METHODS: This cross-sectional, randomized, double-masked clinical trial compared cyclopentolate 1% + phenylephrine 2.5%, tropicamide 1% + phenylephrine 2.5%, and a prepared combination of cyclopentolate 0.2% with phenylephrine 1% for pupillary dilation in preterm infants with dark irides. Thirteen infants were randomized to each regimen. Outcomes measured were pupillary dilation, heart rate, blood pressure, abdominal girth, and intolerance to feeds.

RESULTS: All three mydriatic regimens provided adequate pupillary dilation at 45 minutes, with dilation sustained at 60 minutes. There was a significant increase in mean blood pressure in the cyclopentolate 1% + phenylephrine 2.5% and the tropicamide 1% + phenylephrine 2.5% groups. Although there was no significant change of abdominal girth in any of the three groups, a total of eight patients developed intolerance to feeds; four (50%) of these infants were from the cyclopentolate 1% + phenylephrine 2.5% group.

METHODS: Xenical 120 mg capsules (Roche, Basel, Switzerland) were used as reference material. Generic products were from India, Malaysia, Argentina, Philippines, Uruguay, and Taiwan. Colour, melting temperature, crystalline form, particle size, capsule fill mass, active pharmaceutical ingredient content, amount of impurities, and dissolution were compared. Standard physical and chemical laboratory tests were those developed by Roche for Xenical.

RESULTS: All nine generic products failed the Xenical specifications in four or more tests, and two generic products failed in seven tests. A failure common to all generic products was the amount of impurities present, mostly due to different by-products, including side-chain homologues not present in Xenical. Some impurities were unidentified. Two generic products tested failed the dissolution test, one product formed a capsule-shaped agglomerate on storage and resulted in poor (=15%) dissolution. Six generic products were powder formulations.