Intramuscular injections polysorbates

Therapeutic formulations contain a recombinant form of IFN-a (either interferon alfa-2a or interferon alfa-2b). These are available as powders for reconstitution or as prefilled injection pens. The drug is administered by subcutaneous injection (or intravenous for reconstituted powder formulations) and intramuscular injection. The dosage is usually stated as units per millilitre (refer to BNF for various preparations and dosages). Powder formulations of interferon alfa-2b also contain glycine, sodium phosphate (mono- and dibasic) and human albumin prefilled pens contain sodium chloride, edetate disodium, polysorbate 80 and m-cresol as a preservative. 

Phylloquinone (aquamephyton, konakion, mephyton) is available as tablets and in a dispersion with buffered polysorbate and propylene glycol (konakion) or polyoxyethylated fatty acid derivatives and dextrose (aquamephyton). konakion is administered only intramuscularly. AQUAMEPHYTON should be given by subcutaneous or intramuscular injection because severe reactions resembling anaphylaxis have followed its intravenous administration. 

Regulatory FDA 21CFR 73.1, 73.1001, 172.515, 172.840, 172.842, 173.340,175.105,175.300,176.180,178.3400, 573.860 USDA 9CFR 318.7,381.147 (limitation 1% alone, 1% total combined with polysorbate 60) FEMA GRAS Europe listed UK approved FDA approved for buccals, intramuscular injectables, intravenous, parenterals, ophthalmics, orals, otics, rectals, topicals, vaginals NF, BP, EP compliance... 

A 50/il of 5.0% polysorbate 80 containing 50 mM isonicotinamide was injected intramuscularly. Vertical bars indicate standard deviation. 

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