DESIGN, DEVELOPMENT AND FABRICATION OF MOUTH-DISSOLVING TABLETS CONTAINING EXTRACT OF TRIBULUS TERRESTRIS FOR THE TREATMENT OF HYPERTENSION
DOI:
https://doi.org/10.22159/ijap.2023v15i3.47662Keywords:
Tribulus terrestris, Mouth dissolving tablet, Hypertension, Full factorial designAbstract
Objective: The present work is aim to design, development and fabrication of mouth dissolving tablets containing extract of Tribulus terrestris for the treatment of hypertension.
Methods: The extract of fruits of Tribulus terrestris was formulated as mouth dissolving tablets (MDTs) by full factorial design at 32 levels and prepared by direct compression method using super integrants like sodium starch glycolate and cross povidone. Furthermore, the tablet was evaluated for thickness, hardness, weight variation, wetting time, disintegration time, and in vitro drug release study.
Results: The tablets were analyzed for a variety of characteristics, such as hardness (2.4-2.9 kg/cm2), friability (0.33-1.7%), disintegration time (20-34 s), drug content (95.32-99.09%), water uptake ratio (26-48%), wetting time (29-69 s), and in vitro drug release illustrated in 5 min (99.04-68.21%). There was no interaction between both the drug and the polymer, according to FTIR and DSC studies.
Conclusion: The research revealed that Tribulus terrestris fruits extract can be designed, developed and fabricated into mouth dissolving tablet for the treatment of hypertension with improved bioavailability and expected patient compliance.
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Jire DS, Gosavi NS, Badhe RB, Jagdale DH. Mouth dissolving tablet: a novel drug delivery system. Asian J Pharm Res. 2021;11(3):180-6. doi: 10.52711/2231-5691.2021.00033.
Jana BK, Singh M, Dutta RS, Mazumder B. Current drug delivery strategies for buccal cavity ailments using mouth dissolving wafer technology: a comprehensive review on the present state of the art. Curr Drug Deliv. 2022 Nov 28. doi: 10.2174/1567201820666221128152010. PMID 36443976.
Fukui M, Asakuma H, Horiuchi H, Takii H, Yoshioka M, Hinode D. Oral care tablet containing kiwifruit powder affects tongue coating microbiome. Clin Exp Dent Res. 2022 Jun;8(3):721-8. doi: 10.1002/cre2.591, PMID 35579104.
Garg A, Gupta MM. Mouth dissolving tablets: a review. J Drug Delivery Ther. 2013 Mar 15;3(2). doi: 10.22270/jddt.v3i2.458.
Masih A, Kumar A, Singh S, Tiwari AK. Fast dissolving tablets: a review. Int J Curr Pharm Sci. 2017;9(2):8-18. doi: 10.22159/ijcpr.2017v9i2.17382.
Preeti AV, Agarwal V, Agarwal A. An overview on mouth dissolving tablet: from manufacturing and patented technique to quality control test. Asian J Pharm Clin Res. 2022 Nov 7;15(11):7-13. doi: 10.22159/ajpcr.2022.v15i11.46555.
Al Ashmawy AZG, Eissa NG, El Nahas HM, Balata GF. Fast disintegrating tablet of doxazosin mesylate nanosuspension: preparation and characterization. J Drug Deliv Sci Technol. 2021 Feb 1;61:102210. doi: 10.1016/j.jddst.2020.102210.
Sharifi AM, Darabi R, Akbarloo N. Study of antihypertensive mechanism of Tribulus terrestris in 2K1C hypertensive rats: role of tissue ACE activity. Life Sci. 2003 Oct 24;73(23):2963-71. doi: 10.1016/j.lfs.2003.04.002, PMID 14519445.
Gupta J. Mouth dissolving tablets: an insight into challenges and future prospects of technologies in pharmaceutical industries. Res J Pharm Technol. 2022 Nov 24;15(11):5068-77. doi: 10.52711/0974-360X.2022.00852.
