PROCESS FOR PREPARING A MODIFIED RELEASE SOLID ORAL PHARMACEUTICAL COMPOSITIONS OF CYCLOBENZAPRINE OR SALTS THEREOF

摘要

The present invention provides a process for preparing a modified release solid oral pharmaceutical composition comprising cyclobenzaprine or salts thereof. In particular, the present invention relates to a process for preparing modified release solid oral pharmaceutical composition comprising a core comprising cyclobenzaprine or salts thereof and one or more release modifying polymers, which core is coated with one or more water soluble release modifying polymers; wherein the coating is devoid of water insoluble polymers. The composition may provide extended and specific release of cyclobenzaprine or salts thereof to achieve therapeutically effective plasma concentration over a period of 24 hours to treat muscle spasm associated with painful musculoskeletal conditions when administered to a patient in need thereof. The invention also includes process of preparing such composition.