DEVELOPMENT AND EVALUATION OF LORNOXICAM BASED BUCCAL MUCOADHESIVE TABLETS: A PRELIMINARY STUDY
Main Article Content
Keywords
Lornoxicam, Direct Compression, Mucoadhesion, Sodium Alginate, In-vitro drug release
Abstract
This preliminary investigation was aimed to optimize the fabrication of lornoxicam (LRX) loaded buccal mucoadhesive tablets for local management of pain and inflammation in oral mucosa. The direct compression method was used to produce buccal mucoadhesive tablets. Chitosan, HPMC and sodium alginate were screened in preliminary study to find out requisite concentrations for optimization purpose. Solid state characterization test, such as Fourier Transform Infrared (FTIR) spectroscopy, was carried out to investigate drug excipient compatibility in physical mixtures of drug and polymers. This was followed by further assessment of formulations at in-vitro, ex-vivo and in-vivo levels to determine swelling index, matrix erosion, mucoadhesive strength and time, in-vivo residence time and drug release. The findings deduced from preliminary investigations on mucoadhesive buccal tablets showed that all sodium alginate containing formulations, except F8, did not sustain drug release up to 6 h, and showed poor mucoadhesivity. The mucoadhesive character as well as drug release pattern was influenced by the concentration of HPMC in mucoadhesive buccal tablets. Chitosan containing formulations indicated lower values in terms of swellibility, mucoadhesion and drug release as compared to HPMC containing formulations, due to the presence of reduced hydrophilic interactions between chitosan particles. Additionally, it was noted that swelling index values were greater for formulations containing sodium alginate as compared to formulations containing HPMC, due to greater swelling capability of sodium alginate. The values of surface pH ranged from 6.38 – 7.14 and fall within physiological salivary pH range. The matrix erosion data revealed significantly higher values for sodium alginate containing formulations, whereas HPMC containing formulations showed increased values for ex-vivo mucoadhesive strength, time, in-vivo residence time and in-vitro drug release i.e. 9.55 ± 1.84 g, 5.82 ± 1.11 h, 2.01 ± 0.85 h and sustained drug release for 4 h, respectively, for F4. Thus, it is concluded that mucoadhesive tablet formulation batch F4 was considered as an optimized formulation based on mucoadhesive strength and time and could be subjected to main study.
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2. Nicolini MM, Morales JO. Overview and Future Potential of Buccal Mucoadhesive Films as Drug Delivery Systems for Biologics. AAPS PharmSciTech [Internet]. 2017 Feb 1 [cited 2023 Feb 19];18(1):3–14. Available from: https://link.springer.com/article/10.1208/s12249-016-0525-z
3. Samanthula KS, Satla SR, Bairi AG. Bioadhesive polymers, permeation enhancers and types of dosage forms for buccal drug delivery. J Drug Deliv Ther [Internet]. 2021 Jan 15 [cited 2023 Feb 19];11(1):138–45. Available from: http://jddtonline.info/index.php/jddt/article/view/4495
4. Targhotra M, Chauhan MK. An Overview on Various Approaches and Recent Patents on Buccal Drug Delivery Systems. Curr Pharm Des. 2020 Jun 14;26(39):5030–9.
5. Singh V, Singh AK. Oral mucositis. Natl J Maxillofac Surg [Internet]. 2020 [cited 2023 Feb 19];11(2):159. Available from: /pmc/articles/PMC8051654/
6. McEvoy L, Carr DF, Pirmohamed M. Pharmacogenomics of NSAID-Induced Upper Gastrointestinal Toxicity. Front Pharmacol. 2021 Jun 21;12:1302.
