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DEVELOPMENT OF SUSTAINED RELEASE ANTIPSYCHOTIC HITS FIRST MILESTONE

Development of Sustained Release Antipsychotic Hits First Milestone 05/12/2007 03:35

Development of Sustained Release Antipsychotic Hits First Milestone

Critical Pharmaceuticals today announced that it has reached the first milestone in the development of a sustained release formulation of the first small molecular weight drug to be formulated using its CriticalMix™ technology – risperidone. Up until this point the company has focussed on formulating the products of the biotechnology industry – proteins and peptides – because unlike competing technologies the low temperature, solvent free nature of CriticalMix™ means that they can be formulated without degrading the drug. However after extensive market research Critical Pharmaceuticals found that CriticalMix™ could also offer benefits over competing technologies when applied to small molecular weight drugs.

Andy Lewis, Head of Formulation Development explains, “Our competitors can make sustained release formulations of small molecular weight drugs, but they need to use a lot of solvents to do it. We realised that using solvents when making medicines to be given to patients creates a lot of problems for the manufacturers. Firstly, many of these solvents are very toxic, and without costly extraction procedures, residues can be left in the products. Proving to the regulators that these extraction procedures are effective is also costly and time consuming, so when you want to get your product to market as quickly as possible you would rather not have to do it. Secondly, disposing of large amounts of these solvents is also very expensive and carries with it environmental concerns. By using our CriticalMix™ technology we can formulate drugs in a dry state without using any solvents at all.”

To prove it Critical Pharmaceuticals have begun development of a sustained release formulation of risperidone, an anti-psychotic use to treat schizophrenia. Development has progressed rapidly and the first milestone has been reached – the lead formulations have now been identified and will be taken forward into preclinical testing.

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Syringe

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Dr Andy Lewis, Critical Pharmaceuticals
“Our competitors can make sustained release formulations of small molecular weight drugs, but they need to use a lot of solvents to do it. We realised that using solvents when making medicines to be given to patients creates a lot of problems for the manufacturers. Firstly, many of these solvents are very toxic, and without costly extraction procedures, residues can be left in the products. Proving to the regulators that these extraction procedures are effective is also costly and time consuming, so when you want to get your product to market as quickly as possible you would rather not have to do it. Secondly, disposing of large amounts of these solvents is also very expensive and carries with it environmental concerns. By using our CriticalMix™ technology we can formulate drugs in a dry state without using any solvents at all.”