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Fuisz Pharma announces issuance of oral thin film pharmaceutical patent

Fuisz Pharma has announced the issuance of a new patent, US 9,901,545 (the “’545 Patent”) concerning the manufacture of oral thin film pharmaceuticals.

The ‘545 Patent is entitled: “Method and composition for making an oral soluble film, containing at least one active agent.”

Fuisz Pharma principals Richard Fuisz and Joseph Fuisz are long active in drug delivery systems.  Richard Fuisz was the primary inventor of the Fuisz Technologies’ shearform matrix quick dissolve tablet (e.g. US 4,855,326). 

 Richard and Joseph are inventors on the largest wet cast thin film drug delivery patent estate, which has been successfully employed to protect Suboxone® thin film from generic entrants (e.g. US 7,824,588).  They also developed and patented a novel method of achieving sustained drug release in extruded sheets (US 8,613,285), which was acquired by a global consumer products company. 

They patented new ways of delivering botanical actives by films made through hot melt extrusion (US 9,125,434).  And they developed a method of making monolayer films with bilayer functionality (US 8,617,589) acquired by a leading oral thin film company.

The ‘545 Patent teaches the manufacture of oral thin films by the deposit method, whereby the film former solution as well as the drug are separately deposited into a well to form a film.   After drying the film, the primary packaging is completed by adding a foil topsheet.   Films made by deposit are not cast, but rather “poured” or deposited into the unit dose, primary packaging.

This approach offers various benefits over existing methods, including a single process for manufacturing and packaging, the elimination of active pharmaceutical ingredient loss, and precise dosing for the new generation of low dose drugs.   The approach allows for novel formulations and shapes not commercially practicable with existing methods.

Fuisz Pharma managing member Joseph Fuisz said: “Our goal with this patent was to simplify film manufacture, and increase process yield.   We’ve exceeded these goals with a new, patented methodology that also allows for novel formulations that cannot be made with existing methodologies.  

“This enables new targets in film, not previously possible, and novel formulations that are not subject to copycat products.  Pending continuation and continuation in part patent filings promise additional features and a vibrant estate.”