With more than 45 years of experience, Plastiape offers a complete range of solutions for the delivery of inhalation drug products in the form of unit-dose dry powder inhalers, multidose dry powder inhalers and metered dose inhalers.
Until a few years ago, it seemed as though the days of the single-dose dry powder inhaler (DPI) were numbered. In a desire to find increasingly innovative solutions, many pharmaceutical companies placed their bets on multidose inhalers, the more advanced engineering of which promised a better user experience.
In reality, many of these inhalers proved to be too complex and, in certain cases, unreliable, insufficiently user-friendly or too bulky. The well-known failures of various highly sophisticated devices, which were expected to invade the market like blockbusters, brought about a return to favour of the single-dose inhaler.
Plastiape's strong focus on new product development led to the creation of the RS01 DPI, which was the result of an intensive redesign of a pre-existing model that has been manufactured by the company since the late 1970s.
Compared with multidose and other single-dose inhalers on the market, the RS01 is notable for its compact size, reduced number of parts, and the simplicity and effectiveness of its perforation system. The complete lack of propellants make the RS01 particularly environmental friendly and, therefore, suitable for pharmaceutical companies that, like Plastiape, put respect for the environment at the top of their development strategy.
The robust design of the RS01 and its manufacturing process results in top performance and reliability, which has been acknowledged by Plastiape's high-level customers to such an extent that the technical platform of the RS01 has become part of many current market blockbusters.
The RS01 is already marketed in combination with a wide range of different drug products, based on either milled or spray-dried powders filled into gelatin or HPMC capsules. It was initially designed as a low-resistance inhaler, but modified versions with higher resistance are also available, further expanding the product's scope of application. The shape was intentionally kept as plain and simple as possible in order to enable customisation opportunities with relatively low investment.
This makes the RS01 an ideal platform: on the one hand, it may be considered a simple and cheap solution for generic medicines - even those produced in small volumes - while on the other, it offers a reliable, ready-to-use solution for highly innovative formulations, where it is necessary to limit the number of variables at stake, reducing the risks and costs of developing a device, and thereby leaving researchers free to concentrate their efforts and investments on the formulations themselves.
Plastiape supplies to customers in more than 40 countries around the world. Keystones of its pharmaceutical production are ISO 7 and ISO 8 clean rooms, where moulding machines and assembly lines manufacture standard and customised medical devices for respiratory applications, ophthalmic packaging, drug containers, bottles and tubes with related closures and accessories, as well as single items such as droppers, measuring cups and tamper-evident/child-proof closures.
With its strong expertise in moulding plastic compounds, Plastiape is able to manufacture products in a wide range of polymers including ABS, COP, PE, PP, PET and POM. Technical professionals and regulatory experts work side by side in the R&D department to ensure development efficiency and the capability to satisfy the most demanding customer expectations on formalised design control.
Plastiape's success is based on key factors, such as its proactive response to customers' ideas and needs, top-quality products, process excellence, attention to customer service and strong expertise in compliance-related matters, including the preparation and filing of the FDA drug master file (DMF) as well as the CE marking of medical devices.