FORMULATION AND EVALUATION OF SELF-NANO EMULSIFYING SYSTEM OF ORNIDAZOLE (SNEDDS) AS ANTI-BACTERIAL AGENT
Main Article Content
Keywords
anti-protozoal, ornidazole,, Self emulsifying nano-drug delivery system, anti-amoebic, bioavailability
Abstract
The current research work study deals with the development of SNEDSS of ornidazole. The pure drug ornidazole is act as an antifungal treat on the fungal infection. SNEDDS definitions were effectively planned by developing pseudo ternary phases and assessed. To Formulate and Evaluate the self nano-emulsifying drug delivery system (SNEDDS) of poorly water-soluble drug Ornidazole by using different Oil, Surfactants, Co-surfactant. To improve the solubility of Ornidazole. To construct the ternary phase diagrams of SNEDDS. To formulate the liquid SNEDDS. To evaluate the physicochemical characterization of developed formulations. To perform In-vitro characterization of developed formulations. The development of SNEDDS drug is selected based on its solubility and bioavailability. The Ornidazole is BCS class II drug having poor solubility and high permeability hence it is good choice of drug for development of SNEDDS.8 The short elimination half-life of ornidazole is 12-13 hrs. Then to gives reducing the dose frequency by oral administration shows better first pass effect. The bioavailability is 90 %. The preparation of SEDDS were characterized for % yield, % drug content, Zeta potential & DSC, in-vitro drug release (%CDR) for anti-protozoal activity. The results give prepared SEDDS formulation enhanced drug content. In the optimized A7 trial which release ornidazole. 18.56±1.2 % in 5 min. & remaining drug released up to 60 min. which is 98.94 ±2.45%. The SEDDS formulation were found to be stable under stability condition, which that the better drug delivery system (ODDS) & Novel drug delivery system for improved therapeutic effect of anti-protozoal anti-amoebic drug ornidazole.
References
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28. Vivek P. Chavda, Dhaval Shah, Self-emulsifying delivery systems: one step ahead in improving solubility of poorly soluble drugs, In journal Nanostructures for Cancer Therapy, 2017: 653-718.
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34. Eleni Kontogiannidou, Thomas Meikopoulos, In Vitro Evaluation of Self-Nano- Emulsifying Drug Delivery Systems (SNEDDS) Containing Room Temperature Ionic Liquids (RTILs) for the Oral Delivery of Amphotericin B, Pharmaceutics. 2020 Aug; 12(8): 699.
35. Surya Kovvasu, Self-emulsifying Drug Delivery Systems and their Marketed Products: A Review, Asian Journal of Pharmaceutis,Apr-Jun 2019; 13(2): 73.
36. Y. Nakama, Surfactants, In journal of Cosmetic Science and Technology, 2017: 231-244.
37. Jean-Louis SALAGER, Book of surfactant types and uses: 1-48.
38. Marc Hirsch, Original article on Lowering surface tension – Surfactants in coating materials, February 25, 2021:1-6.
39. Ali Nasr, Effect of oils, surfactants and cosurfactants on phase behavior and physicochemical properties of self-nanoemulsifying drug delivery system (Snedds) for irbesartan and olmesartan, Int J App Pharm, 2006; Vol 8, Issue (1): 13-24.
40. Reza Fattahi, Babak Ghanbarzadeh, The effect of Macro and Nano‐emulsions of cinnamon essential oil on the properties of edible active films, Food Sci Nutr. 2020 Dec; 8(12): 6568– 6579.
41. Theories of Microemulsion Formation, By Pharma Tips: 2011.
42. Kaustav B, Book on Importance of Surface Energy in Nanoemulsion, 2019: 1-432.
43. Jeand Baloch, Muhammad Farhan Sohail,Self-Nanoemulsifying Drug Delivery System (SNEDDS) for Improved Oral Bioavailability of Chlorpromazine: In Vitro and In Vivo Evaluation, Medicina (Kaunas), 2019 May; 55(5): 210.
