In vitro evaluation of dry powder inhalers I: drug deposition of commonly used devices

Steckel, Hartwig; Müller, Bernd W.

doi:10.1016/s0378-5173(97)00113-0

Cited by 89 publications

(56 citation statements)

References 16 publications

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“…In a previous comparison between flow rates of 60 and 90 l/min with a Diskhaler, it was reported that the amount of drug deposited in stage 2 of a twin impinger device was unaffected by peak inspiratory flow rate. 4) That is, if the peak inspiratory flow rate was 60 l/min or more, the influence of flow rate was scant, which was confirmed in the present study. On the other hand, the estimated values ranged from 2.9 to 10.1 mg at flow rates between 20 and 60 l/min, which increased as the flow rate was increased.…”

Section: Discussionsupporting

confidence: 84%

“…There have been several reports on the relationship between peak inspiratory flow rate and drug deposited by various systems, 3,4) with a Diskhaler shown to deliver approximately 12% of the initial dose. 11,12) The present results support and confirm those previous studies, as the estimated amount of drug deposited in stage 2 was 10.1 mg at a flow rate of 60 l/min, adequate for obtaining a good effect from a Diskhaler and similar to the 12% reported previously.…”

Section: Discussionmentioning

confidence: 99%

“…Although several in vitro studies have shown the delivery of drugs into the lungs at unvaried or slightly varied high flow rates, there is no known examination of the detailed relationship of these factors. [2][3][4][5][6] In the present study, we investigated the relationship between inspiratory flow rate and amount of drug delivered into the lungs by quantification of FP after inhalation with an FP-DH equipped with a twin impinger at various inspiratory flow rates. …”

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confidence: 99%

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Analysis of Relationship between Peak Inspiratory Flow Rate and Amount of Drug Delivered to Lungs Following Inhalation of Fluticasone Propionate with a Diskhaler

Yokoyama

Yamamura

Ozeki

et al. 2007

Biological & Pharmaceutical Bulletin

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A fluticasone propionate dry powder inhaler with a Diskhaler (FP-DH), developed for inhalation of corticosteroids, is widely used for the treatment of asthma. A dry powder inhaler (DPI) is a breath controlled drug delivery system, in which a turbulent airstream is created by exploiting the patient's own inspiratory flow rate and is required to aerosolize particles for inhalation at a satisfactory peak inspiratory flow rate, which can achieve sufficient diffusion of the drug into the lungs. Therefore, it is considered that the inspiratory flow rate of the patient has a significant influence on the effects of drugs administered by an FP-DH.It was reported that 28 of 233 patients who inhaled corticosteroids for asthma could not achieve the optimal flow rate of 60 l/min, of whom 5 were treated for exacerbation of symptoms.1) Thus, it is very important to clarify the relationship between inspiratory flow rate and amount of drug delivered into the lungs when using a DPI. Although several in vitro studies have shown the delivery of drugs into the lungs at unvaried or slightly varied high flow rates, there is no known examination of the detailed relationship of these factors. [2][3][4][5][6] In the present study, we investigated the relationship between inspiratory flow rate and amount of drug delivered into the lungs by quantification of FP after inhalation with an FP-DH equipped with a twin impinger at various inspiratory flow rates. MATERIALS AND METHODS Materials A Flutide® 100 Rotadisk ® (GlaxoSmithKline K.K., Lot No. 355) was used as the FP-DH in the present study. A blister contains a mixture of 100 mg of microfine FP blended with lactose to a total weight of 25 mg. Geometric particle size of FP was Ϲ5 mm ( 90%м of particles), 7) aerodynamic particle size of FP was 3.3 mm, 8) and geometric particle size of lactose was 60-90 mm.7) To investigate the amount of drug inhaled, we used an inhalation simulator ( Fig. 1), which consisted of a flow recorder placed in a plastic air-tight box that covered the FP-DH equipped with a twin impinger and a vacuum pump. The FP-DH was kept at angle of 90°to the inlet of the impinger. The flow rate was recorded using a Vitalograph ® 2120 Handheld Storage spirometer (Vitalograph Ltd.), and data was transferred to a computer and analyzed using Vitalograph ® Spirotrac ® IV software. The relative amounts of the drug distributed inside a plastic box (a), and the device (b), throat (c), stage 1 (upper impinger) (d), and stage 2 (lower impinger) (e) were determined by measuring the amounts of drugs in those areas. The experiments were performed at 20°C with 30% relative humidity. The flow rates ranged from 18.7 to 77.3 l/min for 2 s. A Diskhaler is a dry powder type of inhaler that utilizes a breath controlled drug delivery system. The inspiratory flow rate of the patient would have a significant influence on the effects of drugs administered by a Diskhaler. Thus, we investigated the relationship between inspiratory flow rate and amount of drug delivered into the lungs when using a flutica...

