International Journal of Drug Delivery Technology
Volume 14, Issue 3

Quality by Design Approach to Nasal Mucoadhesive Microspheres: Enhanced Sumatriptan Succinate Delivery through Formulation and Characterization

Shivanee Vyas1, Anitha K N2*, Niranjan Babu Mudduluru3, Lalchand D Devhare4

1SVKM’s Institute of Pharmacy, Dhule Maharashtra, India.

2Department of Pharmacology, Government College of Pharmacy, Bangalore, Karnataka, India.

3Seven Hills College of Pharmacy, Tirupati, Andhra Pradesh, India.

4Manwatkar College of Pharmacy, Ghodpeth, Bhadravati, Chandrapur, Maharashtra, India. 

Received: 19th March, 2024; Revised: 23rd May, 2024; Accepted: 26thJuly, 2024; Available Online: 25th September, 2024 

ABSTRACT

The primary therapeutic indications for sumatriptan succinate (STS) include the treatment of migraine and cluster headaches. To enhance mucoadhesion, sodium carboxymethyl cellulose (SCMC) and hydroxyl propyl methyl cellulose (HPMC K15M) were used in this study to develop nasal mucoadhesive microspheres of STS. A central composite design, facilitated by Design Expert software, was employed to assess the impact of polymer concentrations on mucoadhesion, involving nine different formulations. The study’s findings indicated that the microspheres were uniformly sized and spherical and that the polymers were compatible with STS. The optimal formulation, consisting of 220.711 mg of SCMC and 150 mg of HPMC K15M, demonstrated the highest level of mucoadhesion. This combination effectively regulated the discharge of STS from the mucoadhesive microspheres and significantly improved their mucoadhesive properties. These results suggest that the strategic use of SCMC and HPMC K15M can enhance the performance of nasal mucoadhesive microspheres, ensuring a controlled release of STS and improved adhesion to mucosal surfaces. This has the potential to optimize the therapeutic efficacy of STS in treating migraine and cluster headaches.

Keywords: Drug release, Mucoadhesive microspheres, Sodium carboxymethyl cellulose, Sumatriptan succinate. International Journal of Drug Delivery Technology (2024); DOI: 10.25258/ijddt.14.3.56

How to cite this article: Vyas S, Anitha KN, Mudduluru NB, Devhare LD. Quality by Design Approach to Nasal Mucoadhesive Microspheres: Enhanced Sumatriptan Succinate Delivery through Formulation and Characterization. International Journal of Drug Delivery Technology. 2024;14(3):1644-1651.

