Generic placeholder image

Current Drug Delivery

Editor-in-Chief

ISSN (Print): 1567-2018
ISSN (Online): 1875-5704

Review Article

Emerging Trends in Abuse-Deterrent Formulations: Technological Insights and Regulatory Considerations

Author(s): Dhwani Rana, Sagar Salave and Derajram Benival*

Volume 19, Issue 8, 2022

Published on: 07 February, 2022

Page: [846 - 859] Pages: 14

DOI: 10.2174/1567201818666211208101035

Price: $65

Open Access Journals Promotions 2
Abstract

Background: Opioid medications are an integral part of the management of acute and chronic severe pain. However, non-medical practice of these prescription drug products is emerging as a serious public health problem. To control this opioid epidemic, USFDA is encouraging pharmaceutical companies to develop Abuse Deterrent Formulations (ADFs). ADF's are much more difficult to manipulate and abuse when compared to their conventional formulations. This feature of ADFs is due to their ability to incumber extraction of active ingredients, to prevent administration through alternative routes, making abuse of altered product less rewarding.

Objective: The main objective of this review is to abridge different ADFs and various laboratory- based in vitro manipulation and extraction studies, demonstrating that these approved ADFs have the capabilities to deter abuse.

Methods: The method includes the collection of data from different search engines like PubMed, FDA guidance documents, ScienceDirect, Google Patents to get coverage of literature in order to get appropriate information regarding ADFs.

Results: Various in vitro studies demonstrate that ADFs are effective in minimizing opioid drug abuse, including opioid overdose. However, real impact of these ADFs on reducing the drug abuse can be concluded only after receiving the post marketing data.

Conclusion: ADFs are embracing fundamentally different paradigms in the management of severe pain. We believe that the development of abuse deterrent technologies would shift the architype, deterring multipill abuse and can prove as a breakthrough strategy in controlling this opioid epidemic menace.

Keywords: Abuse deterrent formulations, multipill abuse, opioid, pain management, controlled release, Regulatory considerations.

