Diteba Develops IV Approach to Achieve Biowaiver Status

Diteba has developed a novel in vitro approach to qualify acyclovir cream products for biowaiver status in accordance with the recently released FDA draft guidance on acyclovir.
 
This compliant approach combines Diteba’s extensive acyclovir in vitro release testing (IVRT) and in vitro skin permeation testing (IVPT) with the relevant clinical and statistical capabilities of Nutrasource’s regulated products division. This approach provides drug companies with the option to utilize biowaiver in place of costly and time-consuming human clinical trials.
 
Diteba specializes in IVRT and IVPT and provides method development and validation of release rate studies for topical formulations including creams, lotions, ointments, gels, pastes, less viscous solutions and suspensions and transdermal patches for both product development and regulatory purposes.
 
The draft guidance, issued Dec. 28, 2016, allows IVRT, a measure of release of the active pharmaceutical ingredient from the drug product matrix in a controlled lab environment, to be used in conjunction with skin tests using cadaver skin membrane. The FDA has accepted results of this method as comparable to traditional clinical trials, potentially saving sponsors time and costs in product development.
 
"This is great news for any company marketing topical pharmaceuticals," said Neil Holman, Diteba’s vice president of marketing and business development. "Utilizing in vitro release rate and skin permeation testing, sponsors can implement a straightforward, compliant biowaiver study, avoiding costly and time-consuming clinical trials. Many are saying this will be the future for all topical generic drugs, which should lower costs and speed approvals."