IP Library Granted Patent US 8,202,546
Granted Patent B2
US 8,202,546 · App. 12/698,174 · Granted Jun 19, 2012

Nutritional supplement for use under physiologically stressful conditions

Assignee: Vertical Pharmaceuticals, Inc.
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Quick Facts
Patent No.
US 8,202,546
App. No.
12/698,174
Granted
Jun 19, 2012
Kind
B2
Abstract

In one embodiment of the present invention, a pharmaceutically-acceptable single-dosage formulation consists essentially of about 300 mg of vitamin C; about 1200 IUs of vitamin D3; about 125 IUs of vitamin E; about 25 mg of vitamin B1; about 3.4 mg of vitamin B2; about 35 mg of niacin; about 35 mg of vitamin B6; about 1.25 mg of folate; about 70 mcg of vitamin B12; about 5 mg of pantothenic acid; about 300 mcg of biotin; about 50 mg of calcium; about 35 mg of magnesium; about 35 mg of zinc; about 1 mg of copper; about 125 mcg of selenium; about 150 mcg of chromium; about 25 mg of alpha lipoic acid; about 35 mg of co-enzyme Q-10; about 2 mg of lutein; about 500 mcg of lycopene; about 5 mg of pepper extract; and at least one or more excipients.

Claims (199)

1. A pharmaceutically-acceptable single-dosage formulation, consisting essentially of:

between about 150 mg to about 450 mg of vitamin C;

between about 600 IUs to about 1800 IUs of vitamin D3;

between about 75 IUs to about 150 IUs of vitamin E;

between about 15 mg to about 35 mg of vitamin B1;

between about 1.7 mg to about 5.1 mg of vitamin B2;

between about 20 mg to about 50 mg of niacin;

between about 20 mg to about 50 mg of vitamin B6;

between about 0.5 mg to about 2.5 mg of folate;

between about 35 mcg to about 105 mcg of vitamin B12;

between about 2.5 mg to about 7.5 mg of pantothenic acid;

between about 150 mcg to about 450 mcg of biotin;

between about 50 mg to about 100 mg of calcium;

between about 15 mg to about 55 mg of magnesium;

between about 15 mg to about 55 mg of zinc;

between about 0.5 to about 1.5 mg of copper;

between about 75 mcg to about 175 mcg of selenium;

between about 75 mcg to about 225 mcg of chromium;

between about 10 mg to about 40 mg of alpha lipoic acid;

between about 20 mg to about 50 mg of co-enzyme Q-10;

between about 1 mg to about 3 mg of lutein;

between about 250 mcg to about 750 mcg of lycopene;

between about 2.5 mg to about 7.5 mg of pepper extract; and

at least one or more excipients.

2. The pharmaceutically-acceptable single-dosage formulation of claim 1 , wherein the formulation consists essentially of:

about 300 mg of vitamin C;

about 1200 IUs of vitamin D3;

about 125 IUs of vitamin E;

about 25 mg of vitamin B1;

about 3.4 mg of vitamin B2;

about 35 mg of niacin;

about 35 mg of vitamin B6;

about 1.25 mg of folate;

about 70 mcg of vitamin B12;

about 5 mg of pantothenic acid;

about 300 mcg of biotin;

about 75 mg of calcium;

about 35 mg of magnesium;

about 35 mg of zinc;

about 1 mg of copper;

about 125 mcg of selenium;

about 150 mcg of chromium;

about 25 mg of alpha lipoic acid;

about 35 mg of co-enzyme Q-10;

about 2 mg of lutein;

about 500 mcg of lycopene;

about 5 mg of pepper extract; and

at least one or more excipients.

3. The formulation of claim 1 , wherein the single-dosage formulation is administered in a form selected from the group consisting of a pill, a tablet, a caplet, a capsule, a chewable tablet, a quick dissolve tablet, an effervescent tablet, a hard gelatin capsule, and a soft gelatin capsule.

4. The formulation of claim 3 , wherein the single-dosage formulation is administered in a form with an enteric coating.

5. The formulation of claim 1 , wherein the single-dosage formulation is administered in the form of a liquid suspension.

6. The formulation of claim 1 , wherein the single-dosage formulation is administered in the form of a food product.

7. The formulation of claim 1 , wherein the excipients consist essentially of at least one of dicalcium phosphate, microcrystalline cellulose, stearic acid, croscarmellose sodium, magnesium trisillicate, magnesium stearate or hydroxypropyl methylcellulose.

8. The formulation of claim 1 , wherein the at least one or more excipients consist of:

between about 100 mg to about 300 mg of dicalcium phosphate;

between about 25 mg to about 75 mg of microcrystalline cellulose;

between about 10 mg to about 30 mg of stearic acid;

between about 10 mg to about 30 mg of croscarmellose sodium;

between about 5 mg to about 15 mg of magnesium trisillicate;

between about 5 mg to about 15 mg of magnesium stearate; and

between about 5 mg to about 15 mg of hydroxypropyl methylcellulose.

