IP Library Granted Patent US 8,728,535
Granted Patent B2
US 8,728,535 · App. 13/527,264 · Granted May 20, 2014

Nutritional supplement for use under physiologically stressful conditions

Inventors: Steven A. Squashic (Scotch Plains, NJ); Kevin M. Hudy (Hoboken, NJ); David C. Purdy (Freehold, NJ)
Assignee: Vertical Pharmaceuticals, LLC
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Quick Facts
Patent No.
US 8,728,535
App. No.
13/527,264
Granted
May 20, 2014
Kind
B2
Abstract

In one embodiment of the present invention, a pharmaceutically-acceptable single-dosage formulation consists essentially of about 500 mg of vitamin C; about 400 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 folic acid; about 70 mcg of vitamin B12; about 5 mg of pantothenic acid; about 75 mcg of biotin; 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 10 mg of alpha lipoic acid; about 35 mg of co-enzyme Q-10; about 400 mcg of lutein; about 125 mcg of lycopene; and at least one or more excipients.

Claims (187)

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

between about 150 mg to about 750 mg of vitamin C;

between about 315 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 folic acid;

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 50 mcg to about 450 mcg of biotin;

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 350 mcg to about 3 mg of lutein;

between about 100 mcg to about 750 mcg of lycopene; and

at least one or more excipients.

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

about 500 mg of vitamin C;

about 400 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 folic acid;

about 70 mcg of vitamin B12;

about 5 mg of pantothenic acid;

about 300 mcg of biotin;

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 10 mg of alpha lipoic acid;

about 35 mg of co-enzyme Q-10;

about 400 mcg of lutein;

about 125 mcg of lycopene; 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, hydroxypropyl methylcellulose, hypromellose, titanium dioxide, tripotassium citrate, polyvinyl alcohol, fumed silica, citric acid, polyethylene glycol, or talc.

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 750 mg of ascorbic acid;

between about 315 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 50 mcg to about 450 mcg of d-biotin;

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 350 mcg to about 3 mg of lutein;

between about 100 mcg to about 750 mcg of lycopene; and

at least one or more excipients.

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

about 500 mg of ascorbic acid;

about 400 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 75 mcg of d-biotin;

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 10 mg of alpha lipoic acid;

about 50 mg of co-enzyme Q-10;

about 400 mcg of lutein;

about 125 mcg of lycopene; 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 essentially of at least one of dicalcium phosphate, microcrystalline cellulose, stearic acid, croscarmellose sodium, magnesium trisillicate, magnesium stearate, hydroxypropyl methylcellulose, hypromellose, titanium dioxide, tripotassium citrate, polyvinyl alcohol, fumed silica, citric acid, polyethylene glycol, or talc.

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 750 mg of ascorbic acid;

between about 315 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 50 mcg to about 450 mcg of d-biotin;

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 350 mcg to about 3 mg of lutein;

between about 100 mcg to about 750 mcg of lycopene;

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 500 mg of ascorbic acid;

about 400 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 75 mcg of d-biotin;

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 10 mg of alpha lipoic acid;

about 50 mg of co-enzyme Q-10;

about 400 mcg of lutein;

about 125 mcg of lycopene;

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 Oct 26, 2012
From: SQUASHIC, STEVEN A.; HUDY, KEVIN M.; PURDY, DAVID C.
To: VERTICAL PHARMACEUTICALS, INC.
Reel/Frame 029195/0387 →
Continuity (3)
Continuation In Part 12698174 · Feb 2, 2010
Continuation In Part 11197757 · Aug 4, 2005
Related Publication 20130004570A1 · Jan 3, 2013