Aptar Pharma and i2c Pharmaceutical Services join hand for Respitab
Synopsis- Aptar Pharma and i2c Pharmaceutical Services joins hand for co-develop and promote i2c’s pressurized metered dose inhaler (pMDI) technology, Respitab.
Aptar Pharma, a global provider of drug delivery systems, services and active material science solutions, and i2c Pharmaceutical Services, a service provider for the development of pharmaceutical formulations entered an exclusive partnership to co-develop and promote i2c’s pressurized metered dose inhaler (pMDI) technology, Respitab.
As part of the agreement, Aptar Pharma, a market leader in pulmonary drug delivery device solutions for COPD, will evaluate the commercial applications for Respitab, in particular for new, lower global warming potential (GWP) propellants.
Respitab
Respitab is a propellant dispersible tablet that eliminates the need for a complex mixing process used in standard pMDI manufacturing. A patented, innovative platform which enables the transition to the next generation of pMDIs for a range of active pharmaceutical ingredients (APIs) and combination products, Respitab is also a cost-effective approach for new chemical entity (NCE) and generic pMDI products, simplifying the manufacturing process for HFC 152a and other propellants
Tablet Advantages
- Flexible manufacturing with standard equipment
- No requirement for homogenization / mixing vessels
- No pressure vessel = no propellant top-up during filling
- Bulk tablets complying with release specification
- Flexibility of batch sizes
- Ease of scalability
- Manufacture sequence transferable to other sites
- Simplified manufacture cleaning processes
- Reduced waste & API losses
- Economical pathway to full commercialisation
The Process
Step 1
Compression of API & excipients into Respitab using a standard tablet press.
Step 2
Respitab added to canister (at the primary manufacture site or secondary site)
Step 3
Propellant filled through the valve in dedicated or separate gassing room
Step 4
Disintegration of Respitab on addition of propellant or during quarantine period
Step 5
Full dispersion of the API completed at the end of a standard quarantine period
Step 6
Actuator fitting, spray test and packaging
Howard Burnett, Vice President Global Pulmonary Category, Aptar Pharma commented, “We are pleased to partner with i2c on this novel technology which brings many benefits to the filling of metered dose inhalers. This development further enhances Aptar Pharma’s industry-leading portfolio of devices, which, combined with our broad spectrum of Aptar Pharma Services, allows us to offer end-to-end support to our clients and partners.”
We are excited by this partnership with Aptar Pharma which brings together substantial synergies to provide a lower GWP product range to patients in the pMDI format, the most popular inhaler type across the globe,” added Glyn Taylor, CSO of i2c Pharmaceutical Services.
About Aptar Pharma
Aptar Pharma is part of AptarGroup, Inc., a global leader in the design and manufacturing of a broad range of drug delivery, consumer product dispensing and active material science solutions. Aptar’s innovative solutions and services serve a variety of end markets including pharmaceutical, beauty, personal care, home, food and beverage. Using insights, proprietary design, engineering and science to create dispensing, dosing and protective technologies for many of the world’s leading brands, Aptar in turn makes a meaningful difference in the lives, looks, health and homes of millions of patients and consumers around the world. Aptar is headquartered in Crystal Lake, Illinois and has 13,000 dedicated employees in 20 countries.
About i2c
i2c Pharmaceutical Services, as a part of Cardiff Scintigraphics Limited, is a leading independent service provider to the global pharma, medical technology companies and emerging clients for the development of pharmaceutical formulations and inhaler devices from its facilities in Cardiff, Wales. Established almost 30 years ago, i2c have built a wealth of experience and knowledge in the area of respiratory pharmaceutical formulation, device development and research. i2c have fulfilled studies for more than 50 different pharma companies.