Tyvaso DPI: Drug-device characteristics and patient clinical considerations.

Tyvaso DPI is a drug-device combination therapy comprised of a small, portable, reusable, breath-powered, dry powder inhaler (DPI) for the delivery of treprostinil. It is approved for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Tyvaso DPI utilizes single-use prefilled cartridges to ensure proper dosing. Unlike nebulizer devices, administration of Tyvaso DPI is passive and does not require coordination with the device. The low-flow rate design results in targeted delivery to the peripheral lungs due to minimal drug loss from impaction in the oropharynx. The inert fumaryl diketopiperazine (FDKP) excipient forms microparticles that carry treprostinil into the airways, with a high fraction of the particles in the respirable range. In a clinical study in patients with pulmonary arterial hypertension, Tyvaso DPI had similar exposure and pharmacokinetics, low incidence of adverse events, and high patient satisfaction compared with nebulized treprostinil solution. Tyvaso DPI may be considered as a first prostacyclin agent or for those that do not tolerate other prostacyclin formulations, patients with pulmonary comorbidities, patients with mixed Group 1 and Group 3 pulmonary hypertension, or those that prefer an active lifestyle and need a portable, non-invasive treatment. Tyvaso DPI is a patient-preferred, maintenance-free, safe delivery option that may improve patient compliance and adherence.

Device factors affecting pulmonary delivery of dry powders.

The use of orally inhaled dry powder technologies is one way of delivering medicines to the lung for treating local conditions or for achieving systemic effect. These involve dry powder formulations containing an active pharmaceutical ingredient together with inhaler devices. These powder/device systems enable patients to inhale and aerosolize the medicine into suitably sized particles that deposit in the lung. Several inhaler centric aspects of these delivery systems are presented and discussed in context of new product development. Case examples are provided to highlight several inhaler aspects and to guide development of powder/inhaler systems.

Annual Inhaled Drug Delivery Conference.

The Annual Inhaled Drug Delivery Conference organized by Management Forum was held in London, UK, 9-10 November 2010. The meeting focused on a range of disease therapies from the pulmonary indications routinely treated with inhaled medicines (asthma, cystic firbrosis and chronic obstructive pulmonary disease) to novel applications of the inhalation route to treat systemic diseases (irritable bowel disease, schizophrenia, migraine, diabetes and obesity).

Inspiratory efforts achieved in use of the Technosphere insulin inhalation system.

OBJECTIVE: The Technosphere Insulin (TI) inhalation system comprises TI powder premetered into unit dose cartridges and the patient-friendly, reusable, breath-powered MedTone inhaler. This high-resistance system uses a patient's inspiratory effort to effect TI powder de-agglomeration and promote subsequent deep-lung delivery. This study reports on flow and pressure data achieved by patients with diabetes using the MedTone system. METHOD: MedTone inhalers containing empty cartridges were adapted with pneumotach measuring devices to capture inhalation profiles. The measuring apparatuses had negligible impact on the nominal MedTone system resistance level of 0.117 kPa(0.5)/liters/min. Each of 56 subjects inhaled twice to mimic TI clinical study dosing instructions. Achieved inhalation profiles were characterized by peak inspiratory flow (PIF), peak inspiratory pressure (PIP), and average pressure drop from the time of PIP to 4 s (P(avg)). RESULTS: The achieved mean PIF (+/- standard deviation [SD]) in all subjects was 26.74 (+/-6.06) liters/min after the first inhalation and was similar to the mean PIF of 26.25 (+/-6.23) liters/min achieved after the second inhalation. Mean PIP (+/-SD) achieved by subjects was 8.49 (+/-2.86) and 8.1 (+/-2.99) kPa, and mean P(avg) drop (+/-SD) in all subjects was 6.53 (+/-2.24) and 6.09 (+/-2.08) kPa after the respective inhalations. CONCLUSION: Patients with diabetes demonstrated consistent inhalation efforts over two inhalations using the MedTone system. The achieved PIFs and PIPs demonstrate the capacity of this population to obtain sufficient inspiratory effort necessary for delivery of TI using the MedTone inhaler. Adequate postpeak pressures were also revealed, further supporting reliable and sustained inhalation efforts.