TRANSDERMAL DRUG DELIVERY SYSTEM: TRANSDERMAL PATCH AN EFFECTIVE APPROACH TO TREAT MIGRAINE.
Main Article Content
Keywords
Transdermal drug delivery systems (TDDS), Iontophoretic Transdermal system, Migraine, Migraine treatment, Transdermal patch, Sumatriptan
Abstract
In January 2013, the US Food and Drug Administration approved an iontophoretic transdermal system (ITS) (skin patch) formulation of sumatriptan for the immediate treatment of migraine attacks. Migraine is one of the most common primary headache disorders, affecting around 12% of the general population in Western countries. Merriam Webster indicates that the term "transdermal" is very new to the field of medicine and pharmacology, dating it to 1944. Transdermal medications come in a discreet, self-contained dose form. Drug distribution via skin to have a systemic impact without causing variations in the drug's plasma concentration. The topical distribution of therapeutic agents presents numerous benefits in comparison to traditional oral and invasive drug delivery techniques.further offer a prolonged amount of time for the drug's controlled release. This review article discusses the benefits of transdermal drug delivery systems (TDDS) as ionopheretic transdermal system for treatment of acute migraine attacks, use of Sumatriptan as the most effective drug product to treatment of migraine, skin pathways for TDDS, different transdermal patch components, preparation methods, transdermal system evaluation, general clinical considerations when using TDDS, and limitations of TDDS.
References
1. Vega-Vásquez P, Mosier NS, Irudayaraj J. Nanoscale drug delivery systems: from medicine to agriculture. Front Bioeng Biotechnol. 2020; 8:79. https:// doi.org/10.3389/fbioe.2020.00079.
2. Vargason AM, Anselmo AC, Mitragotri S. The evolution of commercial drug delivery technologies. Nat Biomed Eng. 2021. https://doi.org/10.1038/s41 551-021-00698-w.
3. Mali AD, Bathe R, Patil M. An updated review on transdermal drug delivery systems. Int J Adv Sci Res. 2015; 1(6):244–54. https://doi.org/10.7439/ijasr.v1 i6.2243.
4. Li C, Wang J, Wang Y, Gao H, Wei G, Huang Y, et al. Recent progress in drug delivery. Acta Pharm Sin B. 2019; 9(6):1145–62. https://doi.org/10.1016/j.a psb.2019.08.003.
5. Kumar JA, Pullakandam N, Prabu SL, Gopal V. Transdermal drug delivery system: An overview. Int J Pharm Sci Rev Res. 2010;3(2):49–54
6. Chowdary K.P.R and Naidu R.A.S, Transdermal Drug Delivery, A Review of Current Status, Indian Drugs, 1995, 32(9), 414- 422.
7. Divyesh Patel, Nirav Patel, Transdermal Drug Delivery SystemReview, International Journal of Biopharmaceutical and Toxicological Research, 2011, 1(1), 61-80.
8. Chien YW, Novel drug delivery systems, drugs and the Pharmaceutical sciences, Vol.50, Marcel Dekkar, New York, NY;1992;797.
9. Guy RH. Current status and future prospects of transdermal drug delivery, Pharm Res 1996, 13, 1765-1769.
10. Chein YW. Transdermal controlled systemic Medication. New York and Basel, Marcel Dekkar Inc. 1987; 159-176.
11. Yie W,Chien, Novel Drug Delivery Systems, 2nd ed, M. Dekker, 2005, 50, 301-380.
12. Eseldin Keleb, Rakesh Kumar Sharma, Transdermal Drug Delivery System-Design and Evaluation, International Journal of Advances in Pharmaceutical Sciences, 2010, 1(3), 201-211.
13. Aulton.M.E, Pharmaceutics; The science of dosage form design, second edition, Churchill Livingston, Harcourt publishers-2002.
14. Malthiowitz.Z.E, Chickering.D.E, Lehr.C.M, Bioadhesive drug delivery systems; fundamentals, novel approaches and development, Marcel Dekkar, Inc., NewYork, Basel.
