APIGENIN AND BOSWELLIC ACID BILAYER TABLETS: FORMULATION AND THERAPEUTIC EVALUATION
DOI:
https://doi.org/10.53555/eijmhs.v11i1.263Keywords:
Apigenin, Boswellic acid, bilayer tablet, drug release kineticsAbstract
This study focuses on developing and evaluating a bilayer tablet designed to treat asthma and arthritis by combining Apigenin and Boswellic acid. Apigenin delivers immediate bronchodilatory and anti-inflammatory effects, addressing asthma symptoms, while Boswellic acid provides prolonged anti-inflammatory benefits for arthritis. Pre-formulation studies evaluated the solubility and compatibility of the active ingredients with excipients, with FT-IR analysis confirming no adverse interactions. The immediate-release (IR) layer of Apigenin was formulated using super disintegrants such as Crospovidone and Sodium starch glycolate, achieving rapid disintegration in 28.56 seconds and 99.37% release within 45 minutes. The sustained-release (SR) layer of Boswellic acid incorporated HPMC K100 and HPMC E15, ensuring a controlled release of 98.72% over 9 hours. Drug release studies revealed diffusion-based kinetics for Apigenin (Higuchi model) and consistent release for Boswellic acid (zero-order kinetics). The optimized bilayer tablet demonstrated excellent physical properties, including a hardness of 6.3 Kg/cm², friability of 0.6%, and a drug content of 98.1%. Stability tests over three months indicated no significant changes in performance, confirming the tablet’s potential as an effective dual-action therapy for asthma and arthritis.
References
Wang Q, Pan X, Wong HH, Wagner CA, Lahey LJ, Robinson WH, et al. Oral and topical boswellic acid attenuates mouse osteoarthritis. Osteoarthritis and Cartilage [Internet]. 2013 Nov 1;22(1):128–32. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3992997/
Li Q, Abdulla R, Xin X, Xue G, Kang X, Zhao F, et al. Profiling of chemical constituents of Matricarla chamomilla L. by UHPLC-Q-Orbitrap-HRMS and in vivo evaluation its anti-asthmatic activity. Heliyon [Internet]. 2023 Apr 24;9(5):e15470. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10160356/
Srivastava, J. K., Shankar, E., & Gupta, S.. Chamomile: A herbal medicine of the past with a bright future. Molecular Medicine Reports. 2010; 3(6), 895-901. https://doi.org/10.3892/mmr.2010.377
Srivastava, J. K., Pandey, M., & Gupta, S. Chamomile is a novel and selective COX-2 inhibitor with anti-inflammatory activity. Life Sciences. 2009; 85(19-20), 663-669. https://doi.org/10.1016/j.lfs.2009.09.007
Roy NK, Parama D, Banik K, Bordoloi D, Devi AK, Thakur KK, et al. An Update on Pharmacological Potential of Boswellic Acids against Chronic Diseases. International Journal of Molecular Sciences [Internet]. 2019 Aug 22;20(17):4101. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6747466/#sec3-ijms-20-04101title
Ammon, H. P. (2016). Boswellic acids and their role in chronic inflammatory diseases. Advances in Experimental Medicine and Biology, 928, 291-327. https://doi.org/10.1007/978-3-319-41334-1_13
Siddiqui, M. Z. (2011). Boswellia serrata, a potential antiinflammatory agent: An overview. Indian Journal of Pharmaceutical Sciences, 73(3), 255-261. https://doi.org/10.4103/0250-474X.93507
Gupta N. Chamomile: A herbal medicine of the past with a bright future (Review). Molecular Medicine Reports [Internet]. 2010 Sep 28;3(6). Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2995283/#S4title
Wagner, H. (2011). Synergy research: Approaching a new generation of phytopharmaceuticals. Fitoterapia, 82(1), 34- https://doi.org/10.1016/j.fitote.2010.11.016
