Oral dosage and method for treating painful conditions of the oral cavity

• US 5,713,852 A
• Filed: 06/07/1995
• Issued: 02/03/1998
• Est. Priority Date: 06/07/1995
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Szumowski, Danusia, Dong, Liang C., Marks, Susan M., Anthony, Joyce C.
• Primary Examiner(s): McDermott, Corrine M.
• Assistant Examiner(s): BLYVEIS, DEBORAH
• Application Number:
  US08/475,233
• Time in Patent Office: 972 Days
• Field of Search: 604/54, 604/890.1, 604/49, 604/891.1, 424/435
• US Class Current: 604/514
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61P 1/02 Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis

Abstract

A method is described for delivering a beneficial agent, such as an antiinflammatory agent, to the site of a painful condition in the oral cavity of a human being that utilizes an oral dosage form having an immediately releasable topical anesthetic and a sustained release beneficial agent. The topical anesthetic is released substantially independently of the beneficial agent to provide immediate pain relief and the application of the beneficial agent is continued over a long period of time.

Claims

1. A method for treating a site of a painful condition in the oral cavity which comprises:

applying an oral dosage form to the site of the painful condition, the oral dosage form including a topical anesthetic and a non-anesthetic beneficial agent;

anesthetizing the site of the condition by immediately releasing the topical anesthetic from the dosage form; and

continuously applying the non-anesthetic beneficial agent from the dosage form to the anesthetized site, wherein the release of the anesthetic is substantially independent of the release of the beneficial agent.

2. The method of claim 1, wherein about 90% of the non-anesthetic beneficial agent is delivered to the anesthetized site within a time period of about 1.0 to 3 hours.

3. The method of claim 1, wherein release of the anesthetic at the site of the condition provides pain relief from about 0.1 to 10 minutes.

4. The method of claim 1, wherein the topical anesthetic is substantially completely released within 15 to 30 minutes.

5. The method of claim 1, wherein the non-anesthetic beneficial agent is continuously applied by a core of a beneficial agent adapted to deliver the beneficial agent over the extended delivery period.

6. The method of claim 5, wherein said core further comprises an osmotic delivery device comprising a semipermeable wall enclosing a beneficial agent and an expandable driving member.

7. A method according to claim 5, wherein the beneficial agent is continuously applied at a rate of between 50 to 100 μ

g/hour over the delivery period.

8. A method according to claim 1, wherein the beneficial agent is an anti-inflammatory agent.