Volume : 12, Issue : 12, December- 2025
Title:
FORMULATION AND EVALUATION OF NICORANDIL MOUTH DISSOLVING FILMS FOR ENHANCED PATIENT COMPLIANCE
Authors :
Ratnesh Kumar Mishra*, G. Pavan Kumar, Vivek Gupta
Abstract :
The present study aimed to formulate and evaluate Nicorandil mouth dissolving films to enhance patient compliance and provide a rapid onset of therapeutic action. Films were prepared using the solvent casting method with HPMC grades, polyvinyl alcohol, plasticizers, and suitable excipients. The prepared formulations (X1–X4) were evaluated for thickness, weight variation, drug content, moisture uptake, moisture loss, swelling index, mechanical strength, disintegration, and dissolution behavior. All films exhibited uniform thickness and weight distribution, with drug content ranging between 96–98%, confirming uniform drug dispersion. Moisture absorption and loss remained low, indicating stability toward environmental humidity. Among all formulations, X1 demonstrated superior mechanical properties, the highest folding endurance (>800), the shortest disintegration time (15 seconds), and the highest cumulative drug release (93.89% at 300 minutes). Stability studies conducted at 30°C/60% RH and 45°C/75% RH for 30 days indicated no significant variations in physicochemical parameters or drug release behavior, confirming the stability of the optimized formulation. Overall, the results suggest that Nicorandil mouth dissolving films, particularly formulation X1, offer an effective and patient-friendly drug delivery system with rapid disintegration, favorable mechanical strength, and efficient drug release, making them a promising alternative to conventional dosage forms.
Keywords: Nicorandil, Mouth Dissolving Films, Solvent Casting Method, Rapid Disintegration, Patient Compliance, HPMC, Polyvinyl Alcohol, Mechanical Properties, Drug Release, Stability Studies.
Cite This Article:
Please cite this article in press Ratnesh Kumar Mishra et al., Formulation And Evaluation Of Nicorandil Mouth Dissolving Films For Enhanced Patient Compliance, Indo Am. J. P. Sci, 2025; 12(12).
Number of Downloads : 10
References:
1. Horinaka S. Use of nicorandil in cardiovascular disease and its optimization. Drugs. 2011 Jun;71(9):1105-19.
2. Akhtar AJ, Shaikh A, Funnyé AS. Dysphagia in the elderly patient. Journal of the American Medical Directors Association. 2002 Jan 1;3(1):16-20.
3. Dahiya M, Saha S, Shahiwala AF. A review on mouth dissolving films. Current drug delivery. 2009 Oct 1;6(5):469-76.
4. Maheshwari S, Singh A, Varshney AP, Sharma A. Advancing oral drug delivery: The science of fast dissolving tablets (FDTs). Intelligent Pharmacy. 2024 Aug 1;2(4):580-7.
5. Maharaj MK, Kumar A, Shafi T, Malik SH. Mouth-Dissolving Films: A Novel Approach for Oral Drug Delivery in Diabetic Management. Current Pharmaceutical Research. 2025 Jun 20:231-7.
6. Carpenter G, Maheshwari RK. Formulation and development of fast dissolving oral film of a poorly soluble drug, frusemide with improved drug loading using mixed solvency concept and its evaluation. J Drug Deliv Ther. 2018 Nov 1;8(6):132-41.
7. Gupta MK, Gupta R, Khunteta A, Swarnkar SK. An overview of novel techniques employed in mouth dissolving drug delivery system. International Journal of Engineering Science and Generic Research. 2018;4(3):09-27.
8. Kakullamarri PR, Babu KS, Bhupatiraju SR. Formulation And Evaluation Of Rilpivirine Mouth Dissolving Thin Films. Frontiers in Health Informatics. 2024 Apr 1;13(3).
9. Bichave A, Phate S, Naik V, Gaikwad A, Choudhary L, Choudhary U, Patil S. Evaluation Parameters For Mouth Dissolving Films.
10. Sheikh FA, Aamir MN, Shah MA, Ali L, Anwer K, Javaid Z. Formulation design, characterization and in vitro drug release study of orodispersible film comprising BCS class II drugs. Pakistan journal of pharmaceutical sciences. 2020 Jan 3;33.
11. Nalluri BN, Sravani B, Anusha VS, Sribramhini R, Maheswari KM. Development and evaluation of mouth dissolving films of sumatriptan succinate for better therapeutic efficacy. Journal of applied pharmaceutical science. 2013 Aug 30;3(8):161-6.
12. Senthilkumar K, Vijaya C. Formulation development of mouth dissolving film of etoricoxib for pain management. Advances in Pharmaceutics. 2015;2015(1):702963.
13. Deshta U, Khurana B. Formulation and Evaluation of Mouth Dissolving Film of Artemether. Vascular and Endovascular Review. 2025 Nov 20;8(11s):99-116.
14. Pingale PL, Shinkar DM, Boraste SS, Amrutkar SV. Formulation, evaluation and characterization of mouth dissolving film of cisapride. Current Trends in Biotechnology and Pharmacy. 2022;16(4):490-9.
15. Pattewar S, Patil D, Sharma S. Fabrication and characterization of self-microemulsifying mouth dissolving film for effective delivery of piroxicam. Indian J. Pharm. Sci. 2019 May 1;81:503-13.