Long-acting intrauterine systems: Recent advances, current challenges, and future opportunities

Bayarri, 2015, Drug-device combination products: regulatory landscape and market growth, Drugs Today (Barc.), 51, 505, 10.1358/dot.2015.51.8.2376223 Mirena FDA label, https://wwwaccessdatafdagov/drugsatfda_docs/label/2021/021225s042lblpdf (accessed 28 March 2022). Hormonal IUS knowledgebase, https://wwwmayoclinicorg/tests-procedures/mirena/about/pac-20391354 (accessed 11 March 2022). Rademacher, 2018, A global learning agenda for the levonorgestrel intrauterine system (LNG IUS): addressing challenges and opportunities to increase access, Glob. Health: Sci. Pract., 6, 635 Centers for Disease Control and Prevention, https://wwwcdcgov/reproductivehealth/contraception/indexhtm (accessed 5 April 2022). Trussell, 2011, Contraceptive failure in the United States, Contraception, 83, 397, 10.1016/j.contraception.2011.01.021 (WHO) WHO, 19th WHO Model List of Essential Medicines, https://wwwwhoint/medicines/publications/essentialmedicines/EML2015_8-May-15pdf?ua=1 (accessed 24 March 2022). Hubacher, 2015, The levonorgestrel intrauterine system: reasons to expand access to the public sector of Africa, Glob. Health: Sci. Pract., 3, 532 Bao, 2018, Manufacturing and characterization of long-acting levonorgestrel intrauterine systems, Int. J. Pharm., 550, 447, 10.1016/j.ijpharm.2018.09.004 Bao, 2020, Impact of product design parameters on in vitro release from intrauterine systems, Int. J. Pharm., 578, 10.1016/j.ijpharm.2020.119135 Fanse, 2021, Effect of crosslinking on the physicochemical properties of polydimethylsiloxane-based levonorgestrel intrauterine systems, Int. J. Pharm., 609, 10.1016/j.ijpharm.2021.121192 Bao, 2019, Drug release testing of long-acting intrauterine systems, J. Control. Release, 316, 349, 10.1016/j.jconrel.2019.11.015 Liletta FDA label, https://wwwaccessdatafdagov/drugsatfda_docs/label/2019/206229s008lblpdf (accessed 28 March 2022). A. Colas, L. Rudolf, J. Curtis, Silicone Biomaterials: History and Chemistry & Medical Applications of Silicones. An Introduction to Materials in Medicine. Biomaterials Science, second edition, Elsevier, 2004. Kuo, 1999 Momentive, Silicone elastomers product guide, https://wwwpolymershapescom/wp-content/uploads/2020/04/Polymershapes_Momentive_Brochure-Silicone-Elastomerspdf (accessed 14 April 2022). Fanse, 2022, Impact of polymer crosslinking on release mechanisms from long-acting levonorgestrel intrauterine systems, Int. J. Pharm., 612, 10.1016/j.ijpharm.2021.121383 Guerrero, 1977, Age-old methods of contraception, Initiatives Popul., 3, 20 Ancient birth control methods, https://flohealth/menstrual-cycle/sex/birth-control/ancient-birth-control-methods (accessed 4 May 2022). Mbabajende, 1986, Historical survey of modern reversible contraceptive methods, Imbonezamuryango., 5, 14 Bhatt, 2021, A critical review and scientific prospective on contraceptive therapeutics from Ayurveda and allied ancient knowledge, Front. Pharmacol., 12 Quarini, 2005, History of contraception, Women's Health Med., 2, 28, 10.1383/wohm.2005.2.5.28 A. Buttar, S. Seward, “Enovid: The First Hormonal Birth Control Pill”, Embryo Project Encyclopedia, 2009 (accessed 4 May 2022). S.W. Junod, US Food and Drug Administration, 1998, https://www.fda.gov/media/110456/download (accessed 3 May 2022). Peipert, 2018, Lippes loop and the first IUDs: lessons from a bygone era, Am. J. Obstet. Gynecol., 219, 127, 10.1016/j.ajog.2018.06.001 Hubacher, 2002, The checkered history and bright future of intrauterine contraception In the United States, Perspect. Sex. Reprod. Health, 34, 98, 10.2307/3030213 R. Horwitz, “The Dalkon Shield”, Embryo Project Encyclopedia, 2018 (accessed 29 April 2022). Jennifer, 2014, Sterilization as cyborg performance: reproductive freedom and the regulation of sterilization, Front.: J. Women Stud., 35, 107, 10.5250/fronjwomestud.35.1.0107 Paragard FDA