Imprint’s DepotOne needle achieves CE Mark
Imprint Pharmaceuticals (www.imprintpharma.com) is pleased to announce that its DepotOne needle technology has received its CE Mark and is now cleared for use in Europe. This CE Approval means that the DepotOne needle can be incorporated into clinical studies and existing products with minimal additional regulatory work.
DepotOne is a ‘small’ needle which can replace large needles. It has the penetration characteristics of a small needle with the flow of a large needle. The needle delivers highly viscous materials and will eliminate the need to resort to an unacceptably large needle for subcutaneous or intramuscular injections.
DepotOne is revolutionary as it enables higher doses to be injected. A higher deliverable dose means that new therapeutic products can be developed which have substantially improved product characteristics. The technology is particularly applicable for slow release or depot injectables including pegylated compounds, polymers and highly concentrated protein formulations.
Marketers are fully aware of the significant problems posed by the use of larger needles to the reputation and marketability of an injectable therapeutic product. Thus companies are planning to use DepotOne to reduce the impact of the large needle issue so the positive aspects of their product can be highlighted.
The technology is now being used in a number of clinical trials for high value long acting injectable therapeutics. Kevin Maynard, Business Development Director of Imprint Pharmaceuticals said “DepotOne creates a sea change in the presentation of injectable therapeutics. No longer do patients need to be faced with unacceptably large needles. I believe DepotOne will play a vital role in lowering the resistance to uptake of many of the new biological therapies coming through pharmaceutical companies’ product development lines.”
Imprint Pharmaceuticals Ltd is a centre of expertise in complex injectables. The company supplies tools to enhance the delivery and manufacture of these problematic formulations. Imprint has a range of patented injection devices which enhance the delivery of formulations containing particulates, viscous materials, gels and polymers. In addition, Imprint provides consultancy and patented technologies to enable rapid formulation and scale up of manufacture. Our expertise and patented technologies extend the range of complex injectable products enabling our clients to gain a commercial edge.
Dr Kevin Maynard | alfa
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