7. Thriveni R, Rukhsar I, Ramesh DNSV, Patil SS, Byatnal AR, Nair D. Development and clinical evaluation of transmucosal mucoadhesive patch of lornoxicam for the odontogenic pain management: A preliminary study. J Nat Sci Biol Med [Internet]. 2020 [cited 2023 Feb 19];11:12–6. Available from:
https://www.proquest.com/openview/f4ffa8400c46ab8dda25683d4954e779/1?pq-origsite= gscholar&cbl=2035653
8. Amin MJ, Patel KS, Patel DR, Patel ZP, Bajag J V. FORMULATION AND EVALUATION OF SUSTAINED-RELEASE PELLETS OF LORNOXICAM. Int J Appl Pharm. 2021;13(4):221–7.
9. Hanif S, Syed MA, Iqbal Z, Sarfraz RM, Ali S, Shakir R. Formulation and Evaluation of Chitosan-Based Polymeric Biodegradable Mucoadhesive Buccal Delivery for Locally GREENESS of HPLC method for ecological safety View project Solubility & Permeation Enhancement View project. Lat Am J Pharm [Internet]. 2021 [cited 2023 Feb 19];40(4):670–81. Available from: https://www.researchgate.net/publication/350621269
10. Peddapalli H, Bakshi V, Boggula N. Formulation, in vitro and ex vivo characterization of mucoadhesive buccal tablets for antihypertensive drug. Artic Asian J Pharm Clin Res [Internet]. 2018 [cited 2023 Feb 19];11(8):402–11. Available from:
http://dx.doi.org/10.22159/ajpcr.2018.v11i8.26126
11. Naseem F, Shah SU, Rashid SA, Farid A, Almehmadi M, Alghamdi S. Metronidazole Based Floating Bioadhesive Drug Delivery System for Potential Eradication of H. pylori: Preparation and In Vitro Characterization. Polymers (Basel) [Internet]. 2022 Jan 27 [cited 2022 Jan 28];14(3):519. Available from: https://www.mdpi.com/2073-4360/14/3/519/htm
12. Ashish D, Vibhu S. Formulation and Evaluation of Floating Tablet of Thiocolchicoside. Curr Res Pharm Sci [Internet]. 2022 Apr 6 [cited 2022 Oct 21];12(1):59–67. Available from: http://www.crpsonline.com/index.php/crps/article/view/299
13. Moganti M, Nanjappa SH. Formulation and optimization of gastroretentive bilayer tablets of calcium carbonate using D-optimal mixture design. E-Polymers [Internet]. 2021 Jan 1 [cited 2023 Jan 3];21(1):057–71. Available from: https://www.degruyter.com/document/doi/10.1515/epoly-2021-0008/html
14. Novac M, Musuc AM, Ozon EA, Sarbu I, Mitu MA, Rusu A. Design and Evaluation of Orally Dispersible Tablets Containing Amlodipine Inclusion Complexes in Hydroxypropyl-β-cyclodextrin and Methyl-β-cyclodextrin. Materials (Basel) [Internet]. 2022 Jul 28 [cited 2023 May 3];15(15):5217. Available from: https://www.mdpi.com/1996-1944/15/15/5217/htm
15. Baviskar KD, Baviskar RD, Kanke PK, Patil KD. Formulation and Evaluation of Mouth Dissolving Tablet of Lornoxicam Using Novel Natural Superdisintegrants. Am J PharmTech Res [Internet]. 2020 [cited 2023 Apr 11];10(01):44–54. Available from: www.ajptr.com
16. Zewail MB, F.Asaad G, Swellam SM, Abd-allah SM, K.Hosny S, Sallah SK. Design, characterization and in vivo performance of solid lipid nanoparticles (SLNs)-loaded mucoadhesive buccal tablets for efficient delivery of Lornoxicam in experimental inflammation. Int J Pharm. 2022 Aug 25;624:122006.
