Extraction of stearate salts from plastic materials used in pharmaceutical applications.

Plastic materials are widely used in medical items such as solution containers, infusion sets, transfer tubing, devices, processing equipment and systems, filters, and the like. Components in medical items can leach out of such items when they are contacted by a therapeutic product or product-related solution. Stearic acid and stearate salts are commonly present in medical and food packaging, either as plastic additives, processing aids, or contaminants, and their leaching from plastics is well documented. With a pK(a) in the range of 5.1 to 5.6 and limited aqueous solubility (log P(o/w) greater than 8), the leaching of stearic acid (and its related metal salts) into pharmaceutical products is expected to be strongly dependent on the product's pH and polarity. In order to establish and understand the leaching behavior of stearate-containing materials, three compounds (stearic acid, calcium stearate, and zinc stearate) and four polymeric materials containing these compounds were contacted with aqueous buffers in the pH range of 2.5 to 11. The leached levels of calcium, zinc, stearate, palmitate, and total organic carbon (TOC) were measured in the resulting solutions and are reported. For materials containing only stearic acid or salts themselves, the extraction of these entities is pH-dependent. At low pH, the cation counter-ions of the stearate salts are extracted from the plastic materials by a process that can loosely be termed ion exchange. At intermediate pH, little or no extraction of the stearates occurs. At high pH, the stearates are extracted from the materials to a very limited extent due to the solubility of the acid and/or salts in the extraction medium.