Pharmacological properties : תכונות פרמקולוגיות

Pharmacodynamic Properties

5.1 Pharmacodynamic properties
Pharmacotherapeutic group: anti-inflammatory agents, non-steroids, ATC code: S01BC03.
Voltaren Ophtha Eye Drops contain diclofenac sodium, a non-steroidal anti- inflammatory agent with analgesic properties. It has marked prostaglandin synthesis inhibitory activity and this is thought to have an important bearing on its mechanism of action.

Clinical trials have demonstrated that diclofenac inhibits miosis during cataract surgery and reduces ocular inflammation and pain associated with corneal epithelial defects after some types of surgical intervention.

There is no indication that diclofenac has any adverse effects on wound healing.
Voltaren Ophtha Eye Drops contains a cyclodextrin, hydroxypropyl gamma- cyclodextrin (HP-gamma-CD). Cyclodextrins (CDs) increase the aqueous solubility of some lipophilic water-insoluble drugs. It is believed that CDs act as true carriers by keeping hydrophobic drug molecules in solution and delivering them to the surface of biological membranes.

Pharmacokinetic Properties

5.2 Pharmacokinetic properties
In rabbits, peak concentrations of 14C-labelled diclofenac could be demonstrated in the cornea and conjunctiva 30 minutes after application. Elimination was rapid and almost complete after 6 hours.
Concentrations of HP-gamma-CD in plasma and aqueous humor were below detection limits (1 nMol/mL) in rabbits after single or four times daily (q.i.d.) ocular administration for 28 days. Low concentrations of HP-gamma-CD were detected in the aqueous humor of two rabbits (1 after single instillation, 1 after q.i.d. instillation for 28 days).
Penetration of diclofenac into the anterior chamber has been confirmed in humans.