# US 11,896,721 B2 · Multiparticulate L-carnitine compositions and related methods

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- Number: US 11,896,721 B2
- Document ID: US11896721B2
- Status: Granted
- Kind: B2
- Application number: 16/864,715
- Filed: 2020-05-01
- Published: 2020-08-13
- Granted: 2024-02-13
- Earliest claimed: 2011-06-07
- Assignees: Societe des Produits Nestle S.A.
- Applicants: Physician's Seal, LLC
- Inventors: Syed M. Shah; Noreen Hassan
- Web page: https://patentgrep.com/patent/US11896721B2

## CPC

- A61K 9/5073: {having two or more different coatings optionally including drug-containing subcoatings}
- A23L 33/175: Amino acids
- A23P 10/30: Encapsulation of particles, e.g. foodstuff additives
- A61K 9/5026: {obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates}
- A61K 9/5031: {obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)}
- A61K 9/5042: {Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose}
- A61K 31/205: Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
- A61K 31/225: Polycarboxylic acids
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 9/04: Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 13/12: of the kidneys
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- A61P 31/18: for HIV
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- A61K 9/5078: {with drug-free core}
- 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)
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- A23P: SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- 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

An oral controlled-release multiparticulate dosage form comprises a plurality of individually enteric coated particulates containing an L-carnitine that independently disperse in a patient's stomach after oral ingestion and travel through the stomach and past the pyloric sphincter without substantially releasing the L-carnitine in the stomach. The individual particulates contain a solid core containing the L-carnitine, and an enteric coating. The dosage form may be used to treat conditions associated with a reduction of the amount of L-carnitine in the body.

## Claims

### Claim 1

An oral controlled-release multiparticulate dosage form comprising an L-carnitine carried on a plurality of individually enteric coated particulates that independently disperse in a person's stomach after oral ingestion and travel through the stomach and past a pyloric sphincter, the individually enteric coated particulates comprising (a) a spheronized extrudate solid core including the L-carnitine intermixed with a pharmaceutically acceptable binder and a pharmaceutically acceptable filler and (b) an enteric coating over the solid core, a predominant component of the enteric coating being an enteric polymer, wherein the solid core is spheroidal and comprises 30%-90% w/w of the L-carnitine, 15%-70% w/w microcrystalline cellulose filler, and 0.5%-1.5% w/w hydroxypropyl methylcellulose binder.

### Claim 2 (depends on 1)

The dosage form of claim 1, wherein the L-carnitine is selected from at least one of L-carnitine, acetyl-L-carnitine, and propionyl-L-carnitine.

### Claim 3 (depends on 1)

The dosage form of claim 1, wherein the enteric polymer is selected from at least one of methacrylic acid co-polymer, cellulose acetate phthalate, and polyvinyl acetate phthalate.

### Claim 4 (depends on 1)

The dosage form of claim 1, wherein an average diameter of the individually enteric coated particulates is about 0.1-3 mm.

### Claim 5 (depends on 1)

The dosage form of claim 1, further comprising a cellulosic water soluble polymer subcoating over the solid core and under the enteric coating.

### Claim 6 (depends on 1)

The dosage form of claim 1, further comprising polysorbate 80 effective to enhance permeation of the L-carnitine in a person's tissue.