Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form
Reexamination Certificate
1994-10-03
2001-12-11
Webman, Edward J. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Particulate form
C424S486000
Reexamination Certificate
active
06328996
ABSTRACT:
TECHNICAL FIELD
The present invention is directed to the field of bioelastomeric polymers and to uses thereof.
BACKGROUND
Bioelastic polypeptides are a relatively new development that arose in the laboratories of the present inventor and which are disclosed in a series of previously filed patents and patent applications. For example, U.S. Pat. No. 4,474,851 describes a number of tetrapeptide and pentapeptide repeating units that can be used to form a bioelastic polymer. Specific bioelastic polymers are also described in U.S. Pat. Nos. 4,132,746; 4,187,852; 4,500,700; 4,589,882; and 4,870,055. Bioelastic polymers are also disclosed in related patents directed to polymers containing peptide repeating units that are prepared for other purposes but which can also contain bioelastic segments in the final polymer; see U.S. Pat. No. 4,605,413. A number of other bioelastic materials and methods for their use are described in U.S. patent applications including the following: “Bioelastomer containing Tetra/Pentapeptide Units,” U.S. Ser. No. 062,557, filed Jun. 15, 1987, now U.S. Pat. No. 4,898,926; “Reversible Mechanochemical Engines Comprised of Bioelastomers,” U.S. Ser. No. 410,018, filed Sep. 20, 1989, now issued as U.S. Pat. No. 5,032,271; “Bioelastomeric Materials Suitable for the Protection of Wound Repair Sites,” U.S. Ser. No. 184,407, filed Apr. 21, 1988, now issued as U.S. Pat. No. 5,250,516; “Elastomeric Polypeptides as Vascular Prosthetic Materials,” U.S. Ser. No. 184,873, filed Apr. 22, 1988; now U.S. Pat. No. 5,336,256 ; “Polynonapeptide Bioelastomers having an Increased Elastic Modulus,” U.S. Ser. No. 314,115, filed Feb. 23, 1989, now issued as U.S. Pat. No. 5,064,430. All of these patents and patent applications are herein incorporated by reference, as they describe in detail bioelastomers that can be used in the compositions and methods of the present invention. These bioelastic materials have been proposed for a number of uses, as indicated by the general subject matter of the applications and patents as set forth above.
The present invention is directed to a new use of bioelastic materials, namely as part of a drug delivery system that can be finely tuned so that drug is released in a particular environment.
In the past, compositions used for selective drug delivery have been prepared by designing a particular composition that reacts chemically at a preselected rate that depends on the environment in which the composition is found. For example, a coating which is resistant to acid but which dissolves under basic conditions can be applied to a capsule so that the capsule passes through the stomach of a subject to whom the capsule is administered and dissolves in the intestine of that subject (an enteric-coated capsule). Although such materials have proven suitable for a number of uses, there is a continued need for advances in drug delivery systems.
RELEVANT LITERATURE
In addition to the patents and patent applications cited above, a number of publications in the scientific literature are relevant to the present invention. These publications are listed below, and reference is made in the following specification to these literature references by giving the reference number in parentheses at the location where the reference is being cited.
1. Urry, D. W.:
J. Protein Chem.
7, 1-34 (1988).
2. Urry, D. W.:
J. Protein Chem.
7, 81-114 (1989).
3. Urry, D. W.:
American Chemical Society, Div. of Polymeric Materials: Sci. and Engineering
62 (1990).
4. Hollinger, J. O., J. P. Schmitz, R. Yaskovich, M. M. Long, K. U. Prasad, and D. W. Urry:
Calacif. Tissue Int.
42, 231-236 (1988)
5. Urry, D. W.:
Intl. J. Quantum Chem.: Quantum Biol. Symp.
15, 235-245 (1988).
6. Edsall, J. T. and H. A. McKenzie:
Adv. Biophys.
16, 53-183 (1983).
7. Kauzman, W.:
Adv. Protein Chem.
14, 1-63 (1959).
8. Urry, D. W., C-H Luan, R. Dean Harris, and Karl U. Prasad:
Polymer Preprint Am. Chem. Soc. Div. Polym. Chem.
(1990).
9. Urry, D. W.:
J. Protein Chem.
3, 403-436 (1984).
10. Chang, D. K., C. M. Venkatachalam, K. U. Prasad, and D. W. Urry;
J. of Biomolecular Structure
&
Dynamics
6, 851-858 (1989).
