Biowaiver monographs for immediate release solid oral dosage forms: prednisone.
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 prednisone are reviewed. Due to insufficient data prednisone cannot be definitively classified according to the current Biopharmaceutics Classification System (BCS) criteria as both the solubility and the permeability of prednisone are on the borderline of the present criteria of BCS Class I. Prednisone'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; D005079:Excipients / Q000008:administration & dosage; D006801:Humans; D010539:Permeability; D011241:Prednisone / Q000008:administration & dosage / Q000737:chemistry / Q000493:pharmacokinetics*; D012995:Solubility; D013810:Therapeutic Equivalency
D005079:Excipients; D011241:Prednisone