Pharmacokinetic Properties of Acetyl Tributyl Citrate, a Pharmaceutical Excipient

Acetyl tributyl citrate (ATBC) is an (the Food and Drug Administration) FDA-approved substance for use as a pharmaceutical excipient. It is used in pharmaceutical coating of solid oral dosage forms such as coated tablets or capsules. However, the information of ATBC on its pharmacokinetics is limited. The aim of this study is to investigate the pharmacokinetic properties of ATBC using liquid chromatography–tandem mass spectrometric (LC–MS/MS) analysis. ATBC was rapidly absorbed and eliminated and the bioavailability was 27.4% in rats. The results of metabolic stability tests revealed that metabolic clearance may have accounted for a considerable portion of the total clearance of ATBC. These pharmacokinetic data would be useful in studies investigating the safety and toxicity of ATBC.

Plasticizers are chemicals which are added into polymeric materials to increase their flexibility and workability. They are also used in polymers for pharmaceutical applications such as drug carriers and coatings. In the chemical industry, many kinds of plasticizers are utilized. However, for pharmaceutical application, the use of only several kinds of plasticizers has been approved as it requires low toxicity and migration. Pharmaceutically used plasticizers can be categorized into hydrophobic and hydrophilic groups. The hydrophobic plasticizers include acetyl tributyl citrate (ATBC), acetyl triethyl citrate, castor oil, diacetylated monoglycerides, dibutyl sebacate, diethyl phthalate, triacetin, tributyl citrate, and triethyl citrate. The hydrophilic plasticizers include clycerin, polyethylene glycols, polyethylene glycols monomethyl ether, propylene glycol, and sorbitol sorbitan solution…

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Article from Pharmaceutics. 2018 Dec; 10(4): 177

Hyeon Kim, Min Sun Choi, Young Seok Ji, In Sook Kim, Gi Beom Kim, In Yong Bae, Myung Chan Gye, Hye Hyun Yoo, Pharmacokinetic Properties of Acetyl Tributyl Citrate, a Pharmaceutical Excipient, 2018 Dec; 10(4): 177, Published online 2018 Oct 8. doi: 10.3390/pharmaceutics10040177