Graphical Abstract
[1]
Campbell, J.N. In: APS 1995 presidential address Pain Forum, 1996, 5, 85-88.
[http://dx.doi.org/10.1016/S1082-3174(96)80076-6]
[2]
Jones, M.R.; Viswanath, O.; Peck, J.; Kaye, A.D.; Gill, J.S.; Simopoulos, T.T. A brief history of the opioid epidemic and strategies for pain medicine. Pain Ther., 2018, 7(1), 13-21.
[http://dx.doi.org/10.1007/s40122-018-0097-6] [PMID: 29691801]
[3]
Mularski, R.A.; White-Chu, F.; Overbay, D.; Miller, L.; Asch, S.M.; Ganzini, L. Measuring pain as the 5th vital sign does not improve quality of pain management. J. Gen. Intern. Med., 2006, 21(6), 607-612.
[http://dx.doi.org/10.1111/j.1525-1497.2006.00415.x] [PMID: 16808744]
[4]
Baker, D.W. History of the joint commission’s pain standards: Lessons for today’s prescription opioid epidemic. JAMA, 2017, 317(11), 1117-1118.
[http://dx.doi.org/10.1001/jama.2017.0935] [PMID: 28241189]
[5]
Joranson, D.E.; Gilson, A.M.; Dahl, J.L.; Haddox, J.D. Pain management, controlled substances, and state medical board policy: A decade of change. J. Pain Symptom Manage., 2002, 23(2), 138-147.
[http://dx.doi.org/10.1016/S0885-3924(01)00403-1] [PMID: 11844634]
[6]
Fenton, J.J.; Jerant, A.F.; Bertakis, K.D.; Franks, P. The cost of satisfaction: A national study of patent satisfaction, health care utilization, expenditures, and mortality. Arch. Intern. Med., 2012, 172(5), 405-411.
[http://dx.doi.org/10.1001/archinternmed.2011.1662] [PMID: 22331982]
[7]
Tucker, J.; Kathryn, L. Medico-Legal case report and commentary: Inadequate pain management in the context of terminal cancer-the case of lester tomlinson. Pain Med., 2004, 5(2), 218-228.
[http://dx.doi.org/10.1111/j.1526-4637.2004.4029_2.x] [PMID: 15209980]
[8]
Frasco, P.E.; Sprung, J.; Trentman, T.L. The impact of the joint commission for accreditation of healthcare organizations pain initiative on perioperative opiate consumption and recovery room length of stay. Anesth. Analg., 2005, 100(1), 162-168.
[http://dx.doi.org/10.1213/01.ANE.0000139354.26208.1C] [PMID: 15616072]
[9]
National center for health statistics. Schedule of NCHS Statistical Products and Reports. 2021. Available at: https://www.cdc.gov/nchs/pressroom/calendar/2021_schedule.htm
[10]
Food, U.; Administration, D. Guidance for industry: Abuse-deterrent opioids–evaluation and labeling.US Department of Health and Human Services: Silver Spring, MD, 2015.
[11]
Winiecki, S. Understanding abuse deterrent opioids.U.S. Food and Drug Administration, 2018.
[12]
Rivers Allen, J.; Bridge, W. Strange routes of administration for substances of abuse. Am. J. Psychiatry Resid. J., 2017, 12(12), 7-11.
[http://dx.doi.org/10.1176/appi.ajp-rj.2017.121203]
[13]
Gossop, M.; Marsden, J.; Stewart, D.; Treacy, S. Routes of drug administration and multiple drug misuse: Regional variations among clients seeking treatment at programmes throughout England. Addiction, 2000, 95(8), 1197-1206.
[http://dx.doi.org/10.1046/j.1360-0443.2000.95811976.x] [PMID: 11092067]
[14]
Strang, J.; Bearn, J.; Farrell, M.; Finch, E.; Gossop, M.; Griffiths, P.; Marsden, J.; Wolff, K. Route of drug use and its implications for drug effect, risk of dependence and health consequences. Drug Alcohol Rev., 1998, 17(2), 197-211.
[http://dx.doi.org/10.1080/09595239800187001] [PMID: 16203485]
[15]
Comer, S.D.; Collins, E.D.; MacArthur, R.B.; Fischman, M.W. Comparison of intravenous and intranasal heroin self-administration by morphine-maintained humans. Psychopharmacology (Berl.), 1999, 143(4), 327-338.
