DEVELOPMENT AND FULL VALIDATION OF A RAPID, COST‑EFFECTIVE RP‑HPLC METHOD FOR THE QUANTIFICATION OF AMLODIPINE BESYLATE IN BULK DRUG AND TABLET FORMULATIONS
Main Article Content
Keywords
Abstract
Ondansetron HCl, a first-line antiemetic, undergoes extensive pre-systemic metabolism, limiting its oral bioavailability. Fast-dissolving oral films (FDOFs) provide an excellent platform to overcome this by enabling rapid drug release and bypassing hepatic first-pass effects [1, 2].
This study utilized a Quality by Design (QbD) approach to develop and optimize FDOFs of Ondansetron HCl for rapid drug delivery.
A 2³ full factorial design was employed, investigating the impact of polymer blend (HPMC 5 & 15 cPs), glycerine, and poloxamer 407 concentrations. FDOFs, prepared by solvent casting, were evaluated for physicochemical, mechanical, and performance attributes. The optimized film underwent stability testing (40°C/75% RH, 1 month).
Drug-excipient compatibility was confirmed by FTIR/DSC. The statistical model revealed that polymer concentration significantly prolonged dissolving time (p < 0.05) and tensile strength, while surfactant concentration enhanced drug release. The optimized formulation (F6) exhibited a dissolution time of 41 ± 1 sec and released 102.54 ± 0.18% of the drug within 6 minutes. It maintained its critical quality attributes under accelerated stability conditions.
The QbD-based approach successfully yielded a stable and efficacious Ondansetron HCl FDOF, presenting a promising patient-centric alternative for rapid emesis control.
References
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26. Ali MS, Vijendar C, Kumar SD, Krishnaveni J. Formulation and evaluation of fast dissolving oral films of Diazepam. J Pharmacovigilance 2016;4(3):1-5.
27. Shimoda H, Taniguchi K, Nishimura M, Matsuura K, Tsukioka T, Yamashita H, Inagaki N, Hirano K, Yamamoto M, Kinosada Y, Itoh Y. Preparation of a fast dissolving oral thin film containing Dexamethasone: a possible application to antiemesis during cancer chemotherapy. Eur J Pharm Biopharm 2009;73(3):361-365.
28. Kelodiya J, Shah SK, Tyagi CK, Budholiya P. Formulation, Development of Fast Dissolving Sublingual Wafers of An Antiemetic Drug Using Film Former. AJPER 2021;10(4):71-78.
29. Zayed GM, Abd-El Rasoul S, Ibrahim MA, Saddik MS, Alshora DH. In vitro and in vivo characterization of Domperidone-loaded fast dissolving buccal films. Saudi pharm J 2020;28(3):266-273.
30. Pandey GS, Kumar R, Sharma R, Singh Y, Teotia UV. Development and optimization of oral fast dissolving film of Salbutamol Sulphate by Design of Experiment. Am J PharmTech Res 2013;3(4):1-17.
31. Buddhadev S, Buddhadev S. Formulation and evaluation of fast dissolving film of Etophylline. IJAPBR 2017;2(2):48-55.
32. Hussain MW, Kushwaha P, Rahman MA, Akhtar J. Development and evaluation of fast dissolving film for oro-buccal drug delivery of Chlorpromazine. Indian J Pharm Educ Res 2017;51(4S): S539-S547.
33. Nair SS, Padmanabhan R, Sreena K, Development and evaluation of fast dissolving oral thin film containing Prochlorperazine Maleate. EJPMR 2016;3(1):379-384.
34. Thayyilakandy SU, Gayathri PS, Arjun KK, Krishnakumar GA, Nair SC. Fast dissolving sublingual patch of Phenobarbital Sodium: Formulation and in vitro evaluation. Int J App Pharm 2020;12(5):158-165.
35. Al-Mogherah AI, Ibrahim MA, Hassan MA. Optimization and evaluation of Venlafaxine Hydrochloride fast dissolving oral films. SPJ 2020;1-9.
