Tacrolimus is highly lipophilic and is insoluble in water but soluble in alcohol.
Formula 2
Tacrolimus Suspension 0.5mg per mL |
| |
| Tacrolimus 5mg capsules |
6 |
|
| Ora-Plus |
30 |
mL |
| Simple Syrup NF |
30 |
mL |
| |
| Expiry: 30
days. |
| |
Stability:
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. |
| |
|
Shake well before use |
| |
|
|
|
NOTES
- 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
REFERENCES
- 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.
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