11. Chang, D. K. and D. W. Urry:
J. of Computational Chemistry
10, 850-855 (1989).
12. Urry, D. W., B. Haynes, H. Zhang, R. D. Harris, and K. U. Prasad:
Proc. Natl. Acad. Sci. USA
85, 3407-3411 (1988).
13. Urry, D. W., Shao Qing Peng, Larry Hayes, John Jaggard, and R. Dean Harris:
Biopolymers
(1990).
14. Sidman, K. R., W. D. Steber, and A. W. Burg: In
Proceedings, Drug Delivery Systems
(H. L. Gabelnick, Ed.), DHEW Publication No. (NIH)
77, -1238, 121-140
(1976).
15. Urry, D. W., D. K. Chang, H. Zhang, and K. U. Prasad:
Biochem. Biophys. Res. Commun.
153, 832-839 (1988).
16. Robinson, A. B.:
Proc. Nat. Acad. Sci. USA
71, 885-888 (1974).
17. Urry, D. W.: In
Methods in Enzymology,
(L. W. Cunningham and D. W. Frederiksen, Eds.) Academic Press, Inc. 82, 673-716 (1982).
18. Urry, D. W., John Jaggard, R. D. Harris, D. K. Chang, and K. U. Prasad: In
Progress in Biomedical Polymers
(Charles G. Gebelein and Richard L. Dunn, Eds.), Plenum Publishing Co. (1990).
19. Urry, D. W., J. Jaggard, K. U. Prasad, T. Parker, and R. D. Harris: Plenum Press (1990).
20. Urry, D. W., R. D. Harris, and K. U. Prasad:
J. Am. Chem. Soc.
110, 3303-3305 (1988).
21. Sciortino, F., M. U. Palma, D. W. Urry, and K. U. Prasad:
Biochem. Biophys. Res. Commun.
157, 1061-1066 (1988).
22. Sciortino, F., D. W. Urry, M. U. Palma, and K. U. Prasad:
Biopolymers
(1990).
23. Pitt, C. G. and A. Schindler, In
Progress in Contraceptive Delivery Systems
(E. Hafez and W. Van Os, Eds.), MTP Press Limited 1, 17-46 (1980).
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a drug delivery system that can be finely tuned to release a drug at a predetermined rate upon the existence of a set of predetermined conditions in contact with the drug-containing composition.
It is a further object of this invention to provide a drug delivery system that can rapidly release a unit dose of drug upon a relatively small change in physiological conditions.
It is still another object of the invention to provide a drug-containing composition which can be implanted and programmed to release drug over a predetermined period ranging from days to decades depending on the particular composition selected for the matrix portion of the system.
These and other objects of the present invention as will hereinafter become more readily apparent have been accomplished by providing a drug delivery composition comprising a bioelastic polymer, comprising elastomeric units selected from the group consisting of bioelastic pentapeptides, tetrapeptides, and nonapeptides, in the form of a solid matrix, and a drug contained in the matrix. By selecting the side chains present in the polymer portion of the composition, fine control is possible over both the drug release rate and the location at which drug is released in an human or animal body.
REFERENCES:
patent: 3867520 (1975-02-01), Mori et al.
patent: 3888975 (1975-06-01), Ramwell
patent: 4178361 (1979-12-01), Cohen et al.
patent: 4187852 (1980-02-01), Urry et al.
patent: 4351337 (1982-09-01), Sidman
patent: 4474851 (1984-10-01), Urry et al.
patent: 4589882 (1986-05-01), Urry
patent: 4605413 (1986-08-01), Urry et al.
patent: 4671954 (1987-06-01), Goldberg et al.
patent: 4693718 (1987-09-01), Urry et al.
patent: 4741872 (1988-05-01), DeLuca et al.
patent: 4863735 (1989-09-01), Khon et al.
patent: 4898926 (1990-02-01), Urry
patent: 27 23 908 A1 (1977-05-01), None
patent: 31 04 815 A1 (1981-02-01), None
patent: 03 49 428 A1 (1989-06-01), None
ACS Abstract CA 13-59817(7), Chang et al, 1989.*
ACS Abstract CA14-139219 (15), Castiglione—Morglli et al, 1990.*
ACS Abstract CA08-22274(3), Rahman et al 1987.
Bioelastics Research Ltd.
Cooley & Godward LLP
Neeley Richard L.
Webman Edward J.
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