In vitro aerosol characterization of Staccato® Loxapine

Dinh, K; Myers, Dan J.; Glazer, Marc; Shmidt, Tamara; Devereaux, Caitlin; Simis, Kathleen; Noymer, Peter D.; He, Min; Choosakul, Corinna; Chen, Qiang; Cassella, James V.

doi:10.1016/j.ijpharm.2010.10.030

Cited by 39 publications

(29 citation statements)

References 16 publications

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“…The basic concept of this system is rapid and efficient vaporization of a thin film of pure drug coated on a metallic substrate inside a passageway for the inhaled air [162]. Heating to 400°C for evaporation of the drug in approx.…”

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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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

View full text Add to dashboard Cite

show abstract

“…The field has expanded to include not only local therapy for obstructive pulmonary diseases, but also systemic delivery of compounds requiring parenteral application or regimens that might require a fast onset for the desired therapeutic effect. The availability of (93) reliable, cheap, and convenient single-use dry powder inhalation devices could be influential in the development of future vaccination strategies and is likely to become increasingly important in the therapy of respiratory infections.…”

Section: Resultsmentioning

confidence: 99%

“…As mentioned earlier, it was approved by FDA and EMA for the delivery of loxapine marketed as Adasuve® (Teva North America, North Wales, PA, USA). It establishes aerosolization of respirable solid-state particles not by deagglomerating a preformulated dry powder but by resublimation of vaporized drug in situ (93). It consists of a heat package and a breath sensor in a polypropylene housing (see Fig.…”

Section: Staccatomentioning

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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“…39 The Staccato device (Alexza Pharmaceuticals, Mountain View, California) uses thermal aerosol technology that allows flow-independent aerosolization of a drug by rapidly heating the drug that coats a heating substrate. 40 The aerosol cools off and is inhaled at ambient temperature, with a peak temperature of 30 -40°C. This singledose device produces particles in a range of 1-3 m and rapidly achieves high peak plasma levels and systemic effects.…”

Section: Dpimentioning

confidence: 99%

Assessing New Technologies in Aerosol Medicine: Strengths and Limitations

Berlinski

2015

Respir Care

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Aerosols are the mainstay of treatment for pulmonary diseases such as asthma, cystic fibrosis, and COPD. In addition, aerosols are also being used for systemic drug delivery. Patients need devices that are safe, reliable, portable, and easy to use; have few steps in their operation; help them keep track of the remaining doses; are not expensive; and provide age-appropriate positive reinforcement and feedback. Computational fluid dynamics, human factor sciences, and quality by design are now applied to device development. Matching patient, drug, and device remains a challenge. Formulary restrictions, the current status of the industry-academia relationship, and the need to use multiple platforms hinder the process. Patients and families need to participate in the selection of a device that is appropriate for them. Practitioners need comparative data to help them choose the right device. New devices and drugs can be compared with the existing technology using in vitro and in vivo methods (lung imaging, pharmacokinetic and pharmacodynamics studies). Drug manufacturers need to be able to justify coverage of new products by third-party payers by showing a positive cost/benefit relationship. Finally, post-market surveillance is necessary for old drugs with new devices or for new drugs and devices to ensure patient safety.

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In vitro aerosol characterization of Staccato® Loxapine

Cited by 39 publications

References 16 publications

Dry powder inhalation: past, present and future

Dry powder inhalation: past, present and future

Devices for Dry Powder Drug Delivery to the Lung

Assessing New Technologies in Aerosol Medicine: Strengths and Limitations

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