Subchronic (13-week) oral toxicity study of α-cyclodextrin in dogs

Lina, B.A.R.; Bär, A.

doi:10.1016/j.yrtph.2004.05.005

Cited by 26 publications

(8 citation statements)

References 11 publications

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“…Furthermore, α-CD improved the blood fatty acid profile, reducing the saturated fatty acids (−4.5 %) and trans-isomers (−11 %), while increasing unsaturated fatty acids (2.5 %) [ 15 ]. Results from this study are consistent with other animal studies, showing the possible utility of α-CD as a dietary supplement for decreasing serum lipids [ 12 , 16 , 17 ].…”

Section: Introductionsupporting

confidence: 91%

Randomized double blind clinical trial on the effect of oral α-cyclodextrin on serum lipids

et al. 2016

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BackgroundThis single center, double-blinded, cross-over, placebo controlled clinical trial investigated the effect of oral α-cyclodextrin (α-CD), a soluble dietary fiber, on blood lipid and lipoprotein levels in healthy human subjects. α-CD, a cyclical polymer containing 6 glucose subunits, is currently sold as an over the counter food supplement and is also a common additive in many foods. α-CD forms a hydrophobic central cavity that binds lipids and has been shown in animal studies and in previous clinical trials to alter plasma lipid levels.MethodsWe screened for healthy subjects, males and females, between ages 18 to 75. Out of total 103 subjects interviewed, 75 subjects completed the study. Qualified individuals in each gender group were randomized into two groups in terms of which treatment arm they received first (placebo vs. α-CD, receiving 6 grams P.O. a day, for 12–14 weeks with a 7 day wash out between arms). The primary outcome variable, plasma total cholesterol, as well as other tests related to lipids and lipoprotein and glucose metabolism, were measured at baseline and at the end of each arm of the study.Resultsα-CD was well tolerated; no serious adverse events related to α-CD were observed. Approximately 8 % of the subjects on α-CD complained of minor gastrointestinal symptoms versus 3 % on placebo (p = 0.2). Small-LDL particle number decreased 10 % (p < 0.045) for subjects on α-CD versus placebo. Fasting plasma glucose (1.6 %, p < 0.05) and Insulin resistance index (11 %, p < 0.04) were also decreased when on α-CD versus placebo.Conclusionα-CD treatment appears to be safe and well tolerated in healthy individuals and showed a modest reduction in small LDL particles, and an improvement in glucose related parameters.Trial registrationNCT01131299

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Section: Introductionsupporting

confidence: 91%

Randomized double blind clinical trial on the effect of oral α-cyclodextrin on serum lipids

et al. 2016

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“…Presently, oral administration of methylated β CDs is limited by their potential toxicity. Oral administration of α CD is well tolerated and is not associated with any observable adverse effects [34,35] . The same applies to β CD, [36] γ CD, [28] HP β CD [37] and SBE β CD [21] .…”

Section: Introductionmentioning

confidence: 80%

“…Oral administration of aCD is well tolerated and is not associated with any observable adverse effects. [34,35] The same applies to bCD, [36] gCD, [28] HPbCD [37] and SBEbCD. [21] The main side effects of oral administration of high doses of these CDs are similar to those related to poorly digestible carbohydrates and include flatulence and soft stools.…”

Section: Pharmacokinetics and Toxicologymentioning

confidence: 99%

Pharmaceutical applications of cyclodextrins: basic science and product development

Loftsson

Brewster

2010

Journal of Pharmacy and Pharmacology

837

496

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Objectives Drug pipelines are becoming increasingly difficult to formulate. This is punctuated by both retrospective and prospective analyses that show that while 40% of currently marketed drugs are poorly soluble based on the definition of the biopharmaceutical classification system (BCS), about 90% of drugs in development can be characterized as poorly soluble. Although a number of techniques have been suggested for increasing oral bioavailability and for enabling parenteral formulations, cyclodextrins have emerged as a productive approach. This short review is intended to provide both some basic science information as well as data on the ability to develop drugs in cyclodextrin-containing formulations. Key findings There are currently a number of marketed products that make use of these functional solubilizing excipients and new product introduction continues to demonstrate their high added value. The ability to predict whether cyclodextrins will be of benefit in creating a dosage form for a particular drug candidate requires a good working knowledge of the properties of cyclodextrins, their mechanism of solubilization and factors that contribute to, or detract from, the biopharmaceutical characteristics of the formed complexes. Summary We provide basic science information as well as data on the development of drugs in cyclodextrin-containing formulations. Cyclodextrins have emerged as an important tool in the formulator's armamentarium to improve apparent solubility and dissolution rate for poorly water-soluble drug candidates. The continued interest and productivity of these materials bode well for future application and their currency as excipients in research, development and drug product marketing.

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“…FBCx (generically known as a-cyclodextrin; Wacker Biochem, Adrian, MI) is a soluble fiber derived from corn. The World Health Organization has given it an acceptable daily intake of bnot specified.Q Furthermore, based on the safety data presented [18][19][20][21], this material was recently granted Generally Recognized As Safe status by the FDA. FBCx has been shown to bind with free fatty acids in aqueous solution [22].…”

Section: Introductionmentioning

confidence: 99%

The effects of a new soluble dietary fiber on weight gain and selected blood parameters in rats

Artiss¹,

Brogan²,

Brucal³

et al. 2006

Metabolism

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Subchronic (13-week) oral toxicity study of α-cyclodextrin in dogs

Cited by 26 publications

References 11 publications

Randomized double blind clinical trial on the effect of oral α-cyclodextrin on serum lipids

Randomized double blind clinical trial on the effect of oral α-cyclodextrin on serum lipids

Pharmaceutical applications of cyclodextrins: basic science and product development

The effects of a new soluble dietary fiber on weight gain and selected blood parameters in rats

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