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    Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Folic Acid.

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    Authors
    Hofsäss, Martin A
    Souza, Jacqueline de
    Silva-Barcellos, Neila M
    Bellavinha, Karime R
    Abrahamsson, Bertil
    Cristofoletti, Rodrigo
    Groot, D W
    Parr, Alan
    Langguth, Peter
    Polli, James E
    Shah, Vinod P
    Tajiri, Tomokazu
    Mehta, Mehul U
    Dressman, Jennifer B
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    Type
    Article
    Language
    en
    
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    Title
    Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Folic Acid.
    Published in
    J Pharm Sci 2017, 106(12):3421-430
    Publiekssamenvatting
    This 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.
    DOI
    10.1016/j.xphs.2017.08.007
    PMID
    28842299
    URI
    http://hdl.handle.net/10029/621080
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.xphs.2017.08.007
    Scopus Count
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    Miscellaneous

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