Biowaiver Monographs for Immediate Release Solid OralDosage Forms: Prednisolone

Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing prednisolone are reviewed. Data on its solubility, oral absorption, and permeability are not totally conclusive, but strongl...

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Bibliographic Details
Published in:Journal of pharmaceutical sciences 2007-01, Vol.96 (1), p.27-37
Main Authors: Vogt, M., Derendorf, H., Krämer, J., Junginger, H.E., Midha, K.K., Shah, V.P., Stavchansky, S., Dressman, J.B., Barends, D.M.
Format: Article
Language:English
Subjects:
absorption
bioequivalence
Biopharmaceutics Classification System (BCS)
permeability
prednisolone
regulatory science
solubility
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Summary:Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing prednisolone are reviewed. Data on its solubility, oral absorption, and permeability are not totally conclusive, but strongly suggest a BCS Class 1 classification. Prednisolone's therapeutic indications and therapeutic index, pharmacokinetics, and the possibility of excipient interactions were also taken into consideration. Available evidence indicates that a biowaiver for IR solid oral dosage forms formulated with the excipients tabulated in this article would be unlikely to expose patients to undue risks.
ISSN:0022-3549
1520-6017
DOI:10.1002/jps.20768