44. Kareem Rahn-Chique, German Urbina-Villalba, Article on Correct Use of the Lifshitz- Slyosov-Wagner Expression for the Calculation of the Average Radius of an Oil-In-Water (o/w) Emulsion Subject to Coalescence: 2015: 324.
45. Applications of SNEDDS, Wikipedia.
46. Mohammed Al-Swairi, Evaluation of Self-Nanoemulsifying Drug Delivery Systems (SNEDDS) for Poorly Water-Soluble Talinolol: Preparation, in vitro and in vivo Assessment, Front. Pharmacol, 2019; (10) 459: 1-15.
47. Jaydeep Patel, Garala Kevin, Design and development of a self-nanoemulsifying drug delivery system for telmisartan for oral drug delivery, Int J Pharm Investig. 2011 Apr-Jun; 1(2): 112–118.
48. Ornidazole Pharmacology, Medicine India.
49. Mentha oil, Wikipedia.
50. Manoj Mishra, Pharmaceutical preformulation studies in formulation and development of new dosage form: A review, International Journal of Pharma Research & Review, Oct 2016; 5(10):12-20.
51. General tests, processes and apparatus, JP XVI, 25-312.
52. Phuong Tran, Jeong-Sook Park, Recent trends of self- emulsifying drug delivery system for enhancing the oral bioavailability of poorly water- soluble drugs, Journal of pharmaceutical Investigation; (2021),51: 439-463.
53. Darna Bhikshapathi, Formulation and characterization of pioglitazone HCl self emulsifying drug delivery system, Scholars Research Library Der Pharmacia Lettre, 2013, 5 (2):292-30.
54. Ashok Meena, Formulation development of an albendazole self-emulsifying drug delivery system (SEDDS) with enhanced systemic exposure,Acta Pharm,(2012);62: 563–580.
55. Ping Gao, Development of a supersaturable SEDDS (S-SEDDS) formulation of paclitaxel with improved oral bioavailability, J Pharm Sci, 2003 Dec;92(12):2386-98.
56. Prabagar Balakrishnan, Enhanced oral bioavailability of dexibuprofen by a novel solid Self-emulsifying drug delivery system (SEDDS), European Journal of Pharmaceutics and Biopharmaceutics, Aug 2009;Volume 72, Issue 3: 539-545.
57. Nitin Pandurang Gurav, Solubility Enhancement of Satranidazole Using Self Emulsified Drug Delivery Systems, Indian Journal of Pharmaceutical Education and Research, Jul-Sep, 2016; Vol 50, Issue 3 (Suppl.): 68-75.
58. Zwanden Sule Yahaya, Preliminary investigation on coconut oil-based self-emulsifying formulation for the delivery of Metronidazole, Nigerian Journal of Pharmaceutical and Applied Science Research, January 2020; 9(1):18-24.
59. Venkatesh Miryala, Mallesh Kurakula, self- nano emulsifying drug delivery system (snedds) for oral delivery of atorvastatin formulation and bioavailability studies, Journal of Drug Delivery & Therapeutics; 2013, 3(3):131-142.
60. Sailaja Gunnam, Formulation and Evaluation of Self-emulsifying Drug Delivery System of Bosentan, Asian Journal of Pharmaceutics Apr -Jun 2018;12 (2):822- 833.
2. Gursoy R N, Benita S, Self- emulsifying drug delivery systems (SEDDS) for improved oral delivery of lipophilic drugs, Biomed Pharmacother,2004 Apr;58(3):173-82.
3. Manjit Jaiswal, Rupesh Dudhe, and P. K. Sharma, Nanoemulsion: an advanced mode of drug delivery system, Biotech journal,2015 Apr; 5(2): 123–127.
4. Marlyn Laksitorini, Vivitri D. Prasasty, Paul K. Kiptoo, and Teruna J. Siahaan, Pathways and Progress in Improving Drug Delivery through the Intestinal Mucosa and Blood-Brain Barriers, HHS Public Access Ther Deliv. 2014 October; 5(10): 1143–1163.
5. Orme M, Drug Absorption in The Gut, Br. J. Anaetth,1984: 56- 59.
6. Bahman Homayun, Xueting Lin and Dr. Hyo-Jick Choi, challenges and recent progress in oral drug delivery systems for Biopharmaceuticals, Pharmaceutics 2019, 11(3):129.
