Author(s):
Anuradha Parixit Prajapati, Hardik Bharatbhai Prjapati, Kantilal Narkhede, Neha Desai, Mansi Barot, Shailesh Luhar, Sachin Narkhede
Email(s):
anupatel03@gmail.com
DOI:
10.52711/2231-5691.2026.00033
Address:
Anuradha Parixit Prajapati, Hardik Bharatbhai Prjapati, Kantilal Narkhede, Neha Desai, Mansi Barot, Shailesh Luhar, Sachin Narkhede
Department of Pharmaceutics, Smt. BNB Swaminarayan Pharmacy College, Salvav, Vapi, Gujarat, India, 396191.
*Corresponding Author
Published In:
Volume - 16,
Issue - 3,
Year - 2026
ABSTRACT:
Objective: This study aimed to develop a press-coated pulsatile tablet of Fimasartan Potassium Trihydrate (FPT) to enhance bioavailability and achieve timed drug release for effective morning hypertension management. Methods: To improve the solubility and permeability of BCS Class IV FPT, an inclusion complex with Hydroxypropyl-ß-Cyclodextrin (HP-ß-CD) in a 1:2 molar ratio was prepared using the kneading method. Characterization using Fourier-transform infrared spectroscopy (FTIR), differential scanning calorimetry (DSC), and X-ray diffraction (XRD) confirmed complex formation. Core tablets, formulated with Croscarmellose sodium as a superdisintegrant, were press-coated with Hydroxypropyl Methylcellulose (HPMC K4M) and Ethyl cellulose. A 3² factorial design was applied to evaluate the impact of HPMC K4M concentration and coating polymer amount on lag time and drug release. Results: Pre- and post-compression studies confirmed satisfactory tablet properties. The optimized formulation exhibited a lag time of 266 minutes and achieved 90% drug release within 302 minutes, ensuring drug availability during the early morning blood pressure surge. Conclusion: The developed press-coated pulsatile tablet successfully provided controlled, time-specific drug release, improving therapeutic effectiveness and patient adherence. This formulation represents a promising chronotherapeutic approach for hypertension and heart failure management.
Cite this article:
Anuradha Parixit Prajapati, Hardik Bharatbhai Prjapati, Kantilal Narkhede, Neha Desai, Mansi Barot, Shailesh Luhar, Sachin Narkhede. Formulation and Evaluation of Press-Coated Pulsatile Tablets of Fimasartan Potassium Trihydrate for Morning Cardiovascular Treatment. Asian Journal of Pharmaceutical Research. 2026; 16(3):221-8. doi: 10.52711/2231-5691.2026.00033
Cite(Electronic):
Anuradha Parixit Prajapati, Hardik Bharatbhai Prjapati, Kantilal Narkhede, Neha Desai, Mansi Barot, Shailesh Luhar, Sachin Narkhede. Formulation and Evaluation of Press-Coated Pulsatile Tablets of Fimasartan Potassium Trihydrate for Morning Cardiovascular Treatment. Asian Journal of Pharmaceutical Research. 2026; 16(3):221-8. doi: 10.52711/2231-5691.2026.00033 Available on: https://www.asianjpr.com/AbstractView.aspx?PID=2026-16-3-1
REFERENCES:
1. Mangesh A. Bhutkar, Somnath D. Bhinge. Formulation and Evaluation of Valsartan Pulsincap Drug Delivery System for Treatment of Hypertension. Asian J. Pharm. Tech. 2018; 8 (2):65-70.
2. Mohd AH, Raghavendra Rao NG, Srinivasa Rao A. Formulation and evaluation of mini-tablets-filled-pulsincap delivery of lornoxicam in the chronotherapeutic treatment of rheumatoid arthritis. Pak. J. Phar. Sci. 2015; 28(1): 185-193.
3. Sheth A, Doshi N, Patel D, Badmanaban R, CN Patel. Footsteps of Pulsatile Drug Delivery System in Pharmaceutical Sciences. Research J. Pharm. and Tech. 2010; 3(2): 385-389.
4. Arora G, Singh I, Nagpa M, Arora S. Recent Advances in Stimuli Induced Pulsatile Drug Delivery System: A Review. Research J. Pharm. and Tech. 2011; 4(5): 691-703.
5. Sokar MS, Hanafy AS, El-Kamel AH, El-Gamal SS. Pulsatile core-in-cup valsartan tablet formulations: In vitro evaluation. Asian J. Pharm. Sci. 2013; 8: 234-243.
6. Shinde SR, Bhoir SI, Pawar NS, Bhagwat AM. Quantitation of Valsartan in Human Plasma by High Performance Liquid Chromatography with Fluorescence Detection and its Application to Bioequivalence Study. Research J. Pharm. and Tech. 2009; 2 (3): 487-490.
7. Anilbabu G, Naik VV, Ankrao A, Anilbabu K, Neelima PVA. Forulation and evaluation of valsartan drug delivery system. Int. J. Pharm. Analy. Res. 2015; 4(1): 41-47.
8. Sukanya M, Sai K. Design and Development of Chronopharmaceutical Drug Delivery of Simvastatin. J. Che. Pharm. Res. 2012; 4(4): 3195-3200.
9. Bhasakaran S, Moris S, Sheikh A. Design and development of chronomodulated system for arthritis. Int. J. Chem. Pharma. Sci. 2012; 1(4): 1350-1361.
10. Jagdale SC, Sali MS, Barhate AL, Loharkar JN, Chabukswar AR. Formulation development and evaluation of floating pulsatile drug delivery system of atenolol. PDA J. Pharma. Sci. and Tech. 2013; 67: 214-228.
11. Salunkheak S, Diasrj, Mali K, Mahajan N, Ghorpade V. Formulation and evaluation of floating pulsatile drug delivery system of metoprolol tartrate. Sch. Res. Lib. 2011; 3(10): 147-160.