# US 10,765,635 B2 · Multiparticulate including pharmaceutical or probiotic active ingredients for delivery via a shelf stable liquid dosage form

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- Number: US 10,765,635 B2
- Document ID: US10765635B2
- Status: Granted
- Kind: B2
- Application number: 16/269,130
- Filed: 2019-02-06
- Published: 2019-08-08
- Granted: 2020-09-08
- Earliest claimed: 2018-02-06
- Applicants: Nano Pharmaceutical Laboratories LLC
- Inventors: Robert Niichel; Samuel Reinhold, III; Clayton J. Nelsen; Dan A. Finkbeiner; Roy J. McDaniel; Andrew D. Padilla
- Web page: https://patentgrep.com/patent/US10765635B2

## CPC

- A61K 9/5073: {having two or more different coatings optionally including drug-containing subcoatings}
- A61K 9/0095: {Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches (A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006)}
- A61K 9/5042: {Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose}
- A61K 9/10: Dispersions; Emulsions
- A61K 35/741: Probiotics (probiotic yeast, e.g. saccharomyces A61K36/06)
- A61K 2035/115: {Probiotics}
- 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)

## Abstract

Various embodiments of modified-release multiparticulates (in bead or granule from) are described. The modified-release multiparticulates can comprise a core including a pharmaceutical and/or probiotic agent, optionally with additional excipients or binders to aid in creation of the core, one or more functional coatings disposed on the core and configured to provide a modified-release profile of the pharmaceutical and/or probiotic agent when given orally, and a coating of hypromellose acetate succinate (HPMCAS) disposed on the one or more functional coatings and configured to impart multiparticulate stability in aqueous acidic media. Suspensions including the modified-release multiparticulates are also described.

## Claims

### Claim 1

A modified-release multiparticulate, comprising:
a core consisting of one or more active ingredients, wherein at least one of the one or more active ingredients is a probiotic;
at least one functional layer encapsulating the core; and
an exterior coating layer encapsulating the core and the at least one functional layer, the exterior coating comprising hypromellose acetate succinate.

### Claim 2 (depends on 1)

The modified-release multiparticulate of claim 1, wherein the at least one functional layer comprises an enteric polymer, an enteric resin, an insoluble cellulose-based polymer, a combination insoluble cellulose-based polymer system with a water-soluble pore former, a protein-based coating, a lipid coating, or combinations thereof.

### Claim 3 (depends on 1)

The modified-release multiparticulate of claim 1, wherein the at least one functional layer is constituted so as to not alter the release profile of the modified-release multiparticulate.

### Claim 4 (depends on 1)

The modified-release multiparticulate of claim 1, wherein the exterior coating consists of hypromellose acetate succinate.

### Claim 5 (depends on 1)

The modified-release multiparticulate of claim 1, wherein the hypromellose acetate succinate comprises hyroxypropyl methylcellulose that has been further modified with a mixture of monosuccinic acid and acetic acid esters.

### Claim 6 (depends on 1)

The modified-release multiparticulate of claim 1, wherein the hypromellose acetate succinate has between 2 wt % to 16 wt % of actetyl groups and 4 wt % to 28 wt % of succinyl groups.

### Claim 7 (depends on 1)

A suspension comprising:
an acidic aqueous liquid media; and
a plurality of the modified release multiplarticulate of claim 1 suspended in the acidic aqueous liquid media.