Joseph J Reo Deceased93 Battle Hill Ave, Springfield, NJ 07081

2015029, Oct 15, 2015

Dec 16, 2014

14/571890

- Memphis TN, US
John O'Mullane - Mountain Lakes NJ, US
Robert T. Nowak - New Providence NJ, US
Jiansheng Wan - Springfield NJ, US
Mohammed A. Kabir - Lakeland TN, US
Joseph P. Reo - Lakeland TN, US
Malaz A. Abutarif - North Brunswick NJ, US
Glenn E. Fritz - Arlington TN, US

MSD Consumer Care, Inc. - Memphis TN

A61K 31/137
A61K 47/12
A61K 31/4545
A61K 47/38
A61K 9/50
A61K 9/16

The invention discloses a pharmaceutical composition comprising phenylephrine or a pharmaceutically acceptable salt thereof and an erodible layer which is for oral administration wherein the composition delivers phenylephrine or a pharmaceutically acceptable salt thereof via absorption in the colon. The pharmaceutical composition comprises a core comprising phenylephrine or a pharmaceutically acceptable salt thereof and an erodible layer which is in a time-dependent, pH-dependent, or colon-specific enzyme-dependent erodible layer that degrades to expose the core to release phenylephrine in the colon. In one preferred embodiment, the erodible layer encases the core. The composition optionally further comprises phenylephrine in the erodible layer or other additional layer(s). The pharmaceutical composition can further comprise one or more additional therapeutically active agents selected from one or more of the group consisting of antihistamines, analgesics, anti-pyretics, and non-steroidal anti-inflammatory agents. The invention also discloses methods of administering phenylephrine via the colon, thereby increasing the bioavailable amount of therapeutically active unconjugated phenylephrine relative to the total phenylephrine in the plasma.