Patent ID: 8557282

Claim:
A pH-independent extended release dosage form having specified dissolution characteristics, comprising: venlafaxine hydrochloride in an amount of 30-60% based on the total weight of the dosage form; said venlafaxine hydrochloride being coated on a nonpareil inert core; the venlafaxine hydrochloride being optionally connected to a binder in a binder amount of 0.5-10% based on the total weight of the dosage form wherein said binder, when present, is selected from the group consisting of polyvinylpyrrolidone, hydroxypropylcellulose and hydroxypropylmethylcellulose; an isolating layer coating said venlafaxine hydrochloride and comprising 0.5-10% based on the total weight of the dosage form, said isolating layer being polyvinylpyrrolidone; and a controlled release layer coated over said isolating layer, said controlled release layer comprising a controlled release polymer mixed with a plasticizer, said controlled release polymer comprising 2-15% based on the total weight of the dosage form, said controlled release polymer being ethyl cellulose, and said plasticizer comprising 0.1-2% based on the total weight of the dosage form, said plasticizer being dibutyl sebacate; the parameters being selected so as to control release of the venlafaxine hydrochloride over an approximately 24 hour period in a manner that the following pH and rpm independent in vitro dissolution specifications are obtained: Time (hrs) Average % venlafaxine HCl release 2 <30 4 30-55 8 55-80 12 65-90 24 >80.