Abstract

Dear Editor,

The review of buccoadhesive drug delivery systems and their logical use for the local treatment of oropharyngeal candidiasis (OPC) by Pendekal, Shariff, and Tegginamat [1] is a useful reference describing the use of buccoadhesive dosage forms for drug delivery. Although a comprehensive list of active ingredients investigated in bioadhesive dosage forms for the treatment of OPC was presented, one agent omitted was miconazole base. This active ingredient is commercially available as miconazole 50 mg buccal tablet (MBT) (Oravig™, Strativa Pharmaceuticals). Miconazole nitrate 10 mg buccal tablets (Tibozole™, Tibotec Pharmaceuticals) was noted as a 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 [2], which allows immediate and sustained release of miconazole during the day [3]. As the authors indicated, the controlled release of antifungal medication when treating OPC is beneficial to provide prolonged local treatment of the fungal infection. Hypermellose also confers mucoadhesive properties. Among the desired characteristics listed by the authors for buccoadhesive treatments for OPC, convenient dosing should be included since the controlled release drug delivery facilitates once-daily dosing. Both MBT and miconazole nitrate buccal tablets are dosed once-daily, which is in contrast to other local treatments for OPC, such as nystatin oral suspension and clotrimazole troches, that are dosed 4 to 5 times daily. An OPC infection is local to the mouth and throat, and a benefit of treating OPC locally with MBT is minimal systemic drug exposure [3]. 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 [3,4]. 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; miconazole nitrate 10 mg buccal tablet is not commercially available in the United States.

AUTHOR DISCLOSURE AND CONFLICT OF INTEREST

Dr. Naomi Musaji is an employee of Strativa Pharmaceuticals, a division of Par Pharmaceutical, Inc. There are no other affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in this manuscript.

REFERENCES

[1] Pendekal MS, Shariff M, Tegginamat PK. Buccoadhesive dosage form containing antifungal agent for treating oropharyngeal candidiasis: A review. Current Drug Therapy 2011; 6: 55-64.

[2] Aiache JM, Costantini D, Chaumont C, inventors; BioAlliance Pharma, assignee. Sustained-release therapeutic bioadhesive systems. Patent WO/2003/009800. June 2, 2003.

[3] 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.

[4] Oravig [prescribing information]. Woodcliff Lake, NJ: Strativa Pharmaceuticals, a division of Par Pharmaceutical, Inc.; April 2010.

Keywords: Buccal tablet, buccoadhesive, candidiasis, hypermellose, miconazole