The sildenafil orally disintegrating tablet developed by Merdury BioPharmaceutical Inc using its StackDose™ new drug development technology platform has been accepted for publication in the international journal Life. Experiments have confirmed that this formulation can effectively increase the bioavailability of sildenafil. Additionally, the special formulation process makes it less susceptible to the effects of gastric pH, maintaining its efficacy even when proton pump inhibitors (PPIs), which suppress stomach acid, are used.
Sildenafil, the well-known main ingredient in Viagra, has always faced issues with absorption being affected by food and varying bioavailability. As a weakly alkaline drug, sildenafil's effectiveness can be reduced by high-fat foods, and its solubility decreases with increasing pH levels. Sildenafil often causes indigestion as a side effect, leading many patients to use Proton-pump Inhibitor (PPI) to reduce stomach acid secretion. However, long-term use of PPIs can alter stomach acid secretion, affecting sildenafil absorption and raising concerns about the combined use of sildenafil and PPIs.
The experimental results published in the Life journal confirm that the sildenafil orally disintegrating tablets produced using Merdury BioPharmaceutical's StackDose™ technology platform, combining drug powder formulation technology with an exclusive patented binder and 3D powder nozzle molding technology, can effectively address these issues. Previous clinical studies have shown that the bioavailability of the orally disintegrating tablets is not affected by the amount of water consumed. The sildenafil orally disintegrating tablets produced using the StackDose™ platform dissolve faster than conventional tablets under various gastric pH conditions and are not affected by gastric pH. The results indicate that proton pump inhibitors (PPI) do not significantly affect the absorption of the orally disintegrating tablets, and their bioavailability is significantly higher than that of conventional tablets, regardless of the use of acid suppressants. This development, published in the Swiss journal Life, is expected to attract international attention and lead to more collaborations with major international pharmaceutical companies. Merdury BioPharmaceutical is actively preparing for mass production and related certification trials and has signed distribution partners in domestic and Southeast Asian countries to assist with local certification and sales channels.