[http://dx.doi.org/10.1007/s002130050956] [PMID: 10367549]
[16]
American pharmaceutical review. Novel Abuse Deterrent Formulations, 2021.https://www.americanpharmaceuticalreview.com/Featured-Articles/345660-Novel-Abuse-Deterrent-Formulations/
[17]
Paul, B.; Barnes, S.; Demark-Wahnefried, W.; Morrow, C.; Salvador, C.; Skibola, C.; Tollefsbol, T.O. Influences of diet and the gut microbiome on epigenetic modulation in cancer and other diseases. Clin. Epigenetics, 2015, 7(1), 112.
[http://dx.doi.org/10.1186/s13148-015-0144-7] [PMID: 26478753]
[18]
Omidian, A.; Mastropietro, D.; Omidian, H. Routes of opioid abuse and its novel deterrent formulations. J. Dev. Drugs, 2015, 4(5), 1.
[19]
Wilens, T.E.; Adler, L.A.; Adams, J.; Sgambati, S.; Rotrosen, J.; Sawtelle, R.; Utzinger, L.; Fusillo, S. Misuse and diversion of stimulants prescribed for ADHD: A systematic review of the literature. J. Am. Acad. Child Adolesc. Psychiatry, 2008, 47(1), 21-31.
[http://dx.doi.org/10.1097/chi.0b013e31815a56f1] [PMID: 18174822]
[20]
Gupta, M.; Bailey, S.; Lovato, L.M. Bottoms up: Methamphetamine toxicity from an unusual route. West. J. Emerg. Med., 2009, 10(1), 58-60.
[PMID: 19561771]
[21]
El Mazloum, R.; Snenghi, R.; Barbieri, S.; Feltracco, P.; Omizzolo, L.; Vettore, G.; Gaudio, R.M.; Bergamini, M. In: Butt-chugging’a new way of alcohol assumption in young people. Eur. J. Public Health, 2015, 25, 119.
[http://dx.doi.org/10.13140/RG.2.2.20699.57125]
[22]
Cohen, B.; Ruth, L.J.; Preuss, C.V. Opioid analgesics. In: StatPearls Publishing; USA, 2020.
[PMID: 29083658]
[23]
Canales, M.; Gerhard, J.; Younce, E. Lower extremity manifestations of “skin-popping” an illicit drug use technique: A report of two cases. Foot, 2015, 25(2), 114-119.
[http://dx.doi.org/10.1016/j.foot.2015.03.003] [PMID: 26001995]
[24]
Omidian, D.J.M.H. How Abuse-Resistant are the Abuse-Deterrent medications. SOJ Pharm. Pharm. Sci., 2013, 1(1), 2.
[http://dx.doi.org/10.24218/vjpps.2015.02]
[25]
Hamed, E.; Moe, D. Development of tamper deterrent formulations: State of the pharmaceutical industry. 2010, 3(3), 139-146.
[http://dx.doi.org/10.2174/1874473711003030139]
[26]
Simon, K.; Worthy, S.L.; Barnes, M.C.; Tarbell, B. Abuse-deterrent formulations: Transitioning the pharmaceutical market to improve public health and safety. Ther. Adv. Drug Saf., 2015, 6(2), 67-79.
[http://dx.doi.org/10.1177/2042098615569726] [PMID: 25922655]
[27]
Turk, D.C.; O’Connor, A.B.; Dworkin, R.H.; Chaudhry, A.; Katz, N.P.; Adams, E.H.; Brownstein, J.S.; Comer, S.D.; Dart, R.; Dasgupta, N.; Denisco, R.A.; Klein, M.; Leiderman, D.B.; Lubran, R.; Rappaport, B.A.; Zacny, J.P.; Ahdieh, H.; Burke, L.B.; Cowan, P.; Jacobs, P.; Malamut, R.; Markman, J.; Michna, E.; Palmer, P.; Peirce-Sandner, S.; Potter, J.S.; Raja, S.N.; Rauschkolb, C.; Roland, C.L.; Webster, L.R.; Weiss, R.D.; Wolf, K. Research design considerations for clinical studies of abuse-deterrent opioid analgesics: IMMPACT recommendations. Pain, 2012, 153(10), 1997-2008.
[http://dx.doi.org/10.1016/j.pain.2012.05.029] [PMID: 22770841]
[28]
Hale, M.E.; Moe, D.; Bond, M.; Gasior, M.; Malamut, R. Abuse-deterrent formulations of prescription opioid analgesics in the management of chronic noncancer pain. Pain Manag. (Lond.), 2016, 6(5), 497-508.
[http://dx.doi.org/10.2217/pmt-2015-0005] [PMID: 27050830]
