Compositions comprising an RNA polymerase inhibitor and cyclodextrin for treating viral infections

Patent metadata

Field	Value
Publication number	US-10675296-B2
Application number	US-201816031620-A
Country	US
Kind code	B2
Filing date	Jul 10, 2018
Priority date	Jul 11, 2017
Publication date	Jun 9, 2020
Grant date	Jun 9, 2020

Abstract

The present disclosure provides a composition comprising Compound 1, or a pharmaceutically acceptable salt thereof, cyclodextrin, and, optionally, pH adjusting agents.

First claim

What is claimed is:

1. A composition comprising
(i) a Compound 1 in an amount of from 1% to 10% w/w

or a pharmaceutically acceptable salt thereof, and

(ii) cyclodextrin in an amount of from 90% to 99% w/w;
wherein the composition is a lyophilized composition.

2. The composition of claim 1 , wherein the cyclodextrin is a beta-cyclodextrin.

3. The composition of claim 2 , wherein the beta-cyclodextrin is sulfobutylalkylether-beta-cyclodextrin, betadex-sulfobutylether sodium, or hydroxypropyl-beta-cyclodextrin.

4. The composition of claim 2 , wherein the beta-cyclodextrin is betadex-sulfobutylether sodium.

5. The composition of claim 1 , comprising
(i) the Compound 1 in an amount of from 1% to 5% w/w; and
(ii) the cyclodextrin in an amount of from 95% to 99% w/w.

6. The composition of claim 5 , wherein the cyclodextrin is betadex-sulfobutylether sodium.

7. The composition of claim 1 , comprising
(i) the Compound 1 in an amount of from 2% to 4% w/w; and
(ii) the cyclodextrin in an amount of from 96% to 98% w/w.

8. The composition of claim 7 , wherein the cyclodextrin is betadex-sulfobutylether sodium.

9. The composition of claim 1 , comprising
(i) the Compound 1 in an amount of from 3% to 3.5% w/w; and
(ii) the cyclodextrin in an amount of from 96.5% to 97% w/w.

10. The composition of claim 9 , wherein the cyclodextrin is betadex-sulfobutylether sodium.

11. The composition of claim 10 , that is contained in a sealed vial.

12. The composition of claim 1 , consisting essentially of
the Compound 1 in an amount of 3.2% w/w, and the cyclodextrin betadex-sulfobutylether sodium in an amount of 96.8% w/w.

Assignees

• Gilead Sciences Inc

Inventors

• Larson Nate

Classifications

• A61K9/19

  lyophilised {, i.e. freeze-dried, solutions or dispersions (lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00)} · CPC title

• A61K9/0019 Primary

  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) · CPC title

• A61P31/12

  Antivirals · CPC title

• A61K47/6951 Primary

  using cyclodextrin (cyclodextrins used as simple excipients A61K47/40) · CPC title

• A61K47/40

  Cyclodextrins; Derivatives thereof · CPC title