Extended release compositions comprising as active compound venlafaxine hydrochloride

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.