Excipients that meet specific biocompatibility, safety and pharmacopoeia requirements for parenteral use. Excipients must be used according to appropriate local regulations and applicable pharmacopoeia.
Labrafac Lipophile WL1349 and Transcutol have been used in both human and veterinary parenteral medicines.
Transcutol (high purity DEGEE) is a powerful solvent and solubiliser with efficacy across a broad spectrum of API physic-chemical properties. Three grades are available: V, P and HP. All grades conform to EP pharmacopeia specifications for parenteral drug administration routes.
Transcutol is available in different grades of purity. Transcutol V is for veterinary medicines. Transcutol P and HP are grades for human medicines. Transcutol HP is the highest purity grade (99.9%) is therefore the preferred grade for human parenteral medicines.
Labrafac Lipophile WL1349 is a medium chain triglyceride (caprylic/capric triglycerides) which conforms to European and United States-National Formulary Pharmacopoeia requirements for parenteral use. Its safety is supported by toxicological studies confirming its non-irritant and non-corrosive properties and by a long history of use as a vehicle in parenteral nutrition.
It has been used in oral and topical human pharmaceutical products and in veterinary injectables as an oily vehicle and it can be used in parenteral products as a carrier and in emulsions and suspensions.