Formulation and evaluation of oral dissolving films of naproxen sodium from Terminalia randii gum
Main Article Content
Abstract
Background: Oral films are gaining popularity and acceptance as new drug delivery systems, because of ease of administration and better patient compliance. However, most raw materials used in developing countries are imported and expensive. Therefore, there is need to develop local and naturally occurring raw materials as excipients.
Objective: This study evaluated the properties of naproxen sodium films prepared from a natural biodegradable polymer and the effect of formulation variables on the film properties.
Method: Naproxen films were produced by solvent casting method using hydroxypropyl methylcellulose and Terminalia randii gum as individual polymer and different combination ratios (1:1, 1:2 and 3:0). Ofada and corn starches were used as disintegrants and glycerol as plasticizer. The films were assessed for thickness, weight uniformity, surface pH, drug content, fold endurance and release properties. Compatibility of polymer, drug and excipients was assessed using Fourier Transform Infra-Red.
Results: There was thickness uniformity with surface pH ranging between 5.8 and 6.8. The fold endurance was >300 for all formulations except in absence of plasticizer and presence ofTerminalia gum. There was significant (p<0.05) weight variation of the films. Disintegration time ranking was no starch < corn starch <ofada starch. Films with plasticizer had lower disintegration time. Drug released ranking was 1:1>1:2>3:0. Fourier Transform Infra-Red showed that polymer-drug-excipient were compatible.
Conclusion: Terminalia randii gum has potential in naproxen oral disintegrating films formulation when combined with hydroxypropyl methylcellulose in particular ratios.
Downloads
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
How to Cite
Share
References
Khan S, Boateng JS, Mitchell J, Trivedi V (2015). Formulation, Characterisation and Stabilisation of Buccal Films for Paediatric Drug Delivery of Omeprazole, AAPS PharmSciTech, 16(4):800-810
Sharma R, Kamboj S, Singh G, Rana V (2016). Development of aprepitant loaded orally disintegrating films for enhanced pharmacokinetic
performance, European Journal of PharmaceuticalSciences, 84: 55-69
Jaiyeoba MT, Odeniyi MA, Ayorinde JO, Jaiyeoba KT (2013). Oral dissolving films of Chlorpheniramine maleate from wheat starch/polymer blends. Nigerian Journal of Pharmaceutical and Applied Science Research 2 (1): 25-32
Ayorinde JO, Odeniyi MA, Balogun-Agbaje (2016). Formulation and evaluation of oral dissolving films of amlodipine besylate using blends of starches with hydroxypropyl methyl cellulose. Polymers in Medicine, 46(1): 45–51.
Ayorinde JO, Effiong DE, Odeniyi MA (2018). Design and evaluation of oral dissolving films of chlorpheramine from native and modified
Enterolobiumcyclocarpum gum. African Journal of Biomedical Research, 21: 175-182
Liew KB, Odeniyi MA, Peh KK (2015). Application of freeze-drying technology in manufacturing orally disintegrating films. Pharmaceutical Development and Technology, 21 (3): 346 - 353 (DOI: 10.3109/10837450.2014.1003657). 141 West African Journal of Pharmacy (2020) 31 (1)
Renukuntla J, Vadlapudi AD, Patel A, Boddu SH, Mitra AK (2013). Approaches for enhancing oral bioavailability of peptides and proteins,
International Journal of Pharmaceutics, 447: 75-93
Preis M, Pein M, Breitkreutz J (2012). Development of a Taste-Masked Orodispersible Film Containing Dimenhydrinate, Pharmaceutics, 4: 551-562
Trastullo R, Abruzzo A, Saladini B, Gallucci MC, Cerchiara T, Luppi B, Bigucci F (2016). Design and evaluation of buccal films as paediatric dosage form for transmucosal delivery of ondansetron, European Journal of Pharmaceutics and Biopharmaceutics, 105: 115-121
Panda B, Parihar AS, Mallick S (2014). Effect of Plasticizer on drug crystallinity of hydroxypropylmethylcellulose matrix film,
International Journal of Biological Macromolecules, 67: 295-302.
