Site-Specific Microparticle Inhalation Therapy: A New Approach to Nasopharyngeal Symptoms

Background/Objectives: The Inhalable Microparticles (IMPs) is part of a currently invading field of medicine. In fact, the anatomical district of Rhinopharynx, represents a bed for many different pathology and infections, where the dimension of drug aerosol Microparticles (MP), represents a discriminating factor to success therapy. The aims of present work are three: 1) Demonstrate the efficacy of the Rinubes device and the aerosol reproducibility in the nebulization of suspensions or solutions to be deposited in the retropharynx; 2) Compare the performance of Rinubes to two other medical devices on the market and ascertain the production of a finer aerosol of the first compared to the latter; 3) Support the point 1 and 2 by reporting the data concerning a human experimentation using the medical device. Materials and Methods: The medical device Rinubes was used in order to demonstrate the reproducibility of aerosol MPs emission. Low Angle Laser Light Scattering (LALLS) method, was used to evaluate both the dimension and distribution of NPs by the medical device “Rinubes”. In the same way, six different API, used usually in Rhinopharynx pathology (N-acetylcysteine, budesonide, sobrerol, beclomethasone dipropionate, thiamphenicol glycinate acetylcysteinate and ipratropium bromide) were compared in order to investigate the dimension of NPs emission through 4 different devices , including Rinubes. The results of retrospective study including 74 subject treated with standard therapy (ST) and inhalation nebulized Sobrerol, were performed. Data regarding the persistance of clinical symptoms (i.e. cough and nasal constipation), were acquired. Results: No significant statistically differences among all the product tested (p>0.05) were addressed. However, only the cloud generated for the Beclomethasone dipropionate showed a significant finer cloud as indicated by a lower MMD value. The 90% of nanoparticles generated by Rinubes insufflator had a volume diameter less than 137 μm. All drugs tested with Rinubes showed a MMD between 52.1 and 69.7 μm. The lowest value of dimension was reported by beclomethasone dipropionate (52.1 μm). Rinubes demonstrated efficacy and robustness in fine nebulization of all pharmaceutical products analyzed indicating that the device is able to be efficient with all types of formulation tested, whether they are cortisone suspensions or solutions with different dosage strength and different composition of excipients. Rinubes, delivered an aerosol cloud with significantly lower MMD (66.3 µm) than Mad Nasal and Spray-sol (142.1 and 116.0 µm respectively), which would allow a higher fraction of drugs deposited in the retropharynx.