BioAlliance's buccal bioadhesive brings better results
of drug resistance, revealed results of a study that indicated a
new formulation of miconazole administered as a bioadhesive
extended release buccal tablet was more effective compared to the
same drug applied in a topical gel for treatment of thrush.
While current treatment guidelines for oropharyngeal candidiasis (thrush) uses topical or localized therapies such as gel, lozenges and mouthwashes, they have been generally unsuccessful in treating this infection.
Patients have complained about the multiple daily applications, unpleasant taste and transient drug concentration in the oral cavity. The lack of effective local treatments has lead to preferential use of systemic anti-fungal agents.
The current study was able to demonstrate the potential of once-daily application of a buccal tablet formulated to provide an extended release of miconazole.
In order to provide a first-line alternative to treatment using systemic therapies, the current study was designed to demonstrate the potential of a once daily application of a buccal tablet formulated to provide an extended release of miconazole. Miconazole is a well-known antifungal with broad-spectrum activity against various species of Candida. Such an approach would eliminate the problems of patient compliance and tolerance associated with other topical treatments.
Richard Keatinge, vice president of business development for BioAlliance Pharma told In-Pharmatechnologist.com: "The primary advantage of a treatment that is absorbed directly in the mouth allows a steady concentration of a drug to be administered to the site. In the case of thrush, a once a day tablet for 14 days proved an effective treatment over localised therapies such as gels and mouthwashes."
The study was conducted using a proprietary bioadhesive buccal tablet (Lauriad) placed on the cuspid fossa beneath the upper lip. This placement allows the tablet to adhere to the buccal mucosa for an extended period while releasing the antifungal agent.
A natural polymer, with good tolerance and appropriate adhesive properties was used to formulate the drug. The tablet adheres to the gum and then absorbs water, which triggers sustained release of miconazole and tablet erosion. Once the tablet is in place, patients can eat, drink and carry on normal daily activities while the tablet dissolves, slowly or gradually releasing the drug.
The data from the study strongly supports the further development of Miconazole Lauriad' 50mg bioadhesive buccal tablets as an extended release formulation leading to improved antifungal exposure in the oral cavity
Plasma and salivary measurements of miconazole were assessed in 18 subjects over a 24-hour period where a single administration of a 50 mg tablet of miconazole Lauriad gave higher and more prolonged salivary concentrations of the drug than did the gel. The mean duration of tablet adhesion was 15 hours.
Plasma miconazole concentrations were generally below the limit of detection, confirming a very low absorption through the buccal mucosa or the gastrointestinal tract after swallowing saliva.
Keating commented: "A slow releasing formulation administered in the mouth, eliminates patient compliance in a long-term drug programme."
The most practical reasons for new drug or drug delivery development are improving adherence and reducing the toxicity of present regimes. Adherence is relatively poor in all therapeutic areas where long-term drug therapy is required and is a prime factor for drug resistance to establish and take hold.
This study of the once a day topical formulation of miconazole in the form of an extended release bioadhesive buccal tablet is intended to form the basis for further clinical development of the first product utilizing the Lauriad drug delivery platform.
Keatinge added: "In theory this treatment can be applied to other diseases and disorders. We are looking to follow on this bioadhesive with an Acyclovir Lauriad for the treatment of mucosal and buccal herpes, which we expect to file a European IND in the first quarter of 2005."
"In addition, we expect our Fentanyl Lauriad treatment for the relief of severe resistance pain, particularly in cancers, to progress from its current preclinical phase."
Keatinge commented on the growing HIV and Cancer market particularly in the US, Europe and Japan. In addition, he pointed to the growing elderly and diabetic sectors in these markets, a factor that BioAlliance Pharma is addressing with its new treatments.
"The bioadhesive buccal tablet is a proprietary technology, which as far as we know is the only treatment of its kind. The company Tibotic use a different formulation in a HIV treatment that has a similar action. This is only available in Africa, he commented."
BioPharma expect to file a drug application for its Miconazole Lauriad product in Europe next year and in the US for 2006.
