NOVEL SELF-MICROEMULSIFYING DRUG DELIVERY SYSTEM FOR ENHANCED DIABETES MANAGEMENT: EVALUATING THE COMBINED EFFECTS OF GLIMEPIRIDE AND BOSWELLIA SERRATA EXTRACT

Authors

  • Rachappa Dhondiba Mahale Department of Pharmaceutics, School of Pharmacy, RK University, Rajkot, Gujarat, India
  • Vipul P. Patel Department of Pharmaceutics, School of Pharmacy, RK University, Rajkot, Gujarat, India

Abstract

This study aimed to create and assess a novel self-microemulsifying drug delivery system (SMEDDS) for treating diabetes mellitus that contains glimepiride and Boswellia serrata extract. In the creation of SMEDDS formulations, Transcutol-P was employed as the base oil, while the surfactants Tween 80 and propylene glycol/polyethylene glycol 400 served as the co-surfactants. To improve the formulation, pseudoternary phase diagrams were created. While the SMEDDS of B. serrata extract showed a mean droplet size of 27.63 nm, 98.3% transmittance, a zeta potential of -0.11 mV, and a polydispersity index of 0.287, the glimepiride-optimized SMEDDS showed a mean droplet size of 14.8 nm, 98.5% transmittance, a zeta potential of -0.10 mV. In-vivo evaluation on diabetes-induced rats demonstrated significant reductions in SGOT and SGPT levels with the glimepiride and B. serrata extract SMEDDS compared to diabetic control rats and the marketed glimepiride formulation. The formulation showed promising results in controlling serum total protein, triglyceride, and cholesterol levels. The glimepiride and B. serrata extract SMEDDS also exhibited antioxidant activity, reducing malondialdehyde (MDA) absorbance. Histopathological assessment of kidney and pancreas tissues revealed the protective effects of the concomitant administration of glimepiride and B. serrata extract SMEDDS formulation against diabetes-induced damage. Overall, the developed SMEDDS formulation kit showed superior in-vitro and in-vivo performance, suggesting its potential as an effective therapeutic option for managing diabetes mellitus.

Keywords:

Diabetes mellitus, SMEDDS, Glimepiride, Boswellia Serrata Extract, nephropathy, percentage Transmittance and animal studies

DOI

https://doi.org/10.25004/IJPSDR.2023.150415

References

American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S15-S33. doi: 10.2337/dc21-S002. Erratum in: Diabetes Care. 2021 Sep;44(9):2182. PMID: 33298413.

Cho NH, Shaw JE, Karuranga S, Huang Y, da Rocha Fernandes JD, Ohlrogge AW, Malanda B. IDF Diabetes Atlas: Global estimates of diabetes prevalence for 2017 and projections for 2045. Diabetes Res Clin Pract. 2018 Apr;138:271-281. doi: 10.1016/j.diabres.2018.02.023. Epub 2018 Feb 26. PMID: 29496507.

Padhi S, Nayak AK, Behera A. Type II diabetes mellitus: a review on recent drug based therapeutics. Biomed Pharmacother. 2020 Nov;131:110708. doi: 10.1016/j.biopha.2020.110708. Epub 2020 Sep 11. PMID: 32927252.

Sola D, Rossi L, Schianca GP, Maffioli P, Bigliocca M, Mella R, Corlianò F, Fra GP, Bartoli E, Derosa G. Sulfonylureas and their use in clinical practice. Arch Med Sci. 2015 Aug 12;11(4):840-8. doi: 10.5114/aoms.2015.53304. Epub 2015 Aug 11. PMID: 26322096; PMCID: PMC4548036.

Johansen JS, Harris AK, Rychly DJ, Ergul A. Oxidative stress and the use of antioxidants in diabetes: linking basic science to clinical practice. Cardiovasc Diabetol. 2005 Apr 29;4:5. doi: 10.1186/1475-2840-4-5. PMID: 15862133; PMCID: PMC1131912.

Samala S, Veeresham C. Enhanced Bioavailability of Glimepiride in the Presence of Boswellic Acids in Streptozotocin-Induced Diabetic Rat Model. Natural Products Chemistry & Research. 2013; 1(4). Available from doi:10.4172/2329-6836.1000116

Miller DA, Keen JM, Brough C, Ellenberger DJ, Cisneros M, Williams RO 3rd, McGinity JW. Bioavailability enhancement of a BCS IV compound via an amorphous combination product containing ritonavir. J Pharm Pharmacol. 2016 May;68(5):678-91. doi: 10.1111/jphp.12478. Epub 2015 Oct 10. PMID: 26454138.

Shobha Rani G, Lohita M, Jaya Preethi P, Madhavi R, Sunisitha B, Mounika D. Glimepiride: A Review of Analytical Methods. Asian Journal of Pharmaceutical Analysis. 2014; 4(4):178-182.

