# US 9,517,271 B2 · Oral drug delivery system

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- Number: US 9,517,271 B2
- Document ID: US9517271B2
- Status: Granted
- Kind: B2
- Application number: 14/957,148
- Filed: 2015-12-02
- Published: 2016-07-07
- Granted: 2016-12-13
- Earliest claimed: 2002-12-13
- Assignees: Durect Corporation
- Applicants: Durect Corporation
- Inventors: Su Il Yum; Grant Schoenhard; Arthur J. Tipton; John W. Gibson; John C. Middleton; Roger Fu; Michael S. Zamloot
- Web page: https://patentgrep.com/patent/US9517271B2

## CPC

- A61K 31/485: Morphinan derivatives, e.g. morphine, codeine
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/48: Preparations in capsules, e.g. of gelatin, of chocolate {(A61K9/0004 takes precedence; bite capsules A61K9/0056)}
- A61K 9/4825: {Proteins, e.g. gelatin (gelatin capsule shells with substantial amounts of other macromolecular substances A61K9/4816)}
- A61K 9/4858: {Organic compounds}
- A61K 9/4866: {Organic macromolecular compounds}
- A61K 31/4458: only substituted in position 2, e.g. methylphenidate
- A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61K 47/38: Cellulose; Derivatives thereof
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/04: Centrally acting analgesics, e.g. opioids
- A61P 25/20: Hypnotics; Sedatives
- A61P 25/26: Psychostimulants, e.g. nicotine, cocaine
- A61P 25/36: Opioid-abuse
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- 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

## Abstract

Dosage forms and drug delivery devices suitable for administration of pharmaceutical compounds and compositions, including the oral drug administration of compounds.

## Claims

### Claim 1

A composition comprising:
a drug;
sucrose acetate isobutyrate (SAIB);
a cellulose acetate butyrate (CAB) having at least one feature selected from a butyryl content ranging from about 17% to about 38%, an acetyl content ranging from about 13% to about 30%, and a hydroxyl content ranging from about 0.8% to about 1.7%; and
a solvent.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the drug is present in an amount ranging from about 2 mg to about 250 mg.

### Claim 3 (depends on 1)

The composition of claim 1, wherein the composition comprises from about 20 weight percent to about 90 weight percent of the SAIB.

### Claim 4 (depends on 1)

The composition of claim 1, wherein the CAB has a butyryl content ranging from about 17% to about 38%.

### Claim 5 (depends on 1)

The composition of claim 1, wherein the CAB has an acetyl content ranging from about 13% to about 30%.

### Claim 6 (depends on 1)

The composition of claim 1, wherein the CAB has a butyryl content ranging from about 17% to about 38% and an acetyl content ranging from about 13% to about 30%.

### Claim 7 (depends on 1)

The composition of claim 1, wherein the composition comprises from about 1 weight percent to about 8.6 weight percent of the CAB.

### Claim 8 (depends on 1)

The composition of claim 1, wherein the composition comprises from about 20 weight percent to about 50 weight percent of the solvent.

### Claim 9 (depends on 1)

The composition of claim 1, wherein the solvent comprises propylene carbonate, N-methylpyrrolidone (NMP), glycofurol, alpha-tocopherol, diethyl phthalate, or polyethylene glycol 400 (PEG 400).

### Claim 10 (depends on 1)

The composition of claim 1, wherein the solvent comprises triacetin or ethyl lactate.

### Claim 11 (depends on 1)

The composition of claim 1, wherein the solvent comprises triacetin.

### Claim 12 (depends on 1)

The composition of claim 1, further comprising a member selected from caprylic/capric triglyceride, isopropyl myristate (IPM), ethyl oleate, dimethyl phthalate, and benzyl benzoate.

### Claim 13 (depends on 1)

The composition of claim 1, further comprising isopropyl myristate (IPM).

### Claim 14 (depends on 13)

The composition of claim 13, wherein the composition comprises from about 1 weight percent to about 75 weight percent of the IPM.

### Claim 15 (depends on 13)

The composition of claim 13, wherein the composition comprises:
from about 20 weight percent to about 90 weight percent of the SAM;
from about 1 weight percent to about 8.6 weight percent of the CAB;
from about 1 weight percent to about 75 weight percent of the IPM; and
from about 20 weight percent to about 50 weight percent of the solvent.

### Claim 16 (depends on 15)

The composition of claim 15, wherein the composition comprises from 3 weight percent to 7.8 weight percent of the CAB.

### Claim 17 (depends on 16)

The composition of claim 16, wherein the composition comprises from 1 weight percent to 10 weight percent of the IPM.

### Claim 18 (depends on 16)

The composition of claim 16, wherein the composition comprises:
from about 30 weight percent to about 70 weight percent of the SAM; and
from about 25 weight percent to about 48 weight percent of the solvent.

### Claim 19 (depends on 1)

The composition of claim 1, wherein the composition is contained in a capsule.

### Claim 20 (depends on 19)

The composition of claim 19, wherein the capsule comprises gelatin or hydroxyl propylmethyl cellulose.

### Claim 21 (depends on 20)

The composition of claim 20, wherein the capsule comprises a hard capsule comprising gelatin or hydroxyl propylmethyl cellulose.

### Claim 22 (depends on 1)

A method of providing pain relief to a subject in need thereof, the method comprising:
orally administering to the subject an effective amount of the composition of claim 1, wherein the drug comprises an opioid.