7. Savjani KT, Gajjar AK, Savjani JK, Drug solubility: Importance and Enhancement Techniques, ISRN Pharm. 2012; 2(12):45-56.
8. Mark G. Papich and Marilyn N. Martinez, Applying Biopharmaceutical Classification System (BCS) criteria to predict oral absorption of drugs in dogs: Challenges and pitfalls, AAPS J. 2015 Jul; 17(4): 948–964.
9. Kshitija Khedekar and Swati Mittal, Self Emulsifying Drug Delivery System: A Review, Ijpsr (2013); Vol.4, Issue 12:4494-4507.
10. Abhijit A Date , Neha Desai, Rahul Dixit, Mangal Nagarsenker, Self Emulsifying Drug Delivery System: formulation insights,applications and advances, Nanomedicine (Lond), 2010 Dec;5(10):1595-616.
11. Aristote B. Buya, Ana Beloqui, Patrick B. Memvanga and Veronique Préat, Self-Nano- Emulsifying Drug-Delivery Systems:From the Development to the Current Applications and Challenges in Oral Drug Delivery, Pharmaceutics 2020; Vol 12:1194.
12. Mrunali R. Patel and Shivam D. Thakore, Nanoemulsion in drug delivery, In journal Applications of Nanocomposite Materials in Drug Delivery, 2018:1-2.
13. Thakur Gurjeet Singh and Mansi Chitkara, Nanobiomaterials, In journal Fabrication and Self-Assembly of Nanobiomaterials, 2016:5-6.
14. Stefano Buzzaccaro, Antonio Tripodi, Roberto Rusconi1, Daniele Vigolo and Roberto Piazza, Kinetics of sedimentation in colloidal suspensions, J. Phys.: Condens. Matter (2008); 20: 494219- 494228.
15. Gaurang Patel, Ambikanandan Misra, Oral Delivery of Proteins and Peptides,In journal Challenges in Delivery of Therapeutic Genomics and Proteomics, 2011; Vol 1:191- 193.
16. Aristote B. Buya, Ana Beloqui, Patrick B. Memvanga and Veronique Preat, Self-Nano- Emulsifying Drug-Delivery Systems: From the Development to the Current Applications and Challenges in Oral Drug Delivery, Pharmaceutics. 2020 Dec; 12(12): 1194.
17. Zahari Vinarov, Mohammad Abdallah, Impact of gastrointestinal tract variability on oral drug absorption and pharmacokinetics: An UNGAP review, European Journal of Pharmaceutical Sciences,July 2021; Volume 162:10581.
18. Michael Grimm, Mirko Koziolek, Jens-Peter Kühn and Werner Weitschies, Interindividual and intraindividual variability of fasted state gastric fluid volume and gastric emptying of water, European Journal of Pharmaceutical Sciences, 2018; Volume 127: 309-317.
19. Barbara M. Davit, Isadore Kanfer, BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements, AAPS J. 2016 May; 18(3): 612–618.
20. B. Basanta Kumar Reddy, and A. Karunakar, Biopharmaceutics Classification System: A Regulatory Approach, Dissolution Technologies, 2011:31-37.
21. Ashish Gadhave, Determination of Hydrophilic-Lipophilic Balance Value, IJSR, 2014; Volume 3 Issue 4: 573-575.
22. Solubility, Wikipedia: The free encyclopedia.
23. Venkat Ratnam Devadasu,Rakesh K. Tekade, Physicochemical, Pharmaceutical, and Biological Considerations in GIT Absorption of Drugs, In journal of Dosage Form Design Considerations, 2018: 149-178.
24. Prakash Khadka , Jieun Ro, Pharmaceutical particle technologies: An approach to improve drug solubility, dissolution and bioavailability, Asian Journal of Pharmaceutical Sciences December 2014; Volume 9, Issue 6:304-316.
25. Abhijit A Date; Neha Desai; Rahul Dixit; Mangal Nagarsenker, Self-nanoemulsifying Drug Delivery Systems: Formulation Insights, Applications and Advances, Nanomedicine. 2010; 5(10):11-15.
