Intravenous injections polysorbates

Chloramphenicol 1 %, polysorbate 80 6 %, in water for injection has been suggested as an ophthalmic solution [95]. Other formulae have been given and some of these are collected in Table 6.10. A solution of the antibiotic has been prepared in 50% iV,iV-dimethylacetamide as an intravenous injection. N,N-dimethylacetamide is a hydrotropic substance, a group of compounds whose actions are discussed in Section 6.7. Different crystal forms of chloramphenicol palmitate are soluble to differing extents in solutions of polysorbate 60. A detailed study of the solubilization of chloramphenicol in cetomacrogol solutions has been reported by Rogers [98] Regdon-Kiss and Kedvessy [99] have studied the... 

Formulation Aranesp is formulated as a sterile, colorless, preservative-free protein solution for intravenous (IV) or subcutaneous (SC) administration. There are two formulations the polysorbate solution includes excipients such as polysorbate 80, sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous, and sodium chloride in water-for-injection while the albumin solution contains albumin, sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous, and sodium chloride in water-for-injection. The pH for both formulations is 6.2 + 0.2. 

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. 

Polysorbate 80 is a surfactant commonly used in protein parenteral formulations to minimize denaturation at the air-water interface. Polysorbate 80 is also sometimes used in injectable solution formulations of small molecules for the purpose of solubility enhancement owing to micelle formation. Docetaxel, a first-line therapeutic to treat breast and small cell lung cancer, is practically insoluble in water and is solubilized in Taxotere to 40mg/ml in 100% polysorbate 80, and is diluted four-fold with the supplied diluent of 13% ethanol in water, then further diluted to 0.3-0.74mg/ml with saline or dextrose 5% prior to administration by rV infusion. The dose of Taxotere is up to 5 ml of polysorbate 80 per dose, representing the estimated maximum amount administered intravenously. 

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... 

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