36. Nishigaki M, Kawahara K, Nawa M, Futamura M, Nishimura M, Matsuura K, Kitaichi K, Kawaguchi Y, Tsukioka T, Yoshida K, Itoh Y. Development of fast dissolving oral film containing Dexamethasone as an antiemetic medication: clinical usefulness. Int J Pharm 2012; 424:12-17.
37. Sultana F, Arafat M, Pathan SI. Preparation and evaluation of fast dissolving oral thin film of Caffeine. Int J Pharm and Biol Sci 2013;3(1):153-161.
38. Keshavarao KP, Mudit D, Gunashekara K, Anis S, Singh Mangla N, Ajay K. Formulation and evaluation of mouth dissolving film containing Rofecoxib. IRJP. 2011;2(3):273-278.
39. Abdelbary A, Bendas ER, Ramadan AA, Mostafa DA. Pharmaceutical and pharmacokinetic evaluation of a novel fast dissolving film formulation of Flupentixol Dihydrochloride. AAPS Pharmscitech. 2014;15:1-7.
40. Rezaee F, Ganji F. Formulation, characterization, and optimization of Captopril fast-dissolving oral films. AAPS PharmSciTech. 2018;19:1-10.
41. Hirpara F, Debnath SK, Saisivam S. Optimization & screening of different film forming polymers and plasticizers in fast dissolving sublingual film. Int J Pharm Pharm Sci 2012;6(6):41-42.
42. Bala R, Sharma S. Formulation optimization and evaluation of fast dissolving film of Aprepitant by using Design of Experiment. B-FOPCU 2018;56(2):1-10.
43. Galgatte UC, Khanchandani SS, Jadhav YG, Chaudhari PD. Investigation of different polymers, plasticizers and superdisintegrating agents alone and in combination for use in the formulation of fast dissolving oral films. Int J PharmTech Res 2013;5(4):1465-1472.
44. Kulkarni AS, Deokule HA, Mane MS, Ghadge DM. Exploration of different polymers for use in the formulation of oral fast dissolving strips. J Curr Pharm Res 2010;2(1):33-35.
45. Panchal MS, Patel H, Bagada A, Vadalia KR. Formulation and evaluation of mouth dissolving film of Ropinirole Hydrochloride by using pullulan polymers. Int J Pharm Res & Allied Sci 2012;1(3):60-72.
46. Bhikshapathi DV, Madhuri VD, Rajesham VV, Suthakaran R. Preparation and evaluation of fast dissolving oral film containing Naratriptan HCl. Am J Pharm Tech Res. 2014;4(2):799-812.
47. Prabhu P, Dubey A, Kamath K. Formulation and evaluation of fast-dissolving films of Lisinopril. Egypt Pharm J 2015 ;14(1):56-64.
48. Venkateswarlu K. Preparation and evaluation of fast dissolving buccal thin films of Bufotenin. Journal of in silico & in vitro Pharmacology. 2016 Dec;2(4):1-5.
49. Pandey GS, Kumar RA, Sharma RA, Singh YO, Teotia UV. Effects of maltodextrin and glycerin on mechanical properties of oral fast dissolving film of Salbutamol Sulphate. IJAPBC 2014;3(1):199-209.
50. Gad MK, Mohamed MI, Abdelgawad WY. Formulation And Evaluation of Gemifloxacin Intra-pocket Film for Periodontitis. World J Pharm Res 2017;6(16):20-32.
51. Padamwar PA, Phasate PP. Formulation and evaluation of fast dissolving oral film of Bisoprolol Fumarate. UPSR 2015 Jan;6(01):135-142.
52. Shirvan AR, Bashari A, Hemmatinejad N. New insight into the fabrication of smart mucoadhesive buccal patches as a novel controlled-drug delivery system. Eur Polym J 2019; 119:541-550.
53. Tamer MA, Hammid SN, Ahmed BA. Formulation and in vitro evaluation of Bromocriptine Mesylate as fast dissolving oral film. Int. J. Appl. Pharm. 2018;10(1):7-20.
