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Results EXE HIP formation and characterization The highest measured precipitation efficiency was for the molar ratio 1:4 (EXE:DOC)an expected result, given that EXE exhibits 4 cationic function in an acid medium, and each pairing with one anionic function of the selected counter ion This ratio was selected for assessing LBF development LogP measurement show higher lipophilicity increase with DOC as counter ion LabrafacMC60 and propylene glycol were selected as the best solvents A homogeneous formulation with small particle size upon dispersion was selected to favor intestinal absorption EXE and EXE:DOC HIP solubility Formulation characteristics The LBF prototype was defined as: 85% LabrafacMC60 (glycerol monocaprylocaprate) 10% KolliphorRH40 (Polyoxyl 40 castor oil) 5% propylene glycol 6 mg/mL EXE (in native form or HIP) 20 mg/mL sodium caprate The presence of LBF protected EXE from -chymotripsin-induced proteolysis There was rapid degradation of EXE in the presence of chymotrypsin The designed LBF provided a protective effect Customized enteric capsule manufacturing and characterization The EMT dissolution test confirmed the capsules enteric properties No release of encapsulated EMT in acid milieu, followed by rapid and complete EMT release at pH 6.8 Filled capsule enteric properties Customized size #0 gelatin/HPMC-AS double-dipped capsules filled with EXE:DOC HIP showed: No dissolution and retention of enteric properties after 1 hour in HCl 0.1N Disintegration within 5 minutes at pH 6.8 Conclusion This study proposes an innovative and scalable solution to increase oral bioavailability of therapeutic peptides using a combination of lipid-based formulations, hydrophobic ion pairing, permeation enhancer and customized enteric capsules

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The cell-culture pharmacology of LR3 is well-characterized