Spring 2016: Five years ago, Pharma Tech began discussions with an innovative pharmaceuticals development company in the midst of developing a unique, breath-powered delivery system suitable for a variety of active pharma ingredients. Their initial market entry would involve a known chemical entity already approved for the treatment of migraine headaches in different dosage forms. The active pharmaceutical ingredient would be filled into a capsule and then placed into the delivery system’s nosepiece; the company believed that this delivery method would provide significant benefits over others previously approved by FDA.

While Pharma Tech had produced many powder Rx products, it had never filled powder into capsules. However, the company had packaged powders into foil sachets – a requirement for this product – and, given its molding operations in Royston, GA, understood the operation’s molded components aspect. The project comprised filling a low dosage of the drug’s API into capsules for breath-powered inhalation. For its part, Pharma Tech’s new customer had a knowledgeable, dedicated development team and, together, the two companies began the NDA submission process. 

The steps were incremental yet attention-getting: In July 2013, prominent pharmaceuticals company Avanir announced that it would finish product development and NDA submission and market the product upon FDA approval, which was achieved in January of 2016.

As Avanir readied its waiting field force for commercial launch, Pharma Tech ramped up production operations to produce the initial launch quantities. To date, Pharma Tech has filled nearly one million capsules and nosepiece assemblies for this innovative new delivery system with production to continue, keeping pace with the commercial demand for the product. 

In the process, Pharma Tech proved deft at performing a set of diverse, complicated, and unconventional filling and packaging procedures for a drug + delivery system combination that was the first of its kind. The work was an exercise – and a demonstration of – Pharma Tech’s ability to branch out in terms of services while staying in line with its mantra of “Making Products That Fulfill Promises.”