Patent ID: 9642809
Date: 2017-05-09
CPC Classifications: A61K,A61P

Claim:
1. A layered pharmaceutical composition for controlled release of an active substance, comprising: a solid inner layer (A) comprising the active substance and a disintegrant, the solid inner layer (A) being positioned between two outer layers (B1) and (B2), each outer layer (B1) and (B2) comprising one or more substantially water soluble or crystalline polyethylene oxides (PEOs) having a molecular weight (MW) of about 100,000 daltons or greater, wherein the average molecular weight of the PEO present in each outer layer is about 100,000 daltons or greater, wherein each outer layer is free of the disintegrant, and wherein at least one of the outer layers (B1) and (B2) comprises the active substance, and a coating (C) forming a shell covering the solid inner layer (A) and partially covering outer layers (B1) and (B2) with two openings exposing a surface of each outer layer (B1) and (B2), wherein the coating (C) comprises a polymer and is substantially insoluble in and impermeable to gastrointestinal fluids; wherein the solid inner layer (A), without the outer layers (B1) and (B2) and the coating (C), disintegrates within 60 minutes when subjected to a disintegrating test according to the Eur. Ph; and wherein the release of the active substance contained in at least one of the outer layers (B1) and (B2) follows a zero order release pattern for at least 80% w/w release of the total content of the active substance in the outer layers (B1) and (B2).