Biowaiver monographs for immediate release solid oral dosage 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 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.
Vogt
M
M
Department of Pharmaceutical Technology, Johann Wolfgang Goethe University, Frankfurt am Main, Germany.
Derendorf
H
H
Krämer
J
J
Junginger
H E
HE
Midha
K K
KK
Shah
V P
VP
Stavchansky
S
S
Dressman
J B
JB
Barends
D M
DM
D000284:Administration, Oral; D000818:Animals; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry / Q000493:pharmacokinetics*; D001682:Biological Availability; D001702:Biopharmaceutics; D002626:Chemistry, Pharmaceutical; D002986:Clinical Trials as Topic; D004304:Dosage Forms; D017277:Drug Approval; D005079:Excipients / Q000737:chemistry; D006801:Humans; D007408:Intestinal Absorption; D010539:Permeability; D011239:Prednisolone / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry / Q000493:pharmacokinetics*; D018570:Risk Assessment; D012995:Solubility; D013810:Therapeutic Equivalency
D000893:Anti-Inflammatory Agents; D004304:Dosage Forms; D005079:Excipients; D011239:Prednisolone