54. Chonkar AD, Rao JV, Managuli RS, Mutalik S, Dengale S, Jain P, Udupa N. Development of fast dissolving oral films containing Lercanidipine HCl nanoparticles in semicrystalline polymeric matrix for enhanced dissolution and ex vivo permeation. Eur J Pharm Biopharm 2016; 103:179-191.
55. Mushtaque M, Muhammad IN, Hassan SM, Ali A, Masood R. Development and pharmaceutical evaluation of oral fast dissolving thin film of Escitalopram: A patient friendly dosage form. Pak J pharm science. 2020;33(1):183-189.
56. Qin ZY, Jia XW, Liu Q, Kong BH, Wang H. Fast dissolving oral films for drug delivery prepared from chitosan/pullulan electrospinning nanofibers. Int J Biol Macromol 2019; 137:224-231.
57. Koland M, Sandeep VP, Charyulu NR. Fast dissolving sublingual films of Ondansetron Hydrochloride: effect of additives on in vitro drug release and mucosal permeation. J Young Pharm 2010 Jul 1;2(3):216-222.
58. Shendge RS, Salunkhe KS, Girish K. Formulation and evaluation of fast dissolving sublingual film of antihistamine drug. Eur J Mol Clin Med 2020;7(4):2134-2143.
59. Bharti K, Mittal P, Mishra B. Formulation and characterization of fast dissolving oral films containing Buspirone Hydrochloride nanoparticles using design of experiment. J Drug Deliv Sci Technol 2019; 49:420-432.
60. Chauhan SS, Lin S, Madan PL. Preparation and evaluation of Nicotine Hydrogen tartrate fast dissolving films for smoking cessation. Asian Journal of Pharmaceutical Sciences. 2012;7(3):181-192.
61. Singroli R, Sharma R, Rathi JC. formulation and evaluation of fast dissolving oral film of Mesalazine. World J Pharm Res 2021:10(14):869-879.
62. Kumar MP, Prasad MR, Pramod M, Reddy VP. Effect of permeation enhancer on ex-vivo permeation of Ondansetron HCl buccal tablets. UPSR 2011;2(11):2841-2845
63. Jain S. Quality by design (QBD): A comprehensive understanding of implementation and challenges in pharmaceuticals development. Int. J. Pharm. Pharm. Sci. 2014;6(1):29-35.
2. https://www.healthdirect.gov.au/what-causes- vomiting/Accessed
3. date-17 August 2023
4. https://en.wikipedia.org/wiki/Motion_sickness/ Accessed date-17 August 2023
5. https://pubmed.ncbi.nlm.nih.gov/30969528 Accessed date-17 August 2023
6. https://www.researchgate.net/publication/315382947_Chemotherapy-Induced_Nausea_and_ Vomiting_Incidence_and_ Management _in _Jordan/Accessed date-17 August 2023
7. O’Brien B, Zhou Q. Variables related to nausea and vomiting during pregnancy. BIRTH. 1995; 22(2):93–100.
8. Khan S, Kataria P, Nakhat P, Yeole P. Taste masking of Ondansetron Hydrochloride by polymer carrier system and formulation of rapid-disintegrating tablets. AAPS PharmSciTech. 2007;8(2): E1-E7.
9. https://pubmed.ncbi.nlm.nih.gov/1829668/Accessed date-17 August 2023
10. Alipour S, Akbari S, Ahmadi F. Development and in vitro evaluation of fast-dissolving oral films of Ondansetron Hydrochloride. TIPS. 2015;1(1):25-30.
11. Beg S, Jena SS, Patra CN, Rizwan M, Swain S, Sruti J, Rao MB, Singh B. Development of solid self-nanoemulsifying granules (SSNEGs) of Ondansetron Hydrochloride with enhanced bioavailability potential. Colloids Surf. B. 2013; 101:414-423.
12. Patil SL, Mahaparale PR, Shivnikar MA, Tiwari SS, Pawar KV, Sane PN. Fast dissolving oral films: An innovative drug delivery system. IJRRPAS 2(3):482-496.
