Hay fever sufferers, put that tissue away – there is help at hand!

Summer has got off to a flying start in the British Isles, with some fabulously sunny weather enjoyed throughout June. July has brought with it some pretty heavy showers, but we Brits known that’s only to be expected with the tennis underway at Wimbledon! The good news for most of us is that forecasts are looking promising again as we head deeper into July, so hopefully we can continue to relax in the sun, enjoying barbeques and  long evening strolls.

However, for some of us the summer  brings along a runny nose, sneezing and very itchy eyes.  With the bright sun I tend to sneeze quite suddenly (and rather loudly) several times a day, as all those around me in the Malvern office will confirm! I am one of the lucky ones really, as for me it is just a reaction to the bright light, but it is a completely different story for the one in five people in the UK who suffer from hay fever.

Generic Nasal Spray De-formulationHay fever is caused by an allergic reaction to pollens, which originate from anything from grass, trees or even weeds. Different trees and plants produce their pollen at different times of the year. The most common culprit around this time of the year is grass (which is everywhere) and weeds.

With so many people affected by hay fever, there is a high demand for effective and fast acting medication. Nasal sprays meet both these criteria and are high on the list of essentials for most of the hay fever suffers amongst us.  So, it is unsurprising that so many generic drug companies are working on them. The development of a generic nasal spray requires replicating the exact pharmacological  performance of the innovator nasal spray. Generic manufacturers need to demonstrate bioequivalence between their product and the innovator in much the same way as we described for dry powder inhalation formulations for asthma.

Our recent article Scoping the design space for generic nasal spray’ published in “Pulmonary & Nasal Delivery” discusses the regulatory frames work and describes the must have nasal spray de-formulation toolkit. This kit comprises of various technologies offered by Malvern:

  • the Spraytec for real time measurement of droplet size of the formulation by laser diffraction as recommended by FDA guidance*
  • the Morphologi G3 for automated particle size analysis of the API pre and post-actuation required by FDA BE guidance* which suggests using manual microscopy
  • the Morphologi G3-ID for Morphemically Directed Raman Spectroscopy (MDRS)  for chemically identifying API particles when differentiation in terms of particle shape alone is insufficient.

So for those of you who are suffering at the moment, there is help at hand in form of a nasal spray. For those who are struggling to de-formulate a complex innovator nasal spray, there is also help at hand from Malvern Instruments.

*Guidance for Industry, “Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action” Draft guidance, April 2003

Further Resources:

Watch the following webinar to learn more about the use of Morphologi G3 and Spraytec together for development of a nasal spray formulation: “Laser diffraction and imaging – complementary techniques for nasal spray development”

Download this article for understanding the benefits of component specific particle characterization in nasal spray formulation development: “Characterizing a nasal spray formulation from droplet to API particle”

More Posts in the De-formulation Series:

Viva la “sameness” – generic drugs and ensuring equivalence

“To BE or not to BE” – Bio-equivalence strategies for topical formulations

A time for control: generic dry powder inhaler development