MODIFIED RELEASE SOLID ORAL PHARMACEUTICAL COMPOSITIONS OF CYCLOBENZAPRINE OR A SALT THEREOF

摘要

The present invention provides a modified release solid oral pharmaceutical composition comprising cyclobenzaprine or salt thereof. In particular, the present invention relates to modified release solid oral pharmaceutical composition comprising a core comprising cyclobenzaprine or a salt thereof and one or more release modifying substances, which core is coated with one or more water soluble and/ or water insoluble release modifying polymers. The composition may provide extended and specific release of cyclobenzaprine or a salt 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.