Masih A, Kumar A, Singh S, Tiwari AK. Fast dissolving tablets: a review. Int J Curr Pharm Sci. 2017;9(2):8-18. doi: 10.22159/ijcpr.2017v9i2.17382.
Eisa AM, El-Megrab NA, El-Nahas HM. Formulation and evaluation of fast-dissolving tablets of haloperidol solid dispersion. Saudi Pharm J. 2022 Nov 1;30(11):1589-602. doi: 10.1016/j.jsps.2022.09.002, PMID 36465849.
Dave V, Yadav RB, Ahuja R, Yadav S. Formulation design and optimization of novel fast dissolving tablet of chlorpheniramine maleate by using lyophilization techniques. Bull Fac Pharm Cairo Univ. 2017 Jun 1;55(1):31-9. doi: 10.1016/j.bfopcu.2016.12.001.
Baviskar KD, Baviskar RD, Kanke PK, Patil KD. Formulation and evaluation of mouth-dissolving tablet of lornoxicam using novel natural superdisintegrants. AJPTR. 2020;10(1):44-54. doi: 10.46624/ajptr.2020.v10.i1.005.
Kumar R, Patil S, Patil MB, Patil SR, Paschapur MS. Formulation evaluation of mouth dissolving tablets of fenofibrate using the sublimation technique. Int J Chem Tech Res. 2009;1(4):840-50.
Thonte SS VS. Formulation and evaluation of fast dissolving tablet of amlodipine besylate. International Journal of Bio-Pharma Research. 2019 Jul 8;8(7):2717-21.
Singh R, Saxena S, Jain S. Formulation and evaluation of mouth dissolving tablet containing non-stero idal anti-inflammatory drug. Res J Pharm Technol. 2021;14(1):432-6. doi: 10.5958/0974-360X.2021.00078.0.
Kumar I, Chaudhary D, Thakur B, Pandit V. Formulation and evaluation of piroxicam fast dissolving tablets using direct compression and sublimation method. J Drug Delivery Ther. 2020 Jun 15;10(3-s):17-25. doi: 10.22270/jddt.v10i3-s.4063.
Nagaraju T, Gowthami R, Rajashekar M, Sandeep S, Mallesham M, Sathish D. Comprehensive review on oral disintegrating films. Curr Drug Deliv. 2013 Feb 1;10(1):96-108. doi: 10.2174/1567201811310010016, PMID 22920576.
Cornila A, Iurian S, Tomuta I, Porfire A. Orally dispersible dosage forms for paediatric use: current knowledge and development of nanostructure-based formulations. Pharmaceutics. 2022 Aug 3;14(8):1621. doi: 10.3390/pharmaceutics14081621, PMID 36015247.
Kathpalia H, Gupte A. An introduction to fast dissolving oral thin film drug delivery systems: a review. Curr Drug Deliv. 2013 Dec 1;10(6):667-84. doi: 10.2174/156720181006131125150249, PMID 24274635.
Alhagiesa AW, Ghareeb MM. Formulation and evaluation of nimodipine nanoparticles incorporated within orodispersible tablets. Int J Drug Deliv Technol. 2020;10(4):547-2.
Keshari A, Tripathi DPK, Srivastava A, Vishwas R. Formulation and evaluation of effervecent floating tablets of antidiabetic drug. J Drug Delivery Ther. 2015 Nov 15;5(6):43-55. doi: 10.22270/jddt.v5i6.1176.
Jain SK, Shukla M, Shrivastava V. Development and in vitro evaluation of ibuprofen mouth dissolving tablets using solid dispersion technique. Chem Pharm Bull (Tokyo). 2010 Aug 1;58(8):1037-42. doi: 10.1248/cpb.58.1037, PMID 20686256.
Fu Y, Yang S, Jeong SH, Kimura S, Park K. Orally fast disintegrating tablets: developments, technologies. Taste-Masking Clin Stud. 2004;21(6):44.
