Understanding Dry Powder Inhalers: Key Technical and Patient Preference Attributes

Levy, Mark L; Carroll, Will; Alonso, José Luís Izquierdo; Keller, Claus; Lavorini, Federico; Lehtimäki, Lauri

doi:10.1007/s12325-019-01066-6

Cited by 69 publications

(59 citation statements)

References 58 publications

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“…The mean PIF rates observed also reflect the relative inhaler airflow resistances: the highest mean PIF was achieved via the inhaler with the lowest resistance (the center slot 1198 Easyhaler [0.036 √kPa min/L]). 19 The consistency observed between our findings and those from elsewhere adds additional strength to the findings of this study. When using the Easyhaler, no patient with COPD or healthy volunteer failed to achieve the 30L/min PIF rate considered to be the minimum required to achieve delivery and deposition of aerosolized drug deep into the lungs.…”

Section: Discussionsupporting

confidence: 86%

Inspiratory Flow Parameters Through Dry Powder Inhalers in Healthy Volunteers and Patients with Chronic Obstructive Pulmonary Disease (COPD): Device Resistance Does Not Limit Use in COPD

Jõgi¹,

Mattila²,

Vahteristo³

et al. 2021

COPD

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Introduction Achieving correct inhalation technique through an inhaler to ensure effective drug delivery is key to managing symptoms in patients with chronic obstructive pulmonary disease (COPD). However, many patients struggle to use their inhalers correctly, with the resultant reduction in therapeutic benefit. Consequently, appropriate inhaler choice is important to maximize clinical benefit. The primary objective of this study was to characterize inspiratory flow parameters across two Easyhaler ® inhalers and the HandiHaler ® inhaler in patients with COPD and healthy volunteers. Methods In this randomized, open-label, crossover study, subjects (100 patients with COPD; 100 healthy volunteers) were trained to perform inhalations of placebo powder via two variants of Easyhaler and placebo capsules via the HandiHaler inhalers. Subjects then performed three placebo inhalations through each inhaler in a random sequence. Inspiratory flow parameters were assessed, including peak inspiratory flow (PIF), for each inhaler. A parallel sub-study was conducted in patients with COPD from the main study to assess correct use of the inhalers, patient’s preference, ability to learn to use the inhalers, and the feasibility of the In-Check Dial device to measure PIF values. Results Mean PIF rates and inspiratory volumes through the three inhalers were similar between patients with COPD and healthy volunteers, and all subjects achieved the 30 L/min PIF required for effective use of Easyhaler. Almost 70% of the 88 patients enrolled in the sub-study used the Easyhaler and HandiHaler inhalers without errors. The Easyhaler was preferred by 51% of patients, while 25% favored the HandiHaler. Teaching the use of both inhalers to almost 70% of patients was very easy. The In-Check Dial PIF values and those obtained via spirometry were strongly correlated (p<0.0001) for all three inhalers. Conclusion The respiratory performance of patients with COPD does not appear to be a limiting factor in the use of Easyhaler.

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Section: Discussionsupporting

confidence: 86%

Inspiratory Flow Parameters Through Dry Powder Inhalers in Healthy Volunteers and Patients with Chronic Obstructive Pulmonary Disease (COPD): Device Resistance Does Not Limit Use in COPD

Jõgi¹,

Mattila²,

Vahteristo³

et al. 2021

COPD

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“…Again, this might be attributed to the improved flowability and further reduced particle aggregation. 48 , 49 PDI values remained below 0.5 while ZP values of 31.90 ± 1.697 and 31.20 ± 3.11 mV for the improved SD/P4 and SD/P6, respectively, ensured physical stability of the proliposomes similar to their old counterparts. % EE values were comparable with old formulations.…”

Section: Preparation and Characterization Of The Improved Spray-driedmentioning

confidence: 91%

“… 47 By referring to Table 1 , it is evident that formulations SD/P1, SD/P3, SD/P9, SD/P11, SD/P17 and SD/P19 prepared using lower amounts of the carrier (0.5 g) produced significantly (P < 0.05) larger PS values > 600 nm compared to their counterparts prepared using larger amounts of the carrier (1 g). This might be attributed to the increased particle aggregation and hence poor powder flowability with lower carrier amounts, 48 , 49 highlighting the importance of the added carrier.…”

Section: Particle Size (Ps) Polydispersity Index (Pdi) and Zeta Potementioning

confidence: 99%

“…Again, this might be attributed to the improved flowability and further reduced particle aggregation. 48,49 Figure 2 Curcumin release profiles from spray-dried proliposomes formulations (SD/P) in ethanolic phosphate buffer solution (30% v/v; pH 7.4). The release profile of all the investigated formulations showed a distinctive biphasic release profile, where nearly more than 17.00% and less than 24.98% curcumin were released during the first 2 h followed by a sustained release pattern during the 48h testing period.…”

