Budding US contract manufacturer Xemplar is now looking to move into this niche area of manufacturing and help plug the gap.
Most nasal sprays on the market currently contain the active pharmaceutical ingredients (APIs) dissolved or suspended in solutions or mixtures of excipients such as preservatives, viscosity modifiers, emulsifiers, buffering agents.
However, such nasal spray preservatives or stablilising agents are known to negatively affect the nasal mucosa - particularly in children - causing discomfort, irritation and other side effects. One of these preservatives, benzalkonium chloride, has been banned in nasal sprays in Germany and many European manufacturers are reformulating nasal spray products to remove it.
Although the use of preservatives or stablilising agents in nasal spray formulations is still legal in the US, the FDA has made it clear it frowns upon their use and is actively trying to encourage pharma firms to develop drug products free from these potentially harmful ingredients.
One problem though... while many drug delivery manufacturers currently have the capability to manufacture nasal spray products, very few are capable of the aseptic nasal spray manufacturing that is required to make preservative-free nasal products, Charles Eck, president of Xemplar Pharmaceuticals told In-PharmaTechnologist.com.
"There are very few contract manufacturers in the world who can do aseptic manufacturing of nasal sprays," said Eck.
This is because aseptic manufacturing is a "daily operational nightmare," he said.
"Aseptic manufacturing is very expensive and requires a lot of capacity. It is also extremely important that cleanrooms stay clean and there is no contamination."
"Because of this lots of manufacturers do not want to get involved with aseptic manufacturing, however, we are very keen to do it as we see it as a great untapped market and see preservative-free nasal sprays as the way of the future," Eck said.
Xemplar has been steadily muscling its way into the advanced drug delivery contract manufacturing scene and recently won a deal to make the metered-dose components of MAP Pharmaceuticals' new asthma inhaler devices.
To cope with the new manufacturing demand, the company is expanding its existing production facility in Fall River, Massachusetts, adding 12,000 square feet of commercial space designed specifically for the production of pressurised metered dose inhaler products, nasal sprays and dry powder inhalers.
"We can currently meet demand for small quantities of these products for clinical trial purposes but the expansion will give us capacity to produce and fill around 20m units a year," said Eck.
Armed with this added capacity Xemplar said it will be looking to find many new manufacturing agreements with other companies for all types of pressurised metered dose inhalers, nasal sprays and dry powder inhalers, to add to the deal it now has in place with MAP.
"With the new facility we will have the ability to convert to aseptic nasal spray manufacturing if a customer requires it," said Eck.
Only one current commercial-scale manufacturing facility in the US has the capacity to aseptically fill and prepare sterile, unit dose nasal products, and is already doing so.
The facility is run by Intranasal Therapeutics (ITI), a specialty pharma company focused on nasally delivered drugs, and is located on the University of Kentucky's Coldstream Research Campus.
"To satisfy our own requirements and the market's unmet needs, we constructed a manufacturing facility to prepare sterile unit and bi-dose nasally delivered products filled by equipment designed to our specifications," said the firm.
"This custom-designed facility is capable of manufacturing supplies for all clinical trial phases for both internal and partner-funded product candidates and for commercial distribution."
With such a shortage of players, in the US and globally, the field is wide open for those manufacturers who can take on the aseptic challenge and meet future demand in this evolving market.