Ex-vivo product performance of DiskusTMand TurbuhalerTMinhalers using inhalation profiles from patients with severe chronic obstructive pulmonary disease

Burnell, P.K.P.; Small, Therese; Doig, S.; Johal, Baljinder; Jenkins, Ralph H.; Gibson, G J

doi:10.1053/rmed.2001.1044

Cited by 43 publications

(28 citation statements)

References 19 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…It is known that the PIFR of each patient has effects on drug delivery with a DPI 5,6,11,13) and each pharmaceutical company has prepared their own DPI training device for confirming inspiratory flow rate. However, no previous study examined the relationship between PIFR of the training device and drug deposition in the lungs.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Investigation of Appropriate Inhalation Technique for Mometasone Furoate Dry Powder Inhaler

Yokoyama

Ito

Mihashi

et al. 2016

Biological & Pharmaceutical Bulletin

View full text Add to dashboard Cite

The aim of this study was to establish an appropriate inhalation method with a mometasone furoate dry powder inhaler (MF-DPI). Utilizing a tone-based inhalation training device, we investigated the maximum peak inspiratory flow rate time (T max PIFR) and peak inspiratory flow rate (PIFR) to determine whether either had an influence on lung deposition with use of an MF-DPI. A low tone indicated a PIFR of 28 L/min and a high tone that of 40 L/min, while 60 L/min was considered to be the standard. We established an inhalation profile in consideration of a human inhalation pattern, in which T max PIFR was set at 0.5 s (T max PIFR 0.5 s) and 2.5 s (T max PIFR 2.5 s). The reference cut-off value derived with a cascade impactor test was used for evaluation of the rate of delivered dose in the lung, which was the amount of drug from stage 3 to 7 at all PIFRs. We then investigated the relationship of the fine particle fraction (FPF) with the claimed dose at T max PIFR of 0.5 s and PIFR. There were no differences among the T max PIFR values for the doses emitted from the device or for the rate of delivered doses in stages 3-7. However, FPF for the claimed dose at 40 L/min was significantly lower than that at 60 L/min, which was dependent on PIFR. Our results showed that PIFR but not T max PIFR has an effect on lung deposition after inhalation with an MF-DPI.Key words mometasone furoate; dry powder inhaler; maximum peak inspiratory flow rate time; peak inspiratory flow rate; lung deposition A mometasone furoate dry powder inhaler (MF-DPI) is a device utilized for administration of inhaled corticosteroid, which is used for treatment of asthma. MF binds with high affinity to the corticosteroid receptor and has anti-inflammatory potency, [1][2][3] and is formulated for delivery via a breath-actuated DPI using a Twisthaler ® . Doses emitted from the device have been shown to be high, with flow rates ranging from 28.3 to 70 L/min. 4) That study also revealed that the dose emitted from the device has a relationship with flow rate, 4) though the relationship between dose and lung deposition amount is not clear. Furthermore, the mass median aerodynamic diameter (MMAD) of an MF-DPI is 2.0 µm, the smallest among available, thus it is characterized by the design of the particles used, which reach from the central to small airway. An inhalation training device (manufactured by Taisei Kako Co., Ltd.) that emits tones and is used in a manner similar to an MF-DPI has been produced to practice inhalation. This device produces a low tone at a peak inspiratory flow rate (PIFR) of 28 L/ min and a high tone at that of 40 L/min. However, the relationship between PIFR-produced tones and the dose delivered to the lung has not been examined.The rate of drug deposition in the lung has been examined in vitro in inhalation experiments. Those results revealed that PIFR actually sensed by patients was not reflected in those experimental results, as resistance to inhalation was not included in measured PIFR. In addition, individualized inhalation profi...

show abstract

Section: Discussionmentioning

confidence: 99%

“…5,6) Thus, data regarding the rate of drug deposition in the lung in consideration of that influence is required for clinical application, though has not been reported. We previously developed an inhalation simulator that can reproduce a rising inspiratory flow rate similar to a human inhalation pattern.…”

mentioning

confidence: 99%

Investigation of Appropriate Inhalation Technique for Mometasone Furoate Dry Powder Inhaler

