Give people a fish and they eat for a day, teach them to fish and they will never go hungry

          

Tibotec Therapeutics

Our collaboration with Tibotec, a pharmaceutical company, has been established in 2006. Tibotec has generously made available an antifungal drug, called Miconazole or micMAT, that treats oral thrush, a painful condition affecting 25% of AIDS patients every year. This year, with the help of a generous grant from Tibotec we are able to establish a cost recovering non-profit distribution of the drug with the intend to expand it for all of central Africa. Importantly, this program creates jobs in Cameroon.

We are currently in the process to renew the drug license for Miconazole with the Cameroon Ministry of Public Health. If you are a hospital or approved AIDS treatment center in Cameroon and would like more information on how to purchase Miconazole please write us to RRHodel@aol.com and we will forward your information to the proper contacts in Cameroon. Read more

 

Miconazole nitrate,

10mg

 muco-adhesive buccal tablet (MAT)

 

Among HIV-related opportunistic infections and malignancies, oral candidiasis has been ranked as the single most important. The average frequency has been estimated at 53%. Additionally, oesophageal candidiasis is reported among people living with HIV/AIDS with a frequency of 21%.

In addition to its frequency, oral candidiasis also plays a major role in the deterioration of the patient's health status. Due to the painful oral lesions, swallowing is difficult resulting in reduced food intake, causing the already precarious nutritional status of the patient to be further jeopardized. Proper management, including early treatment during relapse, is important to assure a minimum quality of life for the patient.

Existing treatment guidelines of WHO/GPA recommend Nystatin 100.000 IU orally 3 times daily for 7 days or gentian violet as first line treatments for oropharyngeal candidiasis. Ketoconazole 200mg twice daily for 2 weeks is recommended for the treatment of cases with suspected oesophageal candidiasis. However systemic azoles, ketoconazole and fluconazole, may become problematic given the risk of drug-drug interactions with rifampicin, protease inhibitors and NonNucleoside RT inhibitors.

Miconazole MAT is a new formulation for site-specific, sustained intra-oral release of fungicidal levels of miconazole for treatment of oro-pharyngeal candidiasis. The product contains 10 mg of miconazole nitrate in a muco-adhesive buccal tablet formulation.

The pharmacokinetic study with Miconazole MAT demonstrated salivary concentrations of miconazole in the fungicidal range (above 10µg/ml) for at least 8 hours. The extent of buccal exposure expressed as the AUC_last is significantly greater as compared to that seen during use of the miconazole oral gel. Although the daily dose with the MAT is only a fraction of the dose with the oral gel (10 versus 240mg), the total oral exposure to miconazole is almost 5 times higher with the MAT versus the gel.

Plasma levels after administration of miconazole MAT were negligible. No drug interactions have been reported during use of miconazole MAT. 

The Miconazole MAT is a muco-adhesive buccal tablet. The tablet should be applied to the gingiva under the upper lip and be held there for about 20 seconds until the tablet sticks to the mucosa. The tablet remains on the gingiva for about 8 to 13 hours during which time it erodes. At first the tablet can be felt, however, it quickly adapts to the anatomical surroundings of the gingiva.

Do not swallow! Apply the MAT in the morning, once daily for 7 days.  The use of MAT is not recommended in children below age 7.

A well-controlled study in HIV+ patients with low CD4 counts suffering from oral candidiasis showed an 87% clinical cure rate following treatment with MAT. Dysphagia, a surrogate endpoint for oesophageal candidiasis, was eliminated to a similar degree. These clinical responses are within the ranges seen with other systemic antifungals. The table below provides a summary of the results seen with antifungal therapies in HIV/AIDS patients.

Studies with miconazole MAT have demonstrated minor product related adverse effects.

For cost-effectiveness a single generic package containing 5 x 10 blisters of 7 tablets (including three visual aids in French/English) is available. (= 50 patient treatments)