Evaluation of the Efficacy of Injection Lipolysis using Phosphatidylcholine/Deoxycholate Versus Deoxycholate Alone in Treatment of Localized Fat Deposits

Abstract

The practice of injection lipolysis, using drugs generally based on phosphatidylcholine and deoxycholate (PCDC), evolved from the initial intravenous use of those drug formulations to treat blood disorders. Formulations containing phosphatidylcholine and bile salts (phosphatidylcholine bile salt formulations, PBF) are increasingly being utilized to treat localized fat accumulation. Several open label clinical studies have reported promising results using injections of PBFs for the treatment of localized fat accumulation, including lower eyelid fat herniation and “buffalo hump” lipodystrophy. Bile salts have been used to improve the aqueous solubility of phosphatidylcholine. Highly purified phosphatidylcholine can be combined with the secondary bile salt sodium deoxycholate, an anti-microbial, benzyl alcohol, and water to form a stable, mixed micelle preparation that can be rapidly sterilized and used for intravenous administration . Pharmaceutical preparations of this mixture are marketed in other countries for treatment of liver disease and hyperlipidemia, respectively. Deoxycholate is used to solubilize phosphatidylcholine by forming mixed micelles composed of phosphatidylcholine and deoxycholate. It is common practice to combine intravenous medications with bile salts to improve their water solubility. These findings suggest that sodium deoxycholate is the primary active ingredient in the phosphatidylcholine preparations. These findings have been translated clinically. The effects of deoxycholate and the phosphatidylcholine formulation with deoxycholate are nonspecific, such that injection into tissue besides fat may cause necrosis.