Media to simulate the postprandial stomach I. Matching the physicochemical characteristics of standard breakfasts.
To better predict food effects on the bioavailability/bioequivalence of drugs and drug products from in-vitro data, a dissolution medium that simulates the initial composition of the postprandial stomach was developed. First, the physical parameters of two homogenized standard breakfasts often administered to assess food effects in pharmacokinetic studies were measured. These included pH, buffer capacity, osmolality, surface tension and viscosity. Subsequently, the match of the physical parameters of several commercially available liquid meals, including long-life milk, Ensure and Ensure Plus to those of the breakfasts was evaluated. Of the three liquid meals studied, Ensure Plus had the closest physicochemical behaviour to that of homogenized standard breakfasts. By increasing the viscosity of Ensure Plus with 0.45% pectin, it was possible to obtain a medium that closely resembles the FDA standard breakfast.
Klein
Sandra
S
Department of Pharmaceutical Technology, Johann Wolfgang Goethe University, 9 Marie Curie Street, Frankfurt am Main 60439, Germany.
Butler
James
J
Hempenstall
John M
JM
Reppas
Christos
C
Dressman
Jennifer B
JB
D000818:Animals; D055598:Chemical Phenomena; D002627:Chemistry, Physical; D019422:Dietary Sucrose; D005215:Fasting; D005502:Food; D005526:Food, Formulated; D018565:Food-Drug Interactions; D006863:Hydrogen-Ion Concentration; D008892:Milk / Q000737:chemistry; D010368:Pectins / Q000737:chemistry; D010599:Pharmacokinetics; D019518:Postprandial Period; D012995:Solubility; D013270:Stomach / Q000737:chemistry*; D014481:United States; D014486:United States Food and Drug Administration; D014783:Viscosity; D014812:Vitamin K / Q000737:chemistry
D019422:Dietary Sucrose; C029401:Ensure Plus; C082131:Ensure formulated food; D014812:Vitamin K; D010368:Pectins