The pharmaceutical division of Danish company Niro wants the pharmaceutical industry to evaluate spray drying technology at an earlier stage in the development of new pharmaceutical products to avoid the risk of missing out on processing opportunities.
According to Svenn Ryberg, vice president of Niro's pharma division, many companies could have developed their processes more efficiently using spray drying; however, once the process is validated using alternatives it is difficult if not commercially impossible to change.
He points to the desire in the pharmaceutical and biotech industries to achieve ever greater bioavailability. 'With spray drying you can produce stable amorphous solid dispersions by co-precipitating an API with a polymer, thereby greatly improving the dissolution rate,' he explains. 'Today, the best therapeutic effectiveness can often be achieved using this type of technology.'
Specifically, the unprecedented particle control achievable with spray drying opens the way to employing previously unattainable delivery methods and molecular characteristics. The advantages can remove many of he obstacles to turning new discoveries into commercial drugs, Ryberg claims.
The problem, in his view, appears to be that pharmaceutical and biotech companies fail to consider spray drying during the r&d phase. 'This might be for historical reasons, but the cost of the test equipment has often been prohibitive. Today that is not necessarily true,' he said.
Niro has tackled the problem in two ways: by developing relatively inexpensive r&d equipment that accurately mirrors the processing results of larger production equipment; and by the introduction of validated test facilities at its headquarters in Copenhagen that are available for hire for r&d, clinical trials or even initial production of new products.
'We want to encourage manufacturers to consider spray drying early in the product development phase. With modern equipment and our facilities in Copenhagen it's possible for our customers to evaluate fully the benefits, both operationally and clinically, of spray drying and consider the technology objectively before making decisions on plant design,' Ryberg says. 'We are sure that more companies would choose spray drying as a core technology if they had the opportunity to evaluate it sufficiently early in the process.'
Niro's Pharmaceutical Test Station in Copenhagen houses a variety of test equipment allowing manufacturers to evaluate spray drying effectively under different operational conditions. Next year it will bring on line a new PSD1 spray dryer allowing it to handle smaller samples with reliable scale-up to full production.