Formulation and evaluation of oral dissolving films of naproxen sodium from Terminalia randii gum
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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.
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