Abstract
Objectives: The objectives of this study were to prepare, characterize, and examine in human beings a new mucoadhesive tablet releasing natural active agents, for pain reduction and rapid healing of canker sores. Methods: Adhesive tablets were prepared by compression molding of mixed powders of crosslinked poly (acrylic acid) and hydroxypropyl cellulose, absorbed with citrus oil composition and magnesium salts. The tablet erosion and the rate of citrus oil and magnesium salt release were determined as well as the adhesiveness of the tablet by an Instron tensiometer using bovine gingival tissue. A human study was conducted on 248 volunteers suffering from canker sores. The volunteers were divided in 2 groups, one received tablet loaded with the active agents and the other without actives. Results: Tablets adhere well to the mucosal tissue and gradually erode for 8 hours while releasing the citrus oil at a zero order pattern with the magnesium salt being released for 2 hours. Both tablets were effective in reducing pain and decreasing healing time ( P < 0.05) without adverse effects. However, tablets loaded with actives were more effective. Erodable mucoadhesive tablets, releasing citrus oil and magnesium salts, are effective in pain relief and enhance healing of canker sores in human beings. Conclusion: Mucoadhesive tablet was found highly effective in pain reduction and healing time in human beings.
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