# US 12,005,069 B2 · Bortezomib compositions

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- Number: US 12,005,069 B2
- Document ID: US12005069B2
- Status: Granted
- Kind: B2
- Application number: 18/456,759
- Filed: 2023-08-28
- Published: 2023-12-21
- Granted: 2024-06-11
- Earliest claimed: 2021-09-24
- Assignees: Maia Pharmaceuticals, Inc.
- Applicants: MAIA Pharmaceuticals, Inc.
- Inventors: Srikanth Sundaram; Daniel Charles Stewart
- Web page: https://patentgrep.com/patent/US12005069B2

## CPC

- A61K 31/69: Boron compounds
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 31/198: Alpha-amino acids, e.g. alanine or edetic acid [EDTA] (betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00)
- A61K 31/4439: containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole (nicotine A61K31/465)
- A61K 31/573: substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/02: Inorganic compounds
- A61K 47/12: Carboxylic acids; Salts or anhydrides thereof
- A61K 47/183: {Amino acids, e.g. glycine, EDTA or aspartame}
- A61K 47/20: containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
- 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 47/40: Cyclodextrins; Derivatives thereof
- A61P 35/00: Antineoplastic agents
- 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 disclosure relates to ready-to-use liquid aqueous bortezomib compositions bortezomib and pharmaceutical excipients. Other aspects include methods of preparing such ready-to-use liquid aqueous bortezomib compositions, and methods of using such ready-to-use liquid bortezomib compositions in therapeutic applications.

## Claims

### Claim 1

A liquid, ready-to-use aqueous composition consisting of about 1 mg/mL bortezomib, about 10 mg/mL mannitol, about 20 mg/mL dimethyl sulfoxide, about 0.82 mg/mL sodium acetate, water and, optionally, hydrochloric acid, sodium hydroxide, or a combination thereof, wherein the pH of the ready-to-use composition is about 5 to about 6.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the composition has a pH of about 5.5 to about 6.

### Claim 3 (depends on 1)

The composition of claim 1, wherein the composition is in a vial where the head space is filled with nitrogen.

### Claim 4

A liquid, ready-to-use aqueous composition consisting of about 2.5 mg/mL bortezomib, about 25 mg/mL mannitol, about 22 mg/mL dimethyl sulfoxide, about 0.82 mg/mL sodium acetate, water and, optionally, hydrochloric acid, sodium hydroxide, or a combination thereof, wherein the pH of the ready-to-use composition is about 5 to about 6.

### Claim 5 (depends on 4)

The composition of claim 4, wherein the composition has a pH of about 5.25 to about 5.75.

### Claim 6 (depends on 4)

The composition of claim 4, the composition is in a vial where the head space is filled with nitrogen.

### Claim 7

A liquid, ready-to-use aqueous composition consisting of bortezomib, mannitol, dimethyl sulfoxide, sodium acetate, water and, optionally, hydrochloric acid, sodium hydroxide, or a combination thereof, wherein (i) the pH of the ready-to-use composition is about 5 to about 6 and (ii) after storage at 2-8° C. for 12 months, at least 90% of the bortezomib remains in the composition.