Natural Phospholipids

Phospholipids obtained from natural sources have been successfully used in pharmaceutical formulations for decades. Natural phospholipids are purified from renewable sources, e.g., egg yolk, soybeans, or sunflower, using ecologically friendly, non-toxic extraction procedures.Hydrogenation and gentle processes result in modified natural phospholipids with specific functional properties. By strict sourcing of raw materials and the use of sophisticated purification procedures an excellent batch-to-batch consistency is ensured with respect to phospholipid and fatty acid composition.

Lecithin is a complex mixture of phospholipids and other naturally occurring lipid components like triglycerides, fatty acids, sterols, and glycolipids. The most prominent phospholipid in lecithin is phosphatidylcholine (PC). However, other components such as phosphatidylethanolamine (PE) or phosphatidylinositol (PI) may also play an important role in the functionality of lecithin. Purification of these components from crude lecithin affords well defined, high-grade pharmaceutical excipients.

Phospholipids are endogenous, fully biodegradable, and highly biocompatible compounds. The WHO places no Acceptable Daily Intake (ADI) limit for oral use of lecithin and US FDA assigns the GRAS (Generally Recognized as Safe) status for oral use of lecithin. Given parenterally, phospholipids show no toxic effects. For decades they have been used in large quantities in parenteral applications, thus confirming their excellent toxicity profile.

Natural phospholipids are applied as excipients in oral, parenteral, inhalation, and topical dosage forms, e.g. as wetting agents, solubilizers, emulsifiers, liposome builders, and as technical aids.

Lecithin, soy and egg phospholipids are described in pharmacopeias and relevant guidance documentations of regulatory authorities. Furthermore, Lipoid maintains numerous Drug Master Files (DMF) for its products.