Methylphenidate SODAS: A Long-acting Formulation for Treatment of ADHD
Keywords:
ADHD, SODAS, long-acting formulation, methylphenidateAbstract
Methylphenidate (MPH) is a central nervous system stimulant which is most frequently prescribed for the treatment of attention deficit hyperactivity disorder (ADHD). However, MPH immediate release formulation are limited of using due to short half-life, and this leads to the problems associated with multiple daily dosing, inconvenience, and non-compliance. The Spheroidal Oral Drug Absorption System of methylphenidate (SODAS-MPH), a new generation long-acting MPH formulation is developed. SODAS-MPH contains 50% of immediate-release (IR) beads which provide a rapid onset of action within 1 hour and 50% of extended-release (XR) beads, an effect of which lasts up to 8 hours, allowing patients to take once daily dose. Based on the clinical evidence, the efficacy of SODAS-MPH in ADHD patients was non-inferior to IR-MPH and other XR-MPH. SODAS-MPH is also beneficial to patients with swallowing difficulties or gastrointestinal obstruction because the capsule can be opened, allowing the use of the beads inside. Furthermore, the beads can dissolve completely and will not cause an obstruction in the gastrointestinal tract. The recommended dose of SODAS-MPH for the treatment of ADHD should be initiated at 20 mg once daily in the morning and may be adjusted in 10 mg increments at weekly interval to a maximum dosage of 60 mg once daily in children and 80 mg once daily in adults. The dosage adjustment should be considered according to clinical response and related side effects.
References
Centers for Disease Control and Prevention (CDC). Data and statistics about ADHD [Internet]. Atlanta: Centers for Disease Control and Prevention; 2022 [cited 2023 Jan 5]. Available from: https://www.cdc.gov/ncbddd/adhd/data.html
Dopheide JA, Pliszka SR. Attention deficit/hyperactivity disorder. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM, editors. Pharmacotherapy: a pathophysiological approach. 9th ed. New York: McGraw-Hill Education; 2014. p.957-71.
Boon-yasidhi V. Attention deficit hyperactivity disorder: diagnosis and management. J Psychiatr Assoc Thailand [Internet]. 2012 [cited 2023 Jan 5];57(4):373-86. Available from: https://he01.tci-thaijo.org/index.php/JPAT/article/view/5792
American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 5th ed (DSM-5). Washington, DC: American Psychiatric Association; 2013. p.59-66.
Thapar A, Cooper M, Jefferies R, Stergiakouli E. What causes attention deficit hyperactivity disorder?. Arch Dis Child. 2012;97(3):260–5. doi: 10.1136/archdischild-2011-300482.
Brown KA, Samuel S, Patel DR. Pharmacologic management of attention deficit hyperactivity disorder in children and adolescents: a review for practitioners. Transl Pediatr. 2018;7(1):36–47. doi: 10.21037/tp.2017.08.02.
Coghill D, Banaschewski T, Zuddas A, Pelaz A, Gagliano A, Doepfner M. Long-acting methylphenidate formulations in the treatment of attention-deficit/hyperactivity disorder: a systematic review of head-to-head studies. BMC Psychiatry. 2013;13(1):237. doi: 10.1186/1471-244X-13-237.
Liu F, Muniz R, Minami H, Silva RR. Review and comparison of the long acting methylphenidate preparations. Psychiatr Q. 2005;76(3):259–69. doi: 10.1007/s11126-005-2979-0.
Maldonado R. Comparison of the pharmacokinetics and clinical efficacy of new extended-release formulations of methylphenidate. Expert Opin Drug Metab Toxicol. 2013;9(8):1001–14. doi: 10.1517/17425255.2013.786041.
Patrick KS, González MA, Straughn AB, Markowitz JS. New methylphenidate formulations for the treatment of attention-deficit/hyperactivity disorder. Expert Opin Drug Deliv. 2005;2(1):121–43. doi: 10.1517/17425247.2.1.121.