Heer D, Aggarwal G, Kumar H (2014). Development of Fast Dissolving Oral Films and Tablets of Cinnarizine: Effect of Superdisintegrants,
International Journal of Pharmacy and Pharmaceutical Sciences, 6(2): 186-191.
Nalluri BN, Sravani B, Anusha VS, Sribramhini R, Maheswari KM (2013). Development and Evaluation of Mouth Dissolving Films of
Sumatriptan Succinate for Better Therapeutic Efficacy, Journal of Applied Pharmaceutical Science, 3(8): 161-166.13. Han Y, Wang L (2016).
Bamiro OA, Sinha VR, Kumar R, Odeku OA (2010). Characterization and evaluation of Terminalia randii gum as a binder in carvedilol tablet
formulation, Acta PharmaceuticaSciencia, 52: 254-262.
Okunlola A, Ogunkoya TO (2015). Acetylated Starch of Ofada Rice as a Sustained Release Polymer in Microsphere Formulations of Repaglinide, Nigerian Journal of Pharmaceutical Research, 11(1): 1-12
Liew KB, Tan YTF, Peh KK (2012). Characterization of Oral Disintegrating Film Containing Donezepil for Alzheimer Disease, AAPS PharmSciTech, 13 (1): 134 -142. Sodium alginate/carboxymethyl cellulose films containing pyrogallic acid: physical and antibacterial
properties, available on https://onlinelibrary.wiley.com/doi/pdf/10.1002/jsfa.7863, Accessed on 9 May 2018
Liew KB, Tan YTF, Peh KK (2014). Effect of polymer, plasticizer and filler on orally disintegrating film, Drug Development and Industrial Pharmacy, 40:110–119
Nair AB, Kumria R, Harsha S, Attmarad M, Dhubiab BE, Alhaider IA (2013). In vitro techniques to evaluate buccal films. Journal of
Controlled Release, 166:10–21.
Salehi S and Boddohi S (2017). New formulation and approach for mucoadhesive buccal film of rizatriptan benzoate. Progress in Biomaterials, 6:175–187
Morales JO, Mc Conville JT (2011). Manufacture and characterization of mucoadhesive buccal fi lm s , European Journal of Pharmacy Biopharmaceutics, 77:187–199
Yang RK, Fuisz RC, Myers GL, Fuisz JM (2008). Thin film with non-self-aggregating uniform heterogeneity and drug delivery systems made therefrom US Patent 7425292. Available on https://patents.google.com Accessed 29th June 2018.
Patel RS, Poddar SS (2009). Development and characterization of mucoadhesive buccal patches of salbutamol sulphate, Current Drug Delivery, 6: 140–146. 142 West African Journal of Pharmacy (2020) 31 (1)
Kunte S and Tandale P. (2010). Fast dissolving strips: A novel approach for the delivery of verapamil. Journal of Pharmaceutical Bioallied Science, 2(4):325-328
Meher JG. Tarai M, Yadav NP, Patnaik A, Mishra P, Yadav KS (2013). Development and characterization of cellulose-polymethacrylate
mucoadhesive film for buccal delivery of carvedilol, Carbohydrate Polymers, 96: 173-180
Krogars K, Heinämäki J, Karjalainen M, Niskanen A, Leskelä M, Yliruusi J (2003). Enhanced stability of rubbery amylose-rich maize starch films plasticized with a combination of sorbitol and glycerol, International Journal of Pharmaceutics, 251: 205–208.
Talja RA, Helén H, Roos YH, Jouppila K (2007). Effect of various polyols and polyol contents on physical and mechanical properties of potato starch-based films, Carbohydrate Polymer, 67: 288–295.
Ciper M, Bodmeier R (2005). Preparation and characterization of novel fast disintegration capsules for administration in the oral cavity,
International Journal of Pharmaceutics, 303:62–71.