PharmaDirections is Co-inventor on Second Issued Formulation Patent Entitled “Layered Pharmaceutical Formulations”

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PharmaDirections is pleased to announce that United States Patent 8,318,788 has been issued for “Layered Pharmaceutical Formulations”. This was a second patent that was a result of a collaborative formulation development effort between the scientists at Orexigen, PharmaDirections and their sub-contractors.

Formulation Development of Tri-Layer Tablet

Tri-Layer Tablet

PharmaDirections has added another issued patent to their list of patents where they helped invent new technology for their clients. This one is United States Patent 8,318,788 which has been issued for “Layered Pharmaceutical Formulations”. This was a second patent that was a result of a collaborative formulation development effort between the scientists at Orexigen, PharmaDirections and their sub-contractors.

The technology is for multiple layered pharmaceutical formulations for drug products such as Contrave®, a treatment for obesity. The patent is assigned to Orexigen Therapeutics, Inc. who currently has an NDA for Contrave® under review at the FDA. In the example of an oral, controlled release dosage formulation, the middle layer is inert and dissolves in vivo to leave two separated drug containing layers intact until dissolution begins. This was done to separate potentially interacting layers from one another within the tablet and to allow each pharmaceutical layer to have its own controlled release dissolution profile. The pharmacokinetic modeling and formulation design was done at PharmaDirections.

"Our collaborative effort with Orexigen resulted in multiple accomplishments including this issued patent and the submission of 4 other patent submissions,” said Dr. Richard Soltero, President of PharmaDirections. “This brings us to 21 issued and issued patents for our clients where a PharmaDirections staff member was one of the inventors. We have helped a lot pharmaceutical companies find additional intellectual property by solving problems of bioavailability, stability or off-label competition.”

During the period from 2005 to 2008, PharmaDirections developed and manufactured several products for Orexigen including Contrave® and Empatic™. This relationship was published in Orexigen’s S-1statement issued in 2005 where it noted: “PharmaDirections is our primary drug development consultant and manages subcontractors on our behalf.”

About PharmaDirections:

PharmaDirections is a pharmaceutical project management and consulting group focused on CMC (Chemistry, Manufacturing and Controls), formulation development, preclinical and regulatory affairs. They utilize a mix of technical expertise, software and proprietary tools, such as GastroPlus™, when inventing new intellectual property for clients or developing formulations that solve difficult problems.

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Richard Soltero
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