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Purpose To evaluate the efficacy of mucoadhesive insulinloadedwhey protein (WP) /alginate (ALG) microparticles (MP)for oral insulin administration.Methods Insulin-loaded microparticles (ins-MP) made of wheyprotein and alginate were prepared by a cold gelation techniqueand an adsorption method, without adjunction of organic solventin order to develop a biocompatible vehicle for oraladministration of insulin. In vitro characterization, evaluations ofins-MP in excised intestinal tissues and hypoglycaemic effectsafter intestinal administration in healthy rats were performedResults The release properties and swelling behaviors, investigatedin different pH buffers, demonstrated a release based ondiffusion mechanism following matrix swelling. Mucoadhesionstudies in rabbits and insulin transport experiments with excisedintestinal rat tissues revealed that encapsulation in microparticleswith mucoadhesive properties promotes insulin absorption acrossduodenal membranes and bioactivity protection. In vivo experimentsreinforced the interest of encapsulation in whey protein/alginate combination. Confocal microscopic observations associatedwith blood glucose levels bring to light duodenal absorptionof insulin biologically active following in vivo administration.Conclusions Insulin-loaded WP/ALG MP with high quantities ofdrug entrapped, in vitromatrix swelling and protective effect as wellas excellent mucohadesive properties was developped. Improvementof intestinal delivery of insulin and increased in bioavailabilitywere recorded.

Immunoglobulin (Ig) E-mediated pathophysiological mechanisms are common in allergic diseases including severe allergic asthma (SAA). The anti-IgE monoclonal antibody omalizumab may be particularly beneficial for patients with SAA and multiple allergic comorbidities (AC) including perennial/seasonal rhinitis, conjunctivitis, atopic dermatitis (AD), and food allergy. We conducted a post-hoc analysis of the patients from the STELLAIR study (n=872, 149 minors and 723 adults). The patients were classified based on the presence of multiple AC (≥3 AC or <3 AC) or AD as assessed by questionnaire. Response to omalizumab was assessed after 4-6 months (T ) and after 12 months (T ). Asthma response at T was based on global evaluation of treatment effectiveness, reduction of ≥40% in annual exacerbation rate, and a combination of both. Asthma response at T was based on change in yearly exacerbation and hospitalization rates. AC improvement at T was based on patient perception. Patients with ≥3 AC demonstrated a higher combined response to omalizumab (74.7% vs 58.3%) at T and had reduced yearly exacerbation and hospitalization rates (88.9% vs 77.4% and -94.0% vs -70.5%, respectively). Patients with ≥3 AC were more likely to show an improvement in their AC (85.3% vs 51.9%) at T . Results were similar in minors and adults. The presence of AD was associated with greater omalizumab effectiveness at T and a greater AC improvement at T . Improvement of AD and food allergies at T were 73.2% and 38.7%, respectively, in the population overall. This post-hoc analysis of the STELLAIR study shows that omalizumab is beneficial for all SAA patients and especially for patients with multiple AC or AD. In patients with ≥3 AC, omalizumab also improved AC outcomes.