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dc.contributor.authorHofsäss, Martin A
dc.contributor.authorSouza, Jacqueline de
dc.contributor.authorSilva-Barcellos, Neila M
dc.contributor.authorBellavinha, Karime R
dc.contributor.authorAbrahamsson, Bertil
dc.contributor.authorCristofoletti, Rodrigo
dc.contributor.authorGroot, D W
dc.contributor.authorParr, Alan
dc.contributor.authorLangguth, Peter
dc.contributor.authorPolli, James E
dc.contributor.authorShah, Vinod P
dc.contributor.authorTajiri, Tomokazu
dc.contributor.authorMehta, Mehul U
dc.contributor.authorDressman, Jennifer B
dc.date.accessioned2018-01-09T13:09:04Z
dc.date.available2018-01-09T13:09:04Z
dc.date.issued2017-12
dc.identifier.citationBiowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Folic Acid. 2017, 106 (12):3421-3430 J Pharm Scien
dc.identifier.issn1520-6017
dc.identifier.pmid28842299
dc.identifier.doi10.1016/j.xphs.2017.08.007
dc.identifier.urihttp://hdl.handle.net/10029/621080
dc.description.abstractThis work presents a review of literature and experimental data relevant to the possibility of waiving pharmacokinetic bioequivalence studies in human volunteers for approval of immediate-release solid oral pharmaceutical forms containing folic acid as the single active pharmaceutical ingredient. For dosage forms containing 5 mg folic acid, the highest dose strength on the World Health Organization Essential Medicines List, the dose/solubility ratio calculated from solubility studies was higher than 250 mL, corresponding to a classification as "not highly soluble." Small, physiological doses of folic acid (≤320 μg) seem to be absorbed completely via active transport, but permeability data for higher doses of 1-5 mg are inconclusive. Following a conservative approach, folic acid is classified as a Biopharmaceutics Classification System class IV compound until more reliable data become available. Commensurate with its solubility characteristics, the results of dissolution studies indicated that none of the folic acid products evaluated showed rapid dissolution in media at pH 1.2 or 4.5. Therefore, according to the current criteria of the Biopharmaceutics Classification System, the biowaiver approval procedure cannot be recommended for immediate-release solid oral dosage forms containing folic acid.
dc.language.isoenen
dc.rightsArchived with thanks to Journal of pharmaceutical sciencesen
dc.titleBiowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Folic Acid.en
dc.typeArticleen
dc.identifier.journalJ Pharm Sci 2017, 106(12):3421-430en
html.description.abstractThis work presents a review of literature and experimental data relevant to the possibility of waiving pharmacokinetic bioequivalence studies in human volunteers for approval of immediate-release solid oral pharmaceutical forms containing folic acid as the single active pharmaceutical ingredient. For dosage forms containing 5 mg folic acid, the highest dose strength on the World Health Organization Essential Medicines List, the dose/solubility ratio calculated from solubility studies was higher than 250 mL, corresponding to a classification as "not highly soluble." Small, physiological doses of folic acid (≤320 μg) seem to be absorbed completely via active transport, but permeability data for higher doses of 1-5 mg are inconclusive. Following a conservative approach, folic acid is classified as a Biopharmaceutics Classification System class IV compound until more reliable data become available. Commensurate with its solubility characteristics, the results of dissolution studies indicated that none of the folic acid products evaluated showed rapid dissolution in media at pH 1.2 or 4.5. Therefore, according to the current criteria of the Biopharmaceutics Classification System, the biowaiver approval procedure cannot be recommended for immediate-release solid oral dosage forms containing folic acid.


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