Design and in vitro performance testing of multiple air classifier technology in a new disposable inhaler concept (Twincer®) for high powder doses

Boer, Anne H. de; Hagedoorn, Paul; Westerman, Elsbeth M; Brun, P.P.H. Le; Heijerman, H.G.M.; Frijlink, Henderik W.

doi:10.1016/j.ejps.2005.11.013

Cited by 75 publications

(40 citation statements)

References 26 publications

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“…The test inhaler is related to the Twincer™ has an air classifier dispersion system similar to the Novolizer®. [14,15] Performance testing results, specifications of the inhaler in combination with dry powder adenosine, and the first clinical pilot in five asthma patients have been described by Lexmond and colleagues. [8,16]…”

Section: Methodsmentioning

confidence: 99%

Targeting the small airways with dry powder adenosine: a challenging concept

Wiel

Lexmond

Berge

et al. 2017

European Clinical Respiratory Journal

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Background: Small-particle inhaled corticosteroids (ICS) provide a higher small airway deposition than large-particle ICS. However, we are still not able to identify asthma patients who will profit most from small-particle treatment. Objective: We aimed to identify these patients by selectively challenging the small and large airways. We hypothesized that the airways could be challenged selectively using small- and large-particle adenosine, both inhaled at a high and a low flow rate. Design: In this cross-over study 11 asthma subjects performed four dry powder adenosine tests, with either small (MMAD 2.7 µm) or large (MMAD 6.0 µm) particles, inhaled once with a low flow rate (30 l min–1) and once with a high flow rate (60 l min–1). Spirometry and impulse oscillometry were performed after every bronchoprovocation step. We assumed that FEV1 reflects the large airways, and FEF25–75%, R5-R20 and X5 reflect the small airways. Results: The four adenosine tests were not significantly different with respect to the threshold values of FEV1 (p = 0.12), FEF25–75% (p = 0.37), R5-R20 (p = 0.60) or X5 (p = 0.46). Both small- and large-particle adenosine induced a response in the small airways in the majority of the tests. Conclusions: In contrast to our hypothesis, all four adenosine tests provoked a response in the small airways and we could not identify different large- or small-airway responders. Interestingly, even the test with large particles and a high flow rate induced a small-airway response, suggesting that selective challenging of the small airways is not necessary. Future studies should investigate the relation between particle deposition and the site of an airway response.

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Section: Methodsmentioning

confidence: 99%

Targeting the small airways with dry powder adenosine: a challenging concept

Wiel

Lexmond

Berge

et al. 2017

European Clinical Respiratory Journal

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“…In the field of DPI development, the need for high-dose delivery devices becomes urgent, particularly for the delivery of antibiotics in cystic fibrosis (CF), TB, and other infectious lung diseases. Noticeable in this respect is that all known device developments are from academia, such as the Twincer ™ [157], the Cyclops [158], and the Orbital ® multibreath DPI [159,160]. Also, a new high-dose DPI based on fluidized bed design is developed in the academic setting [161].…”

Section: Miscellaneous Innovative Developmentsmentioning

confidence: 99%

Dry powder inhalation: past, present and future

Boer

Hagedoorn

Hoppentocht

et al. 2016

Expert Opinion on Drug Delivery

221

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Introduction: Early dry powder inhalers (DPIs) were designed for low drug doses in asthma and COPD therapy. Nearly all concepts contained carrier-based formulations and lacked efficient dispersion principles. Therefore, particle engineering and powder processing are increasingly applied to achieve acceptable lung deposition with these poorly designed inhalers. Areas covered: The consequences of the choices made for early DPI development with respect of efficacy, production costs and safety and the tremendous amount of energy put into understanding and controlling the dispersion performance of adhesive mixtures are discussed. Also newly developed particle manufacturing and powder formulation processes are presented as well as the challenges, objectives, and new tools available for future DPI design. Expert opinion: Improved inhaler design is desired to make DPIs for future applications cost-effective and safe. With an increasing interest in high dose drug delivery, vaccination and systemic delivery via the lungs, innovative formulation technologies alone may not be sufficient. Safety is served by increasing patient adherence to the therapy, minimizing the use of unnecessary excipients and designing simple and self-intuitive inhalers, which give good feedback to the patient about the inhalation maneuver. For some applications, like vaccination and delivery of hygroscopic formulations, disposable inhalers may be preferred. ARTICLE HISTORY

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“…Particle size distributions of aerosolized colistin sulfomethate were found to be similar in a dose range from 0 to 25 mg using different models of the Twincer, optimized for the specific drug load. Multistage impactor experiments at flow rates of 30 and 60 L/min determined FPFs of approximately 40% and 52-60% (depending on the model), respectively (85). Another study using a four-stage liquid impinger reported the FPF of spray-or spray-freeze dried monovalent influenza vaccine/inulin particles to be 37 and 23%, respectively (88).…”

Section: Twincer®mentioning

confidence: 99%

“…The breath-actuated Twincer device is designed to efficiently deliver high doses of non-particle-engineered dry powders, producing a high fine particle fraction at a low airflow resistance (85). It consists of three plate-like plastic parts forming airflow passages and either a blister chamber or a drug compartment.…”

Section: Twincer®mentioning

confidence: 99%

Devices for Dry Powder Drug Delivery to the Lung

2015

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Abstract. Dry powder inhalers (DPIs) are an important and increasingly investigated method of modern therapy for a growing number of respiratory diseases. DPIs are a promising option for certain patient populations, and may help to overcome several limitations that are associated with other types of inhalation delivery systems (e.g., accuracy and reproducibility of the dose delivered, compliance and adherence issues, or environmental aspects). Today, more than 20 different dry powder inhalers are on the market to deliver active pharmaceutical ingredients (APIs) for local and/or systemic therapy. Depending on the mechanism of deagglomeration, aerosolization, dose metering accuracy, and the interpatient variability, dry powder inhalers demonstrate varying performance levels. During development, manufacturers focus on improving aspects characteristic of their specific DPI devices, depending on the intended type of application and any particular requirements associated with it. With the wide variety of applications related to specific APIs, there exists a range of different devices with distinct features. In addition to the routinely used multi-use DPIs, several single-use disposable devices are under development or already approved. The recent introduction of disposable devices will expand the range of possible applications for use by including agents such as vaccines, analgesics, or even rescue medications. This review article discusses the performance and advantages of recently approved dry powder inhalers as well as disposable single-use inhalers that are currently under development.

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Design and in vitro performance testing of multiple air classifier technology in a new disposable inhaler concept (Twincer®) for high powder doses

Cited by 75 publications

References 26 publications

Targeting the small airways with dry powder adenosine: a challenging concept

Targeting the small airways with dry powder adenosine: a challenging concept

Dry powder inhalation: past, present and future

Devices for Dry Powder Drug Delivery to the Lung

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