Patent ID: 6074689
Filing Date: 2000-06-13
Classification: A61K,C07K

Abstract:
A method for delivering an active protein or peptide to the colon, the method comprising:a) 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 produced by the method comprising:i) 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);ii) 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);iii) while mixing the components of step ii), contacting the components of step ii) with the aqueous PEG solution of step i), said contact being established by introducing the aqueous PEG solution as an atomized spray to the mixing components of step ii);iv) extruding the composition formed in step iii);v) spheronizing the extruded composition of step iv); andvi) drying the spheronized composition of step v) to a moisture level of less than about 7%;vii) screening the dried composition of step vi) and collecting multiparticulate core particles;b) applying an outer enteric coating to the multiparticulate core particles of step a) vii) to form coated multiparticulate particles; andc) orally administering the coated multiparticulate particles to an individual.