Bridging the clinical claims of two nasal oil products using a physical chemical characterization

Sammanfattning: Bioglan AB is manufacturing a nasal water-in-oil microemulsion that is used to prevent allergic reactions in the nose. However some users have reported that the product feels irritating in the nose and throat. Another problem with the product is that it is not temperature stable, forming crystals at low temperature. Sometimes spontaneous crystallization occurs. Therefore a new product has been developed. The aim of the new product is to correct the problems with the old product as well as adding another effect. It should moisturize a dry nasal mucosa. The main goal of the diploma work is making a physical-chemical characterization of the two products and from the results be able to state that the two products are similar enough that no new clinical trials have to be performed. The characterization was made with a variety of techniques. Differential scanning calorimetry was performed to evaluate the temperature stability; Surface tension and spreadability was measured to judge the spreading on the nasal mucosa. NMR spectroscopy was performed to elucidate the microstructure of the products. Mucoadhesion was measured with a tensile strength experiment. The rheological behavior was measured and the phase behavior was briefly studied. The products were tested and evaluated by 20 volunteers per product to give more understanding of how the products are received and how well the physical chemical properties translated to real use. The results indicate the products are similar enough to have the same effect and no new clinical trials have to be performed.