Majeed MH, Zafar MK. ADHD symptoms are stable, then a sudden relapse. Curr Psychiatr [Internet]. 2016 [cited . 2023 Apr 2];15(10):26-30. Available from: https://www.mdedge.com/psychiatry/article/114026/adhd/adhd-symptoms-are-stable-then-sudden-relapse
สำนักงานคณะกรรมการอาหารและยา. ตรวจสอบการอนุญาต [อินเตอร์เน็ต]. นนทบุรี: สํานักงานคณะกรรมการอาหารและยา กระทรวงสาธารณสุข; 2566 [สืบค้นเมื่อ 2 เม.ย. 2566]. สืบค้นจาก: https://porta.fda.moph.go.th/fda_search_all/main/search_center_main.aspx
National Library of Medicine. PubChem, compound summary methylphenidate [Internet]. Bethesda, Maryland: National Library of Medicine; 2023 [cited 2023 Apr 6]. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/Methylphenidate
Siddiqui MA. SODAS® (Spheroidal oral drug absorption system) [Internet]. n.p.: Pharmaceutical Research; 2012 [cited 2023 Apr 6]. Available from: https://pharmaceuticalresearch.wordpress.com/2012/07/05/sodas-spheroidal-oral-drug-absorption-system/
Stahl SM. Stahl’s essential psychopharmacology: neuroscientific basis and practical applications. 5th ed. Cambridge, England: Cambridge University Press; 2022. p.449-85.
Volkow ND, Swanson JM. Variables that affect the clinical use and abuse of methylphenidate in the treatment of ADHD. Am J Psychiatry. 2003;160(11):1909–18. doi: 10.1176/appi.ajp.160.11.1909.
Novartis Pharmaceuticals Corporation. Ritalin LA® (methylphenidate hydrochloride extended-release capsules) prescribing information [Internet]. New Jersey: Novartis Pharmaceuticals Corporation; 2021 [cited 2023 Apr 5]. Available from: https://www.novartis.com/us-en/sites/novartis_us/files/ritalin_la.pdf
Novartis (Thailand) Ltd. Ritalin LA® [package insert]. Bangkok (Thailand): Novartis (Thailand) Ltd; 2021.
Markowitz JS, Straughn AB, Patrick KS, DeVane CL, Pestreich L, Lee J, et al. Pharmacokinetics of methylphenidate after oral administration of two modified-release formulations in healthy adults. Clin Pharmacokinet. 2003;42(4):393–401. doi: 10.2165/00003088-200342040-00007.
Biederman J, Quinn D, Weiss M, Markabi S, Weidenman M, Edson K, et al. Efficacy and safety of Ritalin LA®, a new, once daily, extended-release dosage form of methylphenidate, in children with attention deficit hyperactivity disorder. Paediatr Drugs. 2003;5(12):833–41. doi: 10.2165/00148581-200305120-00006.
Lopez F, Silva R, Pestreich L, Muniz R. Comparative efficacy of two once daily methylphenidate formulations (Ritalin LA® and Concerta®) and placebo in children with attention deficit hyperactivity disorder across the school day. Paediatr Drugs. 2003;5(8):545–55. doi: 10.2165/00148581-200305080-00005.
Haertling F, Mueller B, Bilke-Hentsch O. Effectiveness and safety of a long-acting, once-daily, two-phase release formulation of methylphenidate (Ritalin LA®) in school children under daily practice conditions. Atten Defic Hyperact Disord. 2015;7(2):157–64. doi: 10.1007/s12402-014-0154-x.
Medicines Adverse Reactions Committee. Methylphenidate and risk of birth defects [Internet]. Wellington: Medsafe; 2022 [cited 2023 Apr 5]. Available from: https://www.medsafe.govt.nz/committees/marc/reports/190-Methylphenidate-and-risk-of-%20birth-defects.pdf
Kelsey JJ. Drug principles in lactation. In: Pharmacotherapy Self-Assessment Programs (PSAP) [Internet]. Lenexa, Kansas: The American College of Clinical Pharmacy; 2016 [cited 2023 Apr 5]. Available from: https://www.accp.com/docs/bookstore/psap/p2016b3_sample.pdf
Zhang L, Yao H, Li L, Du Rietz E, Andell P, Garcia-Argibay M, et al. Risk of cardiovascular diseases associated with medications used in attention-deficit/hyperactivity disorder: a systematic review and meta-analysis. JAMA Netw Open. 2022;5(11):e2243597. doi:10.1001/jamanetworkopen.2022.43597
Man KKC, Lau WCY, Coghill D, Besag FMC, Cross JH, Ip P, et al. Association between methylphenidate treatment and risk of seizure: a population-based, self-controlled case-series study. Lancet Child Adolesc Health. 2020;4(6):435–43. doi: 10.1016/S2352-4642(20)30100-0.
