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EC number: 617-116-8
CAS number: 80573-04-2
Single dose of Balsalazide to rat
Dose of Balsalazide (mmol/kg)
ID = Insufficient data to derive parameter
NA = not applicable
Single dose of Balsalazide to rat (the oral equivalent is also shown
for additional information and comparison)
Excretion data for Balsalazide and its metabolites
% recovered in urine
%recovered in faeces
Balsalazide (BSZ) plasma PK parameters after administration of drug
(1.5 g BSZ)
(1.5 g BSZ bid)
(2.25 g BSZ tid )
** Day 13 – only one
dose was administered early in the morning. The bid refers to the double
dose received from days 4-12
*** Day 10- only one
dose was administered early in the morning. The tid refers to the triple
dose received on day 18.
Balsalazide(BSZ) excretion in urine and faeces
%BSZ recovered in faeces
%BSZ recovered in urine
Renal clearance (L/hr)*
Day 1 (1.5 g BSZ)
Day 13 (1.5 g BSZ bid)
Day 19 (2.25 g BSZ tid)
*Renal clearance was determined over the 0 -4 hr collection interval
BSZ and metabolite recovery in urine and faeces*
Balsalazide acid absorption is predicted to occur to a small extent via
the oral route.
Balsalazide acid is predicted to have low (but not necessarily
negligible) absorption via the inhalation route.
Balsalazide acid is predicted to have very low absorption via the dermal
There is minimal available information relating to distribution.
Four main metabolites have been identified in human clinical trials and
in the rat TK study and these are expected to be the same for
1) 5-aminosalicylic acid (ASA, derived from Azo-reductase of the
Balsalazide acid (sodium salt)
2) N- acetyl-5-amino-salicylic acid (NASA, derived by N-acetylation of
3) 4-aminobenzoyl-5-alanine (ABA, derived from Azo-reductase of the
Balsalazide acid (sodium salt)
4) N-acetyl-4-aminobenzoyl-5-alanine (NABA, derived by N-acetylation of
Balsalazide acid is predicted to be predominantly excreted via faeces in
the form of its metabolites ABA and ASA and their N-acetylated
metabolites (NABA and NASA). Very limited amounts of Balsalazide acid is
predicted to be excreted via urine.
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