15. Guy RH. Current status and future prospects of transdermal drug delivery, Pharm Res 1996, 13, 1765-1769.
16. Loyd v. Allen Jr, Nicholas G. Popovich, Howard C. Ansel. Pharmaceutical dosage forms and drug delivery systems, eighth edition, wolter kluwer publishers, New Delhi, 2005.
17. Brown M.B and Jones S.A. Hyaluronic acid: a unique topical vehicle for localized drug delivery to the skin. JEDV 2000; 19: 308-318.
18. Wokovich A.M., Prodduturi S., Doub W.H., Hussain A.S., Buhse L.F. Transdermal drug delivery system (TDDS) adhesion as a critical safety, efficacy and quality attribute. Eur. J. Pharm. Biopharm. 2006; 64:1–8. doi: 10.1016/j.ejpb.2006.03.009.
19. Benson HA, Grice JE, Mohammed Y, Namjoshi S, Roberts MS. Topical and transdermal drug delivery: from simple potions to smart technologies. Curr Drug Deliv. 2019; 16(5):444–60. https://doi.org/10.2174/15672018166661902 01143457
20. Lee HJ, Song CY, Baik SM, Kim DY, Hyeon TG, Kim DH. Device-assisted transdermal drug delivery. Adv Drug Deliv Rev. 2018; 127:35–45. https://doi. org/10.1016/j.addr.2017.08.009.
21. Bird D, Ravindra NM. Transdermal drug delivery and patches - an overview. Med Devices Sens. 2020; 3(6):e10069.
22. Hanbali OA, Khan HS, Sarfraz M, Arafat M, Ijaz S, Hameed A. Transdermal patches: design and current approaches to painless drug delivery. Acta Pharma. 2019; 69(2):197–215. https://doi.org/10.2478/acph-2019-0016.
23. Wang Y, Zeng L, Song W, Liu J. Influencing factors and drug application of iontophoresis in transdermal drug delivery: an overview of recent progress. Drug Deliv Transl Res. 2021. https://doi.org/10.1007/ s13346-021-00898-6.
24. Dhal S, Pal K, Giri S. Transdermal delivery of gold nanoparticles by a soybean oil-based oleogel under iontophoresis. ACS Appl Bio Mater. 2020; 3(10):7029–39. https://doi.org/10.1021/acsabm.0c00893.
25. Moarefian M, Davalos RV, Tafti DK, Acheniec LE, Jones CN. Modeling iontophoretic drug delivery in a microfluidic device. Lab Chip. 2020; 20(18): 3310–21. https://doi.org/10.1039/D0LC00602E.
26. Seah BC, Teo BM. Recent advances in ultrasound-based transdermal drug delivery. Int J Nanomedicine. 2018; 13:7749–63. https://doi.org/10.2147/IJN.S174759.
27. Nguyen HX, Banga AK. Electrically and ultrasonically enhanced transdermal delivery of methotrexate.Pharmaceutics.2018; 10(3):117. https://doi.org/10.3390/pharmaceutics10030117.
28. Escobar-Chávez JJ, Díaz-Torres R, Domínguez-Delgado CL, Rodríguez-Cruz IM, López-Arellano R, Hipólito EAM. Therapeutic applications of sonophoresis and sonophoretic devices. In: Percutaneous Penetration Enhancers Physical Methods in Penetration Enhancement. Springer-Verlag Berlin Heidelberg; 2017. p. 31–58.
29. Dermol-Černe J, Pirc E, Miklavčič D. Mechanistic view of skin electroporation – models and dosimetry for successful applications: an expert review. Expert Opin Drug Deliv. 2020; 17(5):689–704. https://doi.org/10.1080/17425247.2020.1745772.
30. Lin CH, Aljuffali IA, Fang JY. Lasers as an approach for promoting drug delivery via skin. Expert Opin Drug Deliv. 2014; 11(4):599 614. https://doi.org/10.1517/17425247.2014.885501.
31. Agrawal S, Gandhi SN, Gurgar P, Saraswathy N. Microneedles: An advancement to transdermal drug delivery system approach. J Appl Pharm Sci. 2020; 10(3):149–59.