26. Ahmad Mustafa Masoud Eid, The Effect of Surfactant Blends on the Production of Self- Emulsifying System, IJPFR, April-June 2012; 2(2):21-31.
27. Maarit J. Rein, Mathieu Renouf, Bioavailability of bioactive food compounds: a challenging journey to bioefficacy, Br J Clin Pharmacol. 2013 Mar; 75(3): 588–602.
28. Vivek P. Chavda, Dhaval Shah, Self-emulsifying delivery systems: one step ahead in improving solubility of poorly soluble drugs, In journal Nanostructures for Cancer Therapy, 2017: 653-718.
29. Milica Markovic, Shimon Ben-Shabat, Lipids and Lipid-Processing Pathways in Drug Delivery and Therapeutics, Int J Mol Sci. 2020 May; 21(9): 3248.
30. 29) Samuel L. Jones and Anthony T. Blikslager, Disorders of the Gastrointestinal System, Equine Internal Medicine. 2004: 769–949.
31. Kazi Mohsin, Design of Lipid-Based Formulations for Oral Administration of Poorly Water- Soluble Drug Fenofibrate: Effects of Digestion, AAPS PharmSciTech. 2012 Jun; 13(2): 637– 646.
32. Shweta Gupta, Rajesh Kesarla, and Abdelwahab Omri, Formulation Strategies to Improve the Bioavailability of Poorly Absorbed Drugs with Special Emphasis on Self-Emulsifying Systems, ISRN Pharm. (2013); 2013: 848043.
33. Priya Thakare, Vrushali Mogal, Pankaj Borase, Jaydeep Dusane and Sanjay Kshirsagar, A review on self-emulsified drug delivery system, Pharmaceutical and Biological Evaluations April 2016; Vol. 3, Issue (2): 140-153.
34. Eleni Kontogiannidou, Thomas Meikopoulos, In Vitro Evaluation of Self-Nano- Emulsifying Drug Delivery Systems (SNEDDS) Containing Room Temperature Ionic Liquids (RTILs) for the Oral Delivery of Amphotericin B, Pharmaceutics. 2020 Aug; 12(8): 699.
35. Surya Kovvasu, Self-emulsifying Drug Delivery Systems and their Marketed Products: A Review, Asian Journal of Pharmaceutis,Apr-Jun 2019; 13(2): 73.
36. Y. Nakama, Surfactants, In journal of Cosmetic Science and Technology, 2017: 231-244.
37. Jean-Louis SALAGER, Book of surfactant types and uses: 1-48.
38. Marc Hirsch, Original article on Lowering surface tension – Surfactants in coating materials, February 25, 2021:1-6.
39. Ali Nasr, Effect of oils, surfactants and cosurfactants on phase behavior and physicochemical properties of self-nanoemulsifying drug delivery system (Snedds) for irbesartan and olmesartan, Int J App Pharm, 2006; Vol 8, Issue (1): 13-24.
40. Reza Fattahi, Babak Ghanbarzadeh, The effect of Macro and Nano‐emulsions of cinnamon essential oil on the properties of edible active films, Food Sci Nutr. 2020 Dec; 8(12): 6568– 6579.
41. Theories of Microemulsion Formation, By Pharma Tips: 2011.
42. Kaustav B, Book on Importance of Surface Energy in Nanoemulsion, 2019: 1-432.
43. Jeand Baloch, Muhammad Farhan Sohail,Self-Nanoemulsifying Drug Delivery System (SNEDDS) for Improved Oral Bioavailability of Chlorpromazine: In Vitro and In Vivo Evaluation, Medicina (Kaunas), 2019 May; 55(5): 210.
44. Kareem Rahn-Chique, German Urbina-Villalba, Article on Correct Use of the Lifshitz- Slyosov-Wagner Expression for the Calculation of the Average Radius of an Oil-In-Water (o/w) Emulsion Subject to Coalescence: 2015: 324.
45. Applications of SNEDDS, Wikipedia.
46. Mohammed Al-Swairi, Evaluation of Self-Nanoemulsifying Drug Delivery Systems (SNEDDS) for Poorly Water-Soluble Talinolol: Preparation, in vitro and in vivo Assessment, Front. Pharmacol, 2019; (10) 459: 1-15.
47. Jaydeep Patel, Garala Kevin, Design and development of a self-nanoemulsifying drug delivery system for telmisartan for oral drug delivery, Int J Pharm Investig. 2011 Apr-Jun; 1(2): 112–118.
48. Ornidazole Pharmacology, Medicine India.
49. Mentha oil, Wikipedia.
50. Manoj Mishra, Pharmaceutical preformulation studies in formulation and development of new dosage form: A review, International Journal of Pharma Research & Review, Oct 2016; 5(10):12-20.
51. General tests, processes and apparatus, JP XVI, 25-312.
52. Phuong Tran, Jeong-Sook Park, Recent trends of self- emulsifying drug delivery system for enhancing the oral bioavailability of poorly water- soluble drugs, Journal of pharmaceutical Investigation; (2021),51: 439-463.
53. Darna Bhikshapathi, Formulation and characterization of pioglitazone HCl self emulsifying drug delivery system, Scholars Research Library Der Pharmacia Lettre, 2013, 5 (2):292-30.
54. Ashok Meena, Formulation development of an albendazole self-emulsifying drug delivery system (SEDDS) with enhanced systemic exposure,Acta Pharm,(2012);62: 563–580.
55. Ping Gao, Development of a supersaturable SEDDS (S-SEDDS) formulation of paclitaxel with improved oral bioavailability, J Pharm Sci, 2003 Dec;92(12):2386-98.
56. Prabagar Balakrishnan, Enhanced oral bioavailability of dexibuprofen by a novel solid Self-emulsifying drug delivery system (SEDDS), European Journal of Pharmaceutics and Biopharmaceutics, Aug 2009;Volume 72, Issue 3: 539-545.
57. Nitin Pandurang Gurav, Solubility Enhancement of Satranidazole Using Self Emulsified Drug Delivery Systems, Indian Journal of Pharmaceutical Education and Research, Jul-Sep, 2016; Vol 50, Issue 3 (Suppl.): 68-75.
58. Zwanden Sule Yahaya, Preliminary investigation on coconut oil-based self-emulsifying formulation for the delivery of Metronidazole, Nigerian Journal of Pharmaceutical and Applied Science Research, January 2020; 9(1):18-24.
59. Venkatesh Miryala, Mallesh Kurakula, self- nano emulsifying drug delivery system (snedds) for oral delivery of atorvastatin formulation and bioavailability studies, Journal of Drug Delivery & Therapeutics; 2013, 3(3):131-142.
60. Sailaja Gunnam, Formulation and Evaluation of Self-emulsifying Drug Delivery System of Bosentan, Asian Journal of Pharmaceutics Apr -Jun 2018;12 (2):822- 833.
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Aug 18, 2022
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How to Cite
Poonam Ghorpade, Vishal R. Rasve, Mahesh Kshirsagar, Snehal Lad, & Vaishnavi Katkar. (2022). FORMULATION AND EVALUATION OF SELF-NANO EMULSIFYING SYSTEM OF ORNIDAZOLE (SNEDDS) AS ANTI-BACTERIAL AGENT. Journal of Population Therapeutics and Clinical Pharmacology, 29(03), 446–463. https://doi.org/10.53555/jptcp.v29i03.3849
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Author Biographies
Poonam Ghorpade
SAJVPM’s, College of Pharmaceutical sciences and research center, Kada, Beed, MH-414202
Vishal R. Rasve
SAJVPM’s, College of Pharmaceutical sciences and research center, Kada, Beed, MH-414202
Mahesh Kshirsagar
SAJVPM’s, College of Pharmaceutical sciences and research center, Kada, Beed, MH-414202
Snehal Lad
SAJVPM’s, College of Pharmaceutical sciences and research center, Kada, Beed, MH-414202
Vaishnavi Katkar
SAJVPM’s, College of Pharmaceutical sciences and research center, Kada, Beed, MH-414202