Literature DB >> 32690643

Safety, Tolerability, and Pharmacokinetics of a Novel Oral Amphotericin B Formulation (iCo-019) following Single-Dose Administration to Healthy Human Subjects: an Alternative Approach to Parenteral Amphotericin B Administration.

Peter Hnik1, Ellen K Wasan2, Kishor M Wasan3,4.   

Abstract

This study evaluated the safety, tolerability, and pharmacokinetics of a novel oral amphotericin B (AmB) formulation (iCo-019) following single doses to healthy humans. The data from this study suggest that iCo-019 has a long circulation time and systemic exposure without the associated gastrointestinal, liver, and kidney toxicity associated with AmB. This novel oral AmB formulation can serve as a new treatment strategy to overcome the limitations of the use of parenterally administered AmB products.
Copyright © 2020 American Society for Microbiology.

Entities:  

Keywords:  antimicrobial safety; healthy human subjects; oral amphotericin B; pharmacokinetics; phase I human clinical trials; safety and tolerability

Mesh：

Substances：

Year:  2020        PMID： 32690643      PMCID： PMC7508586          DOI： 10.1128/AAC.01450-20

Source DB:  PubMed          Journal:  Antimicrob Agents Chemother        ISSN： 0066-4804            Impact factor:   5.191


  28 in total

1.  Study the effects of PLGA-PEG encapsulated amphotericin B nanoparticle drug delivery system against Leishmania donovani.

Authors:  Rishikesh Kumar; Ganesh Chandra Sahoo; Krishna Pandey; Vnr Das; Pradeep Das
Journal:  Drug Deliv       Date:  2014-03-06       Impact factor: 6.419

2.  Antifungal activity of oral (Tragacanth/acrylic acid) Amphotericin B carrier for systemic candidiasis: in vitro and in vivo study.

Authors:  Heba A Mohamed; Rasha R Radwan; Amany I Raafat; Amr El-Hag Ali
Journal:  Drug Deliv Transl Res       Date:  2018-02       Impact factor: 4.617

3.  Oral particle uptake and organ targeting drives the activity of amphotericin B nanoparticles.

Authors:  Dolores R Serrano; Aikaterini Lalatsa; M Auxiliadora Dea-Ayuela; Pablo E Bilbao-Ramos; Natalie L Garrett; Julian Moger; Josep Guarro; Javier Capilla; M Paloma Ballesteros; Andreas G Schätzlein; Francisco Bolás; Juan J Torrado; Ijeoma F Uchegbu
Journal:  Mol Pharm       Date:  2015-01-15       Impact factor: 4.939

4.  Development and characterization of oral lipid-based amphotericin B formulations with enhanced drug solubility, stability and antifungal activity in rats infected with Aspergillus fumigatus or Candida albicans.

Authors:  Ellen K Wasan; Karen Bartlett; Pavel Gershkovich; Olena Sivak; Brian Banno; Zhao Wong; Jeffrey Gagnon; Byron Gates; Carlos G Leon; Kishor M Wasan
Journal:  Int J Pharm       Date:  2009-01-17       Impact factor: 5.875

5.  Pharmacokinetics and biodistribution of amphotericin B in rats following oral administration in a novel lipid-based formulation.

Authors:  Pavel Gershkovich; Ellen K Wasan; Molly Lin; Olena Sivak; Carlos G Leon; John G Clement; Kishor M Wasan
Journal:  J Antimicrob Chemother       Date:  2009-04-27       Impact factor: 5.790

6.  Effect of aggregation state on the toxicity of different amphotericin B preparations.

Authors:  Raquel Espada; Suriñe Valdespina; Carlos Alfonso; German Rivas; M Paloma Ballesteros; Juan J Torrado
Journal:  Int J Pharm       Date:  2008-05-20       Impact factor: 5.875

7.  Pickering emulsion stabilized by cashew gum- poly-l-lactide copolymer nanoparticles: Synthesis, characterization and amphotericin B encapsulation.

Authors:  A R Richter; J P A Feitosa; H C B Paula; F M Goycoolea; R C M de Paula
Journal:  Colloids Surf B Biointerfaces       Date:  2018-01-31       Impact factor: 5.268

8.  Highly effective oral amphotericin B formulation against murine visceral leishmaniasis.

Authors:  Kishor M Wasan; Ellen K Wasan; Pavel Gershkovich; Xiaohua Zhu; Richard R Tidwell; Karl A Werbovetz; John G Clement; Sheila J Thornton
Journal:  J Infect Dis       Date:  2009-08-01       Impact factor: 5.226

Review 9.  Enhancing drug absorption using lipids: a case study presenting the development and pharmacological evaluation of a novel lipid-based oral amphotericin B formulation for the treatment of systemic fungal infections.

Authors:  Kristina Sachs-Barrable; Stephen D Lee; Ellen K Wasan; Sheila J Thornton; Kishor M Wasan
Journal:  Adv Drug Deliv Rev       Date:  2007-11-05       Impact factor: 15.470

10.  The Development of Oral Amphotericin B to Treat Systemic Fungal and Parasitic Infections: Has the Myth Been Finally Realized?

Authors:  Grace Cuddihy; Ellen K Wasan; Yunyun Di; Kishor M Wasan
Journal:  Pharmaceutics       Date:  2019-02-26       Impact factor: 6.321
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  3 in total

Review 1.  Current approaches of nanomedicines in the market and various stage of clinical translation.

Authors:  Xiaoting Shan; Xiang Gong; Jie Li; Jingyuan Wen; Yaping Li; Zhiwen Zhang
Journal:  Acta Pharm Sin B       Date:  2022-03-01       Impact factor: 14.903

2.  Assessing the Safety, Tolerability, Pharmacokinetics, and Biodistribution of Novel Oral Formulations of Amphotericin B following Single- and Multiple-Dose Administration to Beagle Dogs.

Authors:  Kishor M Wasan; Ellen K Wasan; Peter Hnik
Journal:  Antimicrob Agents Chemother       Date:  2020-10-20       Impact factor: 5.191

Review 3.  Coccidioidomycosis: A Contemporary Review.

Authors:  Nancy F Crum
Journal:  Infect Dis Ther       Date:  2022-03-01
  3 in total

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