label, https://wwwaccessdatafdagov/drugsatfda_docs/label/2019/018680s069s070lblpdf (accessed 11 March 2022). K. Trieman, L. Liskin, A. Kols, W. Rinehart, Johns Hopkins School of Public Health, Population Information Program, Baltimore, MD, 1995, IUDs-an update. Population Reports, Series B. (6). Haupt, 1989, Norplant implant now a step closer to U.S. use, Popul. Today, 17, 4 Green, 2013, The FDA, contraceptive marketing approval and products liability litigation: Depo-Provera and the risk of osteoporosis, Food Drug Law J., 68, 115 Weismiller, 2004, Emergency contraception, Am. Fam. Phys., 70, 707 Christin-Maitre, 2013, History of oral contraceptive drugs and their use worldwide, Best Pract. Res. Clin. Endocrinol. Metabol., 27, 3, 10.1016/j.beem.2012.11.004 Leblanc, 1999, Benefits and risks of third-generation oral contraceptives, J. Gen. Intern. Med., 14, 625, 10.1046/j.1525-1497.1999.08108.x Mirena Prescribing Information, https://wwwmirena-uscom (accessed 17 March 2022). Yoost, 2014, Understanding benefits and addressing misperceptions and barriers to intrauterine device access among populations in the United States, Patient Prefer Adherence, 8, 947, 10.2147/PPA.S45710 Sivin, 1990, Long-term contraception with the levonorgestrel 20 mcg/day (LNg 20) and the copper T 380Ag intrauterine devices: a five-year randomized study, Contraception, 42, 361, 10.1016/0010-7824(90)90046-X Andersson, 1994, Levonorgestrel-releasing and copper-releasing (Nova T) IUDs during five years of use: a randomized comparative trial, Contraception, 49, 56, 10.1016/0010-7824(94)90109-0 Britton, 2020, CE: an evidence-based update on contraception, Am. J. Nurs., 120, 22, 10.1097/01.NAJ.0000654304.29632.a7 Beatty, 2009, The levonorgestrel-releasing intrauterine system: safety, efficacy, and patient acceptability, Ther. Clin. Risk Manag., 5, 561 Peipert, 2012, Preventing unintended pregnancies by providing no-cost contraception, Obstet. Gynecol., 120, 1291, 10.1097/AOG.0b013e318273eb56 Pohjoranta, 2020, Early provision of intrauterine contraception as part of abortion care-5-year results of a randomised controlled trial, Hum. Reprod., 35, 796, 10.1093/humrep/deaa031 Stoddard, 2011, Efficacy and safety of long-acting reversible contraception, Drugs, 71, 969, 10.2165/11591290-000000000-00000 Sitruk-Ware, 2013, Contraception technology: past, present and future, Contraception, 87, 319, 10.1016/j.contraception.2012.08.002 Sitruk-Ware, 2005, The levonorgestrel intrauterine system: long-term contraception and therapeutic effects, Womens Health (Lond.), 1, 171, 10.2217/17455057.1.2.171 Lowe, 2013, Hemoglobin and serum ferritin levels in women using copper-releasing or levonorgestrel-releasing intrauterine devices: a systematic review, Contraception, 87, 486, 10.1016/j.contraception.2012.09.025 Ontario, 2016, Levonorgestrel-releasing intrauterine system (52 mg) for idiopathic heavy menstrual bleeding: a health technology assessment, Ont. Health Technol. Assess. Ser., 16, 1 Intrauterine Devices (IUDs): access for Women in the US, 2020, https://wwwkfforg/womens-health-policy/fact-sheet/intrauterine-devices-iuds-access-for-women-in-the-u-s/(accessed 24 April 2022). Secura, 2010, The contraceptive CHOICE project: reducing barriers to long-acting reversible contraception, Am. J. Obstet. Gynecol., 203, 115.e1, 10.1016/j.ajog.2010.04.017 Suhonen, 2004, Clinical performance of a levonorgestrel-releasing intrauterine system and oral contraceptives in young nulliparous women: a comparative study, Contraception, 69, 407, 10.1016/j.contraception.2003.11.008 Attia, 2013, Role of the levonorgestrel intrauterine system in effective contraception, Patient Prefer Adherence, 7, 777 Gemzell-Danielsson, 2021, Thirty years of mirena: a story of innovation and change in women's healthcare, Acta Obstet. Gynecol. Scand., 100, 614, 10.1111/aogs.14110 Phillips, 2003, The effects of the levonorgestrel intrauterine system (Mirena