Parkash V, Maan S, Yadav SK, Jogpal V. Fast disintegrating tablets: opportunity in drug delivery system. J Adv Pharm Technol Res. 2011 Oct;2(4):223-35. doi: 10.4103/2231-4040.90877, PMID 22247889.
Kakad SB, Rachh PR. Design, development and characterization of immediate release matrix tablet of vildagliptin. Int J Pharm Qual Assur. 2021;12:303-8.
Goel H, Rai P, Rana V, Tiwary AK. Orally disintegrating systems: innovations in formulation and technology. Recent Pat Drug Deliv Formul. 2008 Oct 31;2(3):258-74. doi: 10.2174/187221108786241660, PMID 19075912.
Hadi H. Simultaneous spectrophotometric determination of vitamin B6 by coupling with p-aminophenol. Int J Pharm Qual Assur. 2016;7(4):84-9.
Ghourichay MP, Kiaie SH, Nokhodchi A, Javadzadeh Y. Formulation and quality control of orally disintegrating tablets (ODTs): recent advances and perspectives. BioMed Res Int. 2021 Dec 24;2021:6618934. doi: 10.1155/2021/6618934, PMID 34977245.
Masareddy RS, Kadia RV, Manvi FV. Development of mouth-dissolving tablets of clozapine using two different techniques. Indian J Pharm Sci. 2008 Jul;70(4):526-8. doi: 10.4103/0250-474X.44611, PMID 20046788.
Patel BP, Patel JK, Rajput GC, Thakor RS. Formulation and evaluation of mouth-dissolving tablets of cinnarizine. Indian J Pharm Sci. 2010 Jul;72(4):522-5. doi: 10.4103/0250-474X.73930, PMID 21218071.
Dave V, Yadav S, Sharma S, Vishwakarma P, Ali N. Novel approach of aceclofenac fast dissolving tablet. Pak J Pharm Sci. 2015 Jan 1;28(1):37-41. PMID 25553683.
Madgulkar AR, Bhalekar MR, Padalkar RR. Formulation design and optimization of novel taste-masked mouth-dissolving tablets of tramadol having adequate mechanical strength. AAPS PharmSciTech. 2009 Jun;10(2):574-81. doi: 10.1208/s12249-009-9237-y, PMID 19440844.
Patra S, Sahoo R, Panda RK, Himasankar K, Barik BB. In vitro evaluation of domperidone mouth dissolving tablets. Indian J Pharm Sci. 2010 Nov;72(6):822-5. doi: 10.4103/0250-474X.84607, PMID 21969764.
Sabri LA, Hussein AA. Oral liquid self-nanoemulsion of nebivolol: formulation and in vitro characterization for dissolution rate enhancement. IJDDT. 2021;11(3):1083-91.
Borse LB, Bendale AR, Borse SL, Naphade VD, Jadhav AG. Formulation and evaluation of mouth-dissolving tablet Rivaroxaban and its validation. Biosci Biotech Res Asia. 2022 Dec 20;19(4):943-54. doi: 10.13005/bbra/3043.
Dhondibhau GG, Nagasree K, Dnyaneshwar GS, Suryavanshi KA, Mindhe RS, Gharat PR. Novel formulation design and in-vitro evaluation of extended-release pellets by complexation technique. J Pharm Neg Results. 2022 Oct 10:1658-65. doi: 10.47750/pnr.2022.13.S06.218.
Gaikwad AV, Rajurkar VG, Shivakumar T, Dama GY, Tare HL. Simultaneous estimation of ramipriland valsartan in tablets by HPTLC. Indo Glob J Pharm Sci. 2011;1(1):99-112.
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Copyright (c) 2023 LOKESH BARDE, PRAVIN SURUSE, SHWETA AGRAWAL, RAMESH KALKOTWAR, VIJAYSINH SABLE, HARSHAL TARE
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