[29]
Schaeffer, T. Abuse-deterrent formulations, an evolving technology against the abuse and misuse of opioid analgesics. J. Med. Toxicol., 2012, 8(4), 400-407.
[http://dx.doi.org/10.1007/s13181-012-0270-y] [PMID: 23073726]
[30]
Walter, C.; Knothe, C.; Lötsch, J. Abuse-deterrent opioid formulations: Pharmacokinetic and pharmacodynamic considerations. Clin. Pharmacokinet., 2016, 55(7), 751-767.
[http://dx.doi.org/10.1007/s40262-015-0362-3] [PMID: 26719075]
[31]
Mastropietro, D.J.; Omidian, H. Current approaches in tamper-resistant and abuse-deterrent formulations. Drug Dev. Ind. Pharm., 2013, 39(5), 611-624.
[http://dx.doi.org/10.3109/03639045.2012.680468] [PMID: 22537282]
[32]
Mastropietro, D.J.; Omidian, H. Abuse-deterrent formulations: part 1 - development of a formulation-based classification system. Expert Opin. Drug Metab. Toxicol., 2015, 11(2), 193-204.
[http://dx.doi.org/10.1517/17425255.2015.979786] [PMID: 25374404]
[33]
Stanos, S.P.; Bruckenthal, P.; Barkin, R.L. Strategies to reduce the tampering and subsequent abuse of long-acting opioids: Potential risks and benefits of formulations with physical or pharmacologic deterrents to tampering. Mayo Clin. Proc., 2012, 87(7), 683-694.
[http://dx.doi.org/10.1016/j.mayocp.2012.02.022] [PMID: 22766088]
[34]
Maincent, J.; Zhang, F. Recent advances in abuse-deterrent technologies for the delivery of opioids. Int. J. Pharm., 2016, 510(1), 57-72.
[http://dx.doi.org/10.1016/j.ijpharm.2016.06.012] [PMID: 27291971]
[35]
Shah, J.; Rodriguez, R. Are abuse-deterrent opioid products a double-edged sword? Pract. Pain Manag., 2017, 17(4)
[36]
FDA CDER. Challenge of Developing New Pain Medicines - Developing Novel Analgesics and Abuse-Deterrent Opioid Formulations. 2021. Available at: https://www.fda.gov/media/96436/download
[37]
Rauck, R.L. Mitigation of IV abuse through the use of abuse‐deterrent opioid formulations: An overview of current technologies. Pain Pract., 2019, 19(4), 443-454.
[http://dx.doi.org/10.1111/papr.12760] [PMID: 30597739]
[38]
O’Neill, R.; Lor, K.; Pruskowski, J. Abuse-Deterrent opioid formulations #329. J. Palliat. Med., 2017, 20(6), 676-678.
[http://dx.doi.org/10.1089/jpm.2017.0088] [PMID: 28333577]
[39]
Feng, X.; Zidan, A.; Kamal, N.S.; Xu, X.; Sun, D.; Walenga, R.; Boyce, H.; Cruz, C.N.; Ashraf, M. Assessing drug release from manipulated abuse deterrent formulations. AAPS PharmSciTech, 2020, 21(2), 40.
[http://dx.doi.org/10.1208/s12249-019-1595-5] [PMID: 31897805]
[40]
Meruva, S.; Rezaei, L.; Thool, P.; Donovan, M.D.J.A.P. Use of drug release testing to evaluate the retention of abuse-deterrent properties of polyethylene oxide matrix tablets. AAPS PharmSciTech, 2020, 21(7), 270.
[http://dx.doi.org/10.1208/s12249-020-01804-y] [PMID: 33025237]
[41]
CADTH. Environmental scan; no. 62. Opioid Formulations with Tamper-Resistance or Abuse-Deterrent Features- Products and Policies. 2021. Available at: https://www.cadth.ca/sites/default/files/pdf/ES0298EH0034_Abuse_Deterrent_Opioid_Formulations.pdf
[42]
Bettinger, J.; Archer, K.; Pharm, D.; Wegrzyn, E.L.; Fudin, J. Demystifying Opioid Abuse-Deterrent Technologies, A review of existing and emerging ADF products – and their potential implications on the opioid epidemic. Pract. Pain Manag., 2018, 18(7) Available from: https://www.practicalpainmanagement.com/treatments/pharmacological/opioids/demystifying-opioid-abuse-deterrent-technologies
