CONTROLLED DELIVERY SYSTEM

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Patent No.: US None
App. No.: 16/281,026

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Abstract

The present invention relates to novel anesthetic compositions containing a non-polymeric carrier material and an anesthetic, where the compositions are suitable for providing a sustained local anesthesia without an initial burst and having a duration for about 24 hours or longer. Certain compositions are also provided that include a first anesthetic and a second anesthetic. In such compositions, the second anesthetic is a solvent for the first anesthetic and provides an initial anesthetic effect upon administration to a subject. The non-polymeric carrier may optionally be a high viscosity liquid carrier material such as a suitable sugar ester. The compositions can further include one or more additional ingredients including active and inactive materials. Methods of using the compositions of the invention to produce a sustained anesthetic effect at a site in a subject are also provided.

Claims (60)

1 .- 181 . (canceled)

182 . A method for providing an anesthetic effect at a wound in a subject, comprising administering a controlled delivery composition into the wound, wherein the controlled delivery composition comprises bupivacaine, and further wherein the administering provides a sustained local anesthetic effect at the wound having a duration of at least 48 hours after the administration.

183 . The method of claim 182 , wherein the sustained local anesthetic effect is for at least 72 hours after the administration.

184 . The method of claim 182 , wherein the sustained local anesthetic effect is for up to 4 days after the administration.

185 . The method of claim 182 , wherein the bupivacaine is present in the controlled delivery composition in an amount ranging from 1 wt % to 10 wt %, based on weight of the controlled delivery composition.

186 . The method of claim 182 , wherein the bupivacaine is present in the controlled delivery composition in an amount ranging from 1 wt % to 5 wt %, based on weight of the controlled delivery composition.

187 . The method of claim 182 , wherein the bupivacaine is present in the controlled delivery composition in an amount ranging from 2 wt % to 5 wt %, based on weight of the controlled delivery composition.

188 . The method of claim 182 , wherein the bupivacaine is present in free base form.

189 . The method of claim 182 , wherein the controlled delivery composition comprises a polymer.

190 . The method of claim 189 , wherein the polymer comprises a polyorthoester.

191 . The method of claim 182 , wherein the controlled delivery composition comprises an organic solvent.

192 . The method of claim 191 , wherein the organic solvent comprises dimethyl sulfoxide and glyceryl triacetate.

193 . The method of claim 191 , wherein the organic solvent is present in the controlled delivery composition in an amount ranging from 10 wt % to 55 wt %, based on weight of the controlled delivery composition.

194 . The method of claim 191 , wherein the organic solvent is present in the controlled delivery composition in an amount ranging from 15 wt % to 50 wt %, based on weight of the controlled delivery composition.

195 . The method of claim 191 , wherein the organic solvent is present in the controlled delivery composition in an amount ranging from 25 wt % to 55 wt %, based on weight of the controlled delivery composition.

196 . The method of claim 191 , wherein the organic solvent is present in the controlled delivery composition in an amount ranging from 25 wt % to 50 wt %, based on weight of the controlled delivery composition.

197 . The method of claim 182 , wherein the wound is a surgical wound.

198 . The method of claim 182 , wherein

the bupivacaine is present in the controlled delivery composition in an amount ranging from 2 wt % to 5 wt %, based on weight of the controlled delivery composition; and

the controlled delivery composition comprises an organic solvent present in the controlled delivery composition in an amount ranging from 25 wt % to 50 wt %, based on weight of the controlled delivery composition.

199 . The method of claim 182 , wherein

the bupivacaine is present in the controlled delivery composition in an amount ranging from 2 wt % to 5 wt %, based on weight of the controlled delivery composition; and

the controlled delivery composition comprises a polymer comprising a polyorthoester.

200 . The method of claim 182 , wherein