Pharma Tech Industries Selected to Manufacture Innovative Nasal Delivery System
News Mar 05, 2013
Pharma Tech Industries (PTI) has been selected to handle filling, assembly and packaging services for a migraine relief medication administered through an innovative new method: a breath-powered nasal delivery system. The drug itself is powder-based, and PTI was chosen for this initiative – which will start as developmental, supporting FDA submission for approval and will continue into commercial –due to the company’s experience handling a broad range of powders, and its ability to vertically integrate the entire production process.
The OptiNose delivery system employs a novel means of easily administering drugs deep into the nasal cavity, enabling the treatment of both local and systemic diseases. The new technology offers a much-needed alternative to existing, poor-performing nasal sprays, as well as to tablets and injections (see Page 2 for details). OptiNose has completed Phase III development for a Sumatriptan Succinate medicine that, when taken using its patented device, is expected to shorten the timeframe for relief from migraines when compared to widely used oral migraine medications.
Pharma Tech Industries will play a critical, turn-key role in preparing OptiNose’s NDA batches over the coming months. Utilizing a Planeta Capsule Filler from leading equipment manufacturer MG2, PTI will fill low-dose capsules with dry powder medication, achieving tight weight tolerances at high commercial speeds. From there, the capsules will be loaded into special unit-dose cartridges. PTI will then pack each cartridge – along with the primary nosepiece and an instruction insert for the end-user – into individual cartons, where they are mechanically packed into cases and palletized for shipping.
“We chose Pharma Tech Industries as our CMO through a rigorous selection process that evaluated more than half a dozen potential candidates,” said Peter Miller, CEO of OptiNose. “We are working to bring a groundbreaking delivery system to market, and its commercial development depends upon a partner that can execute with excellence. We believe that Pharma Tech Industries is such a partner.”
“It is exciting to work so closely with the team at OptiNose, who have spearheaded the creation of a very promising new drug delivery system, and we are thankful for this opportunity,” said Tee Noland, Chairman of Pharma Tech Industries. “This project allows PTI to showcase the broad spectrum of capabilities that make us such an attractive option for our customers.”
A Promising Nasal Delivery System for Migraine Sufferers
Intranasal formulations of some triptans – including sumatriptan and zolmitriptan – were developed with the intent of achieving faster onset of action compared to tablets, and a more appealing delivery method than injections. Many patients have nausea and, even without nausea, gastric emptying is often delayed during migraine attacks. This is a key reason tablets may not be as fast and effective as other delivery methods.
Current nasal sprays deliver much of the dose to the anterior third of the nose in front of the nasal valve, where absorption is inefficient and where part of the dose is easily lost to “drip out.” The remainder passes along the floor of the nose to be swallowed, where it offers no advantage over standard oral delivery.
The OptiNose breath-powered, bi-directional™ delivery device simply and reliably delivers medication deep into the nasal cavity, while preventing initial deposition in the mouth and lungs. This has potential to greatly increase the efficiency of nasal absorption of medication while reducing the amount of drug that is swallowed. This new form of drug delivery means that even with a much lower dose, the new migraine product has potential to produce fast and effective pain relief.
Absolute Antibody and Kerafast Merge Increasing Access to Unique Reagents and Recombinant Antibody TechnologyNews
Absolute Antibody Ltd., and Kerafast Inc., have announced a merger of the two companies. The merger brings together two companies with a shared commitment to improving the selection of research tools available to the scientific community.READ MORE
Lonza to Establish Cell- and Gene-Therapy Centers of Excellence to Accelerate GrowthNews
Lonza will establish Centers of Excellence for Cell and Gene Therapy to support and accelerate the growth of this priority area for the company.READ MORE
Comments | 0 ADD COMMENT
3rd Annual Bioprocessing of Advanced Cellular Therapies
May 29 - May 30, 2018