Novel Application of Mixed Solvency Concept to Develop and Formulate Dry Powder Injection for Reconstitution of a Poorly Water Soluble Drug, Amlodipine Besylate and their Evaluations

  • Yashi Thakur Shri G.S. Institute of Technology and Science, 23, Park Road, Indore 452003 (M.P.), India
  • R.K. Maheshwari Shri G.S. Institute of Technology and Science, 23, Park Road, Indore 452003 (M.P.), India

Abstract

In the recent generation of pharmaceutical research, it has been observed that many newly designed and discovered drug products have less water solubility. Thus, leading to difficulties in several developmental, manufacturing and administrative processes. Furthermore, the clinical trials of these drugs have witnessed a great failure due to their poor pharmacokinetics. The lineup of our research work was promotion of mixed solvency concept by formulating the dry powder injection for reconstitution of poorly water-soluble drug amlodipine besylate by decreasing the solubilisers concentration in small proportion for expected synergistic enhancement of drug solubility in water. Solubilisers used are sodium benzoate, sodium caprylate, PVPK-25, sodium citrate, niacinamide, poloxamer 407, sodium acetate, L-arginine, benzoic acid, β-cyclodextrin and lysine hydrochloride to developed the dry powder injection for reconstitution of amlodipine besylate. The reconstitution time of amlodipine besylate injections were found 58 sec, 36 sec and 1 min 10 sec in selected blends. This drug is slightly soluble in water, and it comes in various forms, including tablets and other oral dosage forms. However, no amlodipine besylate dry powder injection or ready-made injections are currently available in the market. Dry powder injection for reconstitution of amlodipine besylate was formulated successfully and mixed solvency concept has been successfully employed.


Keywords: Mixed solvency concept, Amlodipine besylate, Dry powder injection for reconstitution, Solubilisers, Solubility.

Keywords: Mixed solvency concept, Amlodipine besylate, Dry powder injection for reconstitution, Solubilisers, Solubility

Downloads

Download data is not yet available.

Author Biographies

Yashi Thakur, Shri G.S. Institute of Technology and Science, 23, Park Road, Indore 452003 (M.P.), India

Shri G.S. Institute of Technology and Science, 23, Park Road, Indore 452003 (M.P.), India

R.K. Maheshwari, Shri G.S. Institute of Technology and Science, 23, Park Road, Indore 452003 (M.P.), India

Shri G.S. Institute of Technology and Science, 23, Park Road, Indore 452003 (M.P.), India