13. Shirvan AR, Bashari A, Hemmatinejad N. New insight into the fabrication of smart mucoadhesive buccal patches as a novel controlled-drug delivery system. Eur Polym J 2019; 119:541-550.
14. Dixit RP, Puthli SP. Oral strip technology: Overview and future potential. Journal of controlled release. 2009;139(2):94-107.
15. Joshua JM, Hari R, Jyothish FK, Surendran SA. Fast dissolving oral thin films: An effective dosage form for quick releases. Int J Sci Rev Res 2016;38(1):282-289.
16. Kaur P, Kumar V. Formulation development and evaluation of fast dissolving bioadhesive sublingual film of Sumatriptan. World J Pharm Res. 2017;6(14):385-410.
17. https://pubchem.ncbi.nlm.nih.gov/#query=Ondansetron%20HCl/ Assessed date-22 August 2023
18. https://www.scbt.com/p/ondansetron-hydrochloride-103639-04 9:jsessionid=McgKc4FL0zUI5dFKRr0J-af0Yjj6965SHukUikYhtVNmNqiyIW81558969426/Accessed date-22 August 2023
19. https://pubchem.ncbi.nlm.nih.gov/compound/68647/Accessed date-22 August 2023
20. https://go.drugbank.com/drugs/DB00904/Accessed date-22 August 2023
21. Raymond CR, Paul JS, Marianeq EQ. Handbook of Pharmaceutical Excipients. 6th edition. North Yorkshire, UK: Pharmaceutical press.2009. pp.346-349.
22. Raymond CR, Paul JS, Marianeq EQ. Handbook of Pharmaceutical Excipients. 6th edition. North Yorkshire, UK: Pharmaceutical press.2009. pp.185-187.
23. Raymond CR, Paul JS, Marianeq EQ. Handbook of Pharmaceutical Excipients. 6th edition. North Yorkshire, UK: Pharmaceutical press.2009. pp.449-453.
24. Raymond CR, Paul JS, Marianeq EQ. Handbook of Pharmaceutical Excipients. 6th edition. North Yorkshire, UK: Pharmaceutical press.2009. pp.301-303.
25. Raymond CR, Paul JS, Marianeq EQ. Handbook of Pharmaceutical Excipients. 6th edition. North Yorkshire, UK: Pharmaceutical press.2009. pp.535-538.
26. Ali MS, Vijendar C, Kumar SD, Krishnaveni J. Formulation and evaluation of fast dissolving oral films of Diazepam. J Pharmacovigilance 2016;4(3):1-5.
27. Shimoda H, Taniguchi K, Nishimura M, Matsuura K, Tsukioka T, Yamashita H, Inagaki N, Hirano K, Yamamoto M, Kinosada Y, Itoh Y. Preparation of a fast dissolving oral thin film containing Dexamethasone: a possible application to antiemesis during cancer chemotherapy. Eur J Pharm Biopharm 2009;73(3):361-365.
28. Kelodiya J, Shah SK, Tyagi CK, Budholiya P. Formulation, Development of Fast Dissolving Sublingual Wafers of An Antiemetic Drug Using Film Former. AJPER 2021;10(4):71-78.
29. Zayed GM, Abd-El Rasoul S, Ibrahim MA, Saddik MS, Alshora DH. In vitro and in vivo characterization of Domperidone-loaded fast dissolving buccal films. Saudi pharm J 2020;28(3):266-273.
30. Pandey GS, Kumar R, Sharma R, Singh Y, Teotia UV. Development and optimization of oral fast dissolving film of Salbutamol Sulphate by Design of Experiment. Am J PharmTech Res 2013;3(4):1-17.
31. Buddhadev S, Buddhadev S. Formulation and evaluation of fast dissolving film of Etophylline. IJAPBR 2017;2(2):48-55.
32. Hussain MW, Kushwaha P, Rahman MA, Akhtar J. Development and evaluation of fast dissolving film for oro-buccal drug delivery of Chlorpromazine. Indian J Pharm Educ Res 2017;51(4S): S539-S547.
33. Nair SS, Padmanabhan R, Sreena K, Development and evaluation of fast dissolving oral thin film containing Prochlorperazine Maleate. EJPMR 2016;3(1):379-384.
