London, UK-based SR Pharma, a developer of RNAi therapeutics, says that it has made a technical breakthrough 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, most notably extended shelf life and ease of administration.
To date, the AtuRNAi and liposomal components of AtuRNAi drugs have needed to be separately lyophilized, reconstituted and then combined, in a multi-step process. The new SR Pharma process enables 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, the firm says.
"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. We will be applying this technology to the manufacture of our products as we take our siRNA drugs forward towards the clinic," said Klaus Giese, chief scientific officer of SR Pharma.
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