Firoz Shaik, Padmini Karnatham, Rishmitha Dugganpalli, Swarnalatha Panga, Lakshmi Prasanna Akepati
Firoz Shaik*, Padmini Karnatham, Rishmitha Dugganpalli, Swarnalatha Panga, Lakshmi Prasanna Akepati
Department of Pharmaceutics, Sree Vidyanikethan College of Pharmacy, Sree Sainath Nagar, A. Rangampet -517102, Chandragiri Mandal, Chittoor District, Andhra Pradesh.
Volume - 13,
Issue - 8,
Year - 2020
Fast dissolving oral film is used as a novel approach, as it dissolve rapidly in mouth and directly reaches to the systemic circulation. The main aim of the research work was to develop the oral fast dissolving films of an anti hypertensive drug Sacubitril sodium in order to improve the drug release and to avoid the first pass metabolism. Eight formulations (F1-F8) were prepared using solvent casting method. Films were formulated by using HPMC-E5 as water soluble polymer and propylene glycol as a plasticizer. The drug polymer compatibility was studied using FTIR and DSC studies. Formulated films were characterized for their physicochemical parameters like weight variation, surface pH, drug content, folding endurance, disintegration time, dissolving time, in vitro dissolution studies. The surface pH was found to be in the range of 6.35 to 6.75 which is close to salivary pH, which indicates that films may have less potential to irritate the oral mucosa, thereby they are comfortable. FT-IR and DSC studies revealed that the polymer is compatible with the drug. Drug content of films was estimated and the results were found to be satisfactory. In vitro dissolution studies revealed a good drug release from the films. The drug release was higher in formulation F5 and lower in F1, F2, F3, F4 formulations. From the present study, it was concluded that these films represent a promising route to oral drug delivery for fast drug release in the management of hypertension.
Cite this article:
Firoz Shaik, Padmini Karnatham, Rishmitha Dugganpalli, Swarnalatha Panga, Lakshmi Prasanna Akepati. Development and Pharmaceutical Evaluation of Sacubitril sodium Loaded oral fast Dissolving Films. Research J. Pharm. and Tech. 2020; 13(8):3553-3558. doi: 10.5958/0974-360X.2020.00628.9
1. Satoskar Bhandarkar. Pharmacology and Pharmacotherapeutics, Popular Prakashan, Mumbai. 2008.
2. Dixit R.P and Puthli, S.P. Oral strip technology: Overview and future potential. Journal of Controlled Release. 2009; 139: 94–107.
3. Sumitha C, Karuna Sree N, Divya B, Madhavi K, Vimal Kumar Varma M, Charbe NN. Taste masking of ondansetron hydrochloride by polymer carrier system and formulation of rapid-disintegrating films. International .Journal of Chemical Research. 2009; 1(2): 24-27.
4. Arya, A, Chandra A, Sharma V, Pathak K. Fast Dissolving Oral Films: An Innovative Drug Delivery System and Dosage Form. International Journal of Chem Tech Research. 2010; 2(1): 576-583.
5. Ioannis SA, Atsuyoshi N, Sei-ichi A. Chitosan and gelatin based edible films: state diagrams, Mechanical and permeation properties. Carbohydrate Polymers. 1998; 37: 371–382.
6. Nappinnai M, Chandanbala R and Balaijirajan R. Formulation and evaluation of Nitrendipine buccal films. Indian J Pharm Sci, 2008; 70 (5): 631-635.
7. Semalty A, Bhojwani M, Bhatt G K, Gupta G D, Shrivastav AK. Design and evaluation of mucoadhesive buccal ﬁlms of Diltiazem hydrochloride. Indian Journal of Pharmaceutical Sciences. 2005; 67:548-52.
8. Ankita S, Gulab T, Shubhini A. Formulation and evaluation of mucoadhesive buccal patch of acyclovir utilizing inclusion phenomenon. Brazilian Journal of Pharmaceutical Sciences. 2011; 47(4):887-897.
9. Beny B, Abin A and Jayaprakash S. Design and Evaluation of Transdermal Patches of Propanolol Hydrochloride. Research Journal of Pharmacy and Technology. 2009; 2(1):1195-1200.
10. Mridanga Raj R, Sekhar Kumar B and Koushik S. Design, Development and In Vitro Evaluation of Directly Compressed Sustained Release Matrix Tablet of Famotidine. Research Journal of Pharmacy and Technology. 2008; 1(3):175-178.
11. Nikhlesh B, Kavita M, Rampal M, Sujit P. Formulation and Evaluation of Quick Dissolving Films of Promethazine Hydrochloride. Research Journal of Pharmacy and Technology. 2017; 10(4):1025-1028.
12. Aisha K, Vinay P, Shyamala B and Vasiha B. Preparation and Evaluation of Tolterodine Tartarate Transdermal Films for the Treatment of Overactive Bladder. Research Journal of Pharmacy and Technology. 2008; 1(4): 516-521.
13. Sanjib B, Ranabir C, Roy1 A, Choudhury A, Das S and Saha1 S. Preparation and Evaluation of Mucoadhesive Microcapsules of Captopril for Oral Controlled Release. Research Journal of Pharmacy and Technology. 2008; 1(2): 100-105.
14. Radke R S, Gangane P S, Kawtikwar P S and Rai S. Formulation and Evaluation of Sustained Release System for an Effective Management of Motion Sickness. Research Journal of Pharmacy and Technology. 2008; 1(4): 426-429.
15. Hajare A A. and Shetty Y T. Formulation, Characterization and In-Vitro Evaluation of Floating Microspheres of Diltiazem Hydrochloride by Ionotropic Gelation technique. Research Journal of Pharmacy and Technology. 2008; 1(1):52-56.
16. Das S, Bhuyan N R, Chanda R, Bahadur S, Saha S and Choudhury A. Preparation and Evaluation of Sustained Release Enteric Coated Mucoadhesive tablets of Omeprazole for Local Action Research Journal of Pharmacy and Technology. 2008; 1(3): 166-170.
17. Karthikeyan D, Vijayakumar S, Pandey V P, Nandha K, Sengottuvelu S, and Sivakumar T. Preparation and Evaluation of Ocular Inserts For Controlled Delivery of Ciprofloxacin Hydrochloride. Research Journal of Pharmacy and Technology. 2008; 1(1): 40-46.
18. Gattani Y S, Kawtikwar P S and Sakarkar D M. Preparation and Evaluation of Tramadol Hydrochloride Floating Oral Delivery System. . Research Journal of Pharmacy and Technology. 2008; 1(3): 171-174.
19. Vaishali Y, Kashmira B. Umalkar. Formulation Development and Evaluation of Fast Dissolving Films of Telmisartan. Indian Journal of Pharmaceutical Sciences. 2012; 74(2):122-126.
20. Arunkumar N, Rani1C and Mohanraj K P. Formulation and In Vitro evaluation of oral floating tablets of Atorvastatin calcium. Research Journal of Pharmacy and Technology. 2008; 1(4): 492-495.