REFERENCES

  1. Yadav RK, Shah K, Dewangan HK. Intranasal drug delivery of sumatriptan succinate-loaded polymeric solid lipid nanoparticles for brain targeting. Drug development and industrial pharmacy. 48(1):21-28. https://doi.org/10.1080/03639045.2022.2090575
  2. Peng KP, Jürgens T, Basedau H, Ortlieb L, May Sumatriptan prevents central sensitization, specifically in the trigeminal dermatome in humans. European Journal of Pain. 2022;26:2152- 161.
  3. Sirisha Y, Sneha D, Ramya SS. Formulation and evaluation of sumatriptan succinate microspheres by using different Asian Journal of Pharmacy and Technology. 2023;13(2):91-94.
  4. Pandey J, Shankar R, Kumar M, Shukla K, Kumari Development of nasal mucoadhesive microspheres of granisetron: A potential drug. Drug Research. 2020;70:367. DOI: 10.1055/a- 1193-4781
  5. Beg S, Rahman M, Panda SK, Alharbi KS, Alruwaili NK, Ameeduzzafar, et al. Nasal mucoadhesive microspheres of lercanidipine with improved systemic bioavailability and antihypertensive Journal of Pharmaceutical Innovation. 2021;16:237-246.
  6. Bartos C, Varga P, Szabó-Révész P, Ambrus Physico-chemical and in vitro characterization of chitosan-based microspheres intended for nasal administration. Pharmaceutics. 2021;13:608. https://doi.org/10.3390/pharmaceutics13050608
  7. Djekic Novel Mucoadhesive Polymers for Nasal Drug Delivery.Nasal Drug Delivery: Formulations, Developments, Challenges, and Solutions. 2023:189-234. https://doi.org/10.1007/978-3-031- 23112-4_11
  8. Dawre S, Waghela S, Saraogi Statistically designed vitamin D3 Encapsulated PLGA microspheres dispersed in thermoresponsive in-situ gel for nasal delivery. Journal of Drug Delivery Science and Technology. 2022;75:103688. https://doi. org/10.1016/j.jddst.2022.103688
  9. Gavini E, Rassu G, Haukvik T, Lanni C, Racchi M, GiunchediMucoadhesive microspheres for nasal administration of cyclodextrins. Journal of drug targeting. 2009;17:168-179.
  10. Tadavi S, Pawar S. Mucoadhesive Pentoxifylline Microsphere for Non-Invasive Nasal Drug Engineering Proceedings. 2023, 56, 319. https://doi.org/10.3390/ASEC2023-15957
  11. Belgamwar VS, Patel HS, Joshi AS, Agrawal A, Surana SJ, Tekade AR. Design and development of nasal mucoadhesive microspheres containing tramadol HCl for CNS Drug delivery. 2011;18:353-360.
  12. Jain SA, Chauk DS, Mahajan HS, Tekade AR, Gattani SG. Formulation and evaluation of nasal mucoadhesive microspheres of Sumatriptan succinate. Journal of microencapsulation. 2009;26:711-721.
  13. Tatiya GD, Basarkar Formulation development and in vitro evaluation of mucoadhesive microspheres of simvastatin for nasal delivery. International Journal of Pharmaceutical Sciences Review and Research. 2013;21:334-341.
  14. Sangeeta PC, Narwal Formulation and evaluation of mucoadhesive microspheres of dolasetron for nasal delivery. Acta Biomedica. 2023;94:1091-1100.
  15. Tadavi S, Pawar S. Mucoadhesive Pentoxifylline Microsphere for Non-Invasive Nasal Drug Engineering Proceedings 2023;56:319. https://doi.org/10.3390/ASEC2023-15957
  16. Puri V, Kaur VP, Singh A, Singh C. Recent advances on drug delivery applications of mucopenetrative/mucoadhesive particles: A review. Journal of Drug Delivery Science and Technology. 2022;75:103712. https://doi.org/10.1016/j.jddst.2022.103712
  17. Sapra A, Hm H, Amin SM, Kelsi FA, Nur S, Permana AD. Development of mucoadhesive microspheres for intranasal delivery of fluconazole as an alternative treatment of cryptococcal meningitis infection in patients with acquired immunodeficiency. Annales Pharmaceutiques Françaises: Elsevier. 2024.
  18. Devhare LD and Gokhale Antioxidant and Antiulcer Property of Different Solvent Extracts of Cassia Tora Linn. Research Journal of Pharmacy and Technology. 2022;15(3);1109-1113. http://dx.doi.org/10.52711/0974-360X.2022.00185
  19. Tiwari R, Mishra J, Devhare LD and Tiwari An updated review on recent developments and applications of fish collagen. Pharma Times. 2023;55(6):28-36
  20. Adimulapu AK, Devhare LD, Anasuya Patil A, Chachda NO,Dharmamoorthy. Design and Development of Novel Mini Tablet Cap Technology for the Treatment of Cardiovascular Diseases. International Journal of Drug Delivery Technology. 2023;13(3):801-806. DOI: 10.25258/ijddt.13.3.04
  21. Chawla A, Devhare LD, Dharmamoorthy G, Ritika, Tyagi S. Synthesis and In-vivo Anticancer Evaluation of N-(4-oxo-2- (4-((5-aryl-1,3,4 thiadiazole-2yl) amino) Phenyl thiazolidine-3-yl) Benzamide derivative. International Journal of Pharmaceutical Quality Assurance. 2023;14(3):470- DOI: 10.25258/ ijpqa.14.3.02
  22. Gnana RPM, Devhare LD, Dharmamoorthy G, Khairnar MV,Prasidha R. Synthesis, Characterisation, Molecular Docking Studies and Biological Evaluation of Novel Benzothiazole Derivatives as EGFR Inhibitors for Anti-breast Cancer Agents. International Journal of Pharmaceutical Quality Assurance. 2023;14(3):475-480. DOI: 10.25258/ijpqa.14.3.03
  23. Sonule M, Devhare LD, Babu MN, Gunjal SD, Varalaxmi S. Microemulgel-based Hydrogel of Diclofenac Sodium using Lipidium sativum as a Gelling Agent. International Journal of Drug Delivery 2023;13(4):1235-1239. DOI: 10.25258/ ijddt.13.4.19
  24. Shriram BK, Devhare LD, Mehrotra A, Deokar SS, Singh SP. Formulation and Evaluation of Mosquito Repellent International Journal of Drug Delivery Technology. 2023;13(4):1283-1286. http://dx.doi.org/10.25258/ijddt.13.4.26.
  25. Choudhary RK, Beeraka S, Sarkar BK, Dharmamoorthy G, Devhare L. Optimizing Verapamil Hydrochloride In-situ Delivery: A Strategic Formulation Approach using Box- Behnken Design for Enhanced Performance and Comprehensive Evaluation of Formulation Parameters. International Journal of Drug Delivery Technology. 2024;14(1):61-70. DOI: 10.25258/ijddt.14.1.11
  26. Kumar KK, Kiran V, Choudhary RK, Devhare LD, Gunjal SD. Design Development and Characterization of Nicardipine Solid Lipid Nano-Particulars. International Journal of Drug Delivery Technology. 2024;14(1):71-78. DOI: 25258/ijddt.14.1.12
  27. Priya MGR, Prasanth LML, Devhare LD, Yazdan SK, Gunjal S. Synthesis, DNA Binding, Molecular Docking and Anticancer Studies of Copper (II), Nickel (II), and Zinc (II) Complexes of Primaquine-based Ligand. International Journal of Pharmaceutical Quality Assurance. 2024;15(1):69-75. DOI: 25258/ijpqa.15.1.10
  28. Uplanchiwar VP, Raut SY, Devhare LD, et Pharmacological Assessment of Antiulcer Activity of Gloriosa Superba Linn Tubers In Experimentally Induced Gastric Ulcers. Journal of Medical Pharmaceutical and Allied Science. 2021;10(3);2852- 2856.
  29. Tiwari G, Gupta M, Devhare LD, & Tiwari Therapeutic and Phytochemical Properties of Thymoquinone Derived from Nigella Sativa. Current Drug Research Reviews. 2024;16(2):145-https://doi.org/10.2174/2589977515666230811092410