Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ribavirin
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release solid oral dosage forms containing ribavirin are reviewed. Ribavirin is highly soluble, but its permeability characteristics are not well defined. Therefore accordi...
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| Published in | Journal of pharmaceutical sciences Vol. 105; no. 4; pp. 1362 - 1369 |
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| Main Authors | , , , , , , , , , |
| Format | Journal Article |
| Language | English |
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United States
Elsevier Inc
01.04.2016
American Pharmacists Association®. Published by Elsevier Inc |
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| Abstract | Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release solid oral dosage forms containing ribavirin are reviewed. Ribavirin is highly soluble, but its permeability characteristics are not well defined. Therefore according to the Biopharmaceutical Classification System, and taking a “worst case” approach, ribavirin should be assigned to class III. As ribavirin is transported across the brush border membrane of the human jejunum by hCNT2, it shows saturable uptake in the intestine. However, no common excipients have been shown to compete for ribavirin absorption, nor have problems with BE of immediate release ribavirin formulations containing different excipients and produced by different manufacturing methods been reported in the open literature. So the risk of bioinequivalence caused by these factors appears to be low. Ribavirin is considered a narrow therapeutic index drug, as judged by comparing the minimum effective concentration and minimum toxic concentrations in blood. Although ribavirin would not be eligible for approval via a Biopharmaceutical Classification System–based biowaiver procedure according to today's guidances due to its narrow therapeutic index, the risks of biowaiving should be weighed against the considerable risks associated with studying BE of ribavirin products in healthy subjects. |
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| AbstractList | Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release solid oral dosage forms containing ribavirin are reviewed. Ribavirin is highly soluble, but its permeability characteristics are not well defined. Therefore according to the Biopharmaceutical Classification System, and taking a “worst case” approach, ribavirin should be assigned to class III. As ribavirin is transported across the brush border membrane of the human jejunum by hCNT2, it shows saturable uptake in the intestine. However, no common excipients have been shown to compete for ribavirin absorption, nor have problems with BE of immediate release ribavirin formulations containing different excipients and produced by different manufacturing methods been reported in the open literature. So the risk of bioinequivalence caused by these factors appears to be low. Ribavirin is considered a narrow therapeutic index drug, as judged by comparing the minimum effective concentration and minimum toxic concentrations in blood. Although ribavirin would not be eligible for approval via a Biopharmaceutical Classification System–based biowaiver procedure according to today's guidances due to its narrow therapeutic index, the risks of biowaiving should be weighed against the considerable risks associated with studying BE of ribavirin products in healthy subjects. Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release solid oral dosage forms containing ribavirin are reviewed. Ribavirin is highly soluble, but its permeability characteristics are not well defined. Therefore according to the Biopharmaceutical Classification System, and taking a "worst case" approach, ribavirin should be assigned to class III. As ribavirin is transported across the brush border membrane of the human jejunum by hCNT2, it shows saturable uptake in the intestine. However, no common excipients have been shown to compete for ribavirin absorption, nor have problems with BE of immediate release ribavirin formulations containing different excipients and produced by different manufacturing methods been reported in the open literature. So the risk of bioinequivalence caused by these factors appears to be low. Ribavirin is considered a narrow therapeutic index drug, as judged by comparing the minimum effective concentration and minimum toxic concentrations in blood. Although ribavirin would not be eligible for approval via a Biopharmaceutical Classification System-based biowaiver procedure according to today's guidances due to its narrow therapeutic index, the risks of biowaiving should be weighed against the considerable risks associated with studying BE of ribavirin products in healthy subjects.Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release solid oral dosage forms containing ribavirin are reviewed. Ribavirin is highly soluble, but its permeability characteristics are not well defined. Therefore according to the Biopharmaceutical Classification System, and taking a "worst case" approach, ribavirin should be assigned to class III. As ribavirin is transported across the brush border membrane of the human jejunum by hCNT2, it shows saturable uptake in the intestine. However, no common excipients have been shown to compete for ribavirin absorption, nor have problems with BE of immediate release ribavirin formulations containing different excipients and produced by different manufacturing methods been reported in the open literature. So the risk of bioinequivalence caused by these factors appears to be low. Ribavirin is considered a narrow therapeutic index drug, as judged by comparing the minimum effective concentration and minimum toxic concentrations in blood. Although ribavirin would not be eligible for approval via a Biopharmaceutical Classification System-based biowaiver procedure according to today's guidances due to its narrow therapeutic index, the risks of biowaiving should be weighed against the considerable risks associated with studying BE of ribavirin products in healthy subjects. Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release solid oral dosage forms containing ribavirin are reviewed. Ribavirin is highly soluble, but its permeability characteristics are not well defined. Therefore according to the Biopharmaceutical Classification System, and taking a “worst case” approach, ribavirin should be assigned to class III. As ribavirin is transported across the brush border membrane of the human jejunum by hCNT2, it shows saturable uptake in the intestine. However, no common excipients have been shown to compete for ribavirin absorption, nor have problems with BE of immediate release ribavirin formulations containing different excipients and produced by different manufacturing methods been reported in the open literature. So the risk of bio in equivalence caused by these factors appears to be low. Ribavirin is considered a narrow therapeutic index drug, as judged by comparing the minimum effective concentration and minimum toxic concentrations in blood. Although ribavirin would not be eligible for approval via a Biopharmaceutical Classification System–based biowaiver procedure according to today's guidances due to its narrow therapeutic index, the risks of biowaiving should be weighed against the considerable risks associated with studying BE of ribavirin products in healthy subjects. |
| Author | Langguth, Peter Groot, D.W. Polli, James E. Shah, Vinod P. Dressman, Jennifer B. Goodarzi, Navid Cristofoletti, Rodrigo Abrahamsson, Bertil Mehta, Mehul U. Barazesh Morgani, Ahmadreza |
| AuthorAffiliation | 8 Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, Maryland 21201 2 Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran 3 Pharmaceutical Development, AstraZeneca R&D, Mölndal, Sweden 7 Food and Drug Administration, Center for Drug Evaluation, Silver Spring, Maryland 20993 9 International Pharmaceutical Federation FIP, The Hague, The Netherlands 5 RIVM – National Institute for Public Health and the Environment, Bilthoven, Utrecht, The Netherlands 4 Brazilian Health Surveillance Agency (Anvisa), Division of Therapeutic Equivalence, Brasilia, Brazil 10 Institute of Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany 6 Institute of Pharmacy, Johannes Gutenberg University, Mainz, Germany 1 Nanotechnology Research Center, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran |
| AuthorAffiliation_xml | – name: 2 Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran – name: 1 Nanotechnology Research Center, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran – name: 10 Institute of Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany – name: 6 Institute of Pharmacy, Johannes Gutenberg University, Mainz, Germany – name: 9 International Pharmaceutical Federation FIP, The Hague, The Netherlands – name: 3 Pharmaceutical Development, AstraZeneca R&D, Mölndal, Sweden – name: 4 Brazilian Health Surveillance Agency (Anvisa), Division of Therapeutic Equivalence, Brasilia, Brazil – name: 5 RIVM – National Institute for Public Health and the Environment, Bilthoven, Utrecht, The Netherlands – name: 8 Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, Maryland 21201 – name: 7 Food and Drug Administration, Center for Drug Evaluation, Silver Spring, Maryland 20993 |
| Author_xml | – sequence: 1 givenname: Navid surname: Goodarzi fullname: Goodarzi, Navid organization: Nanotechnology Research Center, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran – sequence: 2 givenname: Ahmadreza surname: Barazesh Morgani fullname: Barazesh Morgani, Ahmadreza organization: Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran – sequence: 3 givenname: Bertil surname: Abrahamsson fullname: Abrahamsson, Bertil organization: Pharmaceutical Development, AstraZeneca R&D, Mölndal, Sweden – sequence: 4 givenname: Rodrigo surname: Cristofoletti fullname: Cristofoletti, Rodrigo organization: Brazilian Health Surveillance Agency (Anvisa), Division of Therapeutic Equivalence, Brasilia, Brazil – sequence: 5 givenname: D.W. surname: Groot fullname: Groot, D.W. organization: RIVM – National Institute for Public Health and the Environment, Bilthoven, Utrecht, The Netherlands – sequence: 6 givenname: Peter surname: Langguth fullname: Langguth, Peter organization: Institute of Pharmacy, Johannes Gutenberg University, Mainz, Germany – sequence: 7 givenname: Mehul U. surname: Mehta fullname: Mehta, Mehul U. organization: Food and Drug Administration, Center for Drug Evaluation, Silver Spring, Maryland 20993 – sequence: 8 givenname: James E. surname: Polli fullname: Polli, James E. organization: Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, Maryland 21201 – sequence: 9 givenname: Vinod P. surname: Shah fullname: Shah, Vinod P. organization: International Pharmaceutical Federation FIP, The Hague, The Netherlands – sequence: 10 givenname: Jennifer B. surname: Dressman fullname: Dressman, Jennifer B. email: dressman@em.uni-frankfurt.de organization: Institute of Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany |
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| Keywords | solubility ribavirin BCS absorption biowaiver permeability |
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| Title | Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ribavirin |
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