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P.I.N. Pharmaceutical


Small Volume Oral Transmucosal Dosage Forms Containing


Patent Innovation News


The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Offi ce in March-April, 2016.


Harshada Sant, MS and Hemant N. Joshi, PhD, MBA*


Tara Innovations, LLC www.tarainnovations.com *hemantjoshi@tarainnovations.com


Sufentanil for Treatment of Pain; P. Palmer, T. Schreck, S. Tzannis, L. Hamel, and A.I. Poutiatine; U.S. Patent # 9,320,710, April 26, 2016.


Introduction Paragrapgh Text


This invention provides a dosage form having a volume of less than 30 microliters or a mass of less than 30 mg. Specifi cally, the dosage form is for sublingual administration of sufentanil to a subject wherein the dosage form comprises from about 5 to about 100 micrograms (mcg) of sufentanil, and a bioadhesive material. After sublingual administration, about 60% of drug was absorbed from oral transmucosal route. The Tmax value was observed to be 0.68 to 0.89 hours and the Cmax value was 2.72 ± 0.84 pg/mL per mcg dosed. Enhanced safety, rapid and consistent onset of action, predictable plasma concentrations and higher bioavailability (about 80%) are some of the advantages of this formulation.


Author Name


Author Title Author Company


Use of Gelsolin to Diagnose and Treat Infl ammatory Diseases; T.P. Stossel, T.A.C. Magnuson Osborn, and A. Tarkowski; U.S. Patent # 9,316,639, April 5, 2016.


Infl ammatory diseases are characterized by activation of the immune system in a tissue or in an organ to abnormal levels that may lead to abnormal function of the tissue or organ. Gelsolin was fi rst discovered as an intracellular actin-binding protein. Studies have shown that depletion of plasma gelsolin by injury and infl ammation is associated with adverse outcomes. It was found that gelsolin level goes down in case of an infl ammatory disease like rheumatoid arthritis. Gelsolin depletion is supposed to work by binding abundant actin in cells exposed by tissue breakdown. Recently, gelsolin was found to bind bioactive infl ammatory mediators. The patent describes treatment with gelsolin to prevent and to suppress the manifestations of infl ammatory diseases. The invention uses gelsolin to diagnose infl ammatory diseases and to monitor the eff ect of therapy.


Lyophilized T erapeutic Peptibody Formulations; W.J. Callahan, R.L. Remmele, Jr., G. Ratnaswamy, R.F. Latypov, and D. Liu; U.S. Patent # 9,283,260; March 15, 2016.


Antibodies have a variable domain known as “Fab,” which binds antigen, and a constant domain known as “Fc,” which links to such eff ector functions as complement activation and attack by phagocytic cells. Fc has a long serum half-life, whereas Fab is short-lived. Peptibodies or peptide-Fc fusions are an attractive alternative therapeutic format to monoclonal antibodies. They consist of biologically active peptides grafted onto an Fc domain. This approach retains certain desirable features of antibodies, notably an increased apparent affi nity. The present invention provides formulations useful for lyophilization of therapeutic peptibodies resulting in a highly stable therapeutic peptibody product. The lyophilized therapeutic peptibody composition comprised of a buff er, a bulking agent, a stabilizing agent, and optionally a surfactant.


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| Noy/June 2016 Mavember/December 2011


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