Tacrolimus is highly
lipophilic and is insoluble in water but soluble in alcohol.
New Zealand standardised formulas for a 1 mg per mL suspension are available.
Note that brand switch is in progress May 2014 - October 2014. Confirm which
brand your patient should receive. Only prepare an oral suspension on the
recommendation of the transplant clinician. Oral suspension is not bioequivalent
to using oral capsules.
Sandoz brand Formula
and Batch Sheet
and Batch Sheet
Further information is available
on the Pharmac website - about
the tacrolimus brand change
These formulas use Ora-Plus and syrup in equal parts and have been approved
by the Compounding Pharmacists' Working Group of New Zealand..
As above; alternatives include a 0.5 mg per mL suspension, details are given
Tacrolimus Suspension 0.5mg per mL
5 mg capsules
Syrup 50:50 mixture
| Expiry: 30
Chemically stable for 56 days at room temperature
(24 - 26°C).
| Storage: In
this study the solutions were stored in 2 oz, amber
glass or plastic prescription bottles.
well before use
- During preparation
wear latex gloves to protect hands. Premix the Ora-Plus and
syrup thoroughly and then add to the mortar in portions.
- Ora Plus contains:
microcrystalline cellulose, sodium carboxymethylcellulose, xanthan gum,
citric acid, sodium phosphate, simethicone, methyl paraben and potassium
sorbate; pH = 4.2.
If Ora-Plus is not available use a base of syrup and methylcellulose,
parabens 0.1% and buffer or adjust the pH (use citric acid) to
pH 4 - 5. An expiry date of 30 days suggested.
- McGhee et al3
showed that tacrolimus was adequately absorbed from this preparation
although actual bioavailability was not determined.
- Tacrolimus adsorbs
to PVC, but does not significantly adsorb to glass or plastic bottles
made from polypropylene resin.1,2
- Taormina D., Abdullah
H.Y., Venkataramanan R. et al. Stability and sorption
of FK 506 in 5% dextrose injection and 0.9% sodium chloride
injection in glass, polyvinyl chloride, and polyolefin containers.Am
J Hosp Pharm 1992; 49: 119-123.
- Jacobson P.A.,
Johnson C.E., West N.J., Foster J.A. Stability of tacrolimus
in an extemporaneously compounded oral liquid. Am J Health
Syst Pharm 1997; 54: 178-180.
- McGhee B, McCombs
J.R., Boyle G, Webber S.A., Reyes J.R. Therapeutic use of
an extemporaneously prepared oral suspension of tacrolimus in pediatric
patients. Transplantation 1997; 64: 941-42.