34. Thayyilakandy SU, Gayathri PS, Arjun KK, Krishnakumar GA, Nair SC. Fast dissolving sublingual patch of Phenobarbital Sodium: Formulation and in vitro evaluation. Int J App Pharm 2020;12(5):158-165.
35. Al-Mogherah AI, Ibrahim MA, Hassan MA. Optimization and evaluation of Venlafaxine Hydrochloride fast dissolving oral films. SPJ 2020;1-9.
36. Nishigaki M, Kawahara K, Nawa M, Futamura M, Nishimura M, Matsuura K, Kitaichi K, Kawaguchi Y, Tsukioka T, Yoshida K, Itoh Y. Development of fast dissolving oral film containing Dexamethasone as an antiemetic medication: clinical usefulness. Int J Pharm 2012; 424:12-17.
37. Sultana F, Arafat M, Pathan SI. Preparation and evaluation of fast dissolving oral thin film of Caffeine. Int J Pharm and Biol Sci 2013;3(1):153-161.
38. Keshavarao KP, Mudit D, Gunashekara K, Anis S, Singh Mangla N, Ajay K. Formulation and evaluation of mouth dissolving film containing Rofecoxib. IRJP. 2011;2(3):273-278.
39. Abdelbary A, Bendas ER, Ramadan AA, Mostafa DA. Pharmaceutical and pharmacokinetic evaluation of a novel fast dissolving film formulation of Flupentixol Dihydrochloride. AAPS Pharmscitech. 2014;15:1-7.
40. Rezaee F, Ganji F. Formulation, characterization, and optimization of Captopril fast-dissolving oral films. AAPS PharmSciTech. 2018;19:1-10.
41. Hirpara F, Debnath SK, Saisivam S. Optimization & screening of different film forming polymers and plasticizers in fast dissolving sublingual film. Int J Pharm Pharm Sci 2012;6(6):41-42.
42. Bala R, Sharma S. Formulation optimization and evaluation of fast dissolving film of Aprepitant by using Design of Experiment. B-FOPCU 2018;56(2):1-10.
43. Galgatte UC, Khanchandani SS, Jadhav YG, Chaudhari PD. Investigation of different polymers, plasticizers and superdisintegrating agents alone and in combination for use in the formulation of fast dissolving oral films. Int J PharmTech Res 2013;5(4):1465-1472.
44. Kulkarni AS, Deokule HA, Mane MS, Ghadge DM. Exploration of different polymers for use in the formulation of oral fast dissolving strips. J Curr Pharm Res 2010;2(1):33-35.
45. Panchal MS, Patel H, Bagada A, Vadalia KR. Formulation and evaluation of mouth dissolving film of Ropinirole Hydrochloride by using pullulan polymers. Int J Pharm Res & Allied Sci 2012;1(3):60-72.
46. Bhikshapathi DV, Madhuri VD, Rajesham VV, Suthakaran R. Preparation and evaluation of fast dissolving oral film containing Naratriptan HCl. Am J Pharm Tech Res. 2014;4(2):799-812.
47. Prabhu P, Dubey A, Kamath K. Formulation and evaluation of fast-dissolving films of Lisinopril. Egypt Pharm J 2015 ;14(1):56-64.
48. Venkateswarlu K. Preparation and evaluation of fast dissolving buccal thin films of Bufotenin. Journal of in silico & in vitro Pharmacology. 2016 Dec;2(4):1-5.
49. Pandey GS, Kumar RA, Sharma RA, Singh YO, Teotia UV. Effects of maltodextrin and glycerin on mechanical properties of oral fast dissolving film of Salbutamol Sulphate. IJAPBC 2014;3(1):199-209.
50. Gad MK, Mohamed MI, Abdelgawad WY. Formulation And Evaluation of Gemifloxacin Intra-pocket Film for Periodontitis. World J Pharm Res 2017;6(16):20-32.
51. Padamwar PA, Phasate PP. Formulation and evaluation of fast dissolving oral film of Bisoprolol Fumarate. UPSR 2015 Jan;6(01):135-142.
