Does cyclodextrin affect penetration of diclofenac sodium through amniotic membrane

Purpose To investigate permeability of amniotic membrane (AM) to diclofenac sodium containing eye drops with or without cyclodextrin (CD) Methods Cryopreserved AM pieces on cellulose acetate filter membranes were mounted in the previously established vertical Franz-diffusion cell system equipped with autosampler. In vitro penetration of two commercially available eyedrops containing 0.1% diclofenac sodium was examined. Voltaren Ophtha CD (VO, with CD) and Uniclophen (UN, without CD) were compared. Drug release was determined by quantitative absorbance measurement carried out with a high performance liquid chromatography (HPLC). Results The initial two hours, release of diclofenac from VO was lower than penetration of diclofenac from UN. At 30 minutes only 6.6% of diclofenac penetrated AM from VO vs 11.5% from UN. At 2 hours difference between two eyedrops was not siginificant (25.69% for VO and 27.39% for UN; p>0.05). After two hours, greater concentration of VO could be measured in the acceptor phase than that of UN and this difference remained significant over the study period. Seven and half hour after instillation we detected 56.26% for VO versus 35.62% for UN of baseline concentrations Conclusion Drug penetration of diclofenac sodium was affected by CD. Until 120 minutes following instillation, CD decreased drug release from eyedrop containing CD compared to eyedrop without CD. After 2 hours, however drug penetration became significantly greater from solution with CD compared to solution without CD.