12, wherein said biologically active agent comprises parathyroid hormone.

17. A dosage unit form as defined in claim 12, wherein said biologically active agent comprises recombinant human growth hormone.

18. A dosage unit form as defined on claim 12, wherein said biologically active agent comprises interferon.

19. A dosage unit form as defined in claim 12, wherein said biologically active agent comprises heparin.

20. A dosage unit form as defined in claim 12, wherein said biologically active agent comprises low molecular weight heparin.

21. A dosage unit form as defined in claim 11, comprising a tablet, a capsule, or a liquid.

22. A dosage unit form as defined in claim 21, wherein said dosing vehicle is selected from the group consisting of water, 1,2-propane diol, ethanol, and any combination thereof.

23. A method for administering a biologically-active agent to an animal in need of said agent, said method comprising administering orally to said animal a composition as defined in claim 2.

24. A compound having the formula ##STR69##

or a salt thereof.

25. A method for preparing a composition, said method comprising mixing:

(A) at least one active agent;

(B) at least one compound as defined in claim 24; and

(C) optionally, a dosing vehicle.

26. A composition comprising:

(A) at least one active agent; and

(B) a poly(amino acid) comprising a monomer having the formula ##STR70##

or a salt thereof.

27. A composition as defined in claim 26, wherein the poly(amino acid) comprises a peptide.
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