The multiple benefits of a nasal spray has triggered a boom in product development activity generating greater demand for Melbourn Scientific’s expertise in formulation analysis and performance testing. In response the company has created a dedicated laboratory to provide GMP testing of nasal device performance, the first in Europe to offer such a comprehensive service.
Mark Hammond, CEO of Melbourn Scientific says:
“We predicted a few years ago that nasal delivery of compounds would increase as companies realised the benefits of this route. A nasal device offers a user friendly, painless, non-invasive route for drug administration.
“We are now seeing evidence of continued growth and that clients recognise the advantages of working with partners that have expertise in this area of drug delivery and understand the formulation and analytical challenges that it brings.
The portfolio of nasal spray services offered by Melbourn includes: nasal device performance testing, droplet size and distribution analysis, spray pattern and plume geometry analysis. The new laboratory was included within a recent FDA inspection, which the company passed with ‘no significant deficiencies noted and no 483s issued’.
“The high surface area in the nasal cavity provides drugs with direct access to the systemic circulation providing rapid onset of action. This route also avoids any degradation from first pass metabolism, which means lower doses can be given reducing the possibility of unwanted side effects.”
The nasal cavity has a large surface area and high permeability, and the location of lymphoid tissue at the back of the nasal cavity offers rapid transport into the systemic circulation. The olfactory region at the top of the nasal cavity is of interest for the treatment for age-associated diseases such as Alzheimer’s, as it allows rapid absorption into the central nervous system.
The nasal route can also enhance performance for a wide range of treatments from the instant relief of panic attacks through to needle-free vaccinations.
However, the challenge of a nasal delivery device is to get the particle size right in order to ensure that the drug is deposited within the nasal passages and not the lungs or gastro-intestinal tract. This is where a comprehensive testing regime is beneficial.
Mark explains, “Depending upon the drug and device properties there are a number of considerations for the formulation, here at Melbourn Scientific we have developed a range of screening tools to enable us to fast track formulation development of the product from simple solutions, through suspensions to dry powder blends using a wide range of excipients.
“Our formulation development is supported by standalone testing services with significant investment in specialist equipment. The new lab will make this available as a comprehensive service. “
Equipment includes: the Malvern Spraytec, which is designed to capture information about both pulsed spray and continuous spray events, Morphologi G3 an optical imaging tool that provides more information about individual particles giving data about their size, shape and solidity and the new Proveris’s SprayVIEW, a FDA accepted spray pattern and plume geometry analysis service.
Melbourn Scientific has also appointed a new business development executive Liz Parkhouse to provide a point of contact for the nasal spray testing service. She will be at ICSE to talk to visitors.
See us on ICSE stand no. 8J24, 9-11th October 2012, Madrid. www.icsexpo.com.
Written by Rachel Holdsworth