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Abstract

A solid pharmaceutical composition suitable for oral or rectal administration comprising a unit dosage of a pharmaceutically active ingredient (and optionally one or more inert fillers) homogeneously dispersed in a pharmaceutically acceptable binder, wherein at least a major portion (i.e., at least 50% by weight) of the binder is a microcrystalline solid phase prepared by raising the pH of a dairy whey lactose permeate having a pH below about 7 to a pH between about 8 and 10 to form (i) a lactose-rich aqueous solute phase capable of being autoclaved for 10-20 minutes at 121.degree. C. and 15 psi to form a clear, light-colored solute having a pH of about 7; and (ii) a microcrystalline solid phase which contains substantially all of the dissolved solids from said solute phase which would form a precipitate upon autoclaving said solid phase; separating the microcrystalline solid phase from the solute phase; and drying the separated microcrystalline solid phase to form a nontoxic, tasteless, odorless, chalky white free-flowing powder.

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First Claim