NEWS
Melbourn closes missing link to speed formulation development
Melbourn Scientific, a leading provider of analytical and formulation support for the pharma and biotech industries, is increasing its capabilities in formulation and short-run clinical manufacture and supply. By expanding its capacity in these areas of product development it will help its clients speed up overall project timelines.
Business Development Director Mark Hammond explains: "As part of our product development support for clients we have always provided recommendations for improving the formulation of the drug presentation.
"This may include substitution of more cost effective components or a change of excipient to improve stability or solubility. We can then rapidly test the impact of these modifications on the physical performance of the drug."
Following continuing growth at Melbourn scientific, and increasing demand for its product development support, the company has recently invested in a bespoke suite of clean rooms. This allows enhanced flexibility for supporting multiple development and clinical manufacturing programmes.
Mark continues: "Part of our investment is in equipment such as the Diosna P1/6 High Shear Mixer Granulator for blending powders and granules for small-scale production of reformulated drugs under GMP. This will enable us to produce the small amounts of product needed for physical and chemical performance testing and shorten the time in this phase of drug development."
As well as extensive experience of solid and semi-solid dosage forms, Melbourn's laboratory has a particular expertise in the design and optimisation of inhaled and nasal drug formulations for metered-dose inhalers, dry powder inhalers, nasal sprays and nebulisers.
Mark Hammond continues: Formulation is also about how to ensure a drug reaches the target area effectively. Particle size is crucial to the performance of an inhaled device as it determines were the drug is deposited, however, changing the proportions of excipients can also impact the particle properties."
"There is a growing acceptance of the need for quality by design in the industry," comments Mark. "Integrating formulation more closely with analytical investigations will enable manufacturing intelligence to be collected at all stages of the development process."