17. Nigusse B, Gebre-Mariam T, Belete A. Design, development and optimization of sustained release floating, bioadhesive and swellable matrix tablet of ranitidine hydrochloride. PLoS One [Internet]. 2021 Jun 1 [cited 2023 Feb 14];16(6):e0253391. Available from:
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0253391
18. Kim B, Byun Y, Lee EH. Doe-based design of a simple but efficient preparation method for a non-effervescent gastro-retentive floating tablet containing metformin hcl. Pharmaceutics [Internet]. 2021 Aug 1 [cited 2023 Feb 3];13(8):1225. Available from:
https://www.mdpi.com/1999-4923/13/8/1225/htm
19. Baus RA, Zahir-Jouzdani F, Dünnhaupt S, Atyabi F, Bernkop-Schnürch A. Mucoadhesive hydrogels for buccal drug delivery: In vitro-in vivo correlation study. Eur J Pharm Biopharm. 2019 Sep 1;142:498–505.
20. Sharma D, Sharma A, Garg R. Design, Development and In vitro/Ex vivo Evaluation of Mucoadhesive Buccal Film of Benzydamine Hydrochloride for the Effective Treatment of Aphthous Stomatitis. Recent Pat Drug Deliv Formul. 2019 Jan 30;12(4):277–94.
21. Chappidi SR, Bhargav E, Marikunte V, Chinthaginjala H, Jyothi MV, Pisay M, et al. A Cost Effective (QbD) Approach in the Development and Optimization of Rosiglitazone Maleate Mucoadhesive Extended Release Tablets –In Vitro and Ex Vivo. Adv Pharm Bull [Internet]. 2019 [cited 2023 Jun 20];9(2):281. Available from: /pmc/articles/PMC6664114/
22. Çelik B. Risperidone mucoadhesive buccal tablets: Formulation design, optimization and evaluation. Drug Des Devel Ther [Internet]. 2017 Nov 27 [cited 2023 Jun 20];11:3355–65. Available from: http://dx.doi.org/10.2147/DDDT.S150774
23. Eswaraiah M, Jaya S. Design and in Vitro Characterization of Floating Tablets of Metronidazole. Asian J Pharm Clin Res. 2019;12(3):539–44.
24. Jassim ZE, Mohammed MF, Sadeq ZA. Formulation and evaluation of fast dissolving film of lornoxicam. Asian J Pharm Clin Res. 2018;11(9):217–23.
25. Liu X, Ji Z, Peng W, Chen M, Yu L, Zhu F. Chemical mapping analysis of compatibility in gelatin and hydroxypropyl methylcellulose blend films. Food Hydrocoll [Internet]. 2020 [cited 2023 Jun 9];104:1–6. Available from:
https://sci-hub.st/https://doi.org/10.1016/j.foodhyd.2020.105734
26. Badita CR, Aranghel D, Burducea C, Mereuta P. CHARACTERIZATION OF SODIUM ALGINATE BASED FILMS. Rom J Phys. 2020;65(602):1–8.
27. Ren L, Xu J, Zhang Y, Zhou J, Chen D, Chang Z. Preparation and characterization of porous chitosan microspheres and adsorption performance for hexavalent chromium. Int J Biol Macromol. 2019 Aug 15;135:898–906.
28. Agarwal M, Agarwal K, Shrivastav N, Pandey S, Das R, Gaur P. Preparation of Chitosan Nanoparticles and their In-vitro Characterization. Int J Life Sci Sci Res [Internet]. 2018 [cited 2023 Jun 9];1713–20. Available from: www.ijlssr.com
29. Shah H, Jain A, Laghate G, Prabhudesai D. Pharmaceutical excipients. In: Remington: The Science and Practice of Pharmacy. Academic Press; 2021. p. 633–43.
30. Khaled SA, Alexander MR, Wildman RD, Wallace MJ, Sharpe S, Yoo J, et al. 3D extrusion printing of high drug loading immediate release paracetamol tablets. Int J Pharm. 2018 Mar 1;538(1–2):223–30.
31. Wang Z, Ren X, Feng H, Luo D. Research on the counter-force calibration method of tablet hardness tester. Meas Sensors. 2021 Dec 1;18:100233.