32. Zhao Z, Chen Y, Shi Y. Microneedles: a potential strategy in transdermal delivery and application in the management of psoriasis. RSC Adv. 2020; 10(24):14040–9. https://doi.org/10.1039/D0RA00735H.
33. Jung JH, Jin SG. Microneedle for transdermal drug delivery: current trends and fabrication. J Pharm Investig. 2021. https://doi.org/10.1007/s40005-021-00512-4.
34. Shakya AK, Ingrole RSJ, Joshi G, Uddin MJ, Anvari S, Davis CM, et al. Microneedles coated with peanut allergen enable desensitization of peanut sensitized mice. J Control Release. 2019; 314:38–47. https://doi.org/10.1016/j.jconrel.2019.09.022.
35. Lim J, Tahk D, Yu J, Min DH, Jeon NL. Design rules for a tunable merged-tip microneedle. Microsyst Nanoeng. 2018; 4(1):1–10.
36. Alkilani AZ, Mccrudden MTC, Donnelly RF. Transdermal drug delivery: innovative pharmaceutical developments based on disruption of the barrier properties of the stratum corneum. Pharmaceutics. 2015; 7 (4):438– https://doi.org/10.3390/pharmaceutics7040438.
37. Stanekzai A, Sudhakar CK, Zhakfar AM, Karan VS. Recent approaches in transdermal drug delivery system. Res J Pharm Tech. 2019; 12(9):4550–8. https://doi.org/10.5958/0974-360X.2019.00783.2.
38. Hadgraft J, Lane ME. Passive transdermal drug delivery systems. Am J Drug Deliv. 2006; 4(3):153–60. https://doi.org/10.2165/00137696-200604030-00003.
39. Stovner L., Hagen K., Jensen R., Katsarava Z., Lipton R., Scher A. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia 27: 193–210.
40. Headache Classification Subcommittee of the International Headache Society (2004) The inte rnational classification of headache disorders: 2nd edition. Cephalalgia 24(Suppl. 1): 9–160.
41. Burstein R., Levy D., Jakubowski M. (2005) Effects of sensitization of trigeminovascular neurons to triptan therapy during migraine. Rev Neurol (Paris) 161: 658–660. Silberstein S. (1995) Migraine symptoms: results of a survey of self-reported migraineurs, Headache 35: 387–396
42. Rapoport A., Freitag F., Pearlman S. (2010) Innovative delivery systems for migraine: the clinical utility of a transdermal patch for the acute treatment of migraine. CNS Drugs 24: 929–940.
43. S FDA (2013a) Zecuity™. Full prescribing information. US Food and Drug Administration; A vailableat: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202278s000lbl.pdf (accessed 12 February 2015).
44. S FDA (2013b) NDA approval. US Food and Drug Administration; Available at: http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202278Orig1s000ltr.pdf (accessed 12 February 2015).
45. Vikelis M., Mitsikostas D., Rapoport A. (2012) Sumatriptan iontophoretic patch (SUMATRIPTAN ITS): review of pharmacology, clinical efficacy and safety in the acute treatment of migraine. Neuropsychiatr Dis Treat 8: 429–434.
46. Ferrari M., Saxena P.(1993) On serotonin and migraine: a clinical and pharmacological revie w. Cephalalgia 13: 151–165.
47. Siegel S., O’Neill C., Dube L., Kaldeway P., Morris R., Jackson D., et al. (2007) Aunique iontophoretic patch for optimal transdermal delivery of sumatriptan. Pharm Res 24: 1919–1926.
48. Goldstein J., Pugach N., Smith T. (2009) Acute anti-migraine efficacy and tolerability of Zelrix, a novel iontophoretic transdermal patch of sumatriptan. Cephalalgia 29(Suppl. 1): 20.
49. Derry C., Derry S., Moore R. (2012a) Sumatriptan (oral route of administration) for acute migraine attacks in adults. Cochrane Database Syst Rev 15(2): CD008615.
