References
- Abashzadeh, S., et al., 2011. Formulation and evaluation of an in situ gel forming system for controlled delivery of triptorelin acetate. European journal of pharmaceutical sciences, 44 (4), 514–521.
- Al-Khattawi, A., et al., 2018. The design and scale-up of spray dried particle delivery systems. Expert opinion on drug delivery, 15 (1), 47–63.
- Anderson, M.G., and Miller, J.D., 1997. Therapeutic effects of leuprorelin microspheres on endometriosis and uterine leiomyomata. Advanced drug delivery reviews, 28 (1), 139–155.
- Blasi, P., 2019. Poly(lactic acid)/poly(lactic-co-glycolic acid)-based microparticles: an overview. Journal of pharmaceutical investigation, 49 (4), 337–346.
- Cakmak, H., and Rosen, M.P., 2015. Random-start ovarian stimulation in patients with cancer. Current opinion in obstetrics & gynecology, 27 (3), 215–221.
- Cal, K., and Sollohub, K., 2010. Spray drying technique. I: hardware and process parameters. Journal of pharmaceutical sciences, 99 (2), 575–586.
- Chaisri, W., et al., 2011. Enhanced gentamicin loading and release of PLGA and PLHMGA microspheres by varying the formulation parameters. Colloids and surfaces. B, biointerfaces, 84 (2), 508–514.
- Chen, L., et al., 2019. Novel triptorelin acetate-loaded microspheres prepared by a liquid/oil/oil method with high encapsulation efficiency and low initial burst release. Journal of drug delivery science and technology, 54, 101390.
- Crawford, E., et al., 2015. Extended release, 6-month formulations of leuprolide acetate for the treatment of advanced prostate cancer: achieving testosterone levels below 20 ng/dl. Expert opinion on drug metabolism & toxicology, 11 (9), 1465–1474.
- D’souza, S., et al., 2014. In vitro characterization of six month dosage forms for a GnRH antagonist. Advances in pharmaceutics, 2014, 1–10.
- Feng, S., et al., 2015. Effects of drug and polymer molecular weight on drug release from PLGA-mPEG microspheres. Journal of applied polymer science, 132 (6), n/a–n/a.
- Han, J., et al., 2018. Polymer-based nanomaterials and applications for vaccines and drugs. Polymers, 10 (1), 31.
- Hirota, K., et al., 2016. Characterizing release mechanisms of leuprolide acetate-loaded PLGA microspheres for IVIVC development I: in vitro evaluation. Journal of controlled release, 244 (Pt B), 302–313.
- Islam, M.A., et al., 2012. Design and application of chitosan microspheres as oral and nasal vaccine carriers: an updated review. International journal of nanomedicine, 7, 6077–6093.
- Kakade, S., and Dehghan, M.H., 2018. Effects of formulation parameters on the characteristics of biodegradable microspheres of goserelin acetate. Asian journal of pharmaceutics, 12, S691.
- Kim, M., et al., 2022. New long-acting injectable microspheres prepared by IVL-DrugFluidic™ system: 1-month and 3-month in vivo drug delivery of leuprolide. International journal of pharmaceutics, 622, 121875.
- Knowles, J., et al., 2022. Effects of gonadotropin-releasing hormone agonist administered in microparticles on sperm quality and quantity, and plasma sex steroid levels in northern pike. Animal, 16 (1), 100430.
- Kostanski, J.W., et al., 2000. A novel in vitro release technique for peptide containing biodegradable microspheres. AAPS PharmSciTech, 1 (4), 4–16.
- Kumar, P., and Sharma, A., 2014. Gonadotropin-releasing hormone analogs: understanding advantages and limitations. Journal of human reproductive sciences, 7 (3), 170–174.
- Lee, B.K., Yun, Y., and Park, K., 2016. PLA micro- and nano-particles. Advanced drug delivery reviews, 107, 176–191.
