OINDP packaging can be complicated due to the interacting components involved with each delivery device.
Each orally inhaled and nasal drug product (OINDP) is a miniature “machine” or device packaged with the formulation to create a complete drug delivery system, including a pump, bottle or canister, nozzle, and actuator. To gain quick FDA approval, all possible interactions among the components should be analyzed and rigorously tested.
Graphic used with permission from Aptar Pharma
Breakdown of MDI parts: Photo courtesy of Medscape.com
The coordination of hand movements required to dispense a spray dose should be tested against the appropriate segment of a human population. When developing actuation parameters utilizing our Proveris by Design™ process, we understand the importance of testing within a product’s targeted age and gender group.
Dispensing a spray dose involves a chain of physical events with wide variations, and not everyone actuates OINDPs in the same manner.
"Proveris Scientific Corporation provides expert support for nasal developers. They are fast, reliable and are professionals at installing of their equipment and supports in demanding challenges."
Dr. Peter Svete, Head of Physical Analytics, Lek Pharmaceuticals d.d.
"Proveris provides insightful and thorough test services. We would recommend working with Proveris. Proveris has great expertise in spray analysis."
Elaine Schutte, Chief Development Officer, ProFibrix
"I want to express my sincere gratitude towards Proveris and the service team for being there to make sure our study goes well. The study just completed few minutes ago and thankfully everything went well.......while we conducted SAC study. It was a great display of professionalism by Proveris."
"As customary, Proveris's service team provided excellent service and was able to answer my questions."
"Thank you for the thorough training on our new equipment. I wish more companies would implement your hands on approach when it comes to training. Thanks again."
“We really appreciate the creativity and work conducted at Proveris for their Test Services (Proveris by Design®). Their knowledge, experience, and insight with OINDP’s was very helpful. Thanks to the Proveris team, we have a wonderful solution that we can use for commercial products!”
Mic Iwashima, NDS Division, Shin Nippon Biomedical Laboratories, Ltd