9. The formulation of claim 8 , wherein the at least one or more excipients consist of:

about 200 mg of dicalcium phosphate;

about 50 mg of microcrystalline cellulose;

about 20 mg of stearic acid;

about 20 mg of croscarmellose sodium;

about 10 mg of magnesium trisillicate;

about 10 mg of magnesium stearate; and

about 10 mg of hydroxypropyl methylcellulose.

10. A pharmaceutically-acceptable single-dosage formulation, consisting of:

between about 150 mg to about 450 mg of ascorbic acid;

between about 600 IUs to about 1800 IUs of cholecalciferol;

between about 75 IUs to about 150 IUs of d-alpha tocopherol succinate;

between about 15 mg to about 35 mg of thiamine mononitrate;

between about 1.7 mg to about 5.1 mg of riboflavin;

between about 20 mg to about 50 mg of niacinamide;

between about 20 mg to about 50 mg of pyridoxine hcl;

between about 0.5 mg to about 2.5 mg of folic acid;

between about 35 mcg to about 105 mcg of cyanocobalamin;

between about 2.5 mg to about 7.5 mg of d-calcium pantothenate;

between about 150 mcg to about 450 mcg of d-biotin;

between about 50 mg to about 100 mg of dicalcium malate;

between about 15 mg to about 55 mg of dimagnesium malate;

between about 15 mg to about 55 mg of zinc bisglycinate chelate;

between about 0.5 to about 1.5 mg of copper amino acid chelate;

between about 75 mcg to about 175 mcg of selenium amino acid chelate;

between about 75 mcg to about 225 mcg of chromium amino acid chelate;

between about 10 mg to about 40 mg of alpha lipoic acid;

between about 20 mg to about 50 mg of co-enzyme Q-10;

between about 1 mg to about 3 mg of lutein;

between about 250 mcg to about 750 mcg of lycopene;

between about 2.5 mg to about 7.5 mg of pepper extract; and

at least one or more excipients.

11. The pharmaceutically-acceptable single-dosage formulation of claim 10 , wherein the formulation consists of:

about 300 mg of ascorbic acid

about 1200 IUs of cholecalciferol;

about 125 IUs of d-alpha tocopherol succinate;

about 35 mg of thiamine mononitrate;

about 5.1 mg of riboflavin;

about 50 mg of niacinamide;

about 50 mg of pyridoxine hcl;

about 2.5 mg of folic acid;

about 105 mcg of cyanocobalamin;

about 7.5 mg of d-calcium pantothenate;

about 450 mcg of d-biotin;

about 75 mg of dicalcium malate;

about 55 mg of dimagnesium malate;

about 55 mg of zinc bisglycinate chelate;

about 1.5 mg of copper amino acid chelate;

about 175 mcg of selenium amino acid chelate;

about 225 mcg of chromium amino acid chelate;

about 40 mg of alpha lipoic acid;

about 50 mg of co-enzyme Q-10;

about 3 mg of lutein;

about 750 mcg of lycopene;

about 7.5 mg of pepper extract; and

at least one or more excipients.

12. The formulation of claim 10 , wherein the single-dosage formulation is administered in a form selected from the group consisting of a pill, a tablet, a caplet, a capsule, a chewable tablet, a quick dissolve tablet, an effervescent tablet, a hard gelatin capsule, and a soft gelatin capsule.

13. The formulation of claim 12 , wherein the single-dosage formulation is administered in a form with an enteric coating.

14. The formulation of claim 10 , wherein the single-dosage formulation is administered in the form of a liquid suspension.

15. The formulation of claim 10 , wherein the single-dosage formulation is administered in the form of a food product.

16. The formulation of claim 10 , wherein the excipients consist of at least one of dicalcium phosphate, microcrystalline cellulose, stearic acid, croscarmellose sodium, magnesium trisillicate, magnesium stearate or hydroxypropyl methylcellulose.

17. The formulation of claim 10 , wherein the at least one or more excipients consist of:

between about 100 mg to about 300 mg of dicalcium phosphate;

between about 25 mg to about 75 mg of microcrystalline cellulose;

between about 10 mg to about 30 mg of stearic acid;

between about 10 mg to about 30 mg of croscarmellose sodium;

between about 5 mg to about 15 mg of magnesium trisillicate;

between about 5 mg to about 15 mg of magnesium stearate; and

between about 5 mg to about 15 mg of hydroxypropyl methylcellulose.

18. The formulation of claim 17 , wherein the at least one or more excipients consist of:

about 200 mg of dicalcium phosphate;

about 50 mg of microcrystalline cellulose;

about 20 mg of stearic acid;

about 20 mg of croscarmellose sodium;

about 10 mg of magnesium trisillicate;

about 10 mg of magnesium stearate; and

about 10 mg of hydroxypropyl methylcellulose.