Williamson, E. M. (2001). Synergy and other interactions in phytomedicines. Phytomedicine, 8(5), 401-409. https://doi.org/10.1078/0944-7113-00060
Das MKr, Sahu BP, Hazarika JNR. Development Of Bilayer Tablets For Immediate And Controlled Release Of Allicin. International Journal of Current Pharmaceutical Research [Internet]. 2017 Jul 14;9(4):153. Available from: https://www.researchgate.net/publication/319905365_DEVELOPMENT_OF_BILAYER_TABLETS_FOR_IMMEDIATE_AND_CONTROLLED_RELEASE_OF_ALLICIN
Ryakala H, Dineshmohan S, Ramesh A, Gupta VRM. Formulation and in vitro evaluation of Bilayer tablets of nebivolol hydrochloride and nateglinide for the treatment of diabetes and hypertension. Journal of Drug Delivery [Internet]. 2015 Jan 14;2015:1–14. Available from: https://www.researchgate.net/publication/272082007
Singh N, Pandey D, Jain N, Jain S. Formulation and in vitro evaluation of Bilayer tablets of lansoprazole and amoxycillin trihydrate for the treatment of peptic ulcer. Journal of Drug Delivery and Therapeutics [Internet]. 2021 Jan 15;11(1):23–31. Available from: http://jddtonline.info/index.php/jddt/article/view/4481
Kottala N, Abebe A, Sprockel O, Bergum J, Nikfar F, Cuitiño AM. Evaluation of the performance characteristics of Bilayer tablets: Part i. Impact of material properties and process parameters on the strength of Bilayer tablets. AAPS PharmSciTech [Internet]. 2012 Sep 13;13(4):1236–42. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3513479/
K V. FORMULATION AND EVALUATION OF BILAYER FLOATING TABLETS OF AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM. ResearchGate [Internet]. 2018 May 16; Available from: https://doi.org/10.20959/wjpps20186-11723
Ali H, Khan GA, Elhaj BM, Suliman RS. Evaluation & formulation of paracetamol matrix sustained release tablets using natural polymers. ResearchGate [Internet]. 2016 Nov 21; Available from: https://www.researchgate.net/publication/310599546/
Bose A, Wong TW, Singh N. Formulation development and optimization of sustained release matrix tablet of Itopride HCl by response surface methodology and its evaluation of release kinetics. Saudi Pharmaceutical Journal [Internet]. 2012 Apr 12;21(2):201–13. Available from: https://www.researchgate.net/publication/255987593
Rathore N, Sahu NK. Design, Development, and Evaluation of Bilayer Tablet for Antihypertension Activity. International Journal of Medical Pharmaceutical and Health Sciences (2024);1(1):1-8. Available from: DOI:10.62946/IJMPHS/1.1.1-8
Wadher K, Umekar M, Kakde R. Formulation and evaluation of a sustained-release tablets of metformin hydrochloride using hydrophilic synthetic and hydrophobic natural polymers. Indian Journal of Pharmaceutical Sciences [Internet]. 2011 Jan 1;73(2):208. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3267306/
Ahsan W, Alam MS, Javed S, Alhazmi HA, Albratty M, Najmi A, et al. Study of Drug Release Kinetics of Rosuvastatin Calcium Immediate-Release Tablets marketed in Saudi Arabia. Dissolution Technologies [Internet]. 2022 Jan 1;29(2):GC1. Available from: https://www.researchgate.net/publication/360879053_Study_of_Drug_Release_Kinetics_of_Rosuvastatin_Calcium_Immediate-Release_Tablets_Marketed_in_Saudi_Arabia
Brahmankar, D. M., & Jaiswal, S. B. (2009). Biopharmaceutics and pharmacokinetics: A treatise. Vallabh Prakashan.
Aulton, M. E., & Taylor, K. M. (2013). Aulton's pharmaceutics: The design and manufacture of medicines (4th ed.). Churchill Livingstone Elsevier.
