DERMAL FILLER WITH LIDOCAINE
Disclosed herein are cohesive soft tissue fillers, for example, dermal and subdermal fillers, based on hyaluronic acids and pharmaceutically acceptable salts thereof. In one aspect, hyaluronic acid-based compositions described herein include a therapeutically effective amount of at least one anesthetic agent, for example, lidocaine. The present hyaluronic acid-based compositions including lidocaine have an enhanced stability and cohesivity, relative to conventional compositions including lidocaine, for example when subjected to sterilization techniques or when stored for long periods of time. Methods and processes of preparing such hyaluronic acid-based compositions are also provided.
1 . A stable dermal filler comprising:
(a) a hyaluronic acid crosslinked with 1,4-butanediol diglycidyl ether, and;
(b) lidocaine mixed with the crosslinked hyaluronic acid,
wherein the dermal filler is stable at about 25° C. for at least about 6 months after sterilization of the dermal filler.
2 . The stable dermal filler of claim 1 , wherein the lidocaine is present at a concentration of about 0.3% by weight of the stable dermal filler.
3 . The stable dermal filler of claim 1 , wherein the stable dermal filler requires an extrusion force of between about 10N and about 13N when injected at a rate of about 12.5 mm/minute.
4 . The stable dermal filler of claim 1 , wherein the stable dermal filler has a viscosity of between about 5 Pa*s and about 450 Pa*s when measured at about 5 Hz.
5 . The stable dermal filler of claim 1 , wherein the stable dermal filler is a cohesive dermal filler.
6 . The stable dermal filler of claim 1 , wherein the stable dermal filler comprises particles of cross linked hyaluronic acid.
7 . The stable dermal filler of claim 1 , wherein the concentration of the hyaluronic acid in the stable dermal filler is about 20 mg/ml.
8 . The stable dermal filler of claim 1 , wherein the stable dermal filler has a pH of about 7.
9 . A dermal filler comprising:
(a) a hyaluronic acid crosslinked with 1,4-butanediol diglycidyl ether, and;
(b) 0.3% by weight lidocaine mixed with the crosslinked hyaluronic acid, wherein:
the dermal filler is stable at 25° C. for at least about 6 months after sterilization.
the dermal filler requires an extrusion force of between about 10N and about 13N when injected at a rate of about 12.5 mm/minute.
the dermal filler has a viscosity of between about 5 Pa*s and about 450 Pa*s when measured at about 5 Hz.
10 . The dermal filler of claim 9 , wherein the dermal filler is a cohesive dermal filler.
11 . The dermal filler of claim 0 , wherein the dermal filler comprises particles of cross linked hyaluronic acid.
12 . The dermal filler of claim 9 , wherein the concentration of the hyaluronic acid is about 20 mg/ml.
13 . The dermal filler of claim 9 , wherein the dermal filler has a pH of the about 7.
14 . A dermal filler comprising:
(a) about 20 mg/ml hyaluronic acid crosslinked with 1,4-butanediol diglycidyl ether, and;
(b) about 0.3% by weight lidocaine mixed with the crosslinked hyaluronic acid,
wherein the dermal filler has a pH of about 7.
15 . The dermal filler of claim 14 , wherein the dermal filler is a cohesive dermal filler.
16 . The dermal filler of claim 14 wherein the dermal filler requires an extrusion force of between about 10N and about 13N when injected at a rate of about 12.5 mm/minute.
17 . The dermal filler of claim 14 wherein the dermal filler has a viscosity of between about 5 Pa*s and about 450 Pa*s when measured at about 5 Hz.
18 . The dermal filler of claim 14 , wherein the dermal filler comprises particles of cross linked hyaluronic acid.
19 . A dermal filler comprising:
(a) about 20 mg/ml hyaluronic acid crosslinked with 1,4-butanediol diglycidyl ether, and;
(b) about 0.3% by weight lidocaine mixed with the crosslinked hyaluronic acid, wherein:
the crosslinked hyaluronic acid and/or the lidocaine is stable at about 25° C. for at about 6 months after sterilization of the dermal filler;
the dermal filler has a pH of about 7,
the dermal filler requires an extrusion force of between about 10N and about 13N when injected at a rate of about 12.5 mm/minute;
the dermal filler has a viscosity of between about 5 Pa*s and about 450 Pa*s when measured at about 5 Hz, and;
the dermal filler comprises particles of cross linked hyaluronic acid.