coil) on endometrial morphology, J. Clin. Pathol., 56, 305, 10.1136/jcp.56.4.305 Taraborrelli, 2015, Physiology, production and action of progesterone, Acta Obstet. Gynecol. Scand., 94, 10.1111/aogs.12771 Dinehart, 2020, Levonorgestrel IUD: is there a long-lasting effect on return to fertility?, J. Assist. Reprod. Genet., 37, 45, 10.1007/s10815-019-01624-5 Pieńkowska, 2015, Review of current pharmaceutical applications of polysiloxanes (silicones), 363 Colas, 2004 Linear Polydimethylsiloxanes, https://wwwecetocorg/wp-content/uploads/2014/08/JACC-026pdf (accessed 27 March 2022). OSHA Reproductive Hazards, https://wwwoshagov/reproductive-hazards/hazards (accessed 15 April 2022). Noll, 1968 M. Andriot, J.V. DeGroot, R. Meeks, E. Gerlach, M. Jungk, A.T. Wolf, et al., Silicones in Industrial Applications, Dow Corning Europe, Dow Corning Healthcare Industries, https://citeseerxistpsuedu/viewdoc/download?doi=10115291841&rep=rep1&type=pdf (accessed 24 March 2022). Arkles, 2013 Lassen, 2005 Olewnik-Kruszkowska, 2020, Effect of diatomaceous biosilica and talc on the properties of dielectric elastomer based composites, Energies, 13, 10.3390/en13215828 Sumi, 2012, Effect of colloidal silica dispersions on the properties of PDMS-colloidal silica composites, J. Appl. Polym. Sci., 125, E515, 10.1002/app.36226 Noll, 1968, Chapter 4 - Organosilanes with Organofunctional Groups, 124 Flacktek, https://speedmixercom/the-technology/(accessed 19 April 2022). Drobny, 2014, 4 - Processing Methods Applicable to Thermoplastic Elastomers, 33 Wacker, Solid and liquid silicone rubber- material and processing guidelines, https://wwwwackercom/h/medias/6709-ENpdf (acessed 13 April 2022). Arburg. Silicone injection moulding, https://wwwarburgcom/fileadmin/redaktion/mediathek/prospekte/arburg_silicone_526416_en_gb/# (accessed 14 April 2022). Duesterberg, 2013 Promed Pharma, Pharmaceutical Combination products, https://promedmoldingcom/promed-pharma/(accessed 23 April 2022). Tommi, 2001 Ng, 2017, In vivo oxygen, temperature and pH dynamics in the female reproductive tract and their importance in human conception: a systematic review, Hum. Reprod. Update, 24, 15, 10.1093/humupd/dmx028 H. Jukareinen, K. Markkulla, J. Ala-Sorvari, M. Lehtinen, J. Ruohonen, Membrane or matrix for controlling the permeation rate of drugs. US Patent application, Schering Oy, 2002. Mikolaszek, 2020, Controlled drug release by the pore structure in polydimethylsiloxane transdermal patches, Polymers, 12, 10.3390/polym12071520 Chien, 1987, Controlled release of biologically active agents, J. Pharm. Sci., 77, 371, 10.1002/jps.2600770422 Nusil Product Guide, Avantor sciences, https://www.avantorsciences.com/pages/en/drug-delivery (accessed 18 April 2022). Skyla FDA label, https://wwwaccessdatafdagov/drugsatfda_docs/label/2017/203159s007lblpdf (accessed 13 March 2022). Kyleena FDA label, https://wwwaccessdatafdagov/drugsatfda_docs/label/2016/208224s000lblpdf (accessed 13 March 2022). F. Suraj, B. Quanying, B. Diane, Development of accelerated in vitro drug release testing methods for long-acting levonorgestrel intrauterine systems (unpublished). M. Rockville, FDA Guidance for Industry: extended release oral dosage forms: development, evaluation and application of in vitro/in vivo correlation, 1997. BP2. Nuventra, ‘What is IVIVC?’ 2019, https://wwwnuventracom/resources/blog/what-is-ivivc/(accessed 23 April 2022). Shen, 2015, In vitro–in vivo correlation for complex non-oral drug products: where do we stand?, J. Control. Release, 219, 644, 10.1016/j.jconrel.2015.09.052 Burgess, 2004, Assuring quality and performance of sustained and controlled release parenterals, Eur. J. Pharm. Sci., 21, 679, 10.1016/j.ejps.2004.03.001 Zhou, 2010, Dissolution and in vitro-in vivo correlation: understanding biopharmaceutics properties for pharmaceutical product development and manufacturing II, J. Validat. Technol., 57 Yarbrough, 2015, Antimicrobial