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Formulations and methods for providing prolonged local anesthesia
| Details |
Inventors: Chasin, Mark; Goldenheim, Paul; Sackler, Richard; Tigner, Joseph; Burch, Ronald M;
Assignee: Euro-Celtique S.A. (Luxembourg, LU)
Primary Examiner: Levy; Neil S.
Assistant Examiner:
Attorney, Agent or Firm: Davidson; Davidson & Kappel; LLC;;
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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DETAILED DESCRIPTION Accordingly, the present invention provides for pharmaceutically acceptable augmenting agent or agents in conjunction with a local anesthetic in controlled release form that significantly increases the time period of local anesthesia when administered at a site in a patient.
The augmentation of efficacy provided by the use of the augmenting agent cannot be predicted based on in vitro release (dissolution) of the local anesthetic in controlled release form: the inclusion of the augmenting agent within the controlled release formulations of the invention does not substantially alter or prolong the in vitro dissolution rate of the local anesthetic agent from the formulation; yet, the same formulation when administered in vivo provides a significant increase in the time period of local anesthesia at the site of administration.
The augmenting agents disclosed herein are non-glucocorticoid agent and can be administered prior to, along with, or after administration, e.
g.
, application, infiltration and/or injection of the local anesthetic agent in controlled release form, in each case with a substantial prolongation of local anesthesia in vivo.
The augmenting agent can be compounded in the same controlled release formulation as a local anesthetic agent or agents, in a separate controlled release formulation, e.
g.
, different injectable microspheres, or in a non-controlled release, i.
e.
, immediate release formulation.
The augmenting agent may be administered before, simultaneously with, or after injection or infiltration, implantation or insertion of the controlled release local anesthetic formulation at the desired site.
In those embodiments of the invention directed to formulations where the augmenting agent is included in the formulation with the local anesthetic, the augmenting agent may be included in controlled release form or in immediate release form.
The augmenting agent may be incorporated into any pharmaceutically acceptable carrier and preferably a carrier providing controlled release, including, e
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