Yokoyama

Ito

Mihashi

et al. 2016

Biological & Pharmaceutical Bulletin

View full text Add to dashboard Cite

show abstract

“…There is high dose to dose and device to device variation, and the device cannot be refilled [5,10]. The amount of drug released from the DPI devices is reduced under conditions of high humidity due to particle agglomeration [5].…”

Section: Microdose Inhalermentioning

confidence: 99%

Advancements in Dry Powder Inhaler

Ganga¹,

Shetty²

2017

Asian J Pharm Clin Res

View full text Add to dashboard Cite

The dry powder inhaler (DPI) has become widely known as a very attractive platform for drug delivery. DPIs are being used for the treatment of asthma and chronic obstructive pulmonary disease by many patients. There are over 20 devices presently in the DPI market. DPIs are preferred over nebulizers and pressurized metered dose inhalers. However, some of the challenges of DPI are dependence on inspiratory flow (unsuitable for young children, elderly people), systemic absorption due to deposition of drug in deep lung (unsuitable for local diseases treatment), and increase in upper airway deposition of a large fraction of coarse particles. Hence, there is a need to address these unmet issues. The interpatient variation can be minimized by developing devices independent of patient's inspiratory flow rate or active based powder mechanism. This article reviews DPI devices currently available, advantages of newly developed devices, and formulation technologies. The platform technologies are developed to improve aerosolization and dispersion from the device and decrease the patient related factors. The DPI delivery system has been expanded to treatment of non-respiratory diseases such as migraine and diabetes. The development of innovative DPI device and formulation technologies for delivering therapeutic proteins such as insulin has been accelerated to overcome the problems associated with conventional insulin therapy.

show abstract

“…For example, cascade impaction testing is widely used to evaluate APSD; however, it is a quality control test which is not intended to mimic the patient; its limitations include being operated under fixed flow conditions with deposition through impaction whereas a patient has a variable inhalation profile and deposition in the lungs can be through sedimentation, impaction and diffusion. The limitation of this specific test has been recognised, and various groups have adapted the methodology in an attempt to better mimic the patient by the use of a more realistic throat such as the Alberta Idealised Throat which can be used with patient realistic inhalation profiles (12)(13)(14).…”

Section: Device Changes During the Product Life Cyclementioning

confidence: 99%

Inhalation Devices and Patient Interface: Human Factors

Leiner

Parkins

Lastow

2015

AAPS J

View full text Add to dashboard Cite

The development of any inhalation product that does not consider the patient needs will fail. The needs of the patients must be identified and aligned with engineering options and physical laws to achieve a robust and intuitive-to-use inhaler. A close interaction between development disciplines and real-use evaluations in clinical studies or in human factor studies is suggested. The same holds true when a marketed product needs to be changed. Caution is warranted if an inhaler change leads to a change in the way the patient handles the device. Finally, the article points out potential problems if many inhaler designs are available. Do they confuse the patients? Can patients recall the correct handling of each inhaler they use? How large is the risk that different inhaler designs pose to the public health? The presentations were given at the Orlando Inhalation Conference: Approaches in International Regulation co-organised by the University of Florida and the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) in March 2014.

show abstract

Ex-vivo product performance of DiskusTMand TurbuhalerTMinhalers using inhalation profiles from patients with severe chronic obstructive pulmonary disease

Cited by 43 publications

References 19 publications

Investigation of Appropriate Inhalation Technique for Mometasone Furoate Dry Powder Inhaler

Investigation of Appropriate Inhalation Technique for Mometasone Furoate Dry Powder Inhaler

Advancements in Dry Powder Inhaler

Inhalation Devices and Patient Interface: Human Factors

Contact Info

Product

Resources

About