Class of 2017 Abstract / Objectives: Milk protein allergy is estimated to affect 1.2% to as much as 17% of people of all ages. Advair® Diskus® (FP/SX) utilizes lactose as an excipient which limits the utility of this product for this population. Furthermore, Advair® Diskus® is formulated as an interactive physical mixture via a micronization process. Alternatively, spray dried engineering achieves narrow particle size distribution, allowing greater deposition in the targeted respiratory bronchioles. The purpose of this dry powder inhaler (DPI) study was to conduct an in vitro comparative analysis of the aerodynamic performance of a co-spray dried lactose-free formulation of FP/SX with a mannitol excipient as a molecular mixture versus the Advair® Diskus® 250/50 (FP/SX) interactive physical mixture product. Methods: Utilizing mannitol as an excipient, a co-spray dried FP/SX powder was prepared using the Buchi Mini-Spray Dryer B-290 under closed system configuration. The resulting feed solution was spray dried at pump rates of 25%, 50%, and 100% with all other parameters remaining constant (aspiration, atomization rate, nitrogen gas rate). The primary outcome measure, aerodynamic performance, was assessed using the Copley Next-Generation Impactor (NGI). NGI data for the DPIs was used to calculate mass median aerodynamic diameter (MMAD), geometric standard deviation (GSD), and fine particle fraction (FPF) of each powder, including the Advair® Diskus®. Residual water content was quantified by Karl Fischer titration. Particle characteristics were visualized by scanning electron microscopy. Results: FPF, MMAD, and GSD were calculated from NGI data; Wolfram Alpha software was used to calculate MMAD and GSD. T-test regression was used for comparative analysis of spray-dried and Advair® Diskus® powders. MMAD for each spray dried sample was analyzed using a t-test regression against the MMAD values from the Advair® Diskus®. Using aerodynamic analysis studies triplicated for each powder, there was no significant difference between the spray dried powder and Advair® Diskus® for MMAD and GSD (p-values >0.05). The 50% and 100% pump rate samples had similar FPF to the Advair® Diskus® (p-values >0.05). However, the 25% pump rate sample had a significantly improved FPF compared to the Advair® Diskus® (p <0.01). Conclusions: A co-spray-dried lactose-free formulation of FP/SX with a mannitol excipient demonstrated similar aerodynamic performance to the Advair® Diskus® which consists of a physical mixture of two drugs with lactose. Of significance, 25% pump rate spray-dry conditions demonstrated an improved FPF compared to the Advair® Diskus®.

This diploma thesis deals with the evaluation of clinical manifestations in infants with allergic colitis and their overall nutritional status, anthropometry, blood count and antibodies against cow's milk proteins. Allergic colitis is one of the most common manifestations of infant allergy to cow`s milk protein with gastrointestinal involvement. The theoretical part summarizes the anthropometric evaluation of growth and development, infant nutrition, the most important laboratory indicators of nutritional status. The part is generally devoted to food allergies, mainly allergy to cow's milk protein. The practical part deals with the evaluation of a sample of examined patients in gastroenterology outpatient clinics and nutritional outpatient clinic of the Department of Pediatrics and Adolescent Medicine of the 1st Faculty of Medicine, Charles University and General Hospital in Prague. The observed group of infants with allergic colitis includes infants exclusively breastfed, breastfed by a mother following a non-dairy diet, infants on an extensive hydrolyzate or on an amino acid formula. The main goal of the diploma thesis was to trace the most common clinical manifestations and whether there are any changes in their nutritional status during the disease and its treatment. A total of 45 randomly...