# US 9,517,239 B2 · High-purity large-scale preparation of stannsoporfin

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 9,517,239 B2
- Document ID: US9517239B2
- Status: Granted
- Kind: B2
- Application number: 14/793,921
- Filed: 2015-07-08
- Published: 2016-01-07
- Granted: 2016-12-13
- Earliest claimed: 2006-10-04
- Assignees: Infacare Pharmaceutical Corporation
- Applicants: Infacare Pharmaceutical Corporation
- Inventors: George S. Drummond; Robert Caroselli; Keith A. Cooke; Daniel Levin; David G. Roe; Christopher P. Boucher
- Web page: https://patentgrep.com/patent/US9517239B2

## CPC

- C07F 7/2284: {Compounds with one or more Sn-N linkages}
- 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 31/555: containing heavy metals, e.g. hemin, hematin, melarsoprol
- A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
- A61P 7/00: Drugs for disorders of the blood or the extracellular fluid
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07D 487/22: in which the condensed system contains four or more hetero rings
- C07F 7/003: {without C-Metal linkages}
- C07F: ACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM (metal-containing porphyrins C07D487/22)
- 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
- C07D: HETEROCYCLIC COMPOUNDS (macromolecular compounds C08)

## Abstract

Large scale (bulk) compositions comprising high-purity stannsoporfin are disclosed, as well as methods of synthesizing such compositions.

## Claims

### Claim 1

A method of treating a condition selected from hyperbilirubinemia or elevated serum levels of bilirubin in a subject comprising administering to said subject a composition comprising a therapeutically effective amount of stannsoporfin, wherein said stannsoporfin is at least about 99.0% pure and wherein any individual impurity is present in an amount of less than about 0.08%.

### Claim 2 (depends on 1)

The method of claim 1, wherein said stannsoporfin is administered by injection.

### Claim 3 (depends on 1)

The method of claim 1, wherein said stannsoporfin is administered by intramuscular injection.

### Claim 4 (depends on 1)

The method of claim 1, wherein said subject is an infant.

### Claim 5 (depends on 1)

The method of claim 1, wherein a therapeutically effective amount is 0.5 mg/kg to 25 mg/kg body weight.

### Claim 6 (depends on 1)

The method of claim 1, wherein a therapeutically effective amount is selected from about 1.5 mg/kg, about 3.0 mg/kg and about 4.5 mg/kg body weight.

### Claim 7 (depends on 1)

The method of claim 1, wherein a therapeutically effective amount is from about 1.5 mg/kg to about 4.5 mg/kg.

### Claim 8 (depends on 1)

The method of claim 1, wherein a therapeutically effective amount is from about 1.5 mg/kg to about 3.0 mg/kg.

### Claim 9 (depends on 1)

The method of claim 1, wherein said stannsoporfin is dissolved in a pharmaceutically acceptable vehicle.

### Claim 10 (depends on 1)

The method of claim 1, wherein said stannsoporfin is provided in a solution which is buffered to maintain a suitable pH.

### Claim 11 (depends on 1)

The method of claim 1, wherein the suitable pH is between about 7.0 and about 8.0.

### Claim 12 (depends on 1)

The method of claim 1, wherein the suitable pH is between about 7.2 and about 7.9.

### Claim 13 (depends on 1)

The method of claim 1, wherein the suitable pH is about 7.4.

### Claim 14 (depends on 1)

The method of claim 1, wherein said buffer is selected from a phosphate, citrate, gluconate, lactate, tartrate, glycinate, glycylglycinate, bicarbonate, carbonate, maleate, acetate, histidine, imidazole and combinations thereof.

### Claim 15 (depends on 1)

The method of claim 1, wherein any individual impurity present is present in an amount of less than about 0.07%.

### Claim 16 (depends on 1)

The method of claim 1, wherein the composition contains less than about 20 ppm of palladium.