# US 12,005,037 B2 · Formulations containing expectorants or decongestants

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- Number: US 12,005,037 B2
- Document ID: US12005037B2
- Status: Granted
- Kind: B2
- Application number: 17/933,262
- Filed: 2022-09-19
- Published: 2023-01-19
- Granted: 2024-06-11
- Earliest claimed: 2017-03-27
- Applicants: PuraCap Pharmaceutical LLC
- Inventors: Minh Tran; Yi Zeng; Zhang Julia Zhang; Hengsheng Feng; Dahai Guo
- Web page: https://patentgrep.com/patent/US12005037B2

## CPC

- A61K 31/167: having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
- 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 31/09: having two or more such linkages
- A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone}
- A61K 31/138: Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine (atenolol A61K31/165; pindolol A61K31/404; timolol A61K31/5377)
- A61K 31/485: Morphinan derivatives, e.g. morphine, codeine
- A61P 11/02: Nasal agents, e.g. decongestants
- A61P 11/10: Expectorants
- 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

The present invention relates to bioavailable fill compositions containing one or more of a decongestant, an expectorant, an antitussive, an analgesic, and/or an antihistamine; capsules filled with the bioavailable fill compositions; and methods of making same.

## Claims

### Claim 1

A clear bioavailable liquid composition comprising:
(a) active ingredients selected from the group consisting of:
(i) from 22 wt % to 25 wt % of guaifenesin and from 0.5 wt % to 0.7 wt % of phenylephrine HCl;
(ii) from 22 wt % to 25 wt % of guaifenesin and from 1 wt % to 2 wt % of dextromethorphan HBr;
(iii) from 21 wt % to 24 wt % of guaifenesin, from 0.4 wt % to 1 wt % of phenylephrine HCl, and from 1 wt % to 2 wt % of dextromethorphan HBr; or
(iv) from 21 wt % to 25 wt % of guaifenesin and from 2 wt % to 5 wt % of pseudoephedrine HCl;
(b) a matrix comprising:
20-70 wt % of a pharmaceutically acceptable poly(alkylene glycol), and
0.5-8 wt % of a pharmaceutically acceptable alkylene glycol; and
(c) a polymeric solubilizing agent consisting of 1-30 wt % of polyvinylpyrrolidone; and
(d) 1-10 wt % of water;
wherein the wt % values are based on the total weight of the composition, and
wherein the liquid composition remains clear without recrystallization for up to 2 years at room temperature.

### Claim 2 (depends on 1)

The clear bioavailable liquid composition of claim 1, wherein 860 mg of the composition consists of:
200 mg of guaifenesin;
5.13 mg of phenylephrine HCl;
404.87 mg of polyethylene glycol 400 having a molecular weight of 400 daltons,
20 mg of propylene glycol;
150 mg of polyvinylpyrrolidone having a molecular weight of 2,000 daltons; and
80 mg of water.

### Claim 3 (depends on 1)

The clear bioavailable liquid composition of claim 1, wherein 865 mg of the composition consists of:
200 mg of guaifenesin,
10.526 mg of dextromethorphan HBr,
404.474 mg of polyethylene glycol 400 having a molecular weight of 400 daltons,
20 mg of propylene glycol,
150 mg of polyvinylpyrrolidone having a molecular weight of 2,000 daltons, and
80 mg of water.

### Claim 4 (depends on 1)

The clear bioavailable liquid composition of claim 1, wherein 885 mg of the composition consisting of:
200 mg of guaifenesin,
5.25 mg of phenylephrine HCl,
10.526 mg of dextromethorphan HBr,
419.224 mg of polyethylene glycol 400 having a molecular weight of 400 daltons,
20 mg of propylene glycol,
150 mg of polyvinylpyrrolidone having a molecular weight of 2,000 daltons, and
80 mg of water.

### Claim 5 (depends on 1)

The clear bioavailable liquid composition of claim 1, wherein 850-890 mg of the composition comprises:
200 mg of guaifenesin and
30 mg of pseudoephedrine HCl.

### Claim 6 (depends on 1)

A pharmaceutical composition in a form of a soft gelatin capsule containing:
(a) an outer gelatin shell; and
(b) from 100 mg to 2,000 mg of the clear bioavailable liquid composition of claim 1 which is encapsulated by said outer gelatin shell.