Abstract
Dear Editor,
In the above mentioned review article, a comprehensive list of active ingredients investigated in bioadhesive dosage forms for the treatment of OPC was presented, various kind of active agents and dosage forms have been mentioned but one agent Miconazole base is omitted. The active ingredients are
•Miconazole 50 mg buccal tablet (MBT) (Oravig™, Strativa Pharmaceuticals).
•Miconazole nitrate 10 mg buccal tablets (Tibozole™, Tibotec Pharmaceuticals)
The above mentioned buccal tablets were used in the treatment for OPC. However, the two miconazole buccal tablets are distinct products, and each contains different polymers. MBT utilizes a hydrophilic matrix containing the polymer hypermellose, which allows immediate and sustained release of Miconazole [1].
Advantages Over Conventional Dosage Forms
•Once daily dosing lacking in nystatin oral suspension and clotrimazole troches, which are dosed 4 to 5 times daily.
•Good bioadhesion (hypermellose mucoadhesive polymer)
•Minimal systemic drug exposure
•Controlled drug release pattern
Following single-dose application of MBT, the plasma concentrations of miconazole were below the lower limit of assay quantification (0.4 mcg/mL) in 97% of samples (157/162) from 18 healthy volunteers [2,3]. In those plasma samples with measurable miconazole levels, concentrations did not exceed 0.83 mcg/mL.
Currently in the United States, MBT is the only miconazole buccal tablet available.
REFERENCES [1] Aiache JM, Costantini D, Chaumont C, inventors; BioAlliance Pharma, assignee. Sustained-release therapeutic bioadhesive systems. Patent WO/2003/009800. June 2, 2003.
[2] Cardot JM, Chaumont C, Dubray C, et al. Comparison of the pharmacokinetics of miconazole after administration via a bioadhesive slow release tablet and an oral gel to healthy male and female subjects. Br J Clin Pharmacol 2004; 58(4): 345-51.
[3] Oravig [prescribing information]. Woodcliff Lake, NJ: Strativa Pharmaceuticals, a division of Par Pharmaceutical, Inc.; April 2010.
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