سامانه های آهسته رهش پلیمری هورمون رشد

نوع مقاله: تالیفی

نویسندگان

1 پژوهشگاه رویان

2 پژوهشگاه پلیمر و پتروشیمی ایران

3 پژوهشگاه مهندسی ژنتیک

4 پژوهشگاه پلیمر و پتروشیمی ایران

چکیده

هورمون رشد انسانی (hGH) زنجیر پلی‌پپتیدی با 191 اسید آمینه است که در غده هیپوفیز ترشح شده و با جذب در کبد به ایجاد عامل رشد انسولین مانند IGF-1 منجر می‌شود. IGF-1 موجب رشد ماهیچه‌ها و استخوان‌ها در بدن می‌شود، بنابراین کمبود هورمون رشد در بدن موجب آسیب‌های جدی و ناخوشایند می‌شود. موارد درمانی تایید شده با هورمون رشد عبارت از درمان کمبود هورمون رشد (در کودکان و بزرگ‌سالان)، سندرم ترنر، سندرم پرادر-ویلی، نارسایی مزمن کلیوی و اخیرا کوتاهی قد در کودکان، کاهش وزن در بیماران مبتلا به ایدز و تجمع چربی در بزرگ‌سالان است. نارضایتی بیمار، نیمه‌عمر کوتاه در بدن، سمیت کلیوی ایجادشده با تزریق‌های روزانه و مکرر، عواملی هستند که پژوهشگران را بر آن داشته‌اند که به بررسی سامانه‌های جدید پلیمری رسانش این دارو بپردازند. میکروگوی‌ها، هیدروژل‌ها و سامانه‌های تشکیل‌شونده درجا (ISIs) از جمله مهم‌ترین این سامانه‌ها هستند. در این سامانه‌ها، انتخاب نوع فرایند، انواع و خواص مربوط به پلیمر، حلال و افزودنی‌های به‌کاررفته بسیار مهم هستند، چرا که بر سرعت و مقدار انتشار نهایی دارو اثرگذارند.

کلیدواژه‌ها

موضوعات


عنوان مقاله [English]

Polymer-based Sustained Release Systems of Human Growth Hormone

نویسندگان [English]

  • siavash mirzaei 1
  • hamid mobedi 2
  • hamid gourabi 1
  • mohammad hosaein sanati 3
  • Sakine Khezli 4
1 royan institute
2 iran polymer and petrochemical institute
3 National Institute of Genetic Engineering and Biotechnology
چکیده [English]

Human Growth Hormone (hGH) is a 191 amino acid polypeptide chain which is secreted
in pituitary gland and by absorption in the liver leads to secretion of the insulin-like
growth factor (IGF-1). IGF-1 increases muscles and bones growth, so the growth hormone
deficiency in the body leads to serious and unpleasant injuries. Approved indications for
hGH therapy include treatment of growth hormone deficiency (in children and in adults),
Turner syndrome, Prader–Willi syndrome, chronic renal insufficiency and more recently,
idiopathic short stature in children, AIDS-related wasting and fat accumulation associated
with lip dystrophy in adults. Patients’ dissatisfaction, short half-life, renal toxicity created
in daily injections and frequent injections are factors that have compelled researchers to
investigate the sustained release systems in different forms of this protein. New polymer
drug delivery systems are one of the most effective ways to reduce the frequency of
injections of daily drugs. In situ forming systems (ISIs), microspheres and hydrogels are
the most important and effectively used methods to deliver drugs to the body. The process,
types and properties of the polymer, solvent and additives that are used for such purposes
are very important and affect the speed and amount of final release of the drug.

کلیدواژه‌ها [English]

