Absorption of enteric and non‐enteric coated prednisolone tablets.

Abstract

Relative rates of absorption of enteric and non-enteric preparations of prednisolone were measured in five renal transplant recipients. 2 The absorption of the enteric coated preparation is delayed and the peak plasma concentration is much lower than that attained using the same dose of the uncoated material. 3 The therapeutic implications of these observations are discussed.

Plasma Prednisolone Levels After Administration in Plain and Enteric‐coated Tablets

“…(Hulme, James & Rault, 1975;Leclerq & Copinschi, 1974) which gave rather different results from those obtained by the authors. Wilson et al (1977) consider that the difference in results might be due to differences between the populations studied, differences in tablet formulation, or possibly to modification of the intestinal bacteria by immunosuppression.…”

“…It seems unlikely therefore that food intake accounts for the small differences between these two studies. Hulme, James & Rault (1975) found that plasma concentrations after enteric-coated tablets were much lower than after conventional tablets. Perhaps a larger meal taken as soon as 2 h after the dose, does interfere with drug absorption.…”

“…Other possible reasons for the differences could be that in the study by Hulme et al (1975) In reply to Herxheimer & Mahadeva (1977), the details and treatment of the patients participating in the study (Wilson, May & Paterson, 1977) Leclerq & Copinschi (1974) (2.08 h), whose patients were fasted. It seems unlikely therefore that food intake accounts for the small differences between these two studies.…”

Plasma prednisolone levels from enteric and non‐enteric coated tablets estimated by an original technique.

“…In all except two subjects prednisolone did not appear in the plasma for at least 2 h after the enteric coated preparation had been taken: in these two subjects the lag time for prednisolone appearance was identical with that for the standard tablets. The maximum plasma concentration (Cmax) and the time at which it was attained (tmax) appear in (Leclercq & Copinschi, 1974;Sullivan et al, 1974) or by studying patients already treated with steroids (Hulme, James & Rault, 1975). Alternatively the specificity of this type of assay can be improved by introducing a preliminary thin layer chromatographic step to separate prednisolone from other drugs and metabolites which might interfere with the subsequent protein binding assay (Wilson, Ssendagire, May & Paterson, 1975).…”

Biowaiver Monographs for Immediate Release Solid OralDosage Forms: Prednisolone

“…[10], [11], [14], [31], [32], [35], [42][43][44] Food intake prolongs the time to peak concentration, but does not affect the extent of absorption. [45][46][47] No indication of existence of an absorption window was found in the literature.…”