In vitro dissolution testing of oral controlled release preparations in the presence of artificial foodstuffs. I. Exploration of alternative methodology: microcalorimetry

A liquid chromatography method for quantifying caffeine dissolution from pharmaceutical formulations into colloidal, fat-rich media

“…These are designed to provide a dissolution environment which is more realistic of the fasted or fed gastro-intestinal tract [4]. Milk and other fat emulsions are popular [5][6][7]. A bovine milkbased medium has been proposed as best representing the contents of the fed stomach [4] following studies which demonstrated how high-fat milk (3.5% fat) displayed similar physiochemical characteristics to that of a semi-digested, FDA standardised meal [8][9].…”

“…Intralipid TM is a soya-bean oil/egg lecithin parenteral feeding emulsion that has been explored as a dissolution medium and is reported to have clear potential for modelling high-fat meals [5][6]. It is widely available, has highly reproducible physical characteristics and exhibits greater stability than natural high-fat foods (for example dairy cream) during the extended times required for dissolution tests of ER products [28].…”

Drug release from HPMC matrices in milk and fat‐rich emulsions

“…They reported slower disintegration of immediate release tablets, attributed to a proteinaceous film forming at the tablet surface. Ashby et al 22 investigated theophylline release from matrix tablets in nutritional drinks and other fat emulsions, including milk and Intralipid R 10%. They concluded that Intralipid R provided a more suitable test medium than milk, which varies in fat content between batches and suppliers.…”

Media to simulate the postprandial stomach I. Matching the physicochemical characteristics of standard breakfasts

“…Attempts to simulate the initial composition of the gastric contents after food intake have been proposed by several researchers. For example, milk (Macheras et al 1986(Macheras et al , 1987(Macheras et al , 1988(Macheras et al , 1989a(Macheras et al , b, 1990Buckton et al 1989;KraÈ mer 1995;Galia et al 1998;Nicolaides et al 1999) and artificial liquid meals (Nutridrink and Ensure) (Ashby et al 1989;Buckton et al 1989;Junginger et al 1990), emulsions (Ashby et al 1989;Buckton et al 1989;KraÈ mer 1995) and homogenized meals (KraÈ mer 1995) have been used. However, the composition of these media may not optimally reflect the composition of the meals usually administered in relevant bioavailability/ bioequivalence studies.…”