Inc. (Whitehouse Station, NJ), which currently has no drug products delivered via inhalation technology, Michael Riebe is director for inhalation delivery technology in addition to being the company's director for pharmaceutical research and development.
One of his
primary goals is to enable pharmaceutical development of inhalation drugs at Merck
says that, among pharmaceutical companies, a common misconception is that developing pulmonary-delivery products is quite a bit more expensive than developing oral products."The CMC [chemistry, manufacturing and controls] is more," he
said, "but that's a small percentage of product development costs."CMC costs are driven by the added complexity of pulmonary delivery, integrating an inhalation device with a dose of the drug to be delivered. He
also advises caution in manufacturing operations due to the purity and consistency required of drugs for pulmonary delivery."Sometimes vendors [of delivery devices] change things," says Riebe
."When a component manufacturer changes something about its manufacturing process,for example, changing the base resin used in a polymer that goes into a valve,that can slip through the change control process."
Clinical costs,one of the largest expenses of bringing a drug to market,are the same whether a drug is formulated as oral, pulmonary or injected, he
notes.FDA approvals, however, take significantly longer for pulmonary delivery drugs than for oral drugs."That has been improving over recent years, but still takes longer," he
says."There's not a lot of guidance from FDA
Reibe says pulmonary delivery is most often thought of as being used for local delivery to treat respiratory disease."It's a misconception that it's not for systemic delivery," he