Controlled release budesonide minitablets

A controlled release minitablet comprising an extended release core and a pH dependent delayed release coating thereon, wherein:

• the extended release core comprises a homogeneous mixture of budesonide, a carrier, at least one extended release polymer, a plasticizer, and an acid
• the pH dependent delayed release coating comprises at least one anionic carboxylic polymer chosen from cellulose acetate phthalate, cellulose acetate trimellitate, hydroxypropylmethylcellulose phthalate, polyvinyl acetate phthalate, acrylic acid polymers, and combinations thereof;
• and
• the pH dependent delayed release coating is in direct contact with the homogeneous mixture of the extended release core.

A method of making controlled release minitablets comprising:

• feeding a carrier into a fluidized bed reactor;
• spraying a suspension comprising a homogeneous mixture of budesonide, acid, a plasticizer, and an extended release polymer onto the carrier to produce a granulated mixture;
• milling the granulated mixture;
• compressing the granulated mixture into extended release cores;
• and
• coating the extended release cores with a pH dependent delayed release coating to produce a controlled release minitablet, wherein the pH dependent delayed release coating comprises an anionic carboxylic polymer that is soluble in water at a pH of about 4 to about 8 and insoluble at a pH of about 1 to about 3, and wherein the pH dependent delayed release coating is in direct contact with the homogeneous mixture of the extended release cores.