Formulations and methods for providing prolonged local anesthesia
First Claim
1. A formulation for inducing sustained regional local anesthesia in a patient comprising a substrate comprising a local anesthetic and an effective amount of a biocompatible, biodegradable controlled release material prolonging the release of said local anesthetic from said substrate to obtain a reversible local anesthesia when implanted or injected in a patient, and a non-toxic, augmenting agent effective to prolong the duration of said local anesthesia for a time period longer than that obtainable from the substrate without said augmenting agent, wherein said augmenting agent is not glucocorticosteroid agent.
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Abstract
A formulation and methods for inducing sustained regional local anesthesia in a patient comprising a substrate comprising a local anesthetic and an effective amount of a biocompatible, biodegradable, controlled release material prolonging the release of the local anesthetic from the substrate to obtain a reversible local anesthesia when implanted or injected in a patient, and a pharmaceutically acceptable, i.e., non-toxic, non-glucocorticoid augmenting agent effective to prolong the duration of the local anesthesia for a time period longer than that obtainable from the substrate without the augmenting agent.
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Citations
20 Claims
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1. A formulation for inducing sustained regional local anesthesia in a patient comprising
a substrate comprising a local anesthetic and an effective amount of a biocompatible, biodegradable controlled release material prolonging the release of said local anesthetic from said substrate to obtain a reversible local anesthesia when implanted or injected in a patient, and a non-toxic, augmenting agent effective to prolong the duration of said local anesthesia for a time period longer than that obtainable from the substrate without said augmenting agent, wherein said augmenting agent is not glucocorticosteroid agent.
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13. The formulation of claim 21 wherein the augmenting agent is a dextran having a molecular weight ranging from about 20 kDa to about 200 kDa and is incorporated into said substrate at a percent loading of 0.01 to 30% by weight.
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16. A formulation for inducing sustained regional local anesthesia in a patient comprising
a substrate comprising a local anesthetic and an effective amount of a biocompatible, biodegradable, controlled release-material prolonging the release of said local anesthetic from said substrate to obtain a reversible local anesthesia when implanted or injected in a patient, and a non-toxic non-glucocorticoid augmenting agent effective to prolong the duration of said local anesthesia, said formulation providing an in vitro release of said local anesthetic of from about 10 to about 60 percent after 24 hours, from about 20 to about 80 percent release after 48 hours and from about 40 to about 100 percent release after 72 hours, said formulation providing a reversible local anesthesia at the site when administered in vivo of at least about 24 hours.
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17. A controlled release formulation for inducing sustained regional local anesthesia at a site in a patient comprising
a local anesthetic incorporated in a controlled release formulation consisting essentially of a biocompatible material, said material degrading at least fifty percent in less than six months following implantation into a patient, wherein the local anesthetic is present in a concentration effective to achieve local anesthesia in the patient, and an effective amount of a non-glucocorticoid augmenting agent effective to prolong the duration of the local anesthesia.
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18. Lyophilized particles suitable for deposit at a site in a patient in need of local anesthesia comprising
a substrate comprising a local anesthetic and an effective amount of a biocompatible, biodegradable, controlled release material prolonging the release of said local anesthetic from said substrate to obtain a reversible local anesthesia when injected in a patient and a non-glucocorticoid augmenting agent effective to prolong the duration of said local anesthesia for a time period longer than that obtainable from the substrate without said augmenting agent, wherein said substrate is lyophilized.
Specification