[43]
Fanelli, A.; Sorella, M.C.; Ghisi, D. Morphine sulfate abuse-deterrent formulations for the treatment of chronic pain. Expert Rev. Clin. Pharmacol., 2018, 11(12), 1157-1162.
[http://dx.doi.org/10.1080/17512433.2018.1545573] [PMID: 30403896]
[44]
Nelson, L.S. Are abuse-deterrent opioid formulations all they are crushed up to be? Addiction, 2019, 114(3), 401-402.
[http://dx.doi.org/10.1111/add.14472] [PMID: 30397972]
[45]
FDA CDER. General principles for evaluating the abuse deterrence of generic solid oral opioid drug products guidance for industry 2021. Available at: https://www.fda.gov/files/drugs/published/General-Principles-for-Evaluating-the-Abuse-Deterrence-of-Generic-Solid-Oral-Opioid-Drug-Products-Guidance- for-Industry.pdf
[46]
FDA CDER. Abuse-Deterrent opioids Evaluation and Labeling Guidance for Industry. 2021. Available at: https://www.fda.gov/files/drugs/published/Abuse-Deterrent-Opioids-Evaluation-and-Labeling.pdf
[47]
FDA CDER. FDA’s Actions to address the opioid epidemic 2021. Available at: https://www.fda.gov/files/about%20fda/published/Presentation-FDA%27s-Actions-to-Address-the-Opioid-Epidemic.pdf
[49]
Blaser, M. Antibiotic overuse: Stop the killing of beneficial bacteria. Nature, 2011, 476(7361), 393-394.
[http://dx.doi.org/10.1038/476393a] [PMID: 21866137]
[50]
FDA CDER. OXYCONTIN®, full prescribing information. 2021. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022272s027lbl.pdf
[51]
Litman, R.S.; Pagán, O.H.; Cicero, T.J. Abuse-deterrent opioid formulations. Anesthesiology, 2018, 128(5), 1015-1026.
[http://dx.doi.org/10.1097/ALN.0000000000002031] [PMID: 29252508]
[52]
Arkenau-Maric, E.; Bartholomäus, J.; Kugelmann, H. Abuse-proofed dosage form. U.S. patent 8075872, 2011.
[53]
Bartholomäus, J.; Kugelmann, H.; Arkenau-Marić, E. Abuse-proofed dosage form. U.S. patent 8309060, 2012.
[54]
Crowley, M.M.; Zhang, F.; Koleng, J.J.; McGinity, J.W. Stability of polyethylene oxide in matrix tablets prepared by hot-melt extrusion. Biomaterials, 2002, 23(21), 4241-4248.
[http://dx.doi.org/10.1016/S0142-9612(02)00187-4] [PMID: 12194527]
[55]
Zhang, F.; McGinity, J.W. Properties of sustained-release tablets prepared by hot-melt extrusion. Pharm. Dev. Technol., 1999, 4(2), 241-250.
[http://dx.doi.org/10.1081/PDT-100101358] [PMID: 10231885]
[56]
Erin, K.; Ahmed, E.; Saad, M. Legislative initiatives and review of abuse-deterrent opioid formulations. US Pharm., 2013, 38(10), 21-26.
[57]
Bar-Shalom, D.; Slot, L.; Lee, W.W.; Wilson, C.G. Development of the Egalet technology. In: Modified-Release Drug Delivery Technology; Rathbone, M.J.; Hadgraft, J.; Roberts, M.S., Eds.; Mercel Dekker: NewYork, 2003; 126, pp. 263-271.
[58]
Tygesen, P.H.; Oevergaard, J.M.; Lindhardt, K.; Lyhne-Iversen, L.I.; Olsen, M.R.; Haahr, A-M.; Hoellund-Jensen, J.A.; Hemmingsen, P.K.H. Pharmaceutical compositions resistant to abuse. U.S. patent 8603526, 2013.
[59]
Rahman, Z.; Zidan, A.S.; Korang-Yeboah, M.; Yang, Y.; Siddiqui, A.; Shakleya, D.; Khan, M.A.; Cruz, C.; Ashraf, M. Effects of excipients and curing process on the abuse deterrent properties of directly compressed tablets. Int. J. Pharm., 2017, 517(1-2), 303-311.
[http://dx.doi.org/10.1016/j.ijpharm.2016.12.015] [PMID: 27956191]
[60]
FDA CDER. TARGINIQ ER, full prescribing information. 2021. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205777lbl.pdf
[61]