Section: Preparation and Characterization Of The Improved Spray-driedmentioning

confidence: 99%

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Design and Characterization of Spray-Dried Proliposomes for the Pulmonary Delivery of Curcumin

Adel

ElMeligy

Abdelrahim

et al. 2021

IJN

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Purpose The goal was to directly deliver curcumin, a natural polyphenolic anticancer and anti-inflammatory compound, to the lung tissues with minimal systemic exposure through the fabrication of proliposomes, overcoming its poor aqueous solubility and oral bioavailability. Methods Nano-spray drying was employed to prepare proliposomes using hydroxypropyl beta-cyclodextrin as a carrier. Lecithin and cholesterol were used as lipids, stearylamine and Poloxamer 188 were added as positive charge inducer and a surfactant, respectively. Different characterization parameters were evaluated like percentage yield, entrapment efficiency, drug loading, aerodynamic particle size, in vitro release besides morphological examination. Cytotoxicity studies on cell line A549 lung tumor cells as well as in vivo lung pharmacokinetic studies were also carried. Results The optimized formulations showed superior aerosolization properties coupled their enhanced ability to reach deep lung tissues with a high % of fine particle fraction. Cytotoxicity studies using MTT assay demonstrated enhanced growth inhibitory effect on lung tumor cells A549 and significant reduction of proinflammatory cytokines such as tumor necrosis factor-α, interleukin-6 and interleukin-10 compared to the pure drug. Results of lung pharmacokinetic tests confirmed the superiority of proliposomal curcumin over curcumin powder in both, the rate and extent of lung tissue absorption, as well as the mean residence time within the lung tissues. Conclusion The pulmonary delivery of curcumin-loaded proliposomes as dry powder provides a direct approach to lung tissues targeting while avoiding the limitations of the oral route and offering a non-invasive alternative to the parenteral one.

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“…Various devices can be used to administer OIDs to patients, including dry-powder inhalers (DPIs), pressurized metered-dose inhalers (pMDIs) and nebulizers. These devices have been extensively discussed in several recent works [18][19][20][21][22][23][24][25]. Briefly, DPIs deliver powder particles carrying the drug; pMDIs and nebulizers generate liquid droplets containing the drug.…”

Section: Inhalation Therapymentioning

confidence: 99%

Preclinical Development of Orally Inhaled Drugs (OIDs)—Are Animal Models Predictive or Shall We Move Towards In Vitro Non-Animal Models?

Movia

Prina-Mello

2020

Animals

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Respiratory diseases constitute a huge burden in our society, and the global respiratory drug market currently grows at an annual rate between 4% and 6%. Inhalation is the preferred administration method for treating respiratory diseases, as it: (i) delivers the drug directly at the site of action, resulting in a rapid onset; (ii) is painless, thus improving patients’ compliance; and (iii) avoids first-pass metabolism reducing systemic side effects. Inhalation occurs through the mouth, with the drug generally exerting its therapeutic action in the lungs. In the most recent years, orally inhaled drugs (OIDs) have found application also in the treatment of systemic diseases. OIDs development, however, currently suffers of an overall attrition rate of around 70%, meaning that seven out of 10 new drug candidates fail to reach the clinic. Our commentary focuses on the reasons behind the poor OIDs translation into clinical products for the treatment of respiratory and systemic diseases, with particular emphasis on the parameters affecting the predictive value of animal preclinical tests. We then review the current advances in overcoming the limitation of animal animal-based studies through the development and adoption of in vitro, cell-based new approach methodologies (NAMs).

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Understanding Dry Powder Inhalers: Key Technical and Patient Preference Attributes

Cited by 69 publications

References 58 publications

Inspiratory Flow Parameters Through Dry Powder Inhalers in Healthy Volunteers and Patients with Chronic Obstructive Pulmonary Disease (COPD): Device Resistance Does Not Limit Use in COPD

Inspiratory Flow Parameters Through Dry Powder Inhalers in Healthy Volunteers and Patients with Chronic Obstructive Pulmonary Disease (COPD): Device Resistance Does Not Limit Use in COPD

Design and Characterization of Spray-Dried Proliposomes for the Pulmonary Delivery of Curcumin

Preclinical Development of Orally Inhaled Drugs (OIDs)—Are Animal Models Predictive or Shall We Move Towards In Vitro Non-Animal Models?

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