50. Derry C., Derry S., Moore R. (2012b) Sumatriptan (intranasal route of administration) for acute migraine attacks in adults. Cochrane Database Syst Rev 15(2): CD009663.
51. Meadows K., Pierce M. (2014) Sumatriptan transdermal system can be correctly assembled and applied during migraine attacks. Headache 54: 850–860.
52. FDA (2013a) Zecuity™. Full prescribing information. US Food and Drug Administration; Availableat: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202278s000lbl.pdf
2. Vargason AM, Anselmo AC, Mitragotri S. The evolution of commercial drug delivery technologies. Nat Biomed Eng. 2021. https://doi.org/10.1038/s41 551-021-00698-w.
3. Mali AD, Bathe R, Patil M. An updated review on transdermal drug delivery systems. Int J Adv Sci Res. 2015; 1(6):244–54. https://doi.org/10.7439/ijasr.v1 i6.2243.
4. Li C, Wang J, Wang Y, Gao H, Wei G, Huang Y, et al. Recent progress in drug delivery. Acta Pharm Sin B. 2019; 9(6):1145–62. https://doi.org/10.1016/j.a psb.2019.08.003.
5. Kumar JA, Pullakandam N, Prabu SL, Gopal V. Transdermal drug delivery system: An overview. Int J Pharm Sci Rev Res. 2010;3(2):49–54
6. Chowdary K.P.R and Naidu R.A.S, Transdermal Drug Delivery, A Review of Current Status, Indian Drugs, 1995, 32(9), 414- 422.
7. Divyesh Patel, Nirav Patel, Transdermal Drug Delivery SystemReview, International Journal of Biopharmaceutical and Toxicological Research, 2011, 1(1), 61-80.
8. Chien YW, Novel drug delivery systems, drugs and the Pharmaceutical sciences, Vol.50, Marcel Dekkar, New York, NY;1992;797.
9. Guy RH. Current status and future prospects of transdermal drug delivery, Pharm Res 1996, 13, 1765-1769.
10. Chein YW. Transdermal controlled systemic Medication. New York and Basel, Marcel Dekkar Inc. 1987; 159-176.
11. Yie W,Chien, Novel Drug Delivery Systems, 2nd ed, M. Dekker, 2005, 50, 301-380.
12. Eseldin Keleb, Rakesh Kumar Sharma, Transdermal Drug Delivery System-Design and Evaluation, International Journal of Advances in Pharmaceutical Sciences, 2010, 1(3), 201-211.
13. Aulton.M.E, Pharmaceutics; The science of dosage form design, second edition, Churchill Livingston, Harcourt publishers-2002.
14. Malthiowitz.Z.E, Chickering.D.E, Lehr.C.M, Bioadhesive drug delivery systems; fundamentals, novel approaches and development, Marcel Dekkar, Inc., NewYork, Basel.
15. Guy RH. Current status and future prospects of transdermal drug delivery, Pharm Res 1996, 13, 1765-1769.
16. Loyd v. Allen Jr, Nicholas G. Popovich, Howard C. Ansel. Pharmaceutical dosage forms and drug delivery systems, eighth edition, wolter kluwer publishers, New Delhi, 2005.
17. Brown M.B and Jones S.A. Hyaluronic acid: a unique topical vehicle for localized drug delivery to the skin. JEDV 2000; 19: 308-318.
18. Wokovich A.M., Prodduturi S., Doub W.H., Hussain A.S., Buhse L.F. Transdermal drug delivery system (TDDS) adhesion as a critical safety, efficacy and quality attribute. Eur. J. Pharm. Biopharm. 2006; 64:1–8. doi: 10.1016/j.ejpb.2006.03.009.
19. Benson HA, Grice JE, Mohammed Y, Namjoshi S, Roberts MS. Topical and transdermal drug delivery: from simple potions to smart technologies. Curr Drug Deliv. 2019; 16(5):444–60. https://doi.org/10.2174/15672018166661902 01143457
20. Lee HJ, Song CY, Baik SM, Kim DY, Hyeon TG, Kim DH. Device-assisted transdermal drug delivery. Adv Drug Deliv Rev. 2018; 127:35–45. https://doi. org/10.1016/j.addr.2017.08.009.
