A Design and Evaluation of Bilayer Diclofenac Sodium Tablets Combining Orodispersible and Sustained-Release Systems
DOI:
https://doi.org/10.32350/cpr.42.02Keywords:
bilayer tablet, direct compression, diclofenac sodium, orodispersible, sustained release, wet granulationAbstract
Diclofenac sodium is a popular Non- Steroidal Anti-Inflammatory Drug (NSAID), and an analgesic medication. However, its classic dosage preparations do not ensure the rapid effect and a long-term therapeutic response. The objective of the current study was the creation and testing of a bilayer tablet with an orodispersible immediate-release layer and a sustained-release core of diclofenac sodium. The sustained-release core was made by wet granulation. Whereas, the orodispersible outer coating was made by direct compression using super disintegrants, that is, primogel (Sodium starch glycolate) and crospovidone. The pre-compression and post-compression properties of the powder blends and tablets were determined based on pharmacopeias standards. The physicochemical characteristics of the tablets, such as consistent weight, hardness, and friability were acceptable. The orodispersible layer dissolved within less than 30 seconds, with diclofenac sodium being released as a loading dose. The sustained-release core-maintained drug release over the 10-h study period. This demonstrated prolonged drug release consistent with the intended sustained-release behavior of the formulation. Crospovidone proved to be the best among the tested super disintegrants in terms of wetting, water absorption, and disintegration. The optimized bilayer tablet was able to attain a dual-release profile, providing a rapid and long-lasting therapeutic effect. The proposed formulation strategy offered an encouraging method to improve therapeutic efficacy, decrease the dosing frequency, and increase patient compliance in the treatment of inflammatory conditions.
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Copyright (c) 2026 Hira Javed, Eesha Tariq Bhatty, Rabia Javaid, Omer Mahmood Mumtaz, Aiman Mahmood, Tayyaba Rana, Saleha Babar, Hadeeqa Khan, Rizwana Raheel
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