New high purity drug delivery excipients
08 November 2005
Croda Health Care is launching a range of new high purity drug delivery excipients. Previewed at CPhI Worldwide 2005, Super Refined PEG 300, 400 & 600 NF and Super Refined Oleic Acid NF are designed specifically for pharmaceutical applications and manufactured via the company's proprietary purification technology. Both excipients are claimed to enhance active and formulation stability.
Super Refined PEG 300, 400 & 600 are highly purified polyethylene glycols, offering pharmaceutical formulators the advantages of Croda's proprietary flash chromatography process and the benefits of high purity excipients. Super Refining is a technique that removes polar impurities, such as peroxide species, aldehydes and ketones. Removal of these polar impurities eliminates their adverse interaction with active pharmaceutical ingredients (APIs), thereby enhancing the stability of the drug and/or the vehicle itself. In accelerated stability trials (50°C), Super Refined PEG 400 NF demonstrated a peroxide value at least 50% lower than a standard pharmaceutical grade both initially and after four weeks. Formaldehyde values after four weeks were at least 60% lower.
Super Refining of PEGs also minimises the potential for gelatin cross-linking. Impurities found in some standard Pharmaceutical grades of PEGs can lead to stability problems in gelatin capsules due to the impurities cross-linking with the gelatin. Super Refining removes the impurities that cause this problem.
Polyethylene glycols are widely used as excipients in a variety of pharmaceutical products, including topical, oral and parenteral preparations.
Croda's Super Refined Oleic Acid NF is a high purity lipid designed to aid drug delivery. Oleic acid can enhance transdermal drug transportation and is also employed in pulmonary and nasal delivery systems. By removing polar impurities including primary and secondary oxidation products, Super Refining of oleic acid ensures formulations have greater stability and reduced potential for cellular (skin) irritation, the company claims. In vitro testing with Super Refined Oleic Acid NF, as compared with a standard, has shown a clear reduction in intercellular leakage - an indicator of skin irritation potential. This benefit offers the formulator the option of reduced skin damage for an equivalent formulation.
Super Refined Oleic Acid NF is recommended as an absorption enhancer in topical, transdermal and oral dosages, an excipient in nasal and pulmonary metered dose inhalers (MDIs), and as a component of self emulsifying drug delivery systems (SEDDS).