52. Shirvan AR, Bashari A, Hemmatinejad N. New insight into the fabrication of smart mucoadhesive buccal patches as a novel controlled-drug delivery system. Eur Polym J 2019; 119:541-550.
53. Tamer MA, Hammid SN, Ahmed BA. Formulation and in vitro evaluation of Bromocriptine Mesylate as fast dissolving oral film. Int. J. Appl. Pharm. 2018;10(1):7-20.
54. Chonkar AD, Rao JV, Managuli RS, Mutalik S, Dengale S, Jain P, Udupa N. Development of fast dissolving oral films containing Lercanidipine HCl nanoparticles in semicrystalline polymeric matrix for enhanced dissolution and ex vivo permeation. Eur J Pharm Biopharm 2016; 103:179-191.
55. Mushtaque M, Muhammad IN, Hassan SM, Ali A, Masood R. Development and pharmaceutical evaluation of oral fast dissolving thin film of Escitalopram: A patient friendly dosage form. Pak J pharm science. 2020;33(1):183-189.
56. Qin ZY, Jia XW, Liu Q, Kong BH, Wang H. Fast dissolving oral films for drug delivery prepared from chitosan/pullulan electrospinning nanofibers. Int J Biol Macromol 2019; 137:224-231.
57. Koland M, Sandeep VP, Charyulu NR. Fast dissolving sublingual films of Ondansetron Hydrochloride: effect of additives on in vitro drug release and mucosal permeation. J Young Pharm 2010 Jul 1;2(3):216-222.
58. Shendge RS, Salunkhe KS, Girish K. Formulation and evaluation of fast dissolving sublingual film of antihistamine drug. Eur J Mol Clin Med 2020;7(4):2134-2143.
59. Bharti K, Mittal P, Mishra B. Formulation and characterization of fast dissolving oral films containing Buspirone Hydrochloride nanoparticles using design of experiment. J Drug Deliv Sci Technol 2019; 49:420-432.
60. Chauhan SS, Lin S, Madan PL. Preparation and evaluation of Nicotine Hydrogen tartrate fast dissolving films for smoking cessation. Asian Journal of Pharmaceutical Sciences. 2012;7(3):181-192.
61. Singroli R, Sharma R, Rathi JC. formulation and evaluation of fast dissolving oral film of Mesalazine. World J Pharm Res 2021:10(14):869-879.
62. Kumar MP, Prasad MR, Pramod M, Reddy VP. Effect of permeation enhancer on ex-vivo permeation of Ondansetron HCl buccal tablets. UPSR 2011;2(11):2841-2845
63. Jain S. Quality by design (QBD): A comprehensive understanding of implementation and challenges in pharmaceuticals development. Int. J. Pharm. Pharm. Sci. 2014;6(1):29-35.
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Apr 17, 2020
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Amol Yadavrao Ghodke, & Kundan Patil. (2020). DEVELOPMENT AND FULL VALIDATION OF A RAPID, COST‑EFFECTIVE RP‑HPLC METHOD FOR THE QUANTIFICATION OF AMLODIPINE BESYLATE IN BULK DRUG AND TABLET FORMULATIONS. Journal of Population Therapeutics and Clinical Pharmacology, 27(1), 156-167. https://doi.org/10.69980/qxpkeg21
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Author Biographies
Amol Yadavrao Ghodke
Maharashtra Poly (D Pharm) Institute, Nilanga- 413521, India
Kundan Patil
Government College of Pharmacy, Amravati, India
How to Cite
Amol Yadavrao Ghodke, & Kundan Patil. (2020). DEVELOPMENT AND FULL VALIDATION OF A RAPID, COST‑EFFECTIVE RP‑HPLC METHOD FOR THE QUANTIFICATION OF AMLODIPINE BESYLATE IN BULK DRUG AND TABLET FORMULATIONS. Journal of Population Therapeutics and Clinical Pharmacology, 27(1), 156-167. https://doi.org/10.69980/qxpkeg21