19. A pharmaceutically-acceptable single-dosage formulation, consisting of:

between about 150 mg to about 450 mg of ascorbic acid;

between about 600 IUs to about 1800 IUs of cholecalciferol;

between about 75 IUs to about 150 IUs of d-alpha tocopherol succinate;

between about 15 mg to about 35 mg of thiamine mononitrate;

between about 1.7 mg to about 5.1 mg of riboflavin;

between about 20 mg to about 50 mg of niacinamide;

between about 20 mg to about 50 mg of pyridoxine hcl;

between about 0.5 mg to about 2.5 mg of folic acid;

between about 35 mcg to about 105 mcg of cyanocobalamin;

between about 2.5 mg to about 7.5 mg of d-calcium pantothenate;

between about 150 mcg to about 450 mcg of d-biotin;

between about 50 mg to about 100 mg of dicalcium malate;

between about 15 mg to about 55 mg of dimagnesium malate;

between about 15 mg to about 55 mg of zinc bisglycinate chelate;

between about 0.5 to about 1.5 mg of copper amino acid chelate;

between about 75 mcg to about 175 mcg of selenium amino acid chelate;

between about 75 mcg to about 225 mcg of chromium amino acid chelate;

between about 10 mg to about 40 mg of alpha lipoic acid;

between about 20 mg to about 50 mg of co-enzyme Q-10;

between about 1 mg to about 3 mg of lutein;

between about 250 mcg to about 750 mcg of lycopene;

between about 2.5 mg to about 7.5 mg of pepper extract;

between about 100 mg to about 300 mg of dicalcium phosphate;

between about 25 mg to about 75 mg of microcrystalline cellulose;

between about 10 mg to about 30 mg of stearic acid;

between about 10 mg to about 30 mg of croscarmellose sodium;

between about 5 mg to about 15 mg of magnesium trisillicate;

between about 5 mg to about 15 mg of magnesium stearate; and

between about 5 mg to about 15 mg of hydroxypropyl methylcellulose;

wherein the single-dosage formulation is administered in a form selected from a group consisting of a pill, a tablet, a caplet, a capsule, a chewable tablet, a quick dissolve tablet, an effervescent tablet, a hard gelatin capsule, a soft gelatin capsule, a liquid suspension or a food product.

20. The pharmaceutically-acceptable single-dosage formulation of claim 19 , wherein the formulation consists of:

about 300 mg of ascorbic acid

about 1200 IUs of cholecalciferol;

about 125 IUs of d-alpha tocopherol succinate;

about 35 mg of thiamine mononitrate;

about 5.1 mg of riboflavin;

about 50 mg of niacinamide;

about 50 mg of pyridoxine hcl;

about 2.5 mg of folic acid;

about 105 mcg of cyanocobalamin;

about 7.5 mg of d-calcium pantothenate;

about 450 mcg of d-biotin;

about 75 mg of dicalcium malate;

about 55 mg of dimagnesium malate;

about 55 mg of zinc bisglycinate chelate;

about 1.5 mg of copper amino acid chelate;

about 175 mcg of selenium amino acid chelate;

about 225 mcg of chromium amino acid chelate;

about 40 mg of alpha lipoic acid;

about 50 mg of co-enzyme Q-10;

about 3 mg of lutein;

about 750 mcg of lycopene;

about 7.5 mg of pepper extract;

about 200 mg of dicalcium phosphate;

about 50 mg of microcrystalline cellulose;

about 20 mg of stearic acid;

about 20 mg of croscarmellose sodium;

about 10 mg of magnesium trisillicate;

about 10 mg of magnesium stearate; and

about 10 mg of hydroxypropyl methylcellulose.

Assignments (7)
SECURITY INTEREST Recorded Jun 30, 2023
From: VERTICAL PHARMACEUTICALS, LLC
To: CIBC BANK USA
Reel/Frame 064133/0094 →
RELEASE OF SECURITY INTEREST Recorded Aug 28, 2021
From: CIT BANK, N.A., AS COLLATERAL AGENT
To: VERTICAL PHARMACEUTICALS, LLC
Reel/Frame 057319/0886 →
SECURITY INTEREST Recorded Aug 27, 2021
From: VERTICAL PHARMACEUTICALS, LLC
To: CIBC BANK USA, AS ADMINISTRATIVE AGENT
Reel/Frame 057309/0950 →
SECURITY INTEREST Recorded Feb 3, 2016
From: VERTICAL PHARMACEUTICALS, LLC
To: CIT BANK, N.A., AS COLLATERAL AGENT
Reel/Frame 037656/0879 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 12, 2013
From: SDK VC PHARMA HOLDING CORP.
To: VERTICAL PHARMACEUTICALS, LLC
Reel/Frame 031767/0691 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 12, 2013
From: VERTICAL PHARMACEUTICALS, INC.
To: SDK VC PHARMA HOLDING CORP.
Reel/Frame 031767/0553 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 17, 2010
From: SQUASHIC, STEVEN A.; HUDY, KEVIN M.; PURDY, DAVID C.
To: VERTICAL PHARMACEUTICALS, INC.
Reel/Frame 023943/0674 →
Continuity (2)
Continuation In Part 11197757 · Aug 4, 2005
Related Publication 20100136104A1 · Jun 3, 2010