32. Budianto E, Amalia A. Swelling behavior and mechanical properties of Chitosan-Poly(N-vinyl-pyrrolidone) hydrogels. J Polym Eng [Internet]. 2020 Aug 1 [cited 2023 Jun 21];40(7):551–60. Available from: https://www.degruyter.com/document/doi/10.1515/polyeng-2019-0169/html
33. Esim O, Savaser A, Ozkan CK, Bayrak Z, Tas C, Ozkan Y. Effect of polymer type on characteristics of buccal tablets using factorial design. Saudi Pharm J. 2018 Jan 1;26(1):53–63.
34. Zhang Q, Li X, Jasti BR. Role of physicochemical properties of some grades of hydroxypropyl methylcellulose on in vitro mucoadhesion. Int J Pharm. 2021 Nov 20;609:121218.
35. Pamlényi K, Kristó K, Jójárt-Laczkovich O, Regdon G. Formulation and Optimization of Sodium Alginate Polymer Film as a Buccal Mucoadhesive Drug Delivery System Containing Cetirizine Dihydrochloride. Pharmaceutics [Internet]. 2021 Apr 26 [cited 2023 Mar 18];13(5):619. Available from: https://www.mdpi.com/1999-4923/13/5/619/htm
36. Rahim SA, Al-Zoubi N, Khader H, Alwaraydat R, Al-Akayleh F. Ethanol-induced dose dumping from sodium alginate matrix tablets: Investigation of the effects of medium viscosity and pH. Int J Pharm. 2023 Feb 5;632:122568.
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Published
Mar 19, 2024
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How to Cite
Sidra Mumtaz, Sheikh Abdur Rashid, Hashmat Ullah, Tariq Javed, Nisar Ahmed Shahwani, Rabia Baloch, Ahmed Sadiq Sheikh, & Nitasha Gohar. (2024). DEVELOPMENT AND EVALUATION OF LORNOXICAM BASED BUCCAL MUCOADHESIVE TABLETS: A PRELIMINARY STUDY. Journal of Population Therapeutics and Clinical Pharmacology, 31(3), 1195-1208. https://doi.org/10.53555/jptcp.v31i3.5102
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Author Biographies
Sidra Mumtaz
Gomal Centre of Pharmaceutical Sciences, Faculty of Pharmacy, Gomal University, Dera Ismail Khan - Pakistan
Sheikh Abdur Rashid
Gomal Centre of Pharmaceutical Sciences, Faculty of Pharmacy, Gomal University, Dera Ismail Khan – Pakistan.
Hashmat Ullah
Gomal Centre of Pharmaceutical Sciences, Faculty of Pharmacy, Gomal University, Dera Ismail Khan - Pakistan
Tariq Javed
Gomal Centre of Pharmaceutical Sciences, Faculty of Pharmacy, Gomal University, Dera Ismail Khan – Pakistan.
Nisar Ahmed Shahwani
Department of Pharmaceutical Chemistry, Faculty of Pharmaceutical and Health Sciences, University of Balochistan, Quetta – Pakistan
Rabia Baloch
Teaching Hospital, Dera Ghazi Khan - Pakistan
Ahmed Sadiq Sheikh
Faculty of Pharmacy, MY University, Islamabad 44000- Pakistan
Nitasha Gohar
Faculty of Pharmacy, Capital University of Science and Technology, Islamabad. 44000 - Pakistan
How to Cite
Sidra Mumtaz, Sheikh Abdur Rashid, Hashmat Ullah, Tariq Javed, Nisar Ahmed Shahwani, Rabia Baloch, Ahmed Sadiq Sheikh, & Nitasha Gohar. (2024). DEVELOPMENT AND EVALUATION OF LORNOXICAM BASED BUCCAL MUCOADHESIVE TABLETS: A PRELIMINARY STUDY. Journal of Population Therapeutics and Clinical Pharmacology, 31(3), 1195-1208. https://doi.org/10.53555/jptcp.v31i3.5102