Aptar Pharma, a business segment of Aptar developing solutions for biotechnology, healthcare, and pharmaceutical companies, will be presenting its Pro-Ject auto injector and PremiumCoat at Pharmapack North America on June 9-10 in New York. Pro-Ject is from Aptar Pharma Prescription, and PremiumCoat is from Aptar Stelmi.
Aptar will be manning booth 4004 at the conference.
According to the company, Pro-Ject, has been designed and developed with input from patients and healthcare professionals to provide optimal patient convenience and compliance. It was released in late 2013.
Human factors engineering is an integral part of developing any new drug-delivery device, says Aptar Pharma, and human factors studies address many different ‘human elements’ such as perceptual, cognitive, ergonomic, emotional, social, and even cultural. The outcome of human factors studies should provide a clear understanding of how to avoid errors, identify safety risks, improve patient education/training and competence, and eventually patient compliance. In addition, governments such as the United States, Europe, and others have outlined how to integrate regulatory guidance into drug-delivery devices during their development in order to optimize design and gain approval.
Human factors guidelines were applied to Pro-Ject, according to Aptar Pharma, in order to understand users’ and healthcare professionals’ experiences, expectations, and preferences with auto injectors.
Aptar Pharma's studies confirmed that both training nurses and rheumatoid arthritis patients confirmed the benefits of Pro-Ject in terms of ease of use, ergonomics and design.
“Patient-centric development of drug-delivery devices is now the accepted norm. Applying human factors principles means that the outcomes should benefit all the stakeholders involved,”said Dr. Gerallt Williams, director of scientific affairs at Aptar Pharma Prescription Division, in a released statement. “Aligning Pro-Ject with patient needs during its development process is a major step forward in delivering this benefit.”
Results demonstrated that both training nurses and rheumatoid arthritis patients confirmed the benefits of Pro-Ject in terms of ease of use, ergonomics and design. It was clearly demonstrated that Pro-Ject met expectations and had the support of both prescribers and patients.
Some key benefits noted by Aptar Pharma for Pro-Ject included push-on-skin activation, slow injection, a hidden needle, a large and highly visible indicator window, and audible feedback, meaning the clicking sounds triggered at the beginning and end of the injection process.
PremiumCoat, released this February, is a stopper designed by Aptar Stelmi for the protection of sensitive and high-value drugs, including biopharmaceuticals. It was unveiled at Pharmapack Europe.
“The past three years we have spent developing the technology and then preparing for this new product launch have been very exciting,” said Ghislain Fournier, industrial and technical director of Aptar Stelmi, in a released statement when PremiumCoat was launched. “PremiumCoat is the first product in our range of innovative solutions for high-value injectable drugs.”
PremiumCoat is described as a range elastomeric stoppers, with the surface of the elastomer being coated during manufacturing with a thin fluoropolymer film. This coating acts as an effective barrier to many of the extractables and leachables that can be released from the elastomer and contaminate the drug, according to Aptar Stelmi.
Image courtesy of Aptar Pharma.