# US 10,117,847 B2 · Extended duration local anesthetic formulation

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- Number: US 10,117,847 B2
- Document ID: US10117847B2
- Status: Granted
- Kind: B2
- Application number: 14/960,214
- Filed: 2015-12-04
- Published: 2017-06-08
- Granted: 2018-11-06
- Earliest claimed: 2015-12-04
- Assignees: Ventis Pharma
- Applicants: Ventis Pharma
- Inventors: Jeremy Poulsen; Louis Stanfield; Lawrence Volz
- Web page: https://patentgrep.com/patent/US10117847B2

## CPC

- A61K 31/245: Amino benzoic acid types, e.g. procaine, novocaine (salicylic acid esters A61K31/60)
- A61J 1/2093: {Containers having several compartments for products to be mixed}
- A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone}
- A61K 31/573: substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/02: Inorganic compounds
- A61P 23/02: Local anaesthetics
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- B65D 81/3266: {separated by a common rupturable seal, a clip or other removable fastening device}
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- B65D: CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES

## Abstract

An extended duration anesthetic includes a short duration local anesthetic in a dilute solution and a long duration local anesthetic. The long duration local anesthetic is maintained in a powdered form until the time of administration. Premeasured quantities of the dilute solution and powdered long duration local anesthetic in a kit allow for quick preparation of a solution with desired concentrations of both short duration local anesthetic and long duration local anesthetic at the time of administration.

## Claims

### Claim 1

A kit comprising:
a fluid solution comprising and epinephrine;
a powder mixture comprising tetracaine; and
a syringe suitable for subcutaneous injection of a mixture of the fluid solution comprising lidocaine and epinephrine and reconstituted tetracaine.

### Claim 2 (depends on 1)

The kit of claim 1, wherein the fluid solution comprises 0.25% to 5% by weight lidocaine.

### Claim 3 (depends on 1)

The kit of claim 1, wherein epinephrine comprises no more than one part per 50,000 of the fluid solution.

### Claim 4 (depends on 1)

The kit of claim 1, wherein epinephrine comprises between one part per 250,000 and one part per 150,000 of the fluid solution.

### Claim 5 (depends on 4)

The kit of claim 4, wherein:
the fluid solution comprises substantially 30 cc-100 cc; and
the powder mixture comprises substantially 60 mg-240 mg.

### Claim 6 (depends on 1)

The kit of claim 1, wherein the fluid solution further comprises cortisone-type drug.

### Claim 7 (depends on 1)

The kit of claim 1, further comprising a package having a first compartment for storing the fluid solution, a second compartment for storing the powder mixture, and a breachable barrier separating the first compartment and the second compartment, wherein the breachable barrier is configured to fail when a sufficient pressure is applied to the first compartment, forming a fluid channel between the first compartment and second compartment such that agitation of the first compartment causes mixing of the fluid solution and powder mixture.

### Claim 8

A solution formulated for injection into a patient comprising: lidocaine, and epinephrine, and
tetracaine.

### Claim 9 (depends on 8)

The solution of claim 8, wherein:
the lidocaine comprises between 0.25% and 5.0% by weight of the solution; and
the tetracaine comprises between 0.15% and 0.55% by weight of the solution.

### Claim 10 (depends on 8)

The solution of claim 8, further comprising a cortisone-type drug.

### Claim 11 (depends on 8)

The solution of claim 8, wherein the solution is formulated for injection into the patient's abdomen to produce a transversus abdominis plane (TAP) block.

### Claim 12

An apparatus comprising:
a package having a first compartment of at least 30 ml, a second compartment, and a breachable barrier separating the first compartment and second compartment;
a solution, maintained in the first compartment, comprising epinephrine and at least 0.25% and no more than 0.5% by weight of lidocaine; and
a powdered composition, maintained in the second compartment, of tetracaine,
wherein the powdered composition is formulated to produce a 0.2% concentration by weight of tetracaine in solution when mixed with the solution maintained in the first compartment.

### Claim 13 (depends on 12)

The apparatus of claim 12, wherein the epinephrine comprises one part per 250,000 to one part per 50,000 of the solution.

### Claim 14 (depends on 13)

The apparatus of claim 13, wherein:
the first compartment contains substantially 30 cc-100 cc of the solution; and
the second compartment contains substantially 60 mg-240 mg of the powdered composition.

### Claim 15 (depends on 12)

The apparatus of claim 12, wherein the solution further comprises a cortisone-type drug.

### Claim 16 (depends on 12)

The apparatus of claim 12, wherein the solution further comprises sodium bicarbonate.
