Generex Biotechnology Corp. (fka GNBTQ)

[WeeZuhl]

Formulation and evaluation of simvastatin buccal film


Journal of Applied Pharmaceutical Science Vol. 5 (04), pp. 070-077, April, 2015

Simvastatin is water insoluble crystalline powder (Ungaro et al., 2010). It undergoes extensive first pass metabolism in the liver which results in very low and variable oral bioavailability. The properties of drug like short half-life (2-3 hour), small dose size (5-80mg) and low molecular weight (418.57) makes it suitable candidate for administration by buccal route (Hiremath, 2009). This route of administration is expected to overcome the problem of poor oral bioavailability by at least avoiding the presystemic metabolism of the drug.

The developed films are promising for buccal administration.

Statins, such as Lipitor (atorvastatin) and Zocor (simvastatin) are the greatest-selling class of drugs of all time, and they are perfect candidates for buccal delivery (Generex Rapid Mist). It could be the safest way to deliver them. By avoiding first-pass metabolism in the liver, lower doses could be used. IMO, this would potentially decrease the two most common adverse events associated with statins-- liver enzyme elevations and myalgias. Millions of people cannot tolerate highly-beneficial oral statin therapy due to muscle and liver problems. Could buccal delivery with Generex Rapid Mist be the answer for these people?