FORMULATION AND COMPARATIVE EVALUATION OF ONDANSETRON HYDROCHLORIDE MOUTH DISSOLVING TABLETS IN INDIA
DOI:
https://doi.org/10.22159/ijpps.2019v11i9.33840Keywords:
Hardness, Friability, Disintegration, Dissolution, Ondansetron hydrochloride, Mouth dissolving tablets, FTIR spectroscopy, Quality control tests, Post compression parameters, MDTAbstract
Objective: The aim of the present study was to prepare the ondansetron hydrochloride Mouth Dissolving Tablets (MDTs) followed by its comparison with ethical and non-ethical (generic) marketed tablets.
Methods: Prior to the formulation, drug excipient compatibility study was carried out by FTIR spectroscopy. The λmax was determined by UV spectroscopy. The ondansetron hydrochloride MDTs were prepared by direct compression method using Sodium Starch Glycolate (SSG) as super disintegrant and camphor as a sublimating agent. Then the prepared MDTs were subjected to evaluation of post compression parameters such as thickness and diameter, weight variation, wetting time, hardness, friability, disintegration and dissolution. The results obtained were compared with that of ethical and non-ethical marketed ondansetron hydrochloride 4 mg tablets.
Results: The λmax was found at 310 nm. FTIR study revealed that excipients used in the prepared formulations are compatible with the drug. The thickness and diameter was in the range of 2.646 to 3.27 mm and 6.0 to 8.12 mm, respectively. Friability was in the range of 0.43 to 0.88 % and had a slightly higher friability (1.27%) for sublimated tablets. Wetting time and disintegration time were in the range of 15 to 40 sec and 23 to 50 sec, respectively. The 100 % drug release was found within 180 sec for all the codes. These results were then compared with non-ethical film coated ondansetron marketed tablets.
Conclusion: Ondansetron hydrochloride MDT 4 mg tablets prepared in the laboratory were under specified IP limits. The experimental findings demonstrated that any of these ethical and non-ethical tablets of ondansetron hydrochloride can be selected, advised by the physician or pharmacist, as per the patient’s need and economical status.
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Komal A, Syed QA, Sayed AAS, Najeeb A, Sundas B, Syed SuH. Marine sponges as a drug treasure. Biomol Ther (Seoul) 2016;24:347-62.
Mohamed S, Howaida IAA, Amal ZH, Hanan FA, Mohamed AG. Chemical characterization, antioxidant and inhibitory effects of some marine sponges against carbohydrate metabolizing enzymes. Org Med Chem Lett 2012;2:1-12.
Cong Dat P, Rudolf H, Werner EGM, Nicole DV, Daowan L, Peter P. Aaptamine derivatives from the Indonesian sponge Aaptos suberitoides. J Nat Prod 2013;76:103-6.
Tsukamoto S, Kudo Y, Kato H, Rotinsulu H, Losung F, Mangindaan R, et al. ChemInform abstract: aaptoline a, a new quinoline alkaloid from the marine sponge Aaptos suberitoides. Chem Inform 2014;88:591-4.
Chairman K, Ranjit SAJA, Alagumuthu G. Cytotoxic and antioxidant activity of selected marine sponges. Asian Pac J Trop Dis 2012;2:234-8.
Zineb R, Tarbaoui M, Sagou N, Oumam M, El-Amraoui B, Bennamara A, et al. Determination of polyphenols, tannins, flavonoids and antioxidant activity in extracts of two genus Ircinia marine sponges of atlantic morrocan coast. Asian J Microbiol Biotechnol Environ Sci 2016;9:39-45.
Nicole JDV. An assessment of sponge mariculture potential in the Spermonde archipelago, Indonesia. J Mar Biol Assoc U K 2007;87:1777-84.
Rivera AP, Uy MM. In vitro antioxidant and cytotoxic activities of some marine sponges collected off misamis oriental coast, Philippines. E J Chem 2012;9:354-8.
Noor NS, Awik PDN, Maya S. The anticancer activity of the marine sponge Aaptos suberitoides to protein profile of fibrosarcoma mice (mus musculus). IPTEK J Technol Sci 2016;27:53-8.
Shubina LK, Kalinovsky AI, Fedorov SN, Radchenko OS, Denisenko VA, Dmitrenok PS, et al. Aaptamine alkaloids from the vietnamese sponge Aaptos sp. Nat Prod Commun 2009;4:1085-8.
Sergey AD, Sergey NF, Larisa KS, Alexandra SK, Carsten B, Gunhild KvA, et al. Aaptamines from the marine sponge Aaptos sp. display anticancer activities in human cancer cell lines and modulate AP-1-, NF-κB-, and p53-dependent transcriptional activity in mouse JB6 Cl41 cells. Biomed Res Int 2014. http://dx.doi.org/10.1155/2014/469309
Nhiem NX, Quang NV, Minh CV, Hang DT, Anh HT, Tai BH, et al. Biscembranoids from the marine sponge Petrosia nigricans. Nat Prod Commun 2013;8:1209-12.
Kiem PV, Minh CV, Nhiem NX, Cuc NT, Quang NV, Tuan AHL, et al. Muurolane-type sesquiterpenes from marine sponge Dysidea cinerea. Magn Reson Chem 2014;52:51-6.
Cue NT, Anh HT, Hang DT, Nhiem NX, Dang NH, Nama NH, et al. Sesquiterpenes from the vietnamese marine sponge Dysidea fragilis. Nat Prod Commun 2015;10:1341-2.