peptides in the female reproductive tract: a critical component of the mucosal immune barrier with physiological and clinical implications, Hum. Reprod. Update, 21, 353, 10.1093/humupd/dmu065 Patel, 2021, Drug delivery strategies for management of women’s health issues in the upper genital tract, Adv. Drug Deliv. Rev., 177, 10.1016/j.addr.2021.113955 Piccinato, 2017, Is cytochrome P450 3A4 regulated by menstrual cycle hormones in control endometrium and endometriosis?, Mol. Cell. Biochem., 427, 81, 10.1007/s11010-016-2899-3 Schnyer, 2019, Do menstrual cups increase risk of IUD expulsion? A survey of self-reported IUD and menstrual hygiene product use in the United States, Eur. J. Contracept. Reprod. Health Care, 24, 368, 10.1080/13625187.2019.1643836 FDA. Combination Products Guide, 2018, https://wwwfdagov/combination-products/about-combination-products/combination-product-definition-combination-product-types (accessed 25 April 2022). FDA, Current good manufacturing practice requirements for combination products, 2017, https://wwwfdagov/regulatory-information/search-fda-guidance-documents/current-good-manufacturing-practice-requirements-combination-products (accessed 25 April 2022). FDA, Classification of Products as Drugs and Devices and Additional Product Classification Issues, 2017, https://wwwfdagov/regulatory-information/search-fda-guidance-documents/classification-products-drugs-and-devices-and-additional-product-classification-issues (accessed 25 April 2022). FDA, Bridging for Drug-Device and Biologic-Device Combination Products, 2019, https://wwwfdagov/regulatory-information/search-fda-guidance-documents/bridging-drug-device-and-biologic-device-combination-products (accessed 25 April 2022). FDA, Principles of Premarket Pathways for Combination Products, 2022, https://wwwfdagov/regulatory-information/search-fda-guidance-documents/principles-premarket-pathways-combination-products (accessed 28 April 2022). Lewis, 2012, 11 - Methods for the characterisation and evaluation of drug-device combination products, 233 FDA, Introduction to Complex Products and FDA Considerations, 2017, https://wwwfdagov/media/108937/download. Lionberger, 2008, FDA critical path initiatives: opportunities for generic drug development, AAPS J., 10, 103, 10.1208/s12248-008-9010-2 FDA, Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA, 2020, https://wwwfdagov/media/107626/download (accessed 2 May 2022). Liu, 2018, Test method selection and specification setting in stability testing for combination medical device products, J. GXP Compliance Klein, 2021, A pragmatic regulatory approach for complex generics through the U.S. FDA 505(j) or 505(b)(2) approval pathways, Ann. N. Y. Acad. Sci., 1502, 5, 10.1111/nyas.14662 Tian, 2022, Regulatory perspectives of combination products, Bioact. Mater., 10, 492, 10.1016/j.bioactmat.2021.09.002 Gemzell-Danielsson, 2021, More than just contraception: the impact of the levonorgestrel-releasing intrauterine system on public health over 30 years, BMJ Sex. Reprod. Health, 47, 228, 10.1136/bmjsrh-2020-200962 Rademacher, 2016, Expanding access to a new, more affordable levonorgestrel intrauterine system in Kenya: service delivery costs compared with other contraceptive methods and perspectives of key opinion leaders, Glob. Health Sci. Pract., 4, S83, 10.9745/GHSP-D-15-00327 Adedini, 2019, Trends, patterns and determinants of long-acting reversible methods of contraception among women in sub-Saharan Africa, PLoS ONE, 14, e0217574, 10.1371/journal.pone.0217574 Domsta, 2021, 3D-printing of drug-eluting implants: an overview of the current developments described in the literature, Molecules, 26, 10.3390/molecules26134066 Wang, 2021, Application of 3D printing in implantable medical devices, Biomed Res. Int., 2021, 6653967 FDA Draft Guidance on Levonorgestrel, 2020, https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021225.pdf (accessed 3 May 2022).