21. Bird D, Ravindra NM. Transdermal drug delivery and patches - an overview. Med Devices Sens. 2020; 3(6):e10069.
22. Hanbali OA, Khan HS, Sarfraz M, Arafat M, Ijaz S, Hameed A. Transdermal patches: design and current approaches to painless drug delivery. Acta Pharma. 2019; 69(2):197–215. https://doi.org/10.2478/acph-2019-0016.
23. Wang Y, Zeng L, Song W, Liu J. Influencing factors and drug application of iontophoresis in transdermal drug delivery: an overview of recent progress. Drug Deliv Transl Res. 2021. https://doi.org/10.1007/ s13346-021-00898-6.
24. Dhal S, Pal K, Giri S. Transdermal delivery of gold nanoparticles by a soybean oil-based oleogel under iontophoresis. ACS Appl Bio Mater. 2020; 3(10):7029–39. https://doi.org/10.1021/acsabm.0c00893.
25. Moarefian M, Davalos RV, Tafti DK, Acheniec LE, Jones CN. Modeling iontophoretic drug delivery in a microfluidic device. Lab Chip. 2020; 20(18): 3310–21. https://doi.org/10.1039/D0LC00602E.
26. Seah BC, Teo BM. Recent advances in ultrasound-based transdermal drug delivery. Int J Nanomedicine. 2018; 13:7749–63. https://doi.org/10.2147/IJN.S174759.
27. Nguyen HX, Banga AK. Electrically and ultrasonically enhanced transdermal delivery of methotrexate.Pharmaceutics.2018; 10(3):117. https://doi.org/10.3390/pharmaceutics10030117.
28. Escobar-Chávez JJ, Díaz-Torres R, Domínguez-Delgado CL, Rodríguez-Cruz IM, López-Arellano R, Hipólito EAM. Therapeutic applications of sonophoresis and sonophoretic devices. In: Percutaneous Penetration Enhancers Physical Methods in Penetration Enhancement. Springer-Verlag Berlin Heidelberg; 2017. p. 31–58.
29. Dermol-Černe J, Pirc E, Miklavčič D. Mechanistic view of skin electroporation – models and dosimetry for successful applications: an expert review. Expert Opin Drug Deliv. 2020; 17(5):689–704. https://doi.org/10.1080/17425247.2020.1745772.
30. Lin CH, Aljuffali IA, Fang JY. Lasers as an approach for promoting drug delivery via skin. Expert Opin Drug Deliv. 2014; 11(4):599 614. https://doi.org/10.1517/17425247.2014.885501.
31. Agrawal S, Gandhi SN, Gurgar P, Saraswathy N. Microneedles: An advancement to transdermal drug delivery system approach. J Appl Pharm Sci. 2020; 10(3):149–59.
32. Zhao Z, Chen Y, Shi Y. Microneedles: a potential strategy in transdermal delivery and application in the management of psoriasis. RSC Adv. 2020; 10(24):14040–9. https://doi.org/10.1039/D0RA00735H.
33. Jung JH, Jin SG. Microneedle for transdermal drug delivery: current trends and fabrication. J Pharm Investig. 2021. https://doi.org/10.1007/s40005-021-00512-4.
34. Shakya AK, Ingrole RSJ, Joshi G, Uddin MJ, Anvari S, Davis CM, et al. Microneedles coated with peanut allergen enable desensitization of peanut sensitized mice. J Control Release. 2019; 314:38–47. https://doi.org/10.1016/j.jconrel.2019.09.022.
35. Lim J, Tahk D, Yu J, Min DH, Jeon NL. Design rules for a tunable merged-tip microneedle. Microsyst Nanoeng. 2018; 4(1):1–10.
36. Alkilani AZ, Mccrudden MTC, Donnelly RF. Transdermal drug delivery: innovative pharmaceutical developments based on disruption of the barrier properties of the stratum corneum. Pharmaceutics. 2015; 7 (4):438– https://doi.org/10.3390/pharmaceutics7040438.
