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Abstract

Disclosed is a method for delivering an active protein or peptide to the colon. The steps of the method include providing a multiparticulate dosage core particle comprising 3 components, the total weight of the 3 components in dry form defining a batch size. The multiparticulate core particle is produced by the method comprising: a) providing an aqueous PEG solution, the dry weight of the PEG component representing from about 2.5% to about 15% of the batch size (weight/weight), the water component of the aqueous PEG solution representing approximately 30-60% of the batch size (weight/weight); b) providing a homogenous mixture of the active protein or peptide and microcrystalline cellulose, both in dry form, the active protein or peptide comprising from about 50% to about 95% of the batch size (weight/weight) and the microcrystalline cellulose comprising from about 2.5% to about 35% of the batch size (weight/weight); c) while mixing the components of step b), contacting the components of step b) with the aqueous PEG solution of step a), said contact being established by introducing the aqueous PEG solution as an atomized spray to the mixing components of step b); d) extruding the composition formed in step c); e) spheronizing the extruded composition of step d); f) drying the spheronized composition of step e) to a moisture level of less than about 7%; and g) screening the dried composition of step f) and collecting multiparticulate core particles. An outer enteric coating is then applied to the multiparticulate core particles to form coated multiparticulate particles. The coated multiparticulate particles are then administered orally to an individual. Also disclosed is a composition for delivering an active protein or peptide to the colon, the composition being produced by the method described in the preceding paragraph. In preferred embodiments, the active protein to be delivered is an immunoglobulin.

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