SR Pharma plc has announced that it has made an advanced technical process in the formulation of siRNA drugs, that enables its proprietary lyophilized (freeze dried) liposomally formulated siRNA (AtuRNAi) drugs to be stored at room temperature and reconstituted in one simple step, thus providing significant benefits, notably extended shelf life and ease of administration.
To date, the AtuRNAi and liposomal components of AtuRNAi drugs have needed to be separately lyophilized (freeze-dried), reconstituted and then combined, in a multi-step process.
The SR Pharma process is designed to enable siRNA drugs pre-formulated as liposomal nanoparticles to be freeze-dried and then simply reconstituted with water immediately prior to patient administration with no additional preparation steps such as sonication being required.
"This is a significant breakthrough in the manufacture of siRNA drugs. A dry powder formulation extends the shelf-life and simplifies the distribution chain, with the one-step reconstitution process enhancing ease of administration," said Dr Klaus Giese, CSO of SR Pharma.
"We will be applying this technology to the manufacture of our products as we take our siRNA drugs forward towards the clinic."
Details of the process were presented at recent scientific conferences (TIDES in Carlsbad, CA, May 1-4 2006 and RNAi in Boston, MA, April 3-5 2006).
The presentations showed how this stable and lyophylised dry powder drug formulation only required the addition of water to rehydrate the drug and prepare it for injection.
Iain Ross, Executive Chairman of SR Pharma, stated, "This new breakthrough in the manufacturing process of liposomal-based formulations of siRNA based products underlines the leadership position of SR Pharma in the emerging sector of RNA interference and drug delivery."