DESIGN, DEVELOPMENT AND OPTIMIZATION OF MOUTH DISSOLVING TABLET OF AMBRISENTAN USING DESIGN EXPERT SOFTWARE
DOI:
https://doi.org/10.22159/ijap.2023v15i4.36398Keywords:
Superdisintegrants, Ambrisentan, Crospovidone, Optimization, Mouth dissolving tabletAbstract
Objective: The rationale of the current work is to design, develop and optimize of mouth dissolving tablet of ambrisentan to treat hypertension.
Methods: Sodium starch glycolate and crospovidone were used as the super disintegrants in the direct compression method to create nine ambrisentan mouth-dissolving tablet formulations. Wetting time, drug content, in vitro disintegration time, dispersion time, and dissolution time were all assessed for the produced formulations.
Results: Based on the results obtained, formulation F6 containing 30 mg of crospovidone exhibited good wetting time, dispersion time, disintegration time and drug release. The hardness of formulations AS1 to AS9 was found to be in the range of 2.5 to 3.11 Kg/cm2. The friability of formulations AS1 to AS9 was found to be less than 1%. A water absorption ratio was performed for ensuring the moisture sorption and water uptake properties of super disintegrants. The in vitro drug release of formulation AS6 containing a concentration of Crospovidone 30 mg, shows 91.30% drug release respectively at the end of 12 min.
Conclusion: The mouth-dissolving tablets of ambrisentan were successfully designed, developed, and fabricated. It can be reasonably concluded that the AS6 batch of mouth-dissolving tablets of ambrisentan with 30 mg of crospovidone exhibited maximum cumulative drug release in 12 min.
Downloads
References
Garg A, Gupta MM. Mouth dissolving tablets: a review. J Drug Delivery Ther. 2013 Mar 15;3(2). doi: 10.22270/jddt.v3i2.458.
Jire DS, Gosavi NS, Badhe RB, Jagdale DH. Mouth dissolving tablet: a novel drug delivery system. Asian J Pharm Res. 2021 Aug 14;11(3):180-6. doi: 10.52711/2231-5691.2021.00033.
Masih A, Kumar A, Singh S, Tiwari AK. Fast dissolving tablets: a review. Int J Curr Pharm Sci. 2017 Mar 1;9(2):8. 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 7:7-13. doi: 10.22159/ajpcr.2022.v15i11.46555.
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.
Shukla D. Mouth dissolving tablets I: An overview of formulation technology. Sci Pharm. 2009 Mar 6;77(2):309-26. doi: 10.3797/scipharm.0811-09-01.
Iqbal H, Naz S, Ali H, Bashir L, Zafar F, Akram S. Formulation development and optimization studies of mouth dissolving tablets of tizanidine HCl. Pak J Pharm Sci. 2020 Jan 1;33(1 Suppl):245-51. PMID 32122855.
Sharma V, Chopra H. Formulation and evaluation of taste masked mouth dissolving tablets of levocetirizine hydrochloride. Iran J Pharm Res. 2012;11(2):457-63. PMID 24250469.
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;58(8):1037-42. doi: 10.1248/cpb.58.1037, PMID 20686256.
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;10(2):574-81. doi: 10.1208/s12249-009-9237-y, PMID 19440844.
Masareddy RS, Kadia RV, Manvi FV. Development of mouth dissolving tablets of clozapine using two different techniques. Indian J Pharm Sci. 2008 Feb 1;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.
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.
Nakamura S, Fukai T, Sakamoto T. Orally disintegrating tablet manufacture via direct powder compression using cellulose nanofiber as a functional additive. AAPS PharmSciTech. 2021;23(1):37. doi: 10.1208/s12249-021-02194-5, PMID 34950985.
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;2021:6618934. doi: 10.1155/2021/6618934, PMID 34977245.
Douroumis D. Orally disintegrating dosage forms and taste-masking technologies. Expert Opin Drug Deliv. 2011;8(5):665-75. doi: 10.1517/17425247.2011.566553, PMID 21438776.
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.
Comoglu T, Unal B. Preparation and evaluation of an orally fast disintegrating tablet formulation containing a hydrophobic drug. Pharm Dev Technol. 2015 Jan 1;20(1):60-4. doi: 10.3109/10837450.2013.862636, PMID 24295202.
Parkash V, Maan S, Deepika, Yadav SK, Hemlata, 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.
Fu Y, Yang S, Jeong SH, Kimura S, Park K. Orally fast disintegrating tablets: developments, technologies, taste-masking and clinical studies. Crit Rev Ther Drug Carrier Syst. 2004;21(6):433-76. doi: 10.1615/critrevtherdrugcarriersyst.v21.i6.10, PMID 15658933.
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). doi: 10.22270/jddt.v5i6.1176.
Aher S, Saudagar R, Chaudhari D. Formulation and evaluation of taste masked fast dissolving tablet of prazosin hydrochloride. J Drug Delivery Ther. 2018 Jul 15;8(4). doi: 10.22270/jddt.v8i4.1785.
Siraj SN, Kausar SH, Khan GJ, Khan T. Formulation and evaluation of oral fast dissolving tablet of ondansetron hydrochloride by coprocess excipients. J Drug Delivery Ther. 2017 Sep 15;7(5). doi: 10.22270/jddt.v7i5.1498.
Rahane R, Rachh PR. A review on fast dissolving tablet. J Drug Delivery Ther. 2018 Sep 6;8(5):50-5. doi: 10.22270/jddt.v8i5.1888.
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.
Singh R, Saxena S, Jain S. Formulation and evaluation of mouth dissolving tablet containing non-steroidal anti-inflammatory drug. Res J Pharm Technol. 2021;14(1):432-6. doi: 10.5958/0974-360X.2021.00078.0.
Kumar R, Patil S, Patil MB, Patil SR, Paschapur MS. Formulation evaluation of mouth dissolving tablets of fenofibrate using sublimation technique. Int J Chemtech Res CODEN. 2022;24(1):412–6.
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.
Eisa AM, El-Megrab NA, El-Nahas HM. Formulation and evaluation of fast dissolving tablets of haloperidol solid dispersion. Saudi Pharm J. 2022;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;55(1):31-9. doi: 10.1016/j.bfopcu.2016.12.001.
Published
How to Cite
Issue
Section
Copyright (c) 2023 S. D. MANKAR, AJAY SATPUTE, S. S. SIDDHESHWAR, S. B. BHAWAR, S. B. DIGHE
This work is licensed under a Creative Commons Attribution 4.0 International License.