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Post by bones1026 on Nov 2, 2018 21:47:37 GMT -5
Also, I’m thinking inhaling opioids would be akin to snorting heroin, and we’re all probably aware of the current problems associated with inhaling opioids. It might not go over well with the FDA at this point in time. If I remember correctly the Torrey Pines/MannKind collaboration was for a pain med they called “non addictive”. I don’t think we ever got the details, but whatever it was, it wasn’t an opioid. I agree, a technosphere opioid would never get approved. Yet they just approved a pain pill today that is 50x more potent than Fentanyl..Makes you wonder with the state of our country today with opioids..but we can’t get an Ultra Rapid labeling...too risky🤷♂️ |
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Post by mango on Nov 2, 2018 22:08:17 GMT -5
Bucket #4.  TPI-2088 in Bucket #4 is a new molecule for treating pain. We can see MannKind's prior work with a Torrey Pines discovered tetrapeptide called, TPI-23, in this paper whose link is now broken, but whose information was archived offline: abstracts.aaps.org/Verify/aaps2013/postersubmissions/T3083.pdfStability of Novel Pain Therapy Tetrapeptide TPI-23 in Technosphere® Inhalation Powder and Identification of Related-Compounds by Liquid Chromatography/Mass SpectrometryY. Livson, E. Harris, K. Fabio, J. Guarneri MannKind Corporation PurposeTo evaluate the stability of TPI23 tetrapeptide WsSF-NH2 under room temperature and accelerated conditions in a Technosphere inhalation powder using HPLC, and to identify the major related-compounds present using LC/MS. MethodsTPI23/Na2FDKP Technosphere inhalation powder was prepared at 50% weight API and placed on stability under room temperature and accelerated stability conditions in open container and inhalation cartridges. LC/UV separation was carried out on a Phenomenex Kinetex 2.6 C18 column (150x3.0mm) column at a flow rate of 0.5mL/min with an analysis time of 50 minutes. Compounds were eluted using a linear gradient consisting of mobile phase A of water/tetrahydrofuran/trifluoroacetic acid/ammonium hydroxide (970/30/1/1 (v/v/v/v)) and mobile phase B of acetonitrile/methanol/isopropanol/trifluoroacetic acid (850/150/30/1 (v/v/v/v)). Initial assay and stability analyses were conducted on a Waters 2695 Separations Module equipped with a Waters 2487 Dual Absorbance Detector. Related- compounds were identified using HPLC coupled with an Agilent 1100 Trap XCT mass spectrometer and an Agilent 6210 TOF mass spectrometer. ESI mass spectra were acquired in positive ion mode with full scan monitoring. TPI23 was subjected to forced degradation conditions to confirm the identity of the impurities formed in the inhalation powder during the stability study. ResultsSamples stored at room temperature lost 3.3% TPI23 assay after 16 weeks in an open container and 0.7% assay after 4 weeks in cartridges. Samples stored under accelerated conditions were most susceptible to degradation, with TPI23 assay losses after 4 weeks of 7.6% (open dish) and 8% (cartridges). Five major impurities (A-E) were present at more than 0.15 area% (ADE increased, BC remained constant). ConclusionTPI23 in a 50% weight Technosphere inhalation powder was stable (>96%) for up to 16 weeks when stored at room temperature, whereas samples stored for 4 weeks under accelerated stability conditions lost about 8% API. Using LC/MS and forced degradation experiments, five related-compounds were identified. Acknowledgement: TPI-23 was discovered by the Torrey Pines Institute for Molecular Studies, Port St. Lucie, FL. |
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Post by mango on Nov 2, 2018 22:40:30 GMT -5
Perhaps because maybe most opioid treatments will soon be a thing of the past ? Don’t know but from the manholdem himself: t's important to understand that Torrey Pines is a partner ONLY in co-developing an opioid pain relief medication with MannKind's Technosphere delivery system. Torrey Pines is NOT a pharmaceutical company that has the cash to develop and/or marketing this co-patented pain medication. It is a research institute. Both Torrey Pines and MannKind Corporation would need to find and sign a big pharmaceutical company (BP) to fund the regulatory (FDA/EMEA) trials and, assuming approval, to market it globally. This happens to be one of the API types - a unique API that has never been approved - that Hakan once said is the most expensive and would take the longest to develop into a marketable product. MannKind has other API that can exit the pipeline much faster and cheaper than this opioid, IMHO. MannKind's new chemical entity I would imagine would not cross the blood-brain barrier, and effectively alleviate pain without activating opioid receptors in the CNS, but by binding selectively to neurons in the PNS—while dramatically reducing or even eliminating unwanted side-effects currently associated with opioid analgesics like: respiratory depression, addiction, somnolence, tolerance, constipation... There's been an opioid addiction crisis in this country since the 1800's. We need to find a solution to this. |
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