Michael Wahlberg, GEA Niro’s head of operations, told in-PharmaTechnologist why the process engineering specialist decided to roll out the new service and what it can provide for drug industry customers.
“For many pharmaceutical companies spray drying is a new technology or has not been the first choice,” explained Wahlberg, adding that “you can obtain several benefits using spray drying as opposed to other technologies, but being a new and emerging technology, many companies… have been reluctant to make the [necessary] investment.”
Spray drying offers drug firms a way of converting liquid phase pharmaceuticals into solids in a single process step that, Wahlberg said, provides a high degree of control for particle morphology and eliminates the milling steps required by other techniques.
He also highlighted improved drug bioavailability, particularly for active pharmaceutical ingredients (API) that suffer from poor aqueous solubility, as other advantages the process provides.
“Using spray drying makes it possible to co-precipitate an API with a polymer fixing the amorphous API in a solid dispersion. In order to achieve this, a very fast drying rate, [which] can be obtained by spray drying, is a necessity.”
The test centre houses two GEA Niro PharmaSD units: a laboratory sized PSD-1 for initial development stage work; and a PSD-4 commercial sized unit that is capable of producing around 70kg of an API per hour.
Wahlberg said that GEA Niro expects demand for the new service to be considerable, explaining that: “We know that many companies are considering spray drying, but they need assistance to develop the right process and they need someone to help produce samples for safety, stability and toxicology studies and of clinical trials materials.
He added that: “There are only few companies that have the same state-of-the-art facilities we have [that are] of a similar size.“
The firm also hopes the new contract service will attract more buyers for its PharmaSD range but, according to Wahlberg this is not the primary motivation for founding the service.
“Not all companies that have an interest in spray drying have a need that can justify investing in a plant right now, and at the same time we have a vast expertise within the technology that can be of great use for these companies.”