Kiem PV, Nhiem NX, Tai BH, Anh HT, Hang DT, Cuc NT, et al. Bis-sesquiterpene from the marine sponge Dysidea fragilis. Nat Prod Commun 2016;11:439-41.
Huyen LT, Hang DTT, Nhiem NX, Yen PH, Anh HLT, Quang TH, et al. Naphtoquinones and sesquiterpene cyclopentenones from the sponge Smenospongia cerebriformis with their cytotoxic activity. Chem Pharm Bull 2017;65:589-92.
Kiem PV, Huyen LT, Hang DT, Nhiem NX, Tai BH, Anh HL, et al. Sesquiterpene derivatives from marine sponge Smenospongia cerebriformis and their anti-inflammatory activity. Bioorg Med Chem Lett 2017;27:1525-9.
Phan VK, Nguyen TVT, Dan TTH, Chau VM. Cytotoxic constituents from Vietnamese marine sponge Haliclona oculata (Linnaeus, 1759). Lett Org Chem 2015;12:708-12.
Pham VC, Nguyen TKC, Vu TQ, Pham TB, Phan VK, Nguyen HN, et al. Antimicrobial constituents from the Bacillus megaterium LC isolated from marine sponge Haliclona oculata. Nat Prod Sci 2014;20:202-5.
Kanti BP, Syed IR. Plant polyphenols as dietary antioxidants in human health and disease. Oxid Med Cell Longev 2009;2:270-8.
Swanson AK, Druehl LD. Induction, exudation and the UV protective role of kelp phlorotannins. AQUAT BOT 2002;73:241-53.
Jamuna S, Subramaniam P, Krishnamoorthy K. Phytochemical analysis and evaluation of leaf and root parts of the medicinal herb, Hypochaeris radicata L. for in vitro antioxidant activities. Asian Pac J Trop Biomed 2014;4:S359-S67.
Dang XC, Vu NB, Tran TTV, Le NH. Effect of storage time on phlorotannin content and antioxidant activity of six Sargassum species from Nhatrang Bay, Vietnam. J Appl Phycol 2016;28:567-72.
Athira KKA, Keerthi TR. Analyses of methanol extracts of two marine sponges, Spongia officinalis var. ceylonensis and Sigmadocia carnosa from southwest coast of India for their bioactivities. Int J Curr Microbiol Appl Sci 2016;5:722-34.
Green G. Ecology of toxicity in marine sponges. Mar Biol 1977;40:207-15.
Valerie JP, Karen EA, Raphael RW, Cliff R, Koty S. Chemical defenses: from compounds to communities. Biol Bull 2007;213:226-51.
Emadi Konjin P, Verjee Z, Levin AV, Adeli K. Measurement of intracellular vitamin C levels in human lymphocytes by reverse-phase high-performance liquid chromatography (HPLC). Clin Biochem 2005;38:450-6.
Amit G, Suraj RJ, Shubham SG, Bharat S. Quantification and determination of antioxidants in Syzygium cumini: revalance to human health. Innovare J Health Sci 2017;5:21-4.
Vinayak RC, Sudha SA, Chatterji A. Bioscreening of a few green seaweeds from India for their cytotoxic and antioxidant potential. J Sci Food Agric 2011;91:2471-6.
Alencar DB, Melo AA, Silva GC, Lima RL, Pires Cavalcante KM, Carneiro RF, et al. Antioxidant, hemolytic, antimicrobial, and cytotoxic activities of the tropical atlantic marine zoanthid Palythoa caribaeorum. An Acad Bras Cienc 2015;87:1113-23.
Velho Pereira S, Parvatkar P, Furtado IJ. Evaluation of antioxidant producing potential of halophilic bacterial bionts from marine invertebrates. Indian J Pharm Sci 2015;77:183-9.
Ali T, Samira J. Antioxidative and cytotoxic effect of marine sponge (Geodia perarmata) extracts against breast and colorectal cancer cells. 2nd Int'l Conference on Advances in Environment, Agriculture and Medical Sciences (ICAEAM'15); June; Antalya, Turkey; 2015. p. 54–7.
Vennila S, Brindha D. Antioxidant and free radical scavenging effect of Morinda citrifolia fruit extract Int J Pharm Pharm Sci 2014;6:55-9.
Joseph V, Kavimani S. Evaluation of apoptosis regulating efficacy of chosen marine sponge extracts. Asian J Biomed Pharm Sci 2014;4:50-5.
Syamsudin A, Awik PDN, Sri N, Edwin S, Wan LH. Cytotoxic and antioxidant activities of marine sponge diversity at pecaron bay pasir putih situbondo East Java, Indonesia. Asian J Pharm Pharmacol 2013;6:685-9.
Utkina NK, Makarchenbo AE, Slachdokova DV, Virovaya MV. Antioxidant activity of phenolic metabolites from marine sponges. Chem Nat Compd 2004;40:373-7.
Veermaneni A, Thiyagarajan D, Magharla DD. In vitro antioxidant activity and wound healing activity of wheatgrass by 1,1-diphenyl, 2 picrylhydrazyl method. Asian J Pharm Clin Res 2018;11:170-3.
Cathrine L, Prabavathi Nagaraja N. Preliminary phytochemical analysis and antibacterial activity of leaf extracts of Vitex leucoxylon L. F. Int J Curr Pharm Res 2011;3:71-3.
Dewi KP, Berna E, Nuraini P. Fractionation of the n-hexane extract of Garcinia bancana miq. (Manggis hutan) leaves and its antioxidant activity based on 1,1-diphenyl-2-picrylhydrazyl and ferric reducing antioxidant power assays. Int J Appl Pharm 2018;10:407-11.
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