Table I Information of the Formulations Used in This Study
Active principal ingredient (API) Brand Manufacturer Formulation type/release mechanism Excipients Dose tested (mg) Administration recommendations (26)
Mesalazine Salofalk® Dr. Falk Pharma (UK) Granules/delayed release pH-dependent Aspartame (E 951), carmellose sodium, cellulose, citric acid, silica, hypromellose, magnesium stearate, Eudragit L 100, Eudragit NE 40 D containing 2% nonoxynol 100, povidone K 25, simeticone, sorbic acid, talc, titanium dioxide (E 171), triethyl citrate, vanilla custard flavour 135 Granules should be placed on the tongue and washed down with water without chewing.
Pentasa® Ferring (UK) Granules/extended release pH-independent coating Ethylcellulose, povidone 135 Granules should be placed on the tongue and washed down with water or orange juice, without chewing. Contents of one sachet should be weighed and divided immediately before use; any remaining granules should be discarded.
Montelukast Singulair® Merck Sharp & Dohme Ltd. (UK) Granules/immediate release Mannitol, hydroxy-propyl cellulose, magnesium stearate 4 Granules may be swallowed or mixed with cold, soft foods (not liquid), and taken immediately.
Actavis® Actavis (UK) Chewable tablets/immediate release Lactose monohydrate, aspartame 5 Tablet should not be taken with food; should be taken at least 1 h before or 2 h after food.