Pierrel Research USA Launches Orabloc™ A New Purer Articaine
Pierrel Research USA, Inc., a subsidiary of Pierrel SpA, the Italian-based, global pharmaceutical services company, announces the US launch of Orabloc™ (Articaine hydrochloride 4% with epinephrine 1:100,000 and Articaine hydrochloride 4% with epinephrine 1:200,000). Orabloc is a new purer formulation of Articaine with epinephrine, an injectable dental anesthetic for routine dental procedures and oral surgery. “With the availability of Orabloc, US dentists will now have a purer choice in Articaine anesthetics,” said Canio Mazzaro, Chairman, and CEO of Pierrel SpA. “Up to this point, all available US brands of Articaine are manufactured in Canada using the terminal sterilization method. Pierrel manufactures Orabloc using an aseptic method in our FDA-approved facility in Capua, Italy and the result is a purer formulation of Articaine. Orabloc is an Articaine with less degradation products and impurities such as articaine acid and epinephrine sulphonic acid. What’s more, Orabloc requires less overage of epinephrine, so there is less vasoconstrictor in each injection. Less vasoconstrictor is clearly more desirable and is consistent with recommendations from the American Heart Association to use the lowest available amount of vasoconstrictor.” Mr. Mazzaro went on to say, “Orabloc is not only the first aseptically manufactured Articaine available in the US, it is one of the few Italian pharmaceutical products approved by FDA in the last 30 years. The approval clearly shows the need and value of Orabloc as its approval in the US is now joined by approvals in Canada, Italy, and Russia with approvals pending in Germany, UK, France, Austria, and Poland.” According to Bernardo Verrengia, Scientific and Regulatory Advisor for Pierrel SpA and a key team leader in the development of Orabloc, “Orabloc offers the same rapid onset of action that dentists expect from existing Articaine: anesthesia within 1-9 minutes, with complete anesthesia lasting about 1 hour for infiltrations, up to 2 hours for nerve block. Additionally, our aseptic manufacturing process provides significantly increased shelf life for Orabloc up to 24 months at 25°C (77°F), compared to 18 months shelf life for terminally sterilized Articaine.
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