Choosing the appropriate drug and device combination for the targeted patient group can be tricky.
An orally inhaled or nasal drug product (OINDP) consists of three elements: the patient’s ergonometric capability, the mechanics of the delivery device, and the drug formulation. Unraveling the complex relationships that exist among these elements early will expedite the development process and lead to better drug products. We have proven this concept in over 100 OINDP projects we’ve conducted independently, with customers, and with the FDA over the past 12 years. Our approach incorporates regulatory guidelines, methodical experimentation, compelling analysis, and interactive consultation.
Here, we have an example illustrating the limits to the range of velocities, accelerations, and stroke lengths that humans are capable of exerting on a particular nasal spray product. The results of this study are useful for patient training, drug development efforts, and establishing CMC methods.
By identifying the human usage performance range of an OINDP according to current FDA and other regulatory guidelines for in vitro testing, our patented process routinely saves customers years of development time and millions of dollars. The process also reduces the risks associated with failed batches and using unachievable product specifications in a regulatory submission.
"Together with Proveris's instruments and software, the complete solution provides the scalability Aptar Pharma needs to perform robust, high through-put product testing."
Salim Haffar, President, Aptar Pharma
"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