Composite anesthetic article and method of use

• US 5,226,901 A
• Filed: 01/02/1991
• Issued: 07/13/1993
• Est. Priority Date: 04/11/1988
• Status: Expired due to Term

• Current Assignee: MD, Inc.
• Original Assignee: MD, Inc.
• Inventors: Masih, Shabir Z., Dhaliwal, Avtar S.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Finkel, Sharon
• Application Number:
  US07/636,704
• Time in Patent Office: 923 Days
• Field of Search: 424/663, 424/686, 424/43, 604/49, 604/50, 604/415
• US Class Current: 604/415
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients

Abstract

An aqueous composition for reducing pain at the site of injection of local parenteral anesthetic material, for improving the onset thereof, and for increasing its duration, and a means for preparing and dispensing the same, the composition containing a local parenteral anesthetic which in normal doses gives an acid pH of from about 2.5 to about 6.9, wherein the anesthetic comprises from about 0.5 to about 2.0% by weight of the composition, the composition further containing sufficient NaHCO₃ to maintain the pH thereof between about 7.0 and about 7.6, and further containing from about 0.0004 moles of dissolved CO₂ per ml of composition up to the saturation level of dissolved CO₂ at a CO₂ head pressure of up to about 2.5 atmospheres.

Claims

1. The method for preparing an aqueous solution of a buffered parenteral anesthetic, said solution having a pH of from about 7.0 to about 8.5 and ready for immediate injection into the human body at the time of medical procedure, said method comprising providing a first vial containing a dilute aqueous acid buffering system containing essentially electrolyte-free water and sodium bicarbonate, providing a second vial containing a parenteral anesthetic having in non-buffered form a pH of below 7.0, each of said vials having a closure cap thereon hermetically sealing the same, and each said cap having a portion which is readily penetrable by the needle of a syringe, inserting said needle through said cap portion of said first vial into said buffering system and withdrawing the same into said syringe, and inserting said needle through said cap portion of said second vial and injecting said buffering system into said second vial to contact said anesthetic and buffer the same to a pH of above 7.0.

2. The method of claim 1 wherein the amount of buffering system withdrawn from said first vial and injected into said second vial is predetermined to give a concentration of said anesthetic in said solution of from about 0.5 to about 2.0% by weight thereof.

3. The method of claim 2 wherein said syringe needle is retained in said second vial and the buffered solution of anesthetic is withdrawn by said syringe when needed and injected into the patient directly from said syringe.

4. The method of claim 1 wherein said non-buffered anesthetic has a pH of from about 3.5 to about 6.5, the dissolved solids of said buffering system consists essentially of sodium bicarbonate at a concentration of from about 3 to about 20 wt. %, and said system contains at least about 0.0004 moles of dissolved CO₂ per ml of said system, and said system has a pH of from about 7.0 to about 8.5.

5. The method of claim 4 wherein said cap is comprised of elastomeric material.

6. The method of claim 5 wherein the concentration of the sodium bicarbonate is about 7.0 to about 8.0 wt. %.

7. The method of claim 5 wherein the anesthetic material is an aqueous solution of one or a mixture of lidocaine hydrochloride or (-)-3, 4-dihydroxy- -[(methylamino) methyl] benzyl alcohol.

8. The method of claim 5 wherein the anesthetic material is an aqueous solution of one or a mixture of lidocaine hydrochloride or (-)-3, 4-dihydroxy- -[(methylamino) methyl] benzyl alcohol.

9. The method of claim 5 wherein the concentration of the sodium bicarbonate is about 7.5 wt. %.