# US 2019/0167699 A1 · Prostate function support formula

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- Number: US 2019/0167699 A1
- Document ID: US20190167699A1
- Status: Published application
- Kind: A1
- Application number: 15/829,797
- Filed: 2017-12-01
- Published: 2019-06-06
- Earliest claimed: 2017-12-01
- Applicants: Innovus Pharmaceuticals, Inc.
- Inventors: Bassam Damaj
- Web page: https://patentgrep.com/patent/US20190167699A1

## CPC

- A61K 31/575: substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
- A61K 9/2013: {Organic compounds, e.g. phospholipids, fats}
- A61K 9/2054: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose}
- A61K 9/2095: {Tabletting processes}
- A61K 31/01: Hydrocarbons
- A61K 31/191: having two or more hydroxy groups, e.g. gluconic acid
- A61K 31/198: Alpha-amino acids, e.g. alanine or edetic acid [EDTA] (betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00)
- A61K 31/355: Tocopherols, e.g. vitamin E
- A61K 31/375: Ascorbic acid, i.e. vitamin C; Salts thereof
- A61K 31/4415: Pyridoxine, i.e. Vitamin B6 (pyridoxal phosphate A61K31/675)
- A61K 33/04: Sulfur, selenium or tellurium; Compounds thereof
- A61K 33/30: Zinc; Compounds thereof
- A61K 33/34: Copper; Compounds thereof
- A61K 36/185: Magnoliopsida (dicotyledons)
- A61K 36/736: Prunus, e.g. plum, cherry, peach, apricot or almond
- A61K 36/82: Theaceae (Tea family), e.g. camellia
- A61K 36/889: Arecaceae, Palmae or Palmaceae (Palm family), e.g. date or coconut palm or palmetto
- A61P 13/08: of the prostate
- A61P 13/10: of the bladder
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The invention provides unit dosage forms and methods that are effective to improve prostate function. Such unit dosage forms and methods are useful to decrease bladder discomfort and improve urinary flow in men.

## Claims

### Claim 1

A unit dosage form suitable for oral administration in a human comprising:
300 mg±30 mg of Saw Palmetto;
450 mg±45 mg of Beta-Sitosterol;
150 mg±15 mg of Pygeum Africanum;
75 mg±7.5 mg of Green Tea extract;
15 mg±1.5 mg of Lycopene; and
30 mg±3 mg of Stinging Nettle.

### Claim 2 (depends on 1)

The unit dosage form of claim 1 that further comprises Vitamin E.

### Claim 3 (depends on 1)

The unit dosage form of claim 1 that further comprises Vitamin B-6.

### Claim 4 (depends on 1)

The unit dosage form of claim 1 that further comprises zinc as zinc gluconate.

### Claim 5 (depends on 1)

The unit dosage form of claim 1 that further comprises selenium as amino acid chelate.

### Claim 6 (depends on 1)

The unit dosage form of claim 1 that further comprises copper as copper gluconate.

### Claim 7 (depends on 1)

The unit dosage form of claim 1 that further comprises 2-(3,4-dihydroxyphenyl)-3,5,7-trihydroxy-4H-chromen-4-one.

### Claim 8 (depends on 1)

The unit dosage form of claim 1 that further comprises one or more amino acids selected from L-alanine, L-glutamic acid and glycine.

### Claim 9 (depends on 1)

The unit dosage form of claim 1 that further comprises one or more excipients selected from hydroxypropyl methylcellulose, rice concentrate, and silica.

### Claim 10 (depends on 1)

The unit dosage form of claim 1 that further comprises one or more excipients selected from gelatin, magnesium stearate, stearic acid, and microcrystalline cellulose.

### Claim 11 (depends on 1)

The unit dosage form of claim 1 that is formulated as a capsule or a tablet.

### Claim 12 (depends on 1)

A method to improve prostate function in a man in need thereof comprising administering a unit dosage form of claim 1 to the man.

### Claim 13 (depends on 12)

The method of claim 12 wherein bladder discomfort is decreased.

### Claim 14 (depends on 12)

The method of claim 12 wherein urinary flow is improved.

### Claim 15 (depends on 12)

The method of claim 12 wherein the unit dosage form is administered in the form of three capsules or tablets per day.

### Claim 16 (depends on 1)

The unit dosage form suitable for oral administration in a human of claim 1 comprising:
300 mg±15 mg of Saw Palmetto;
450 mg±22.5 mg of Beta-Sitosterol;
150 mg±7.5 mg of Pygeum Africanum;
75 mg±3.75 mg of Green Tea extract;
15 mg±0.75 mg of Lycopene; and
30 mg±1.5 mg of Stinging Nettle.