The RS01 Monodose Dry Powder Inhaler patented, manufactured and marketed by Plastiape has several appealing distinctive features, the first and quite relevant one being that it does exist.
‘existence’ is actually a far-from-obvious attribute in the particular field of inhalation devices. The regular devotees of medical exhibitions and specialized magazines are familiar with well-conceived and highly sophisticated concepts. These nevertheless often remain at the stage of concepts for many years – to be then replaced by even more elaborated concepts of the ‘next generation’.
“ROBUST DESIGN RESULTING INTO ROBUST MANUFACTURING PROCESS”
The RS01 concept was brought into existence by Plastiape during the last decade, as a result of an intensive design refinement of the previous monodose-in-capsule devices manufactured by the company since the late 70ies.
The main improvement of RS01 in comparison with other pre-existing monodose devices is the very refined design of the piercing unit.
This required the study of new manufacturing techniques and a different assembly sequence in comparison with the older devices.
The decision to initially invest into pilot tooling and a first small scale assembly line proved crucial in achieving optimal component design and assembling once the product entered its large-scale industrialization stage.
The very robust design process fully achieved its target of identifying and preventing any possible causes of failure, mainly thanks to the inclusion of a fully automated control of all critical functions directly into the assembly lines.
Tens of millions of units have already been successfully delivered to the worldwide market.
All of them were assembled into the state-of-the-art ISO 7 Clean Rooms located at Plastiape’s main site in Osnago, Italy.
The robust design of the product and of the manufacturing process results into top reliability.
To the maximum satisfaction of Plastiape, the excellent performance and reliability of RS01 was acknowledged by top level customers to such an extent that the technical platform of RS01 was transferred into current market blockbusters.
The RS01 is already marketed in combination with a wide range of different drug products, based either on milled or on spray-dried powders, filled either into hard-gelatine or into HPMC capsules.
The device was intentionally designed as low resistance inhaler, but modified versions with higher resistance are also available, further expanding its scope of application.
The original shape was intentionally kept as plain and standard as possible, at the same time granting customization opportunities with relatively low investments.
The following picture shows just one of the many possible examples.
The design activities leading to RS01 were also aiming to reduce the overall size and weight and to reduce the number of components.
The device consists of ten components only. On top of other advantages in terms of patient compliance and safety and environmental carefulness, this also resulted into an affordable device price, coupled with the absence of any tooling investment charged to the customers.
Plastiape’s service to customers also includes technical and regulatory support.
A Type III Drug Master File was filed at the FDA and is regularly revised and updated to include new variants.
“THE MOST IMPORTANT STAKEHOLDERS”
There are plenty of pharmaceutical and biopharmaceutical research companies studying radical therapeutical innovations aiming to improve the patients’ quality of life and searching for treatments of diseases for which an efficient remedy is not yet available.
Many of these research companies could not afford the very high costs and the long leadtimes necessary to design and to industrialize a new DPI.
Moreover, their work is so hard and demanding on the purely chemical and pharmaceutical side of the development, that they could not have the resources to efficiently take care of the device optimization too.
Only thanks to the fact that a Dry Powder Inhaler does exist, does work well, is reliable and affordable many research laboratories were able and will be able to bring their innovation to the clinical studies.
Some patients might be treated in future thanks to some of the many innovative drug products developed in combination with the RS01 Monodose Dry Powder Inhaler. Plastiape regards these patients as its most important stakeholders.