- Lee, D.-S., et al., 2020. Development of level A in vitro-vivo correlation for electrosprayed microspheres containing leuprolide: physicochemical, pharmacokinetic, and pharmacodynamic evaluation. Pharmaceutics, 12 (1), 36.
- Liu, W., Yang, X.L., and Ho, W.S., 2011. Preparation of uniform-sized multiple emulsions and micro/nano particulates for drug delivery by membrane emulsification. Journal of pharmaceutical sciences, 100 (1), 75–93.
- Luan, X., and Bodmeier, R., 2006. In situ forming microparticle system for controlled delivery of leuprolide acetate: influence of the formulation and processing parameters. European journal of pharmaceutical sciences, 27 (2–3), 143–149.
- Makadia, H.K., and Siegel, S.J., 2011. Poly lactic-co-glycolic acid (PLGA) as biodegradable controlled drug delivery carrier. Polymers, 3 (3), 1377–1397.
- Mallardé, D., et al., 2003. PLGA-PEG microspheres of teverelix: influence of polymer type on microsphere characteristics and on teverelix in vitro release. International journal of pharmaceutics, 261 (1–2), 69–80.
- Mao, S., et al., 2012. Recent advances in polymeric microspheres for parenteral drug delivery–part 1. Expert opinion on drug delivery, 9 (9), 1161–1176.
- Mao, S., et al., 2007. Effect of WOW process parameters on morphology and burst release of FITC-dextran loaded PLGA microspheres. International journal of pharmaceutics, 334 (1–2), 137–148.
- Mckeage, K., and Lyseng-Williamson, K.A., 2017. Triptorelin 3- and 6-month sustained-release formulations in locally advanced or metastatic prostate cancer: a profile of their use in the EU. Drugs & therapy perspectives, 33 (7), 321–325.
- Mostafa, N.M., et al., 2014. Evaluation of the pharmacokinetics and pharmacodynamics of two leuprolide acetate 45 mg 6-month depot formulations in patients with prostate cancer. Clinical pharmacology in drug development, 3 (4), 270–275.
- Ng, S.-M., et al., 2010. Novel microencapsulation of potential drugs with low molecular weight and high hydrophilicity: hydrogen peroxide as a candidate compound. International journal of pharmaceutics, 384 (1–2), 120–127.
- Okada, H., et al., 1994. Preparation of three-month depot injectable microspheres of leuprorelin acetate using biodegradable polymers. Pharmaceutical research, 11 (8), 1143–1147.
- Okada, H., 1997. One- and three-month release injectable microspheres of the LH-RH superagonist leuprorelin acetate. Advanced drug delivery reviews, 28 (1), 43–70.
- Ozyigit, G., et al., 2019. Prognostic significance of castrate testosterone levels for patients with intermediate and high risk prostate cancer. World journal of clinical oncology, 10 (8), 283–292.
- Panigrahi, D., et al., 2021. Quality by design prospects of pharmaceuticals application of double emulsion method for PLGA loaded nanoparticles. SN applied sciences, 3 (6), 638.
- Park, K., et al., 2012. Triptorelin acetate-loaded poly(lactide-co-glycolide) (PLGA) microspheres for controlled drug delivery. Macromolecular research, 20 (8), 847–851.
- Park, S., et al., 2017. Comparative in vitro release and clinical pharmacokinetics of leuprolide from luphere 3M depot, a 3-month release formulation of leuprolide acetate. Drug development and industrial pharmacy, 43 (3), 441–447.
- Periti, P., Mazzei, T., and Mini, E., 2002. Clinical pharmacokinetics of depot leuprorelin. Clinical pharmacokinetics, 41 (7), 485–504.
- Piacentini, E., Drioli, E., and Giorno, L., 2014. Membrane emulsification technology: twenty-five years of inventions and research through patent survey. Journal of membrane science, 468, 410–422.
- Qi, F., et al., 2014. Comparative studies on the influences of primary emulsion preparation on properties of uniform-sized exenatide-loaded PLGA microspheres. Pharmaceutical research, 31 (6), 1566–1574.
