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Publication Number
US-10952962-B1
Publication Date
2021-03-23
Expiration Date
Abstract
Disclosed herein is a ready-to-use liquid formulation comprising lidocaine hydrochloride and epinephrine hydrochloride. Also disclosed herein is a process for preparing a ready-to-use liquid formulation comprising lidocaine hydrochloride and epinephrine hydrochloride, as well as methods for using the ready-to-use liquid formulation.
Core Innovation
The invention relates to a ready-to-use liquid formulation comprising lidocaine hydrochloride and epinephrine hydrochloride, with the epinephrine amount stated based on epinephrine free base. The formulation additionally includes sodium chloride, sodium metabisulfite, citric acid, EDTA sodium, and sufficient sterile water for injection, with a sufficient amount of a pH adjuster to obtain a pH of about 3.4.
The formulation is defined by specified amounts of lidocaine hydrochloride of about 10 mg/mL or about 20 mg/mL and epinephrine hydrochloride of about 10 mcg/mL based on epinephrine free base, together with sodium chloride of about 7 mg/mL, sodium metabisulfite of about 5.2 mcg/mL, citric acid of about 0.2 mg/mL, and EDTA sodium of about 0.2 mg/mL. The pH adjuster is hydrochloric acid, sodium hydroxide, or a combination thereof.
The disclosed concept further includes packaged presentation and performance and protection features, including a syringe product with a defined volume and retention of potency after storage. The light-sensitive container includes quantitative protection by having light transmission less than 5% at any wavelength between 290 nm and 450 nm.
Claims Coverage
The independent claims cover a ready-to-use liquid formulation with specified amounts of lidocaine hydrochloride and epinephrine hydrochloride, specified excipients, and a pH adjuster to obtain a pH of about 3.4. The main inventive features include the defined formulation composition and the defined pH target, with additional limitations on the pH adjuster identity, syringe volume, potency retention after storage, and light transmission in a light-sensitive container.
Defined lidocaine–epinephrine ready-to-use liquid formulation at pH about 3.4
A ready-to-use liquid formulation comprising lidocaine hydrochloride at about 10 mg/mL or about 20 mg/mL; epinephrine hydrochloride at about 10 mcg/mL based on epinephrine free base; sodium chloride about 7 mg/mL; sodium metabisulfite about 5.2 mcg/mL; citric acid about 0.2 mg/mL; EDTA sodium about 0.2 mg/mL; sufficient sterile water for injection; and sufficient amount of a pH adjuster to obtain a pH of about 3.4.
pH adjuster selected to obtain pH about 3.4
The pH adjuster is hydrochloric acid, sodium hydroxide, or a combination thereof.
Syringe product fill volume about 5 mL
A syringe product containing about 5 mL of the ready-to-use liquid formulation.
Potency retention after storage
The syringe includes lidocaine and epinephrine that retain at least 90% potency after about 3 months of storage at about 25°C.
Light transmission limitation in a light-sensitive container
A light-sensitive container for the syringe, where the container has light transmission of less than 5% at any wavelength between 290 nm and 450 nm.
Across the independent claims, the coverage centers on a specific ready-to-use lidocaine hydrochloride/epinephrine hydrochloride liquid formulation with specified excipient amounts and a pH adjuster sufficient to obtain a pH of about 3.4. Dependent claim themes further specify the pH adjuster identity, a syringe volume of about 5 mL, a potency retention requirement after storage, and a quantified light transmission limit for a light-sensitive container.
Stated Advantages
Documented Applications
No documented applications found
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