Efficacy of a Mucoadhesive Patch Compared with an Oral Solution for Treatment of Aphthous Stomatitis
ABSTRACT The purpose of this study was to evaluate the efficacy and tolerability of a mucoadhesive patch compared with a pain-relieving oral solution for the treatment of aphthous stomatitis.
Patients with active aphthous stomatitis were randomly treated either once a day with a mucoadhesive patch containing citrus oil and magnesium salts (n = 26) or three times a day with an oral solution containing benzocaine and compound benzoin tincture (n = 22). All patients were instructed to apply the medication until pain had resolved, and completed a questionnaire detailing multiple clinical parameters followed by an evaluation of the treatment.
The mucoadhesive patch was found to be more effective than the oral solution in terms of healing time (mean +/- SD: 36.0 +/- 22.8 hours vs 134.7 +/- 57.7, p < 0.001) and pain intensity after 12 and 24 hours (3.7 +/- 2.8 vs 6.3 +/- 2.6, p = 0.003, and 2.3 +/- 2.7 vs 5.7 +/- 2.5, p < 0.001, respectively). Local adverse effects 1 hour after treatment were significantly (p < 0.01) less frequent among the mucoadhesive patch patients compared with the oral solution patients.
The mucoadhesive patch was found to be significantly more effective and better tolerated than the oral solution in the treatment of aphthous stomatitis.
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ABSTRACT: To determine the effectiveness of botulinum toxin type A to reduce pain of recurrent aphthous ulcer, a single blinded placebo controlled trial of botulinum toxin A injection was performed. A total of 70 patients were enrolled and randomly received a botulinum toxin type A 1 unit or placebo. The patients were asked to note the level of pain on the visual analogue scale for 6 days. They also had to record any eventual side effects or recurrence for 6 months. More patients quickly recovered following Botulinum toxin type A injection than placebo; they would feel almost no pain after about 3 days. Botulinum toxin type A exhibits quick pain treatment effect following injection on aphthous ulcer. The author also believes that it can prevent recurrence for at least 6 months after injection.Archives of Oto-Rhino-Laryngology 07/2008; 266(3):445-8. DOI:10.1007/s00405-008-0756-z · 1.61 Impact Factor
Article: Mucoadhesive drug delivery systems[Show abstract] [Hide abstract]
ABSTRACT: Mucoadhesion is commonly defined as the adhesion between two materials, at least one of which is a mucosal surface. Over the past few decades, mucosal drug delivery has received a great deal of attention. Mucoadhesive dosage forms may be designed to enable prolonged retention at the site of application, providing a controlled rate of drug release for improved therapeutic outcome. Application of dosage forms to mucosal surfaces may be of benefit to drug molecules not amenable to the oral route, such as those that undergo acid degradation or extensive first-pass metabolism. The mucoadhesive ability of a dosage form is dependent upon a variety of factors, including the nature of the mucosal tissue and the physicochemical properties of the polymeric formulation. This review article aims to provide an overview of the various aspects of mucoadhesion, mucoadhesive materials, factors affecting mucoadhesion, evaluating methods, and finally various mucoadhesive drug delivery systems (buccal, nasal, ocular, gastro, vaginal, and rectal).04/2011; 3(1):89-100. DOI:10.4103/0975-7406.76478
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ABSTRACT: To develop fenretinide oral mucoadhesive patch formulations and evaluate their in vitro and in vivo release performance for future site-specific chemoprevention of oral cancer. Solubilization of fenretinide in simulated saliva (SS) was studied by incorporating nonionic surfactants (Tween® 20 and 80, and Brij® 35 and 98), bile salts (sodium salt of cholic, taurocholic, glycocholic, and deoxycholic acids), phospholipid (lecithin), and novel polymeric solubilizer (Souplus®). Adhesive (polycarbophil: hydroxypropyl methylcellulose 4KM) and drug release (Fenretinide/Eudragit® RL PO with or without solubilizers) layers were prepared by solvent casting. Oral mucoadhesive patches were formed by attaching drug and adhesive layers onto backing layer (Tegaderm™ film). Physical state of drug in Eudragit® films was examined by X-ray diffraction (XRD). Evaluation of in vitro and in vivo fenretinide release from the patch was conducted in SS containing 5%w/v sodium deoxycholate and rabbits, respectively. Fenretinide was quantified by HPLC. Tween® 20 and 80, Brij® 98, and sodium deoxycholate exhibited the highest fenretinide solubilization potential among the solubilizers. Drug loading efficiency in Eudragit® films was 90%-97%. XRD suggested fenretinide was amorphous in solubilizer-free and solubilizer-loaded films. Solubilizer-free patch exhibited poor in vitro and in vivo controlled drug release behavior. Increases in drug loading (5-10 wt%) or changes in polymeric matrix permeability did not provide continuous drug release. Co-incorporation of either single or mixed solubilizers in fenretinide/Eudragit® patches, (20 wt% Tween® 20, Tween® 80 and sodium deoxycholate or 20 wt% Tween® 80 + 40 wt% sodium deoxycholate solubilizers) led to significantly improved continuous in vitro/in vivo fenretinide release. Fenretinide/Eudragit® RL PO patches with 20 wt% Tween® 80 + 40 wt% sodium deoxycholate solubilizers exhibit excellent release behavior for further preclinical and/or clinical evaluation in oral cancer chemoprevention.Pharmaceutical Research 06/2011; 28(10):2599-609. DOI:10.1007/s11095-011-0489-3 · 3.95 Impact Factor