World News: 12:45 GMT Friday 9th November 2018. [Fuisz Pharma LLC via Globe Newswire via SPi World News]
Miami, FL, Nov. 09, 2018 (GLOBE NEWSWIRE) -- Fuisz Pharma LLC announced today that it has received a Notice of Allowance from the United States Patent Office in connection with its patent application () entitled, “Package, System and Methods for Custody and Control of Drugs, and Method and Composition for Making an Oral Soluble Film, containing at least one active agent.”
In the FUISZ Custody and Control system, each dose receives an individualized serial identifier that is on each of outside and inside of the unit dose package. These serial dosage identifiers are recorded, preferably by the dispensing pharmacist, for the individual patient in a secure database. Custody and Control of drug is extended from the dispensing pharmacist to the patient receiving the drug.
Preferred embodiments employ drug dosage forms that are physically difficult to transfer from the original packaging or are otherwise are prone to stability issues when removed from the original packaging. For example, a liquid suspension, solution, or an oral film strip.
The presence of the individual identifier of the dosage unit on the inside of the unit dose package is critical insofar as such identifier is not possible to scratch out, or otherwise obscure by a receiving patient intending illicit transfer of prescribed and dispensed doses.
This constitutes a Custody and Control System that allows verification of the custody a dosage unit, either by medical emergency or by law enforcement personnel or both.
The implementation of the system becomes a critical component of Risk Evaluation and Mitigation Strategy (REMS) for drugs prone to diversion and abuse.
Joseph Fuisz, Managing Member of Fuisz Pharma, stated: “Today’s announced patent allowance represents a milestone for our Custody and Control system, conceived and designed to reduce the scourge of opioid abuse by reducing the diversion of prescribed opioids to non-prescribed persons and the identification of counterfeit drug units.”
“Currently, there is no effective system to demarcate where opioids legally manufactured and prescribed and used by the intended patient ends, and illicit, diversion begins.”
“Historically, formulators wanted to make stable products that enjoyed physical and chemical stability for reasons of cost and convenience. The principal manifestation of such efforts is the modern tablet that requires no barrier packaging in normal storage conditions.”
“In more recent times, in response to the scourge of opioid abuse, formulators have attempted to develop dosage forms resistant to abuse. In so doing, formulators faced a conundrum of how to make a tablet bioavailable at its intended site – typically absorption in the GI tract – that was otherwise difficult to misuse, for example by crushing and using for nasal insufflation or injection. There is an inherent tension in this effort, and results have been quite mixed and in certain cases have failed due to unintended adverse consequences, like in the case of Opana ER®.”
“In our newly patented system, we invert the classic formulation paradigm. Because the traceability of the dose is anchored in unit packaging, preferred non-limitative embodiments are dosage forms that are not stable or otherwise easy to handle outside of the packaging. This ties the dose to the traceable packaging. Preferred dosage forms include oral thin film, solutions, suspensions and other dosage forms that are not readily removed and stable without packaging.”
“Moreover, our system builds upon, leverages and improves the actions currently underway in connection with Title II of the Drug Quality and Security Act () This substantially reduces the logistical and cost burden of implementation. Similarly, the unit dose packaging called for in this system echoes the provisions of the empowering FDA to require unit dose packaging. ”
Richard Fuisz M.D., founding Member, states:
“Our Blockchain like System results in a HIPPA compliant database of the travels of each individual dosage unit from manufacturer to pharmacy and ultimately to end user. No longer is the Physician left with demands for his clairvoyance regarding the abuse of certain drugs. We are in an untenable situation in which prescribing physicians are not only second guessed for prescribing needed analgesics, but for the precise number of pills prescribed which is impossible to absolutely predict in medical practice. At last this system allows complete transparency of the travels of an individual dosage unit……manufacturer to user. It turns logic on its head, as the stable “tablet” of old has become the worst offender in opioid abuse, since it is so easy to remove from any package and stick in one’s pocket. This patent allowance will not be favored by some K street lobbyists. It calls for the ultimate reformulation to less stable dosage units, like film.”
FUISZ earlier received a patent issuance for the parent case, (Method and composition for making an oral soluble film, containing at least one active agent) relating to the manufacture of oral thin films by the deposit method. Fuisz also recently announced an additional allowance for this same case: US Serial No. (Method and composition for making an oral soluble film). The patent allowance announced today will represent the third patent issued in this estate.
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), similarly acquired. And they developed a method of making monolayer films with bilayer functionality (US 8,617,589) acquired by a leading oral thin film company.
Fuisz Pharma LLC is a private pharmaceutical technology company originated by Joseph Fuisz () and Richard Fuisz (). The Fuiszes have made substantial contributions in drug delivery including orally dissolving tablets and novel particle coating systems at Fuisz Technologies; inventing and developing thin film drug delivery technologies, as well as developing extruded sheet technology. The Fuiszes have extensive experience working with big and specialty pharma. Fuisz Pharma is also active in diagnostic systems including breath diagnostics. Fuisz Pharma has its headquarters in Miami. .
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Globe Newswire: 12:45 GMT Friday 9th November 2018
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