Respitab
This propellant dispersible tablet is a cost-effective and innovative manufacturing platform, which enables transition to the next generation pMDI’s for a range of API’s and combination products.
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 specifications
- 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
Key Features
Suspension pMDI Technology
Standard Jet-milled Micronised API
Tuneable To Match Existing Products
Excipients Improve Suspension Stability
No Ethanol Or Surfactants Required
Suitable For APIs With Different Physicochemical Properties
Highly Efficient Aerosol Properties And Dose Uniformity Characteristics
Micronised Particulate Excipient– E.G. Inhalation Grade Lactose
Excipient Is 10’s Of Microns, Readily Dispersible, But Not Inhaled
Excipient Is Pre-mixed With API(s) To Form An Ordered Blend
Could Respitab be utilised with your formulation?
Respitab Salbutamol pMDIs
Respitab Salmeterol/Fluticasone HFA 134a pMDI
Could Respitab be utilised with your formulation?
Key Advantages
Progressive
Works with HFA 134a, 227 and HFC 152a
Scalability
Independent (pressure vessel-free) process from pilot scale clinical trials to commercial batches
Simplicity
Avoids formulation-specific development of a process to fill pMDI cans with micronised drug blends, or engineered particles.
Safety
Separates drug filling from gassing, minimising operator exposure to hazards
Stability
No issues of drug/excipient interactions e.g. partial solubility in ethanol
Environment-friendly
Avoids API losses, suspension instability and propellant top-up during batch filling
Economic
A faster, more affordable streamlined development with less manufacturing
capital equipment and simpler cleaning procedures
Patent
The invention relates to a method for the manufacture of a pressurised Metered Dose Inhaler (pMDI) and components for use in said method, in particular, a pMDI compatible tablet (i.e. one that is able to be dispersed or disintegrates within a liquid phase, such as a propellant, used in a pMDI formulation) which contains at least one active pharmaceutical ingredient (API) and, optionally, one or more excipients.