Purdue Pharma, L.P. FDA accepts for review Purdue Pharma’s new drug application for Targiniq™ ER (oxycodone HCl/naloxone HCl controlled-release) tablets CII. 2021. Available at: https://www.prnewswire.com/news-releases/fda-accepts-for-review-purdue-pharmas-new-drug-application-for-targiniq-er-oxycodone-hclnaloxone-hcl-controlled-release-tablets-cii-233441891.html
[62]
Inspirion Delivery Technologies L.L.C. Inspirion delivery technologies receives fda approval for morphabond™(morphine sulfate) extended-release tablets cii, an opioid analgesic formulated with abuse-deterrent properties. 2021. Available at: https://www.prnewswire.com/news-releases/inspirion-delivery-technologies-receives-fda-approval-for-morphabond-morphine-sulfate-extended-release-tablets-cii-an-opioid-analgesic-formulated-with-abuse-deterrent-properties-300153910.html
[63]
Shah, M.S.; Difalco, R.J. Abuse resistant drugs, method of use and method of making. U.S. patent 10729657, 2020.
[64]
Mastropietro, D.J.; Omidian, H. Abuse-deterrent formulations: Part 2: Commercial products and proprietary technologies. Expert Opin. Pharmacother., 2015, 16(3), 305-323.
[http://dx.doi.org/10.1517/14656566.2014.970175] [PMID: 25421961]
[65]
Opioids, A-D. A new abuse-deterrent opioid-xtampza ER. JAMA, 2016, 316(9), 986-987.
[http://dx.doi.org/10.1001/jama.2016.9540] [PMID: 27599334]
[66]
Lamb, Y.N.; Garnock-Jones, K.P.; Keam, S.J. Oxycodone deteRx® ER capsules: A review in severe, chronic pain. Drugs, 2016, 76(18), 1759-1769.
[http://dx.doi.org/10.1007/s40265-016-0660-6] [PMID: 27832472]
[67]
Gudin, J. Oxycodone DETERx®: A novel abuse-deterrent, extended-release analgesic option for the treatment of patents with chronic pain. Pain Ther., 2016, 5(2), 171-186.
[http://dx.doi.org/10.1007/s40122-016-0062-1] [PMID: 27873179]
[68]
Mayock, S.P.; Saim, S.; Fleming, A.B. In vitro drug release after crushing: Evaluation of Xtampza® ER and other ER opioid formulations. Clin. Drug Investig., 2017, 37(12), 1117-1124.
[http://dx.doi.org/10.1007/s40261-017-0561-9] [PMID: 28940174]
[69]
Gudin, J.; Levy-Cooperman, N.; Kopecky, E.A.; Fleming, A.B. Comparing the effect of tampering on the oral pharmacokinetic profiles of two extended-release oxycodone formulations with abuse-deterrent properties. Pain Med., 2015, 16(11), 2142-2151.
[http://dx.doi.org/10.1111/pme.12834] [PMID: 26108255]
[70]
Liang, A.; Matthews, F.; Boehm, G.; Tang, L.; Johnson, F.; Stauffer, J. Pharmaceutical composition. U.S. patent 8623418, 2014.
[71]
Matthews, F.; Boehm, G.; Tang, L.; Liang, A. Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist. U.S. patent 8158156, 2012.
[72]
Matthews, F.; Boehm, G.; Tang, L.; Liang, A. Pharmaceutical composition comprising an opioid antagonist and an opioid agonist. U.S. patent 8877247, 2014.
[73]
Johnson, F.; Setnik, B.; Inc, C.; Bridgewater, N.; Johnson, F. Morphine sulfate and naltrexone hydrochloride extended-release capsules: naltrexone release, pharmacodynamics, and tolerability. Pain Physician, 2011, 14(4), 391-406.
[http://dx.doi.org/10.36076/ppj.2011/14/391] [PMID: 21785483]
[74]
FDA CDER. ARYMO, ER, Full prescribing information. 2021. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208603s000lbl.pdf
[75]
Butreddy, A.; Nyavanandi, D.; Narala, S.; Austin, F.; Bandari, S. Application of hot melt extrusion technology in the development of abuse-deterrent formulations: An overview. Curr. Drug Deliv., 2021, 18(1), 4-18.