References

1. Michael J, Akers, Parenteral Preparation: Chapter 26: 495.
2. United States Pharmacopoeia, 30 National Formulary 25. The United States Pharmacopoeial Convention Incorporation: Rockville, 2007; MD, 33.
3. Indian Pharmacopoeia, The Indian Pharmacopoeia Commission; 2007 Ghaziabad, 36.
4. Maheshwari RK, Shilpkar R, Formulation development and evaluation of injection of poorly soluble drug using mixed solvency concept, International Journal of Pharma and Biosciences, 2012; 3(1):179-189.
5. Solanki SS, Soni LK, Maheshwari RK, Study on mixed solvency concept in formulation development of aqueous injection of poorly water soluble drug, Journal of Pharmaceutics, 2013; 1-8.
6. Pawar PB, Rawat S, Mahajan YY, Galgatte UC, Maheshwari RK, Formulation development and evaluation of aqueous injection of poorly soluble drug made by novel application of mixed solvency concept, International Journal of Drug Delivery, 2013; 5(2):152-166.
7. Solanki SS, Soni LK, Maheshwari RK, Solubilization of poorly water soluble drug using mixed solvency approach for aqueous injection, Journal of Pharmaceutical Research International, 2014; 4(5):549-568.
8. Gour V, Garg A, Shukla A, Yadav AK, Development and evaluation of metronidazole injection by mixed solvency approach, Asian Journal of Biomaterial Research, 2014; 2(1):38-45.
9. Gayakwad PS, Gavit AJ, Rajput PV, Bari MM, Barhate SD, Maheshwari RK, Formulation development and evaluation of an aqueous injection of gatifloxacin by novel mixed solvency technique, World Journal of Pharmaceutical Research, 2014; 3(4):1642-1664.
10. Solanki SS, Development of parenteral formulation of poorly water soluble drugs: the role of novel mixed-solvency concept, Asian Journal of Pharmaceutics (AJP), 2017; 11(1):1-10.
11. Maheshwari N, Maheshwari RK, Formulation development of dry injection for reconstitution of a poorly water soluble drug, candesartan cilexetil, using mixed solvency concept and their evaluations, International Journal of Science and Research (IJSR), 2018; 8(12):1313-1320.
12. Padiyar A, Maheshwari RK, Novel dry injection for reconstitution of aspirin using solid solubilisers, Journal of Drug Delivery and Therapeutics, 2017; 7(7):44-45.
13. Khan MA, Enhancement of solubility of poorly water soluble drugs diclofenac sodium by mixed solvency approach, Research Journal of Pharmaceutical Dosage Forms and Technology, 2013; 5(1):39-41.
14. Kendre PN, Pande VV, Chavan KM, Novel formulation strategy to enhance solubility of quercetin, Pharmacophore, 2014; 5(3):358-370.
15. Kumar CJ, Kumar MD, Solubility enhancement of theophylline drug using mixed solvency approach, International Journal of Chemical Separation Technology, 2015;1(2):1-4.
16. Gadade D, Lohade, TS, Lahoti SR, Rawat SS, Maheshwari RK, Solubility enhancement of ofloxacin by mixed solvency approach, Indian Drugs, 2015; 55(6):34-40.
17. Jain S, Khan A, Jain SD, Maheshwari RK, Solubility enhancement of paracetamol by mixed solvency method, Research & Reviews: Journal of Computational Biology, 2019; 8(2):19-22.
18. Kushwaha A, Gupta MK, Goswami A, Formulation and evaluation of optimized batch in situ gel of ondansetron hydrochloride, Pharmacia: An International Journal of Pharmaceutical Sciences, 2016; 3(1):11-16.
19. Kumar D, Domperidone nasal gel using fenugreek seed as mucoadhesive agent: water solubility problem sort-out, Trends in Pharmaceuticals and Nanotechnology, 2019; 2(1):1-11.
20. Agrawal A, Maheshwari RK, Formulation development and evaluation of in situ nasal gel of poorly water soluble drug using mixed solvency concept, Asian Journal of Pharmaceutics (AJP), 2014; 5(3):131-140.
21. Maheshwari RK, Rajagopalan R, Formulation and evaluation of paracetamol syrup made by mixed-solvency concept, Der Pharmacia Lettre, 2012; 4(1):170-174.
22. Maheshwari RK, Rajagopalan R, Formulation and evaluation of tinidazole syrup made by mixed solvency concept technique, Der Pharmacia Lettre, 2011; 3(6):266-271.
23. Soni LK, Solanki SS, Maheshwari RK, Evaluation of analgesic, anti-inflammatory and ulcerogenic liability of oral solution (syrup) formulation developed by novel mixed solvency concept, Advances in Pharmacology & Toxicology, 2015; 16(2):21-30.
24. Gahlot N, Maheshwari RK, Formulation and development of vaginal films of poorly water soluble drug, metronidazole, using mixed solvency concept and their evaluations, Journal Of Drug Delivery And Therapeutics, 2018; 8(6):41-48. https://doi.org/10.22270/jddt.v8i6.2085