37. Stanekzai A, Sudhakar CK, Zhakfar AM, Karan VS. Recent approaches in transdermal drug delivery system. Res J Pharm Tech. 2019; 12(9):4550–8. https://doi.org/10.5958/0974-360X.2019.00783.2.
38. Hadgraft J, Lane ME. Passive transdermal drug delivery systems. Am J Drug Deliv. 2006; 4(3):153–60. https://doi.org/10.2165/00137696-200604030-00003.
39. Stovner L., Hagen K., Jensen R., Katsarava Z., Lipton R., Scher A. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia 27: 193–210.
40. Headache Classification Subcommittee of the International Headache Society (2004) The inte rnational classification of headache disorders: 2nd edition. Cephalalgia 24(Suppl. 1): 9–160.
41. Burstein R., Levy D., Jakubowski M. (2005) Effects of sensitization of trigeminovascular neurons to triptan therapy during migraine. Rev Neurol (Paris) 161: 658–660. Silberstein S. (1995) Migraine symptoms: results of a survey of self-reported migraineurs, Headache 35: 387–396
42. Rapoport A., Freitag F., Pearlman S. (2010) Innovative delivery systems for migraine: the clinical utility of a transdermal patch for the acute treatment of migraine. CNS Drugs 24: 929–940.
43. S FDA (2013a) Zecuity™. Full prescribing information. US Food and Drug Administration; A vailableat: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202278s000lbl.pdf (accessed 12 February 2015).
44. S FDA (2013b) NDA approval. US Food and Drug Administration; Available at: http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202278Orig1s000ltr.pdf (accessed 12 February 2015).
45. Vikelis M., Mitsikostas D., Rapoport A. (2012) Sumatriptan iontophoretic patch (SUMATRIPTAN ITS): review of pharmacology, clinical efficacy and safety in the acute treatment of migraine. Neuropsychiatr Dis Treat 8: 429–434.
46. Ferrari M., Saxena P.(1993) On serotonin and migraine: a clinical and pharmacological revie w. Cephalalgia 13: 151–165.
47. Siegel S., O’Neill C., Dube L., Kaldeway P., Morris R., Jackson D., et al. (2007) Aunique iontophoretic patch for optimal transdermal delivery of sumatriptan. Pharm Res 24: 1919–1926.
48. Goldstein J., Pugach N., Smith T. (2009) Acute anti-migraine efficacy and tolerability of Zelrix, a novel iontophoretic transdermal patch of sumatriptan. Cephalalgia 29(Suppl. 1): 20.
49. Derry C., Derry S., Moore R. (2012a) Sumatriptan (oral route of administration) for acute migraine attacks in adults. Cochrane Database Syst Rev 15(2): CD008615.
50. Derry C., Derry S., Moore R. (2012b) Sumatriptan (intranasal route of administration) for acute migraine attacks in adults. Cochrane Database Syst Rev 15(2): CD009663.
51. Meadows K., Pierce M. (2014) Sumatriptan transdermal system can be correctly assembled and applied during migraine attacks. Headache 54: 850–860.
52. FDA (2013a) Zecuity™. Full prescribing information. US Food and Drug Administration; Availableat: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202278s000lbl.pdf
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Mar 6, 2022
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Kehar Singh, Dr. Gaikwad Dushyant Dadabhau, & Satbir Singh. (2022). TRANSDERMAL DRUG DELIVERY SYSTEM: TRANSDERMAL PATCH AN EFFECTIVE APPROACH TO TREAT MIGRAINE. Journal of Population Therapeutics and Clinical Pharmacology, 29(01), 356–367. https://doi.org/10.53555/jptcp.v29i01.6117
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Author Biographies
Kehar Singh
Research Scholar, Department of Pharmacy, Sunrise University, Alwar, Rajasthan
Dr. Gaikwad Dushyant Dadabhau
Professor, Department of Pharmaceutical Science, Sunrise University, Alwar, Rajasthan India.
Satbir Singh
Research Scholar, Department of Pharmacy, Sunrise University, Alwar, Rajasthan