Drug regulators and the biomanufacturing industry need to embrace drug delivery via the skin to solve solubility problems with peptides and proteins, according to Across Barriers’ Udo Bock.
Speaking to in-PharmaTechnologist.com at this year’s Achema in Frankfurt, Germany, the firm’s chief technical officer said industry is still largely “unfamiliar” with the delivery method.
However Bock said that now more than ever – with the latest advancements in topical drug delivery – the sector should be looking to the mechanism to solve challenges presented when trying to administer peptides and proteins orally, which often stumbles in the GI (gastrointestinal) tract.
“The critical issue for both the regulators and researchers is that both seem to be unfamiliar with these new technologies, so there should be a training and learning phase on both sides to use more of these technologies,” he said. “We also need to review the data on existing projects.”
He also said the delivery method could present opportunities for companies looking for new formulations of drugs about to come off patent.
Of the upcoming technologies, he said that now a wider range of drugs can be delivered via the skin, because devices like ultra sound, microneedles, lasers can change what was once the “main barrier” – the stratum corneum – for a period of time long enough to absorb the drug.
“The tech is safe, and opens up doors for biopharmaceuticals like small peptides or bigger protein structures into the skin,” he said.
Bock continued to hail the technology as a solution to other issues in the industry, including lifecycle management and patient compliance.
He said: “The method has interesting applications for long-term diseases such as pain relief, as it is minimally invasive. Skin delivery, for instance creams or patches, has the some of the best patient compliance rates.”
As for highly potent compounds, he told us the delivery method is often beneficial because only small amount is needed as the formulation drops its payload directly into the blood stream from the skin, which benefits both patient and drugmaker.
He added: “Another benefit is that you can remove the formulation once you put it on top of skin. You can remove the patch or cream, you can’t do that with any other formulation.”
Though Bock believes there aren’t enough companies working with delivery by skin at the moment, he predicts a huge boom in business to come, including more service providers popping up across the spectrum.
“From an economical standpoint, it doesn’t make sense for every company to put this sort of department in place, so there will be a whole new range of service providers from pre-clinical to clinical to regulatory specialists,” he said.
And in a bit of friendly advice to developers, he suggested in vitro analysis on skin samples for candidate selection is the key to study success.
“When are you working for the first time with new chemical entities you don’t know how it works in the skin,” he said. “It gives you better understanding to know how it works.”
He said in vitro analysis could even provide enough information for approval if backed by previous data, but admitted it would only be in rare cases.
“In some cases where you have from data products on the market enough safety arguments you can maybe get the acceptance through just in vitro data, but it’s not a general rule,” he said.