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Section: Discussionsupporting

confidence: 84%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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Analysis of Relationship between Peak Inspiratory Flow Rate and Amount of Drug Delivered to Lungs Following Inhalation of Fluticasone Propionate with a Diskhaler

Yokoyama

Yamamura

Ozeki

et al. 2007

Biological & Pharmaceutical Bulletin

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“…This correlates well with the findings of Steckel and Müller (1997) who reported a fine particle fraction of 10.13±2.51% for the Intal ® Spinhaler ® , determined using the twin impinger at a flow rate of 60 l/min. Considering the high % deposition (50%) of micronised sodium cromoglicate in stage 1 of the twin impinger, in comparison to stage 2, this being the respirable fraction (less than 6.4 µm), a low fine particle fraction was measured.…”

Section: Twin Impinger Studiessupporting

confidence: 91%

Particle engineering of materials for oral inhalation by dry powder inhalers. II—Sodium cromoglicate

Nolan

Tajber

et al. 2011

International Journal of Pharmaceutics

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Sodium cromoglicate is an antiasthmatic and antiallergenic drug used in inhalation therapy and commonly administered by a dry powder inhaler.In the present study we sought to examine the feasibility of producing nanoporous microparticles (NPMPs) of this hydrophilic material by adaptation of a spray drying process previously applied to hydrophobic drugs, and to examine the physicochemical and in vitro deposition properties of the spray dried particles in comparison to a commercial product. The storage stability of successfully prepared NPMPs was assessed under a number of conditions Spray dried sodium cromoglicate was amorphous in nature. NPMPs of sodium cromoglicate displayed superior aerodynamic properties resulting in improved in vitro drug deposition, as assessed by Andersen Cascade Impactor and twin impinger studies, in comparison to the commercial product, Intal ® . Deposition studies indicated that porosity and sphericity were important factors in improving deposition properties. The optimum solvent system for NPMP production was water:methanol:n-butyl acetate, as spherical NPMPs spray dried from this solvent system had a higher respirable fraction than non-spherical NPMPs of sodium cromoglicate (spray dried from methanol:n-butyl acetate), non-porous sodium cromoglicate (spray dried from water) and micronised sodium cromoglicate (Intal ® ).While particle morphology was altered by storage at high humidity (60% RH) and in vitro deposition performance deteriorated, it was possible to maintain NPMP morphology and aerosolisation performance by storing the powder with dessicant.

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“…As a part of DPI formulation investigation, carrier property has been studied in various ways. 9) And various factors have been reported to affect the inhalation property of DPI formulations, for example, humidity, 10,11) air flow, 12) inhaler design, 4,13) particle size 14) and carrier surface property. 6,7,15) Among these properties, carrier surface property would be considered preferable to apply pharmaceutical ideas to improve the inhalation property.…”

mentioning

confidence: 99%

Novel Approach to DPI Carrier Lactose with Mechanofusion Process with Additives and Evaluation by IGC

et al. 2006

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In vitro evaluation of dry powder inhalers I: drug deposition of commonly used devices

Cited by 89 publications

References 16 publications

Analysis of Relationship between Peak Inspiratory Flow Rate and Amount of Drug Delivered to Lungs Following Inhalation of Fluticasone Propionate with a Diskhaler

Analysis of Relationship between Peak Inspiratory Flow Rate and Amount of Drug Delivered to Lungs Following Inhalation of Fluticasone Propionate with a Diskhaler

Particle engineering of materials for oral inhalation by dry powder inhalers. II—Sodium cromoglicate

Novel Approach to DPI Carrier Lactose with Mechanofusion Process with Additives and Evaluation by IGC

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