Malleable controlled release local anesthetic with hemostatic composition
AssigneeRilento Pharma, LLC
InventorKhashayar Kevin Neshat
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Abstract
A malleable sustained release formulation is created utilizing a local anesthetic wherein the composition is made sustained release by incorporating it into a bovine or porcine hemostatic agent. The composition is malleable enough to fit into a cavity such as a dental cavity and form the shape of the cavity. In addition to providing sustained release of the anesthetic, the composition also provides quicker reduction in bleeding.
Claims13
A malleable sustained release formulation designed for packing and sticking in a dental extraction cavity, a surgical cavity or a wound cavity of a patient, the formulation comprising:
- a homogenous dry blend including
- a. a local anesthetic formulated into sustained release microparticles of a size between 0.1 and 100 microns, the microparticles encapsulating the local anesthetic for forming a primary sustained release vehicle for the local anesthetic by diffusion from the microparticles, and
- b. a gelatin powder, wherein the gelatin is selected from the group consisting of a bovine skin hemostatic agent and porcine skin hemostatic agent and having a Bloom value of about 200 to about 400;
- and
- an aqueous solution in an amount of about 1.5 to about 10 parts by weight to about 1 part by weight of the gelatin powder within the dry blend,
- wherein the gelatin powder and the aqueous solution form a gelled matrix with the local anesthetic sustained release microparticles incorporated into and suspended within the gelled matrix such that the gelled matrix comprises a secondary sustained release vehicle for the local anesthetic microparticles by diffusion through the matrix, and
- wherein the gelled matrix is present in an amount of about 1 to about 7 parts by weight to 1 part by weight of the local anesthetic microparticles such that the gelled matrix with the local anesthetic microparticles suspended therein is a malleable putty prior to its insertion into the cavity of a patient such that a bolus of the malleable formulation can be mixed by hand under low shear ambient conditions for molding a bolus manually sized and shaped to fit the cavity and be retained therein.
A malleable sustained release formulation designed for packing and sticking in a dental extraction cavity, a surgical cavity or a wound cavity of a patient, the formulation comprising:
- a homogenous dry blend including
- a. bupivacaine formulated into sustained release microparticles formed from poly(lactic-co-glycolic acid) of a size between 0.1 and 100 microns, the microparticles encapsulating the bupivacaine for forming a primary sustained release vehicle for the bupivacaine by diffusion from the microparticles, and
- b. a gelatin powder comprising a porcine skin hemostatic agent having a Bloom value of about 200 to about 400;
- and
- an aqueous solution in an amount of about 1.5 to about 10 parts by weight to about 1 part by weight of the gelatin powder within the dry blend,
- wherein the gelatin powder and the aqueous solution form a gelled matrix with the bupivacaine sustained release microparticles incorporated into and suspended within the gelled matrix such that the gelled matrix comprises a secondary sustained release vehicle for the bupivacaine microparticles by diffusion through the matrix, and
- wherein the gelled matrix is present in an amount of about 1 to about 7 parts by weight to 1 part by weight of the bupivacaine microparticles such that the gelled matrix with the bupivacaine microparticles suspended therein is a malleable putty prior to its insertion into the cavity of a patient such that a bolus of the malleable formulation can be mixed by hand under low shear ambient conditions for molding a bolus manually sized and shaped to fit the cavity and be retained therein.
Dependencies are inferred from the claim text.