# US 10,369,539 B2 · Process for preparing products comprising stabilised actives and compositions comprising same

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- Number: US 10,369,539 B2
- Document ID: US10369539B2
- Status: Granted
- Kind: B2
- Application number: 14/586,548
- Filed: 2014-12-30
- Published: 2015-12-03
- Granted: 2019-08-06
- Earliest claimed: 2014-12-30
- Assignees: Biolingus IP LLC
- Applicants: Biolingus IP LLC
- Inventors: Sai Ying Ko
- Web page: https://patentgrep.com/patent/US10369539B2

## CPC

- B01J 13/043: {Drying and spraying}
- A23K 40/30: by encapsulating; by coating
- A23P 10/30: Encapsulation of particles, e.g. foodstuff additives
- A61K 9/006: {Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays}
- A61K 9/1676: {having a drug-free core with discrete complete coating layer containing drug (adsorbates of liquid drug formulations on inert powders without simultaneous granulation step A61K9/141; with further drug-free outer coating A61K9/5078; drug conjugated to non-active particles A61K47/6921)}
- A61K 9/1682: {Processes}
- A61K 9/2081: {with microcapsules or coated microparticles according to A61K9/50}
- A61K 38/1816: {Erythropoietin [EPO]}
- A61K 38/193: {Colony stimulating factors [CSF]}
- A61K 38/20: Interleukins [IL]
- A61K 38/21: Interferons {[IFN]}
- A61K 38/22: Hormones (derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin A61K38/33, e.g. corticotropin A61K38/35)
- A61K 38/27: Growth hormone [GH], i.e. somatotropin
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 7/00: Drugs for disorders of the blood or the extracellular fluid
- A61P 7/02: Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/10: Antimycotics
- A61P 35/00: Antineoplastic agents
- A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- B05D 1/02: performed by spraying
- B01J: CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- A23K: FODDER
- A23P: SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- B05D: PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL (conveying articles or workpieces through baths of liquid B65G, e.g. B65G49/02)

## Abstract

The present invention broadly relates to a process for preparing products comprising active components, and in particular biological materials, wherein the active components are stabilised. The invention further relates to compositions comprising the products, and in particular compositions comprising therapeutic biological materials.

## Claims

### Claim 1

A process for preparing a product comprising exenatide, the process comprising:
providing a coating liquid comprising exenatide, a saccharide and a water-miscible solvent;
(ii) providing particles comprising one or more water-soluble gel-forming compounds;
(iii) fluidising the particles within a processing chamber of an apparatus in such a manner that the particles move in an upward direction within the chamber in a helical path;
(iv) spraying the coating liquid onto the particles so as to provide coated particles; and
(v) allowing the coated particles to dry.

### Claim 2 (depends on 1)

The process of claim 1, wherein the process stabilises exenatide.

### Claim 3 (depends on 1)

The process of claim 1, wherein the process prepares sustained release dosage forms.

### Claim 4

A product prepared by a process comprising the steps of:
providing a coating liquid comprising exenatide, a saccharide and a water-miscible solvent;
(ii) providing particles comprising one or more water-soluble gel-forming compounds;
(iii) fluidising the particles within a processing chamber of an apparatus in such a manner that the particles move in an upward direction within the chamber in a helical path;
(iv) spraying the coating liquid onto the particles so as to provide coated particles; and
(v) allowing the coated particles to dry.

### Claim 5 (depends on 4)

A method of using the product of claim 4 for delivering exenatide to a subject comprising administering to the subject the product of claim 4.

### Claim 6 (depends on 4)

A method for the treatment of diabetes comprising administering the product of claim 4 to a subject in need thereof.

### Claim 7 (depends on 6)

The method of claim 6, wherein the product is formulated for oromucosal administration.

### Claim 8 (depends on 7)

The method of claim 7, wherein the administration is sublingual and/or buccal.

### Claim 9 (depends on 4)

A method for regulating blood glucose levels comprising administering the product of claim 4 to a subject in need thereof.

### Claim 10 (depends on 9)

The method of claim 9, wherein the product is formulated for oromucosal administration.

### Claim 11 (depends on 10)

The method of claim 10, wherein the administration is sublingual and/or buccal.