25. Carpenter G, Maheshwari RK, Formulation and development of fast dissolving oral film of a poorly soluble drug, frusemide with improved drug loading using mixed solvency concept and its evaluation, Journal of Drug Delivery and Therapeutics, 2018; 8(6):132-141. https://doi.org/10.22270/jddt.v8i6.2034
26. Mulani P, Maheshwari RK, Formulation development of aqueous topical solutions and gels of poorly water soluble drug nimesulide, using novel application of mixed solvency concept and their evaluations, International Journal of Science and Research (IJSR), 2018; 8(12):1521-1529.
27. Singh S, Maheshwari RK, Gahlot N, Formulation development of topical solutions of poorly water-soluble drug indomethacin employing novel application of mixed solvency concept and their evaluation, International Journal of Green Pharmacy (IJGP), 2018; 12(2)S3:73-79.
28. Maheshwari RK, Chaklan N, Singh S, Novel pharmaceutical application of mixed solvency concept for development of solid dispersions of piroxicam, European Journal of Biomedical and Pharmaceutical Sciences, 2015; 1(3):578-591.
29. Mansuk AG, Deshmukh D, Maheshwari, RK, Pachpute T, Formulation optimization and characterization of solid dispersion of piroxicam prepared by novel application of mixed solvency concept, Pharmaceutical Resonance, 2020; 2(2):41-46.
30. Bagel J, Maheshwari RK, Novel application of mixed solvency concept in the development of fast dissolving solid dispersion of poorly water-soluble drug, torsemide and its evaluations, World Journal of Pharmaceutical Research, 2020; 9(1):1820-1839
31. Chouhan M, Gupta D, Choukse R, Maheshwari RK, Formulation and evaluation fast dissolving tablets of lovastatin using solid dispersion method, Journal of Drug Delivery & Therapeutics, 2019; 9(2-A):29-31.
32. Agrawal R, Maheshwari RK, Novel application of mixed solvency concept in the development of oral liquisolid system of a poorly soluble drug, cefixime and its evaluations, Journal of Drug Delivery and Therapeutics, 2018; 8(6-s):5-8. https://doi.org/10.22270/jddt.v8i6-s.2167
33. Barua D, Indurkhya A, Maheshwari RK, Kumar P, Formulation of rifabutin liquisolid system using mixed solvency concept and their evaluation, International Journal of Pharmacy and Pharmaceutical Sciences, 2019; 4(2):2455-698.
34. Jain S, Maheshwari RK, Formulation development of oral liquisolid system of poorly water soluble drug, piroxicam, using mixed solvency concept and their evaluations, International Journal of Science and Research (IJSR), 2018; 8(12):1703-1711.
35. Rathod M, Agarwal S, Development and evaluation of furosemide microspheres made by mixed solvency concept, International Journal of Pharmaceutical Erudition, 2013; 2(4):22-31.
36. Maheshwari RK, Chandna C, Mixed solvency concept in reducing surfactant concentration of self-emulsifying drug delivery systems of candesartan cilexetil using D-optimal mixture design, Asian Journal of Pharmaceutics, 2013; 7(2):83-91.
37. Maheshwari RK, Jain S, Padria A, Mulani P, Baghel JS, Maheshwari N, Eco-friendly extraction using solids - A novel application of mixed solvency concept, Journal of Drug Delievery & Therapeutics, 2019; 9(2):244-249 https://doi.org/10.22270/jddt.v9i2.2409
38. Padiyar A, Maheshwari RK, Jain S, Formulation and development of high concentration diclofenac sodium injection using mixed solvency concept and its evaluation, International Journal of Advanced Pharmaceutics, 2016; 6:78-84.
39. Jat P, Maheshwari RK, Formulation development of dry powder injection for reconstitution of poorly water-soluble drug, indomethacin, using mixed solvency concept and their evaluations, International Journal Of Pharmaceutical Research And Applications, 2021; 6 (2):314-326.
40. Jain A, Maheshwari RK, Novel application of mixed solvency concept in formulation and development of fast dissolving oral films of poorly water soluble drug, amlodipine besylate and their evaluations, International Journal Of Pharmaceutical Research And Applications 2021; 6 (2):35-55.
41. Padria A, Maheshwari RK, Thakur Y, Ludhiani S, Formulation and development of model dry powder injection for reconstitution of poorly water soluble drug, diazepam by using mixed solvency concept and their evaluations, International Journal Of Pharmaceutical Research And Applications, 2021; 6 (1):1286-1286
Statistics
387 Views | 33 Downloads
How to Cite
1.
Thakur Y, Maheshwari R. Novel Application of Mixed Solvency Concept to Develop and Formulate Dry Powder Injection for Reconstitution of a Poorly Water Soluble Drug, Amlodipine Besylate and their Evaluations. JDDT [Internet]. 15Aug.2021 [cited 2Feb.2023];11(4-S):101-8. Available from: http://jddtonline.info/index.php/jddt/article/view/4991