# US 2010/0168053 A1 · Oral delivery system for methylcobalamin to treat disorders

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- Number: US 2010/0168053 A1
- Document ID: US20100168053A1
- Status: Published application
- Kind: A1
- Application number: 12/723,421
- Filed: 2010-03-12
- Published: 2010-07-01
- Earliest claimed: 2008-03-17
- Assignees: Revitapop
- Inventors: STAN KURTZ
- Web page: https://patentgrep.com/patent/US20100168053A1

## CPC

- A61K 31/714: Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
- A23G 3/368: {containing vitamins, antibiotics}
- A23G 3/563: {products with an inedible support, e.g. a stick}
- A61K 9/0056: {Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals}
- A61K 31/519: ortho- or peri-condensed with heterocyclic rings
- A61K 31/7056: containing five-membered rings with nitrogen as a ring hetero atom
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 3/02: Nutrients, e.g. vitamins, minerals
- A61P 11/06: Antiasthmatics
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/06: Antimigraine agents
- A61P 25/14: for treating abnormal movements, e.g. chorea, dyskinesia
- A61P 25/22: Anxiolytics
- A61P 25/24: Antidepressants
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/12: Antivirals
- A61P 37/00: Drugs for immunological or allergic disorders
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- 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)
- A23G: COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION

## Abstract

A method of treating a disorder by lollipop administering methylcobalamin, with or without folinic acid by direct delivery to the trigeminal nerve. The disorders addressed are: a) attention deficit hyperactivity disorder (ADHD); b) anxiety, depression, stress and chronic stress; c) socialization problems, mood problems, behavior problems, memory problems; d) dyslexia, depth perception problems, color viewing problems, visual and auditory processing problems, light modulation problems, night vision problems; e) speech problems such as finding words, apraxia, and articulation problems, sleep regulation problems, eye or muscle movement problems; and f) chronic fatigue problems, digestion problems, sensitivity to chemicals, viral infection, inflammatory conditions such as rheumatoid arthritis, sciatica, and fibromyalgia, asthma, irritable bowel, colitis, tinnitus, migraines, nail biting, autoimmune problems. In some embodiments, the disorders that are particularly addressed are ADHD, anxiety, stress and chronic stress, and irritable bowel. A lollipop for treating a psychological or neuro-physiological disorder and method of making thereof.

## Claims

### Claim 1

A method of treating a psychological or neuro-physiological disorder, comprising administering orally a lollipop including methylcobalamin, or a pharmaceutically acceptable salt thereof, to a person in an amount sufficient to treat the disorder in the person.

### Claim 2 (depends on 1)

The method of claim 1, wherein the disorder is selected from the group consisting of:
attention deficit hyperactivity disorder (ADHD), anxiety, depression, stress and chronic stress, socialization problems, mood problems, behavior problems, memory problems, dyslexia, depth perception problems, color viewing problems, visual and auditory processing problems, light modulation problems, night vision problems, speech problems such as finding words, apraxia, and articulation problems, sleep regulation problems, eye or muscle movement problems, chronic fatigue problems, digestion problems, sensitivity to chemicals, viral infection, inflammatory conditions such as rheumatoid arthritis, sciatica, and fibromyalgia, asthma, irritable bowel, colitis, tinnitus, migraines, nail biting, and autoimmune problems.

### Claim 3 (depends on 1)

The method of claim 1, wherein the administered lollipop includes methylcobalamin in a dosage of about 0.1 mg to 10 mg.

### Claim 4 (depends on 1)

The method of claim 1, wherein the administered lollipop further includes folinic acid or a pharmaceutically acceptable salt of folinic acid.

### Claim 5 (depends on 4)

The method of claim 4, wherein the administered lollipop includes folinic acid in a dosage of about 25 mcg to 300 mcg.

### Claim 6 (depends on 1)

The method of claim 1, further comprising administering one to three lollipops per day.

### Claim 7

A lollipop for orally treating a psychological or neurophysiological disorder, comprising methylcobalamin, or a pharmaceutically acceptable salt thereof, in an amount sufficient to treat the disorder in the person.

### Claim 8 (depends on 7)

The lollipop of claim 7, wherein the disorder is selected from the group consisting of: attention deficit hyperactivity disorder (ADHD), anxiety, depression, stress and chronic stress, socialization problems, mood problems, behavior problems, memory problems, dyslexia, depth perception problems, color viewing problems, visual and auditory processing problems, light modulation problems, night vision problems, speech problems such as finding words, apraxia, and articulation problems, sleep regulation problems, eye or muscle movement problems, chronic fatigue problems, digestion problems, sensitivity to chemicals, viral infection, inflammatory conditions such as rheumatoid arthritis, sciatica, and fibromyalgia, asthma, irritable bowel, colitis, tinnitus, migraines, nail biting, and autoimmune problems.

### Claim 9 (depends on 7)

The lollipop of claim 7, further comprising methylcobalamin in a dosage of about 0.1 mg to 10 mg.

### Claim 10 (depends on 7)

The lollipop of claim 7, further comprising folinic acid or a pharmaceutically acceptable salt of folinic acid.

### Claim 11 (depends on 10)

The lollipop of claim 10, further comprising folinic acid in a dosage of about 25 mcg to about 300 mcg.

### Claim 12

A method of making a lollipop for orally treating a psychological or neuro-physiological disorder comprises:
providing a candy base;
heating the candy base and to form a liquid;
adding to the liquid in a selected amount at least one of methylcobalamin and a pharmaceutically acceptable salt thereof;
mixing the liquid containing the methylcobalamin additive;
pouring the liquid and methylcobalamin mixture into a mold;
inserting a stick to the mixture in the mold to form the lollipop; and
allowing the mixture to cool and solidify around the stick.

### Claim 13 (depends on 12)

The method of claim 12, wherein the selected amount of methylcobalamin additive results in a dosage of about 0.1 mg to 10 mg per lollipop.

### Claim 14 (depends on 12)

The method of claim 12, further comprising adding to the candy base and flavoring before heating a selected amount of at least one of folinic acid and a pharmaceutically acceptable salt of folinic acid.

### Claim 15 (depends on 14)

The method of claim 14, wherein the selected amount of folinic acid and/or salt thereof results in a dosage of about 25 mcg to about 300 mcg per lollipop.

### Claim 16 (depends on 12)

The method of claim 12, further comprising adding at least one of omega 3 oil, fatty acids, B vitamins such as B6 and pyridoxal 5-phosphate (P5P), B2, and B5, vitamins A, D, and K, minerals such as zinc, calcium, magnesium, taurine and selenium.

### Claim 17 (depends on 12)

The method of claim 12, comprising heating the candy base and flavoring to between the melting point of the candy base and not more than 100° C.

### Claim 18 (depends on 12)

The method of claim 12, comprising adding a flavoring and/or a dye coloring to the candy base before adding the methylcobalamin and/or pharmaceutical salt thereof.

### Claim 19 (depends on 12)

The method of claim 12, comprising adding at least one or more adjuvant, excipient and auxiliary substance before pouring the liquid and methylcobalamin mixture into the mold.

### Claim 20 (depends on 12)

The method of claim 12, wherein no stick is placed in the mold and the mold content is provided as a lozenge.
