The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.

The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.

Date of Patent:
Mar. 31, 2020

Filed:

Jan. 12, 2018
Applicant:

Durect Corporation, Cupertino, CA (US);

Inventors:

Su Il Yum, Los Altos, CA (US);

Jaymin Shah, Sunnyvale, CA (US);

Sung Yun Kwon, Fremont, CA (US);

Xiaoping Song, Saratoga, CA (US);

Assignee:

Durect Corporation, Cupertino, CA (US);

Attorneys:
Primary Examiner:
Assistant Examiner:
Int. Cl.
CPC ...
A61K 31/4535 (2006.01); A61K 9/00 (2006.01); A61K 9/70 (2006.01); A61K 9/20 (2006.01); A61K 31/485 (2006.01); A61K 9/06 (2006.01);
U.S. Cl.
CPC ...
A61K 31/4535 (2013.01); A61K 9/006 (2013.01); A61K 9/0056 (2013.01); A61K 9/06 (2013.01); A61K 31/485 (2013.01); A61K 9/2009 (2013.01); A61K 9/2063 (2013.01); A61K 9/7007 (2013.01);
Abstract

The invention pertains to methods that include administering to a subject a transoral dosage form comprising a pharmaceutical carrier and sufentanil, and maintaining a mean pH ranging from about 3.5 to about 5.5 during a dosing period after administration of the transoral dosage form as determined using an in vitro donor media test. Related dosage forms are also disclosed. Also disclosed are transoral dosage forms and related methods, wherein a transoral dosage form may comprise: (1) about 5 to about 1000 micrograms of sufentanil; (2) about 50 micrograms to about 100 milligrams of naloxone; and (3) acidifying material in an amount sufficient to provide a mean pH ranging from about 3.5 to about 5.5 during a dosing period after administration of the transoral dosage form as determined using an in vitro donor media test; wherein the dosing period begins no earlier than about 1 minute after administration of the transoral dosage form, and ends no later than about 120 minutes after administration of the transoral dosage form.


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