Bioavailability of a Novel, Water-Soluble Vitamin E Formulation in Malabsorbing Patients

Abstract

In cystic fibrosis (CF), pancreatic insufficiency and a diminished bile acid pool cause malabsorption of important nutrients and dietary components leading to deficiency, poor nutritional status, and oxidative stress. Of particular significance is the malabsorption of fat-soluble nutrients and antioxidants, which are important for normal immune and neurologic function. Patients with CF often are deficient in these compounds despite supplementation with the current standard of care therapy. The objective was to compare the pharmacokinetic profile of this water-soluble vitamin E formulation (Aqua-E) with an oil-based softgel formulation in a malabsorbing patient population. Patients with CF who had documented malabsorption were recruited for participation in this pharmacokinetic study. Patients who met inclusion and exclusion criteria discontinued vitamin E supplementation, except for that in a multivitamin, for 7 to 21 days before the day of dosing. Patients were randomized to a single dose of 20 ml of Aqua-E or three oil-based softgels, which contained equivalent amounts of tocopherols. Blood was drawn from patients at time 0, 2, 4, 8, 24, 48, and 168 hr and analyzed for tocopherols. Eight patients were enrolled in the study and randomized to Aqua-E or softgels. The primary outcome, the absorption of gamma-tocopherol in Aqua-E (AUC=115 micro g/ml(*)hr), was significantly greater than that of oil-based softgels (AUC=25.3 micro g/ml(*)hr; P=0.013). Total-tocopherols (alpha+gamma+delta) in Aqua-E (AUC=294 micro g/ml(*)hr) showed a strong trend toward increased absorption compared with that of oil-based softgels (AUC=117 micro g/ml(*)hr; P=0.09). In conclusion, this novel, water-soluble formulation showed a marked and statistically significant increase in absorption of gamma-tocopherol in malabsorbing patients with CF compared with an oil-based formulation.

Vitamin E Modifies High-Fat Diet-Induced Increase of DNA Strand Breaks, and Changes in Expression and DNA Methylation of Dnmt1 and MLH1 in C57BL/6J Male Mice

“…The drinking water of animals was supplemented with vitamin E: “Aqua E” [33] containing 20 IU d-α-tocopherol, 15 mg other tocopherols, and 2 mg tocotrienols per mL. Aqua E has been used to guarantee an equivalent Vitamin E absorption: according to Papas et al (2007), Aqua E showed a better bioavailability in malabsorbing patients compared to conventional based supplements [33].…”

“…Aqua E has been used to guarantee an equivalent Vitamin E absorption: according to Papas et al (2007), Aqua E showed a better bioavailability in malabsorbing patients compared to conventional based supplements [33]. Body weight and food intake were measured weekly, water/vitamin E uptake as an average per cage daily.…”

Oral protein calorie supplementation for children with chronic disease

“…However, the review did not include the minimum number of studies (n = 10) for any analysis. Furthermore, while funnel plot asymmetry may indicate publication bias, this is not inevitably the case (Egger 1997). This issue will be considered for a future version of this review provided there is a sufficient number of included studies.…”

Guidelines for the diagnosis and management of chylomicron retention disease based on a review of the literature and the experience of two centers

“…In the attempt to promote liposoluble vitamin absorption, new pharmacologic formulations of vitamin E have been developed. Tocopheryl polyethylene glycol succinate is a hydrosoluble form of vitamin E. This water-soluble formulation showed a marked and statistically significant increase in the absorption of gamma-tocopherol in malabsorbing patients with cystic fibrosis (CF) compared with a classic oil-based formulation [51]. Recently, intestinal absorption of water-soluble vitamin E (tocofersolan) was compared with a water-miscible form in 12 CF or cholestatic children [52].…”