[http://dx.doi.org/10.2174/1567201817999200817151601] [PMID: 32811398]
[76]
Nukala, P.K.; Palekar, S.; Patki, M.; Patel, K. Abuse deterrent immediate release egg-shaped tablet (egglets) using 3D printing technology: Quality by design to optimize drug release and extraction. AAPS PharmSciTech, 2019, 20(2), 80.
[http://dx.doi.org/10.1208/s12249-019-1298-y] [PMID: 30645704]
[77]
Butreddy, A.; Sarabu, S.; Dumpa, N.; Bandari, S.; Repka, M.A. Extended release pellets prepared by hot melt extrusion technique for abuse deterrent potential: Category-1 in vitro evaluation. Int. J. Pharm., 2020, 587, 119624.
[http://dx.doi.org/10.1016/j.ijpharm.2020.119624] [PMID: 32653597]
[78]
Ong, J.J.; Awad, A.; Martorana, A.; Gaisford, S.; Stoyanov, E.; Basit, A.W.; Goyanes, A. 3D printed opioid medicines with alcohol-resistant and abuse-deterrent properties. Int. J. Pharm., 2020, 579, 119169.
[http://dx.doi.org/10.1016/j.ijpharm.2020.119169] [PMID: 32087263]
[79]
Palekar, S.; Kumar Nukala, P.; Vartak, R.; Patel, K. Abuse deterrent immediate release film technology (ADRIFT): A novel bilayer film technology for limiting intentional drug abuse. Int. J. Pharm., 2020, 590, 119944.
[http://dx.doi.org/10.1016/j.ijpharm.2020.119944] [PMID: 33011254]
[80]
Soni, A. Development and Characterization of Bilayer Abuse Deterrent Extended Release Tablet Using Various Model Drugs for Opioids Overdose Crisis., 2021.
[81]
U.S. Food and Drug Administration. Questions and answers: FDA approves a risk evaluation and mitigation strategy (REMS) for extendedrelease and long-acting (ER/LA) opioid analgesics. 2021. Available at: https://www.fda.gov/drugs/information-drug- class/questions-and-answers-fda-approves-risk-evaluation-and-mitigation-strategy-rems-extended-release-and
[82]
Prince, V. Pain management in patents with substance-use disorders. Chronic illnesses, 2001, 171-85.
[83]
Gudin, J. Risk evaluation and mitigation strategies (REMS) for extended-release and long-acting opioid analgesics: Considerations for palliative care practice. J. Pain Palliat. Care Pharmacother., 2012, 26(2), 136-143.
[http://dx.doi.org/10.3109/15360288.2012.679724] [PMID: 22764852]
[84]
Dharmadhikari, N.B.; Zala, Y.R.; Shanghvi, D. Abuse deterrent immediate release biphasic matrix solid dosage form. U.S. patent 9642811, 2017.
[85]
Medgadget. RESPMETER Opioid Overdose Detector Wins FDA Breakthrough Device Status. https://www.medgadget.com/2020/03/respmeter-opioid-overdose-detector-wins-fda-breakthrough-device-status.html
[86]
Altair Medical. Altair medical awarded FDA breakthrough device status to address the global opioid crisis. Available at: https://www.altairmedical.com/news-articles/2020/20200210_fda.html
[87]
Singh, R.; Lillard, J.W. Jr. Nanoparticle-based targeted drug delivery. Exp. Mol. Pathol., 2009, 86(3), 215-223.
[http://dx.doi.org/10.1016/j.yexmp.2008.12.004] [PMID: 19186176]
[88]
Med-Botics. OXALERT EPO, Prevention of opioid-induced respiratory depression and death. Available at: https://www.med-botics.com
[89]
Bridge, The opioid withdrawal therapy device, released by Masimo. Medgadget; , 2020.
[90]
First electronic device for opioid withdrawal therapy approved by FDA. In: Medgadget; 2017.
[91]
First electronic device for opioid withdrawal therapy approved by FDA. Medgadget, 2021. Available at: https://i-h-s.com/products/bridge/

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy