The technology, which recently received European patent protection, attaches highly-soluble polymers to insoluble solid dose formulations in a highly-controlled manner, significantly improving the solubility of the drug in question. Polytherics CEO Keith Powell told in-PharmaTechnologist.com that poor drug solubility and aggregation are a major problem for the pharmaceutical industry meaning the firm's approach has many potential applications. Powell added that the technology is designed to "prolong the circulation and decrease toxicity of insoluble molecules." He explained that the complexing polymer "prevents aggregation and allows water to readily associate with the molecule - giving better dispersion." Since launching its TheraPEG technology, which improves the stability of protein-based drugs via the pegylation of disulphide bonds, PolyTherics has developed patent-protected proprietary technologies and expertise in the modification of drugs to improve their performance. "This is our second technology breakthrough, with TheraPE' for proteins and this new technology for small molecules, we believe Polytherics can help new drugs reach the clinic with a greater chance of success," said Powell. He added that the company is beginning to scale up its manufacturing operations, and will seek to produce batches up to 5kg. Powell went on to say that the firm would be seeking other royalty or developmental milestone-based licensing opportunities. Other solubilisation methods At present, methods like pegylation or liposomal-encapsulation are used to improve the solubility of otherwise insoluble drugs. While such approaches can be highly effective at improving solubility, they are costly to apply, require specialist handling and cannot be used with all solid dosage pharmaceuticals. Additionally, the reticulo-endothelial system (RES), which screens the bloodstream for foreign bodies, has been shown to preferentially target liposomal material for phargocytotic degradation. While so-called stealth-liposomes, which are studded with inert polyethylene glycol (PEG) spikes, are able to escape RES detection, current research suggests that the PEG molecules themselves may impede the binding of the liposome to drug delivery surfaces, potentially reducing therapeutic efficacy. Modified amphotericin B for leishmaniasis Polytherics' technology has already been employed by the Drugs for Neglected Diseases Initiative (DNDi), which licensed rights to a more soluble form of the fungicide amphotericin B for the treatment of leishmaniasis. Leishmaniasis, which is thought to affect around 350 million people in 88 countries worldwide, is caused by a protozoan parasite that is transmitted by the bite of the female sand-fly. The disease results in erupting skin lesions and, if left untreated, can cause significant damage to the liver and spleen. The improved solubility and circulatory half-life of the new amphotericin formulation is designed to extend its period of therapeutic efficacy and allow the drug to combat any residual infection that may not have been addressed during initial treatment. PolyTherics has retained exclusive rights to develop the drug for anti-fungal indications and intends to pursue this opportunity independently. An unmodified liposomal formulation of amphotericin B, Gilead Sciences' AmbiSome, has been approved for treating leishmaniasis and other severe infections since 1996. The product made sales of $260m in 2007.