Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
1998-10-28
2001-02-13
Witz, Jean C. (Department: 1651)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C424S195110
Reexamination Certificate
active
06187811
ABSTRACT:
TECHNICAL FIELD OF THE INVENTION
This invention relates to the treatment of benign prostatic hyperplasia (BPH) using tocotrienols. Specifically, this invention relates to compositions and the use of compositions comprising individual tocotrienols, mixtures of tocotrienols and mixtures of one or more tocotrienols with other anti-BPH substances.
BACKGROUND OF THE INVENTION
It is estimated that over half of men over age 50 and three quarters of men over age 70 experience benign prostatic hyperplasia (BPH). BPH is a condition characterized by a swelling of the prostate; the gland is responsible for secreting an alkaline fluid that is incorporated in seminal fluid. The prostate gland is located below the bladder and surrounds part of the urethra. While prostate enlargement is regarded as a normal part of aging, BPH progression can cause a number of lower urinary tract symptoms and related complications. As the prostate swells, the urethra becomes constricted and obstructs the bladder. This obstruction leads to many of the symptoms of BPH: painful urination, decreased flow, difficulty starting or stopping flow, nocturnal urination, incomplete voiding and others. Complications such as recurrent urinary tract infections, pyelonephritis, chronic and acute urinary retention, dilatation and hydronephrosis can also occur. In some cases, BPH has also been linked to chronic and acute renal failure.
There are two general approaches to addressing BPH: drug treatment and surgery. Currently available drug treatments include the use of alpha-blockers, hormonal therapeutics and herbal medicines. Alpha-blockers relax smooth muscle by selectively blocking alpha-1 adrenoreceptors in the bladder neck and prostate, thereby relieving some of the symptoms associated with BPH. This class includes drugs such as prasozin, doxazosin, indoramin, asfuzasin, terazosin and tamsulosin. Disadvantages of the alpha-blockers include frequency of dosing, side effects and cost. Hormonal therapeutics are anti-androgens that prevent certain hormonal changes involved with BPH. Finasteride (Proscar®, Merck & Co., Inc.) is the leading drug of this class. It prevents the production of dihydrotestosterone (DHT), an androgen that accumulates within the prostate and causes the prostatic enlargement associated with BPH. Finasteride acts by specifically inhibiting steroid 5-alpha reductase, an enzyme responsible for converting testosterone into DHT. Although relatively free from side effects, finasteride is expensive and has a much slower onset of action than the alpha-blockers.
Herbal medicines are a popular alternative to synthetic drugs for treating BPH. These include phytosterols (e.g., beta-sitosterol), saw palmetto berry extracts, Pinus extracts, Picea extracts, Hypoxis extracts, Redix urticae extracts, pumpkin seed extracts (such as cubicin), pygeum, ginseng, cayenne (capsicum), goldenseal root and pollen extracts (such as cernilton).
Despite the existence of these therapeutic options, surgery remains the most effective method of treating BPH, particularly in cases of acute and chronic retention. Surgical methods include transurethral resection of the prostate, transurethral incision, thermotherapy, stents and ultrasound. However, the inherent dangers of surgery, the frequency of post-operative morbidity and the likelihood of needing repeat procedures make surgery an undesired option.
Accordingly, there is still a well-recognized and unmet need for new agents to treat benign prostatic hyperplasia.
SUMMARY OF THE INVENTION
The present invention satisfies the need for new therapeutic agents effective in the treatment of benign prostatic hyperplasia.
One embodiment of this invention provides a method for treating benign prostatic hyperplasia in a patient comprising the step of administering to the patient a therapeutically effective amount of a composition comprising a tocotrienol, a mixture of tocotrienols or a combination of one or more tocotrienols with one or more additional anti-BPH substances.
Another embodiment of this invention provides novel compositions comprising a combination of one or more tocotrienols with one or more additional anti-BPH substances.