Jo K, Kim H, Khadka P, Jang T, Kim SJ, Hwang SH, Lee J. Enhanced intestinal lymphatic absorption of saquinavir through supersaturated self-microemulsifying drug delivery systems. Asian J Pharm Sci. 2020 May;15(3):336-346. doi: 10.1016/j.ajps.2018.11.009. Epub 2019 Feb 14. PMID: 32636951; PMCID: PMC7327769.

Sun D. Infrared Spectroscopy for Food Quality Analysis and Control. Academic Press 2009; 145-178.

Tawab MA, Kaunzinger A, Bahr U, Karas M, Wurglics M, Schubert-Zsilavecz M. Development of a high-performance liquid chromatographic method for the determination of 11-keto-beta-boswellic acid in human plasma. J Chromatogr B Biomed Sci Appl. 2001 Sep 25;761(2):221-7. doi: 10.1016/s0378-4347(01)00335-8. PMID: 11587352.

Shah SA, Rathod IS, Suhagia BN, Pandya SS, Parmar VK. A simple high-performance liquid chromatographic method for the estimation of boswellic acids from the market formulations containing Boswellia serrata extract. J Chromatogr Sci. 2008 Sep;46(8):735-8. doi: 10.1093/chromsci/46.8.735. PMID: 18796232.

Pozharitskaya ON, Ivanova SA, Shikov AN, Makarov VG. Separation and quantification of terpenoids of Boswellia serrata Roxb. extract by planar chromatography techniques (TLC and AMD). J Sep Sci. 2006 Sep;29(14):2245-50. doi: 10.1002/jssc.200600078. PMID: 17069256.

Dalwadi S, Thakkar VT, Rana HB. Hybrid Liquisolid Technique: A Novel Approach to Enhance the In-vitro Performance of Antidiabetic Drugs. Current Drug Therapy. 2021; 16:409-422. Available from DOI: 10.2174/1574885516666210531130134

Hyma P, Laharika Reddy D, Abbulu K. Formulation and Characterization of Novel Self Micro emulsifying Drug Delivery System of Glimepiride. The Experiment. 2014; 24 (1):1640-1648

Sangshetti JN, Deshpande M, Zaheer Z, Shinde DB, Arote R. Quality by design approach: Regulatory need. Arabian Journal of Chemistry. 2017;10: S3412–S3425. Available from doi: 10.1016/j.arabjc.2014.01.025

Borhade V, Nair H, Hegde D. Design and evaluation of self-microemulsifying drug delivery system (SMEDDS) of tacrolimus. AAPS PharmSciTech. 2008;9(1):13-21. doi: 10.1208/s12249-007-9014-8. Epub 2008 Jan 4. PMID: 18446456; PMCID: PMC2976874.

Visetvichaporn V, Kim KH, Jung K, Cho YS, Kim DD. Formulation of self-microemulsifying drug delivery system (SMEDDS) by D-optimal mixture design to enhance the oral bioavailability of a new cathepsin K inhibitor (HL235). Int J Pharm. 2020 Jan 5;573:118772. doi: 10.1016/j.ijpharm.2019.118772. Epub 2019 Nov 23. PMID: 31765770.

Yadav P, Rastogi V, Verma A. Application of Box–Behnken design and desirability function in the development and optimization of self-nanoemulsifying drug delivery system for enhanced dissolution of ezetimibe. Future Journal of Pharmaceutical Sciences, 2020; 6(7): 1-20. Available from doi:10.1186/s43094-020-00023-3

Mahale RD. Patel VP. Effect Of SMEEDS Formulation Of Glimepiride In Combination With Boswellic Acid Extract In Diabetic Induced Rats To Mimic Diabetic Complications. Neuro Quantology. 2022; 20:14: 486-495. Available from Doi: 10.48047/nq.2022.20.14. NQ88069

Published

28-07-2023
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“NOVEL SELF-MICROEMULSIFYING DRUG DELIVERY SYSTEM FOR ENHANCED DIABETES MANAGEMENT: EVALUATING THE COMBINED EFFECTS OF GLIMEPIRIDE AND BOSWELLIA SERRATA EXTRACT”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 15, no. 4, July 2023, pp. 507-18, https://doi.org/10.25004/IJPSDR.2023.150415.

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Research Article

How to Cite

“NOVEL SELF-MICROEMULSIFYING DRUG DELIVERY SYSTEM FOR ENHANCED DIABETES MANAGEMENT: EVALUATING THE COMBINED EFFECTS OF GLIMEPIRIDE AND BOSWELLIA SERRATA EXTRACT”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 15, no. 4, July 2023, pp. 507-18, https://doi.org/10.25004/IJPSDR.2023.150415.