  • hGH
  • sustained release
  • microsphere
  • Hydrogel
  • in situ forming
1. Cai Y., Xu M., and Yuan M., Developments in Human Growth Hormone Preparations: Sustained-Release, Prolonged Halflife, Novel Injection Devices, and Alternative Delivery Routes, Int. J. Nanomed., 9, 3527–3535, 2014.
2. Diez J.J., Sangiao-Alvarellos S., and Cordido F., Treatment with Growth Hormone for Adults with Growth Hormone Deficiency Syndrome: Benefits and Risks Review, Int. J. Mol. Sci., 19, 893, 2018.
3. Cázares D.J., Ganem R.A., and Kalia YN, Human Growth Hormone: New Delivery Systems, Alternative Routes of Administration, and their Pharmacological Relevance, Eur. J. Pharm. Biopharm., 78, 278–288, 2011.
4. Caicedo A. and Rosenfeld R., Challenges and Future for the Delivery of Growth Hormone Therapy, Growth Horm. IGFRes., 38, 39-43, 2017.
5. Martin C., Baerdemaeker A.D., and Poelaert J., Controlled- Release of Opioids for Improved Pain Management, Mater. Today Nano, 19, 491-502, 2016.
6. Alhalmi A., Altowairi M., Alzobaidi N., and Almoiliqy M., Sustained Release Matrix System: An Overview, World J. Pharm. Pharm., 7, 1470-1486, 2018.
7. Bhagwat R.R. and Vaidhya I.S., Novel Drug Delivery Systems: An Overview, Int. J. Pharm. Sci. Res., 4, 970–982, 2013.
8. Priya V.S.V., Roy H.K., and Prasanthi N.L., Polymers in Drug Delivery Technology, Types of Polymers and Applications Polymers in Drug Delivery Technology, Sch. Acad. J. Pharm., 5, 305-308, 2016.
9. Yoo H.S., Photo-Cross-Linkable and Thermo-Responsive Hydrogels Containing Chitosan and Pluronic for Sustained Release of Human Growth Hormone (hGH), J. Biomater. Sci. Polym. Ed., 18, 1429–1441, 2007.
10. Kwak H.H., Shim W.S., and Choi M.K., Development of a Sustained-Release Recombinant Human Growth Hormone Formulation, J. Controlled Release, 137, 160–165, 2009.
11. Rafi M., Singh S.M., and Kanchan V., Controlled Release of Bioactive Recombinant Human Growth Hormone from PLGA Microparticles, J. Microencapsulation, 27, 552–560, 2010.
12. Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Rey L. and May J.C. (Eds.), Infoma Healthcare, 3rd ed., New York, London, 2010.
13. Hwang J.S., Lee H.S., Lee K.H., Yoo H.W., Lee D.Y., Suh B.K., et al., Once-Weekly Administration of Sustained-Release Growth Hormone in Korean Prepubertal Children with Idiopathic Short Stature: A Randomized Controlled Phase. II. Study, Horm. Res., 90, 54–63, 2018.
14. Wei Y., Wang Y.X., and Wang W., mPEG-PLA Microspheres with Narrow Size Distribution Increase the Controlled Release Effect of Recombinant Human Growth Hormone, J. Mater. Chem., 21, 12691-12699, 2011.
15. Kim H.K., Chung H.J., and Park T.G., Biodegradable Polymeric Microspheres with “Open/Closed” Pores for Sustained Release of Human Growth Hormone, J. Controlled Release, 112, 167–174, 2006.
16. Amin D., Lijing T., Yifeng Z., Pengpeng C., and Wangyan N., Synthesis and Characterization of Bovine Serum Albumin- Loaded Microspheres Based on Star-Shaped PLLA with a Xylitol Core and Their Drug Release Behaviors, Polym. Bull., 75, 2917-2931, 2018.
17. FDA Approves Nutropin Depot (TM), First Long-Acting Dosage Form of Recombinant Growth Hormone for Growth Hormone Deficiency in Children, https://www.gene.com, available in Dec 23, 1999.
18. Park M.R., Chun C.J., and Ahn S.W., Sustained Delivery of Human Growth Hormone Using a Polyelectrolyte Complex- Loaded Thermosensitive Polyphosphazene Hydrogel, J. Controlled Release, 147, 359–367, 2010.
19. Weert M., Van D., Hennink W.E., and Jiskoot W., Protein Instability in Poly(lactic-co-glycolic acid) Microparticles, Pharm. Res., 17, 1159–1167, 2000.
20. Yi W., Yuxia W., and Aijun K.W., A Novel Sustained-Release Formulation of Recombinant Human Growth Hormone and Its Pharmacokinetic, Pharmacodynamic and Safety Profiles, Mol. Pharm., 9, 2039−2048, 2012.
21. Jostel A., Mukherjee A., and Alenfall J., A New Sustained- Release Preparation of Human Growth Hormone and its Pharmacokinetic, Pharmacodynamic and Safety Profile, Clin. Endocrinol (oxf.) 62, 623–627, 2005.
22. Jin S., Wha C., Kim S.J., and Kim C.W., Characterization of Recombinant Human Growth Hormone Variants from Sodium Hyaluronate-Based Sustained Release Formulation of rhGH Under Heat Stress, Anal. Biochem., 485, 59–65, 2015.
23. Vlugt-Wensink K.D.F., Vrueh R., and Gresnigt M.G., Preclinical and Clinical in Vitro in Vivo Correlation of an hGH Dextran Microsphere Formulation, Pharm. Res., 24, 2239–2248, 2007.
24. Wei Y., Wang Y., and Kang A., A Novel Sustained-Release Formulation of Recombinant Human Growth Hormone and its Pharmacokinetic, Pharmacodynamic and Safety Profiles, Mol. Pharm., 9, 2039–2048, 2012.
25. Park M.R., Chun C.J., and Ahn S.W., Cationic and Thermo Sensitive Protamine Conjugated Gels for Enhancing Sustained Human Growth Hormone Delivery, Biomaterials, 31, 1349–1359, 2010.
26. Huynh C.T., Kang S.W., and Li Y., Controlled Release of Human Growth Hormone from a Biodegradable pH/Temperature- Sensitive Hydrogel System, Soft Matter, 7, 8984-8990, 2011.
27. Yang J.A., Kim H., Park K., and Hahn S.K., Molecular Design of Hyaluronic Acid Hydrogel Networks for Long-Term Controlled Delivery of Human Growth Hormone, Soft Matter, 7,868–870, 2011.
28. Park S.Y., Chung H.J., Lee Y., and Park T.G., Injectable and Sustained Delivery of Human Growth Hormone Using Chemically Modified Pluronic Copolymer Hydrogels, J. Biotechnol., 3, 669–675, 2008.
29. Lille C.H.U., In-situ Forming PLGA Implants for Intraocular Dexamethasone Delivery, Int. J. Pharm., 548, 337-348, 2018.
30. Vapar E.A., Baykara T., and Tamer B., Evaluation of Solvent Effects on Drug Release from Injectable Phase Sensitive Liquid Implant Systems, J. Fac. Ank. Univ., 37, 101–109, 2008.
31. Thakur R.R.S., McMillan H.L., and Jones D.S., Solvent Induced Phase Inversion-Based In Situ Forming Controlled Release Drug Delivery Implants, J. Controlled Release, 176, 8–23, 2014.
32. Holy C.E., Dang S.M., and Davis J.E, In Vitro Degradation of a Novel Poly(lactide-co-glycoside) 75/25 Foam, Biomaterials, 20, 1177–1185, 1999.
33. Ogawa Y., Okada H., Heya T., and Shimamoto T., Controlled Release of LHRH Agonist Ieuprolide Acetate from Microcapsules: Serum Drug Level Profiles and Pharmacological Effects in Animals, J. Pharm. Pharmacol, 41, 439–444, 1989.