Abstract
Purpose: A low-viscosity formulation for pulmonary deliveryof rh-insulin as model peptide drugs was developed using a solution of sodiumhyaluronate. Method: The effects of differentconcentrations and pH values of low-viscosity solutions of hyaluronate onthe pulmonary absorption of rh-insulin were examined after intratracheal administrationin rats. The permeation of fluorescein isothiocyanate (FITC)–dextran(molecularweight 4300; FD-4) and insulin through excised rat trachea in vitro were alsoexamined. Results: The hyaluronate (2140kDa) solutions (0.1% and 0.2%w/v) at pH 7.0 significantly enhanced the pharmacologicalavailability (PAB) of insulin compared to the aqueous solution of insulinat pH 7.0. The absorptionenhancing effect at a concentration of 0.1% w/v hyaluronatewas greater than that at a concentration of 0.2% w/v hyaluronate. Furthermore,the greatest absorptionenhancing effect was obtained, regardless of the molecularweight of hyaluronate, when the concentration of hyaluronate was adjustedto 0.47 µM. Absorption-enhancing effects were consistent with the effectof a 0.1% w/v hyaluronate preparation at pH 4.0 and 7.0 on the permeationof FITC-dextran and insulin through excised rat trachea in vitro. Conclusion: Low-viscosity hyaluronate preparationwas shown to be a useful vehicle for pulmonary delivery of peptide drugs.
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