- Qi, P., et al., 2019. Goserelin acetate loaded poloxamer hydrogel in PLGA microspheres: core-shell di-depot intramuscular sustained release delivery system. Molecular pharmaceutics, 16 (8), 3502–3513.
- Ramazani, F., et al., 2016. Strategies for encapsulation of small hydrophilic and amphiphilic drugs in PLGA microspheres: State-of-the-art and challenges. International journal of pharmaceutics, 499 (1–2), 358–367.
- Ravivarapu, H.B., Lee, H., and Deluca, P.P., 2000a. Enhancing initial release of peptide from poly(d,l-lactide-co-glycolide) (PLGA) microspheres by addition of a porosigen and increasing drug load. Pharmaceutical development and technology, 5 (2), 287–296.
- Ravivarapu, H.B., Moyer, K.L., and Dunn, R.L., 2000b. Sustained activity and release of leuprolide acetate from an in situ forming polymeric implant. AAPS PharmSciTech, 1 (1), 1–8.
- Rodríguez-Vázquez, M., et al., 2015. Chitosan and its potential use as a scaffold for tissue engineering in regenerative medicine. BioMed research international, 2015, 821279.
- Schneider, F., Tomek, W., and Gründker, C., 2006. Gonadotropin-releasing hormone (GnRH) and its natural analogues: a review. Theriogenology, 66 (4), 691–709.
- Schwach, G., et al., 2004. Biodegradable PLGA microparticles for sustained release of a new GnRH antagonist: part II. In vivo performance. European journal of pharmaceutics and biopharmaceutics, 57 (3), 441–446.
- Shi, N.-Q., et al., 2020. Microencapsulation of luteinizing hormone-releasing hormone agonist in poly (lactic-co-glycolic acid) microspheres by spray-drying. Journal of controlled release, 321, 756–772.
- Soo-Ling, B., et al., 2018. Approaches to improve therapeutic efficacy of biodegradable PLA/PLGA microspheres: a review. Polymer reviews, 58 (3), 495–536.
- Tamber, H., et al., 2005. Formulation aspects of biodegradable polymeric microspheres for antigen delivery. Advanced drug delivery reviews, 57 (3), 357–376.
- Teutonico, D., Montanari, S., and Ponchel, G., 2012. Leuprolide acetate: pharmaceutical use and delivery potentials. Expert opinion on drug delivery, 9 (3), 343–354.
- Wang, N., et al., 2013. Preparation of triptorelin acetate-loaded PLGA microspheres by premix membrane emulsification. Guocheng gongcheng xuebao/the chinese journal of process engineering, 13, 862–869.
- Witt, R.R., et al., 2016. Ovarian suppression in a marsupial following single treatment with a gonadotrophin-releasing hormone agonist in microspheres. Reproduction, fertility, and development, 28 (12), 1964–1973.
- Woo, B.H., et al., 2001. Preparation, characterization and in vivo evaluation of 120-day poly(d,l-lactide) leuprolide microspheres. Journal of controlled release, 75 (3), 307–315.
- Wu, J., et al., 2015. Uniform-sized particles in biomedical field prepared by membrane emulsification technique. Chemical engineering science, 125, 85–97.
- Zhang, K., et al., 2014. PEG-PLGA copolymers: their structure and structure-influenced drug delivery applications. Journal of controlled release, 183, 77–86.
- Zhou, J., et al., 2018. Reverse engineering the 1-month Lupron Depot®. The AAPS journal, 20 (6), 105.
- Zhou, J., et al., 2020. Effect of manufacturing variables and raw materials on the composition-equivalent PLGA microspheres for 1-month controlled release of leuprolide. Molecular pharmaceutics, 17 (5), 1502–1515.
- Zhu, G., and Schwendeman, S.P., 2000. Stabilization of proteins encapsulated in cylindrical poly(lactide-co-glycolide) implants: mechanism of stabilization by basic additives. Pharmaceutical research, 17 (3), 351–357.