Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from gramineae
Reexamination Certificate
1999-05-14
2001-08-21
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from gramineae
C514S841000
Reexamination Certificate
active
06277418
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to pharmaceutical compositions derived from corn extracts useful as contraceptive compositions and antineoplastic compositions.
2. Description of the Background
Contraception is often desired to control reproduction. While a plurality of contraceptive compositions and methods are available commercially, most methods of chemical contraceptives are active through a limited number of pathways. Thus, the majority of contraceptive compositions still involve the use of one or more natural or synthetic hormones such as estrogen, progestin and ethinyl estradiol.
While natural and synthetic hormones are effective, their use has not been without substantial and undesirable side effects. Numerous side effects have been associated with the use of natural or synthetic hormones in contraceptives, such as, for example, thrombophlebitis, thrombosis, pulmonary embolism, coronary thrombosis, myocardial infarction, cerebral thrombosis, cerebral hemorrhage, hypertension, irregular bleeding, and irregular menstrual cycle.
Even with the reduction (but not elimination) of side effects through improved formulation, a number of disadvantages are still associated with current contraceptive compositions. Oral contraceptives rely on a high degree of patient compliance. For example, the risk of pregnancy increases with each pill missed or each pill taken out of order. Also, implantable contraceptives have many undesirable side effects and enjoy limited consumer acceptance. Another disadvantage of conventional contraceptives is that they are only effective when taken by females. Thus, the type of contraceptive choices available to couples is limited.
SUMMARY OF THE INVENTION
The present invention overcomes many of the limitations, problems and disadvantages associated with current strategies and designs for contraception and provides compositions and methods for contraception. As embodied and broadly described herein, the present invention is directed to a corn extract, such as an extract from corn cob, useful as a contraceptive. In addition, extracts of the present invention are also useful as antineoplastic agents.
One embodiment of the invention is directed to a process for producing a therapeutic substance. In this process, a
Zea mays
plant product is extracted to produce a solvent extract, the solvent extract is dried to produce an extracted solid, the extracted solid is resolubilized in a solvent to form a resolubilized extract, the resolubilized extract is purified in a chromatography process, such as a reverse phase column chromatography process, and an active fraction is collected from the chromatography process. The Zea mays plant product used for starting material may be corn kernel, corn cob, animal bedding material made from corn cob, and mixtures of these materials.
Another embodiment of the invention is directed to a therapeutic substance produced by the process of the invention. The therapeutic substance may be in the form of a salt, a compound, a complex or a combination of these forms.
Another embodiment of the invention is directed to a pharmaceutical preparation that contains the therapeutic substance produced by the process of this invention.
The pharmaceutical preparation may include, in addition to the active ingredients, a pharmaceutically acceptable carrier.
Another embodiment of the invention is directed to a composition for effecting contraception in a patient. The composition is preferably made using the process of the invention. The patient may be any mammal such as, for example, humans, monkeys, mice, rats, guinea pigs, rabbits, hamsters, horses, cattle, pigs, sheep, goats, dogs and cats.
Another embodiment of the invention is directed to a method of contraception comprising isolating an extract from a
Zea mays
plant product using a polar solvent and administering an effective amount of the extract to an individual to effect contraception.
Another embodiment of the invention is directed to a method for treating a patient with a neoplastic disorder comprising administering to the patient an antineoplastic composition comprising an effective quantity of the therapeutic compound of the invention. The antineoplastic composition of the invention may further comprise an antineoplastic compound or agent, which may be, for example, methotrexate.
Another embodiment of the invention is directed to a method of inhibiting neoplastic activity comprising the steps of isolating an antineoplastic extract from a
Zea mays
plant product using a polar solvent and administering an effective amount of the antineoplastic extract to an individual. The method may further comprise the step of administering an antineoplastic compound, such as methotrexate.
Another embodiment of the invention is directed to an isolated and purified compound derived from an extract of
Zea mays
having a molecular weight of 348 amu. Preferably, the compound is isolated from extract that is derived from
Zea mays
corn cob using a polar solvent.
Another embodiment of the invention is directed to an isolated and purified compound derived from an extract of
Zea mays
having a molecular weight of 353 amu. Preferably, the compound is isolated from extract that is derived from
Zea mays
corn cob using a polar solvent.
Another embodiment is directed to an isolated and purified compound derived from an extract of a
Zea mays
plant product, the extract being derived from the
Zea mays
plant product according to the methods of the invention, the compound eluting as a single UV-absorption peak from a C
18
reversed phase HPLC column having a flow rate of 2 ml per minute, as described below, the compound eluting approximately 56 minutes after injection of the extract sample onto the column, and having a molecular weight of either 348 amu or 353 amu.
Another embodiment is directed to an isolated and purified compound derived from an extract of a
Zea mays
plant product, the extract being derived from the
Zea mays
plant product according to the methods of the invention, the compound eluting as a single UV-absorption peak from a C
18
reversed phase HPLC column having a flow rate of 2 ml per minute, as described below, the compound eluting approximately 60 minutes after injection of the extract sample onto the column, and having a molecular weight of either 348 amu or 353 amu.
Other embodiments and advantages of the invention are set forth, in part, in the description which follows and, in part, will be obvious from this description and may be learned from the practice of the invention.
REFERENCES:
patent: 4950481 (1990-08-01), Keri et al.
patent: 8102022 (1997-10-01), None
patent: 9122146 (1998-08-01), None
patent: WO 92/03142 (1992-03-01), None
Kraft, “The Manufacture, Shipping and Receiving and Quality Control of Rodent Bedding Materials,”Laboratory Animal Care, vol. 30, No. 2, pp. 366-376 (1980).
Port, et al., “The Effect of Corrncob Bedding on Reproductivity and Leucine Incorporation in Mice,”Laboratory Animal Care, vol. 19, No. 1, pp. 46-49 (1969).
Iturrian, et al., “Comparison of Bedding Material: Habitat Preference of Pregnant Mice and Reproductive Performance,”Laboratory Animal Care, vol. 18, No. 2, pp. 160-164 (1968).
Clark, et al., “Effect of Estradiol-17&agr; on Nuclear Occupancy of the Estrogen Receptor, Stimulation on Nuclear Type II Sites and Uterine Growth,”J. Steroid Biochem., vol. 16, pp. 323-328 (1982).
Clark, et al., “The Agonistic and Antagonistic Actions of Estriol,”J. Steroid Biochem, vol. 20, No. 4B, pp. 1005-1013 (1984).
Markaverich, et al., “Two Binding Sites for Estradiol in Rat Uterine Nuclei: Relationship to Uterotropic Response,”Endocrinology, vol. 105, No. 6, pp. 1458-1462 (1979).
Noble, et al., “Spontaneous and Estrogen-produced Tumors in Nb Rats and Their Behavior after Transplantation,”Cancer Research, vol. 35, pp. 766-780 (Mar. 1975).
Markaverich, et al., “The Effect of Low Dose Continuous Exposure to Estradiol on the Estrogen Receptor (Type I) and Nuclear Type II Sites,”Endocrinology, vol. 114, No. 3, pp. 814-
Faith Robert
Mani Shaila
Markaverich Barry M.
Baylor College of Medicine
Brobeck Phleger & Harrison LLP
Tate Christopher R.
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