Table 1.
Comparison of Available Formulations of Loteprednol Etabonate
| Ingredients | Function | LE suspension 0.2%31,a | LE suspension 0.5%32,b | LE suspension 1%39,c | LE (submicron) gel 0.38%3,d | LE gel 0.5%41,e |
|---|---|---|---|---|---|---|
| Active substance | ||||||
| LE | Steroid, anti-inflammatory | 2.0 mg/mL | 5.0 mg/mL | 10.0 mg/mL | 3.8 mg/g | 5.0 mg/g |
| Key excipients32,39 | ||||||
| Povidone | Suspending and/or viscosity-increasing agents | + | + | − | − | − |
| Polycarbophil | − | − | − | + | + | |
| Hypromellose | − | − | − | + | − | |
| Tyloxapol | Surfactants and/or wetting agents | + | + | − | − | + |
| Poloxamer | − | − | + | + | − | |
| Glycerin | Tonicity agents/humectants | + | + | + | + | + |
| Propylene glycol | − | − | − | + | + | |
| Edetate disodium dehydrate | Chelant/antimicrobial enhancer | + | + | + | + | + |
| BAK | Antimicrobial preservative | 100 ppm | 100 ppm | 100 ppm | 30 ppm | 30 ppm |
| pH | 5.538 | 5.538 | N/A | 6.543 | 6.543 | |
a
Alrex® (LE ophthalmic suspension) 0.2%, Bausch + Lomb.
b
Lotemax® (LE ophthalmic suspension) 0.5%, Bausch + Lomb.
c
Inveltys® (LE ophthalmic suspension) 1%, Kala Pharmaceuticals.
d
Lotemax® SM (LE ophthalmic gel) 0.38%, Bausch + Lomb.
e
Lotemax® (LE ophthalmic gel) 0.5%, Bausch + Lomb.
BAK, benzalkonium chloride; LE, loteprednol etabonate; N/A, information not available; ppm, parts per million.