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Details for Patent: 6,413,550

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Details for Patent: 6,413,550

Title: Proteinoid carriers and methods for preparation and use thereof
Abstract:Improved proteinoid carriers and methods for their preparation and use as oral delivery systems for pharmaceutical agents are described. The proteinoid carriers are soluble within selected pH ranges within the gastrointestinal tract and display enhanced stability towards at least one of photolysis or decomposition over time. The proteinoid carriers are prepared from proteinoids having between 2 and 20 amino acids and having a molecular weight of between about 250 and 2400 daltons.
Inventor(s): Milstein; Sam J. (Larchmont, NY), Kantor; Martin L. (Mamaroneck, NY)
Assignee: Emisphere Technologies, Inc. (Tarrytown, NY)
Filing Date:Nov 23, 1998
Application Number:09/197,899
Claims:1. A proteinoid carrier comprising a proteinoid comprising

i) a monomer selected from the group consisting of tyrosine, phenylalanine, and a mixture thereof;

ii) a monomer selected from the group consisting of glutamic acid, pyroglutamic acid, glutamine, aspartic acid, and a mixture thereof; and

iii) optionally a monomer selected from the group consisting of lysine, arginine, omithine, and a mixture thereof,

said proteinoid being a microsphere or microcapsule forming proteinoid and being soluble within a selected pH range and said proteinoid having a molecular weight ranging from 250 to 600 daltons.

2. The proteinoid carrier of claim 1, wherein said proteinoid carrier comprises a proteinoid microsphere.

3. The proteinoid carrier of claim 1, wherein said proteinoid carrier comprises a proteinoid microcapsule.

4. The proteinoid carrier of claim 1, wherein said proteinoid comprises a monomer selected from the group consisting of lysine, arginine, omithine, and a mixture thereof and said proteinoid is acid-soluble.

5. The proteinoid carrier of claim 1, wherein said proteinoid is a base-soluble proteinoid.

6. The proteinoid carrier of claim 1, wherein said proteinoid carrier having a diameter equal to or less than 10 microns.

7. The proteinoid carrier of claim 1, further encapsulating a cargo.

8. The proteinoid carrier of claim 7, wherein said cargo comprises a fragrance, cosmetic agent, dye, and water soluble vitamin.

9. The proteinoid carrier of claim 7, wherein said cargo is a biologically active agent.

10. The proteinoid carrier of claim 9, wherein said biologically active agent comprises an antigen, monoclonal antibody, calcitonin, erythropoietin, alpha interferon, heparin, insulin, growth hormone, atrial naturetic factor, factor IX, an antimicrobial agent, aspirin, or interleukin-II.

11. A composition comprising a biologically active agent encapsulated within a proteinoid microcapsule, said microcapsule comprising a proteinoid comprising

i) a monomer selected from the group consisting of tyrosine, phenylalanine, and a mixture thereof;

ii) a monomer selected from the group consisting of glutamic acid, pyroglutamic acid, glutamine, aspartic acid, and a mixture thereof; and

iii) optionally a monomer selected from the group consisting of lysine, arginine, omithine, and a mixture thereof,

said proteinoid being a microcapsule forming proteinoid and being soluble within a selected pH range and said proteinoid having a molecular weight ranging from 250 to 600 daltons.

12. The composition of claim 11, wherein said proteinoid comprises a monomer selected from the group consisting of lysine, arginine, ornithine, and a mixture thereof and said proteinoid is acid-soluble.

13. The composition of claim 11, wherein said proteinoid is a base-soluble proteinoid.

14. The composition of claim 11, wherein said biologically active agent comprises an antigen, monoclonal antibody, calcitonin, erythropoietin, alpha interferon, heparin, insulin, growth hormone, atrial naturetic factor, factor IX, an antimicrobial agent, aspirin, or interleukin-II.

15. A pharmaceutical preparation comprising an oral dosage form of calcitonin encapsulated within a proteinoid microcapsule, said microcapsule comprising a proteinoid comprising

i) a monomer selected from the group consisting of tyrosine, phenylalanine, and a mixture thereof;

ii) a monomer selected from the group consisting of glutamic acid, pyroglutamic acid, glutamine, aspartic acid, and a mixture thereof; and

iii) optionally a monomer selected from the group consisting of lysine, arginine, omithine, and a mixture thereof,

said proteinoid being a microcapsule forming proteinoid and being soluble within a selected pH range and said proteinoid having a molecular weight ranging from 250 to 600 daltons.

16. A pharmaceutical preparation comprising an oral dosage form of a monoclonal antibody encapsulated within a proteinoid microcapsule, said microcapsule comprising a proteinoid comprising

i) a monomer selected from the group consisting of tyrosine, phenylalanine, and a mixture thereof;

ii) a monomer selected from the group consisting of glutamic acid, pyroglutamic acid, glutamine, aspartic acid, and a mixture thereof; and

iii) optionally a monomer selected from the group consisting of lysine, arginine, omithine, and a mixture thereof,

said proteinoid being a microcapsule forming proteinoid and being soluble within a selected pH range and said proteinoid having a molecular weight ranging from 250 to 600 daltons.

17. A pharmaceutical preparation comprising an oral dosage form of erythropoietin encapsulated within a proteinoid microcapsule, said microcapsule comprising a proteinoid comprising

i) a monomer selected from the group consisting of tyrosine, phenylalanine, and a mixture thereof;

ii) a monomer selected from the group consisting of glutamic acid, pyroglutamic acid, glutamine, aspartic acid, and a mixture thereof; and

iii) optionally a monomer selected from the group consisting of lysine, arginine, ornithine, and a mixture thereof,

said proteinoid being a microcapsule forming proteinoid and being soluble within a selected pH range and said proteinoid having a molecular weight ranging from 250 to 600 daltons.

18. A pharmaceutical preparation comprising an oral dosage form of Factor IX encapsulated within a proteinoid microcapsule, said microcapsule comprising a proteinoid comprising

i) a monomer selected from the group consisting of tyrosine, phenylalanine, and a mixture thereof;

ii) a monomer selected from the group consisting of glutamic acid, pyroglutamic acid, glutamine, aspartic acid, and a mixture thereof; and

iii) optionally a monomer selected from the group consisting of lysine, arginine, omithine, and a mixture thereof,

said proteinoid being a microcapsule forming proteinoid and being soluble within a selected pH range and said proteinoid having a molecular weight ranging from 250 to 600 daltons.

19. A method for delivering calcitonin to a mammal which comprises orally administering the pharmaceutical preparation according to claim 15.

20. A method for delivering erythropoietin to a mammal which comprises orally administering the pharmaceutical preparation according to claim 17.

21. A method for delivering Factor IX to a mammal which comprises orally administering the pharmaceutical preparation according to claim 18.
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