ORNx Formulation Technology
Orion's proprietary formulation technology enables manufacture of pure drug particle agglomerates which achieve the higher bioavailability as compared to the micronized drug without the use of excipients and surfactants. This enables the use of novel anti-inflammatory drugs for use in high concentration injectables. Extensive data have already been collected ranging from manufacturing and stability, to FDA enabling toxicology and histology
Titratable Dissolution Kinetics
Drugs can be formulated to meet desired dissolution profile. Orion's ORNx formulation technology dramatically increase surface area vs. micronized drug, allowing for more rapid and complete dissolution across a range of kinetic profiles.
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Enables Intravitreal Injection
The need for alternative to steroids to treat ocular inflammation is addressed by Orion's first target product ORNx-KI, a powerful clinical-stage kinase inhibitor. ORNx-KI increases bioavailability and allows for lower doses of drug to be delivered enables use of previously abandoned molecules.
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Scalable Manufacturing
Wet milling manufacture is scalable and final product maintains physical properties such as crystallinity, solubility, and storage stability. Additionally, the pure drug particle agglomerates maintain their size and surface area after drying and during storage.
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REFERENCES
1: Pornputtapitak W, El-Gendy N, Berkland C. NanoCluster Itraconazole Formulations Provide a Potential Engineered Drug Particle Approach to Generate Effective Dry Powder Aerosols. J Aerosol Med Pulm Drug Deliv. 2015 Oct;28(5):341-52. doi: 10.1089/jamp.2014.1155. Epub 2015 Feb 13. PubMed PMID: 25679514.
2: Kuehl C, El-Gendy N, Berkland C. NanoClusters surface area allows nanoparticle dissolution with microparticle properties. J Pharm Sci. 2014 Jun;103(6):1787-98. doi: 10.1002/jps.23980. Epub 2014 Apr 30. PubMed PMID: 24788354.
3: Pornputtapitak W, El-Gendy N, Mermis J, O'Brien-Ladner A, Berkland C. NanoCluster budesonide formulations enable efficient drug delivery driven by mechanical ventilation. Int J Pharm. 2014 Feb 28;462(1-2):19-28. doi: 10.1016/j.ijpharm.2013.12.030. Epub 2013 Dec 25. PubMed PMID: 24374223.
4: El-Gendy N, Selvam P, Soni P, Berkland C. Development of budesonide nanocluster dry powder aerosols: preformulation. J Pharm Sci. 2012 Sep;101(9):3434-44. doi: 10.1002/jps.23197. Epub 2012 May 23. PubMed PMID: 22623018.
5: El-Gendy N, Huang S, Selvam P, Soni P, Berkland C. Development of budesonide nanocluster dry powder aerosols: formulation and stability. J Pharm Sci. 2012 Sep;101(9):3445-55. doi: 10.1002/jps.23176. Epub 2012 May 22. PubMed PMID: 22619045.
6: El-Gendy N, Selvam P, Soni P, Berkland C. Development of budesonide nanocluster dry powder aerosols: processing. J Pharm Sci. 2012 Sep;101(9):3425-33. doi: 10.1002/jps.23168. Epub 2012 Apr 26. PubMed PMID: 22539360.
7: Pornputtapitak W, El-Gendy N, Berkland C. Nanocluster budesonide formulations enhance drug delivery through endotracheal tubes. J Pharm Sci. 2012 Mar;101(3):1063-72. doi: 10.1002/jps.22818. Epub 2011 Nov 17. PubMed PMID:
22095757.
8: Aillon KL, El-Gendy N, Dennis C, Norenberg JP, McDonald J, Berkland C. Iodinated NanoClusters as an inhaled computed tomography contrast agent for lung visualization. Mol Pharm. 2010 Aug 2;7(4):1274-82. doi: 10.1021/mp1000718. PubMed PMID: 20575527; PubMed Central PMCID: PMC4207657.
9: Peek LJ, Roberts L, Berkland C. Poly(D,L-lactide-co-glycolide) nanoparticle agglomerates as carriers in dry powder aerosol formulation of proteins. Langmuir. 2008 Sep 2;24(17):9775-83. doi: 10.1021/la8012014. Epub 2008 Aug 5. PubMed PMID: 18680321; PubMed Central PMCID: PMC3729861.
10: 3: Shi L, Plumley CJ, Berkland C. Biodegradable nanoparticle flocculates for dry powder aerosol formulation. Langmuir. 2007 Oct 23;23(22):10897-901. Epub 2007 Sep 26. PubMed PMID: 17894513.
2: Kuehl C, El-Gendy N, Berkland C. NanoClusters surface area allows nanoparticle dissolution with microparticle properties. J Pharm Sci. 2014 Jun;103(6):1787-98. doi: 10.1002/jps.23980. Epub 2014 Apr 30. PubMed PMID: 24788354.
3: Pornputtapitak W, El-Gendy N, Mermis J, O'Brien-Ladner A, Berkland C. NanoCluster budesonide formulations enable efficient drug delivery driven by mechanical ventilation. Int J Pharm. 2014 Feb 28;462(1-2):19-28. doi: 10.1016/j.ijpharm.2013.12.030. Epub 2013 Dec 25. PubMed PMID: 24374223.
4: El-Gendy N, Selvam P, Soni P, Berkland C. Development of budesonide nanocluster dry powder aerosols: preformulation. J Pharm Sci. 2012 Sep;101(9):3434-44. doi: 10.1002/jps.23197. Epub 2012 May 23. PubMed PMID: 22623018.
5: El-Gendy N, Huang S, Selvam P, Soni P, Berkland C. Development of budesonide nanocluster dry powder aerosols: formulation and stability. J Pharm Sci. 2012 Sep;101(9):3445-55. doi: 10.1002/jps.23176. Epub 2012 May 22. PubMed PMID: 22619045.
6: El-Gendy N, Selvam P, Soni P, Berkland C. Development of budesonide nanocluster dry powder aerosols: processing. J Pharm Sci. 2012 Sep;101(9):3425-33. doi: 10.1002/jps.23168. Epub 2012 Apr 26. PubMed PMID: 22539360.
7: Pornputtapitak W, El-Gendy N, Berkland C. Nanocluster budesonide formulations enhance drug delivery through endotracheal tubes. J Pharm Sci. 2012 Mar;101(3):1063-72. doi: 10.1002/jps.22818. Epub 2011 Nov 17. PubMed PMID:
22095757.
8: Aillon KL, El-Gendy N, Dennis C, Norenberg JP, McDonald J, Berkland C. Iodinated NanoClusters as an inhaled computed tomography contrast agent for lung visualization. Mol Pharm. 2010 Aug 2;7(4):1274-82. doi: 10.1021/mp1000718. PubMed PMID: 20575527; PubMed Central PMCID: PMC4207657.
9: Peek LJ, Roberts L, Berkland C. Poly(D,L-lactide-co-glycolide) nanoparticle agglomerates as carriers in dry powder aerosol formulation of proteins. Langmuir. 2008 Sep 2;24(17):9775-83. doi: 10.1021/la8012014. Epub 2008 Aug 5. PubMed PMID: 18680321; PubMed Central PMCID: PMC3729861.
10: 3: Shi L, Plumley CJ, Berkland C. Biodegradable nanoparticle flocculates for dry powder aerosol formulation. Langmuir. 2007 Oct 23;23(22):10897-901. Epub 2007 Sep 26. PubMed PMID: 17894513.