DETAILED DESCRIPTION OF THE INVENTION
As used herein, the following definitions apply (unless expressly noted to the contrary):
“anti-BPH” refers to agents or substances that have a beneficial effect on the cause or symptoms of BPH either alone or in combination with a tocotrienol or mixture thereof. Preferably, these anti-BPH substance and agents are selected from alpha-blockers, anti-androgens (such as steroid 5-alpha reductase inhibitors), herbal medicines and anti-inflammatory agents. More preferably, these anti-BPH substances and agents are selected from the group of alpha-blockers consisting of prasozin, doxazosin, indoramin, asfuzasin, terazosin and tamsulosin; the anti-androgen, finasteride, the group of herbal medicines (including a part or extract thereof, as appropriate) consisting of phytosterols (such as sitosterol (such as beta-sitosterol), sitosterol esters (such as fatty acid esters of sitosterol), sitostanol (such as beta-sitostanol), sitostanol esters (such as fatty acid esters of sitostanol), avenasterol, D-5 avenasterol, D-7 avenasterol, brassicasterol, 22,23-dihydobrassiccasterol, ergosterol, desmosterol, poriferasterol, sargasterol, fucosterol, chaunasterol, campesterol, D-7 campesterol, campesto-3,5-dienol, campostanol, cholesterol, 24 M cholesterol, 9,19 cyclolanosterol, 24 M-9,19 cyclolanosterol, stigmasterol, D-5,24 stigmasterol, D-7 stigmaterol, stigmasta-3 enol +1S, stigmasta-3,5 dienol and stigmasta-3,5,22 trienol), other plant unsaponifiables (such as ferulic acid, ferulic acid esters (e.g., ferulic acid esterified with triterpene alcohols, sterols and methanol), sterol esters (such as 4-methyl sterols), triterpene alcohols (such as cycloartanol, B-amyrin, cycloartenol, 24-methylene cycloartanol and cyclobranol), oryzanols (such as gamma-oryzanol), hydrocarbons (such as squalene) and carotenoids(such as beta carotene)), saw palmetto berry, Pinus, Picea, Hypoxis, Redix urticae, conjugated linoleic acid (including cis-9, cis-11-octadecadienoic acid, cis-9, trans-11-octadecadienoic acid, trans-9, cis-11-octadecadienoic acid, trans-9, trans-11-octadecadienoic acid, cis-10, cis-12-octadecadienoic acid, cis-10, trans-12-octadecadienoic acid, trans-10, cis-12-octadecadienoic acid, trans-10, trans-12-octadecadienoic acid and other stable isomers thereof), tocopherols (alpha-, beta-, gamma-, or delta-tocopherol), pumpkin seed (including cubicin), pollen (including cernilton), ginseng (e.g., Chinese and Siberian), juniper berry, Urtica droica L.and urens L., pygeum (including
Pygeum africanum
), goldenseal, gravel root, hydrangea, sea holly, kelp, garlic, marshmallow leaves, horsetail, cayenne (capsicum) and false unicorn root and conventional anti-inflammatory agents (such as non-steroidal anti-inflammatory agents (e.g., aspirin, naproxen salts and ibuprofen)). Most preferably, the anti-BHP agents useful in this invention are selected from the group consisting of saw palmetto berry, Pinus, Picea, Hypoxis, Redix urticae, conjugated linoleic acid, pumpkin seed, pollen, ginseng, juniper berry, Urtica droica L., Urtica urens L., pygeum, goldenseal, gravel root, hydrangea, sea holly, kelp, garlic, marshmallow leaves, horsetail, cayenne and false unicorn root and extracts thereof. The markers and tests for measuring the anti-BPH activities of such agents are well established in the art. In addition to the anti-BHP agents listed above, the use of tocopherols (preferably, alpha-, beta-, gamma-, or delta-tocopherol) and conventional non-steroidal anti-inflammatory agents (such as aspirin, naproxen salts and ibuprofen) is also preferred in the methods of this invention.
“Composition” as used herein refers to a preparation for administration via any acceptable route known to those of ordinary skill in the art. Such routes include, but are not limited to oral, nasal, inhalational, parenteral, intravenous and topical administration. “Composition” enco
LipoGenics, Inc.
Lyon & Lyon LLP
Witz Jean C.
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