Founded in 1970, Plastiape rapidly established itself as a packaging producer for the pharmaceutical industry. Plastiape today is a solid company exporting to some of the most demanding and competitive international markets. Its wide range of products and services and its notable technological differentiation, together with its identification of well-defined specialist areas, constitute the premises for further growth
The RS01 Monodose Dry Powder Inhaler (patented, manufactured, and marketed by Plastiape) has several appealing and distinctive features, the first and quite relevant one being that it does, in fact, exist.
The second positive feature of the RS01 device is that it actually works. This shouldn't be taken for granted, either. The area of dry powder inhalation has often seen unfortunate experiences where devices reaching advanced clinical trials or even market stages were withdrawn shortly after the launch for various reasons.
How the RS01 device functions is quite intuitive to the patient, as its working principles are similar to those of pre-existing devices:
Inhalation by the patient lifts the capsule from its housing and makes it spin at high speed around its main axis, thus assisting in powder disaggregation. The powder evacuates the capsule through the two holes created by the piercing system and is inhaled by the patient through the mouthpiece. At the bottom of the mouthpiece, a grid prevents the capsule from reaching the mouthpiece duct.
The device ensures excellent performance in terms of total emitted dose (TED) and fine particle fraction (FPF). Superlative dose consistency, which is common to most monodose systems using capsules is further enhanced by the improved piercing system which is particular to the RS01.
The RS01 concept was brought into existence by Plastiape over the last decade, as a result of an intensive design refinement of previous monodose capsule devices manufactured by the company since the late 70s. The primary improvement of RS01 (compared with other, pre-existing monodose devices) is the advanced and refined design of the piercing unit. This improvement required the study of new manufacturing techniques and a different assembly sequence. The initial decision to invest in pilot tooling and a first small scale assembly line proved crucial in achieving optimal component design and assembly, once the product entered its large-scale industrialization stage. The robust design process fully achieved its target of identifying and preventing any possible causes of failure, mainly due to the inclusion of fully automated control of all critical functions directly into the assembly line.
Tens of millions of units have already been successfully delivered to the international market, all of them assembled at the company's state-of-the-art ISO 7 Clean Room, located at Plastiape’s headquarters in Osnago, Italy.
The robust design of the product and of the manufacturing process results into superior reliability.
The excellent performance and reliability of the RS01 was acknowledged by top level customers to such an extent that the technical platform of the RS01 was transferred into current market blockbusters.
The RS01 is already marketed in combination with a wide range of milled or spray-dried powder drug products, filled either into hard gelatin or HPMC capsules. The device was intentionally designed as a low resistance inhaler, but modified versions with higher resistances are also available, further expanding the device's scope of application. The original shape was intentionally kept as unassuming as possible, though customization opportunities with relatively low investment are available.
There are plenty of pharmaceutical and bio-pharmaceutical research companies studying radical therapeutic innovations to improve patients' quality of life and searching to treat 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 lead times necessary to design and to commercialize a new dry powder inhaler (DPI). Moreover, the work of these researchers is often so demanding with regard to chemical and pharmaceutical development that they often do not have the resources to take care of device optimization efficiently. Thanks to the fact that a DPI exists, works well, and is reliable and affordable, many research laboratories are now able and will continue to be able to bring their innovations to clinical studies.
The design activities leading to the RS01 also aimed to reduce overall size and weight and to reduce the number of components. The device consists of only ten components. On top of other advantages in terms of patient compliance and safety and environmental carefulness, this simplification also results in an affordable device price, coupled with the absence of any tooling investment charged to the customer. Plastiape’s service to customers also includes technical and regulatory support. A Type III Drug Master File was filed with the FDA and is regularly revised and updated to include new variants.
Visit the Plastiape website for more details on their new monodose dry powder inhaler!