Bingöl-Kızıltunç P, Yürümez E, Atilla H. Does methylphenidate treatment affect functional and structural ocular parameters in patients with attention deficit hyperactivity disorder? - a prospective, one year follow-up study. Indian J Ophthalmol. 2022;70(5):1664-8. doi: 10.4103/ijo.IJO_2966_21.
Wolraich ML, Hagan JF Jr, Allan C, Chan E, Davison D, Earls M, et al. Clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Pediatrics. 2019;144(4):e20192528. doi: 10.1542/peds.2019-2528.
Bolea-Alamañac B, Nutt DJ, Adamou M, Asherson P, Bazire S, Coghill D, et al. Evidence-based guidelines for the pharmacological management of attention deficit hyperactivity disorder: update on recommendations from the British Association for Psychopharmacology. J Psychopharmacol. 2014;28(3):179–203. doi: 10.1177/0269881113519509.
Almagor D, Duncan Don, Gignac M, editors. Canadian ADHD practice guidelines. 4.1th ed. [Internet]. Toronto: Canadian ADHD Resource Alliance (CADDRA); 2020 [cited 2023 Mar 3]. Available from: https://adhdlearn.caddra.ca/purchase-guidelines/
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2023 Association of Hospital Pharmacy (Thailand)
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
ข้อความภายในบทความที่ตีพิมพ์ในวารสารเภสัชกรรมโรงพยาบาลทั้งหมด รวมถึงรูปภาพประกอบ ตาราง เป็นลิขสิทธิ์ของสมาคมเภสัชกรรมโรงพยาบาล (ประเทศไทย) การนำเนื้อหา ข้อความหรือข้อคิดเห็น รูปภาพ ตาราง ของบทความไปจัดพิมพ์เผยแพร่ในรูปแบบต่าง ๆ เพื่อใช้ประโยชน์ในเชิงพาณิชย์ ต้องได้รับอนุญาตจากกองบรรณาธิการวารสาร (สมาคมเภสัชกรรมโรงพยาบาล (ประเทศไทย)) อย่างเป็นลายลักษณ์อักษร
สมาคมเภสัชกรรมโรงพยาบาล (ประเทศไทย) อนุญาตให้สามารถนำไฟล์บทความไปใช้ประโยชน์และเผยแพร่ต่อได้ โดยอยู่ภายใต้เงื่อนไขสัญญาอนุญาตครีเอทีฟคอมมอน (Creative Commons License: CC) โดย ต้องแสดงที่มาจากวารสาร – ไม่ใช้เพื่อการค้า – ห้ามแก้ไขดัดแปลง, Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0)
ข้อความที่ปรากฏในบทความในวารสารเป็นความคิดเห็นส่วนตัวของผู้เขียนแต่ละท่านไม่เกี่ยวข้องกับสมาคมเภสัชกรรมโรงพยาบาล (ประเทศไทย) และบุคลากรในสมาคมฯ แต่อย่างใด ความรับผิดชอบองค์ประกอบทั้งหมดของบทความแต่ละเรื่องเป็นของผู้เขียนแต่ละท่าน หากมีความผิดพลาดใด ๆ ผู้เขียนแต่ละท่านจะรับผิดชอบบทความของตนเอง ตลอดจนความรับผิดชอบด้านเนื้อหาและการตรวจร่างบทความเป็นของผู้เขียน ไม่เกี่ยวข้องกับกองบรรณาธิการ
.png){kind=spacer}
