Use of sustained release dexamethasone in post-cataract surgery inflammation
Inventors
Wong, Vernon G. • White, William S. • Hu, Mae W. • Huang, Glenn T. • Karasina, Faina
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-10159683-B2
Publication Date
2018-12-25
Expiration Date
Abstract
The present embodiments provide for a treatment regimen and use of a short-term sustained release liquid formulation of dexamethasone in citrate, wherein a single administration of a minute dosage form into the anterior chamber of the eye provides for anti-inflammatory therapy following cataract surgery.
Core Innovation
The invention relates to a kit and unit dosage form for the treatment of inflammation in the eye using dexamethasone in a citrate vehicle comprising triethyl acetyl citrate (ATEC). The formulations consist essentially of dexamethasone and triethyl acetyl citrate, with the w/w ratio of dexamethasone:triethyl acetyl citrate selected from about 6:94, about 9:91, and about 12:88.
The described formulations are provided as short-term sustained-release anti-inflammatory dexamethasone compositions intended for administration after cataract surgery, including into the anterior chamber of the eye, with a single administration and minute-volume injection. The unit doses are described in the range of about 1–3 weeks sustained release, with release duration assertions including release for at least 3 days and release for at least 7 days up to about 35 days, and retention after 3 days of at least about 30%.
The document further describes testing and outcomes that support the sustained-release concept, including in vitro release using infinite sink methods and in vivo release in rabbit aqueous humor. Clinical evaluation is described as a Phase II human clinical trial with anterior chamber inflammation measures (ACC grade), including a proportion of patients with ACC Grade=0 at day 8 across dose groups, and comparisons versus marketed steroid/NSAID eye drops and an implant.
Claims Coverage
The partial content includes three independent claims (clm-00001, clm-00007, and clm-00011). Across these independent claims, the inventive coverage centers on a kit with a specified dexamethasone/triethyl acetyl citrate ratio and guided dosing components, and unit dosage forms defined by minute-volume quantities and compositions consisting essentially of about 9% (w/w) dexamethasone and about 91% (w/w) triethyl acetyl citrate.
Inflammation treatment kit with dexamethasone and triethyl acetyl citrate formulation
A kit for the treatment of inflammation in the eye comprising a vial containing a formulation consisting essentially of dexamethasone and triethyl acetyl citrate, wherein the w/w ratio of the dexamethasone:triethyl acetyl citrate is selected from about 6:94, about 9:91, and about 12:88; an injection syringe; a needle; a cannula; a dose loading guide; and a dose delivery guide.
Minute-volume unit dosage form with defined dexamethasone:triethyl acetyl citrate composition
A unit dosage form consisting essentially of about 4 µL to about 6 µL of a composition consisting essentially of about 9% (w/w) dexamethasone and about 91% (w/w) triethyl acetyl citrate.
Injection syringe unit dosage form with dexamethasone and triethyl acetyl citrate
A unit dosage form comprising an injection syringe containing about 4 µL to about 6 µL of a composition consisting essentially of about 9% (w/w) dexamethasone and about 91% (w/w) triethyl acetyl citrate.
The claim coverage in the provided text is focused on the same core formulation components (dexamethasone with triethyl acetyl citrate/ATEC) while varying the claim type between a guided kit and minute-volume unit dosage forms. The independent claims define key formulation ratios and constrain dosage volume, with additional dependent claims further specifying syringe volume and dexamethasone dose amounts.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
Interested in licensing this patent?