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The RS01 concept was brought into existence by Plastiape over the last decade as a result of the intensive refinement of previous monodose-in-capsule device designs, manufactured by the company since the late 1970s. Patented, manufactured, and marketed by Plastiape, the RS01 has many distinctive features, including a sleek, refined design and the simple fact that it is a product that actually works the way it should.
The device function 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 benefits 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 resulting in superior reliability.
Tens of millions of units have already been successfully delivered to the international market; marketed in combination with a wide range of milled or spray-dried powder drug products and 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.
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.
Since it was founded in 1970 Plastiape has rapidly established itself as a packaging producer for the pharmaceutical industry and today is a solid company exporting to some of the most demanding and competitive international markets.
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