Conference Proceedings

Dry Powder Inhalers: An Overview

Paul J Atkins PhD

Introduction
Powder Inhalers Today
Unit-Dose Devices
Multi-Dose Devices
Factors That Impact Performance and Patient Acceptance
DPI Development
Future DPI Developments
Summary

Dry powder inhalers (DPIs) are a widely accepted inhaled delivery dosage form, particularly in
Europe, where they currently are used by a large number of patients for the delivery of medications
to treat asthma and chronic obstructive pulmonary disease. The acceptance of DPIs in the United
States after the slow uptake following the introduction of the Serevent Diskus in the late 1990s has
been driven in large part by the enormous success in recent years of the Advair Diskus. This
combination of 2 well-accepted drugs in a convenient and simple-to-use device has created an
accepted standard in pulmonary delivery and disease treatment that only a few years ago could not
have been anticipated. The DPI offers good patient convenience, particularly for combination
therapies, and also better compliance. The design and development of any powder drug-delivery
system is a highly complex task. Optimization of the choice of formulation when matched with
device geometry is key. The use of particle engineering to create a formulation matched to a simple
device is being explored, as is the development of active powder devices in which the device inputs
the energy, making it simpler for patients to receive the correct dose. Patient interface issues are
also critically important. However, one of the most important factors in pulmonary delivery from
a DPI is the requirement for a good-quality aerosol, in terms of the aerosol’s aerodynamic particle size,
and its potential to consistently achieve the desired lung deposition in vivo. Key words: dry powder inhaler,
DPI, lactose, aerosol, asthma, bronchodilator, chronic obstructive pulmonary disease, COPD, corticosteroids,
drug delivery. [Respir Care 2005;50(10):1304 –1312. © 2005 Daedalus Enterprises]

Introduction and chronic obstructive pulmonary disease, using drugs

such as short-acting and long-acting ␤ agonists, cortico-
The most frequent use of inhalation therapy is for the steroids, and anti-cholinergic agents. Traditionally, these
treatment of obstructive airway diseases, including asthma agents have been delivered via pressurized metered-dose
inhaler (MDI). However, in recent years, dry powder in-
halers (DPIs) have gained wider use, particularly in the
United States, partly because of the introduction of the
Paul J Atkins PhD is affiliated with Oriel Therapeutics, Research Trian-
gle Park, North Carolina.

Paul J Atkins PhD presented a version of this article at the 36th RESPI-
RATORY CARE Journal Conference, Metered-Dose Inhalers and Dry Pow- Correspondence: Paul J Atkins PhD, Oriel Therapeutics, PO Box 14087,
der Inhalers in Aerosol Therapy, held April 29 through May 1, 2005, in 630 Davis Drive, Research Triangle Park NC 27709. E-mail:
Los Cabos, Mexico. [email protected].

1304 RESPIRATORY CARE • OCTOBER 2005 VOL 50 NO 10

 DRY POWDER INHALERS: AN OVERVIEW

first combination of a long-acting ␤ agonist (salmeterol) inspiration (a limitation of MDIs) because DPIs are essen-
and a corticosteroid (fluticasone propionate) in a conve- tially breath-actuated. However, this breath-actuation is
nient multi-dose DPI (Advair Diskus, GlaxoSmithKline, also one of their disadvantages. Some DPIs require in-
Research Triangle Park, North Carolina).1 spiratory flow of ⱖ 60 L/min to effectively de-aggregate
Key to all inhalation dosage forms (either MDI or DPI) the powder,6,7 which cannot always be achieved by all
is the need to generate the optimum “respirable dose” asthmatic patients, particularly infants. All the currently
(particles ⬍ 5.0 ␮m) of a therapeutic agent that will reach available DPIs suffer from this potential drawback and can
the site of action (ie, the lung). This is a critical perfor- be characterized as “passive” inhalers (ie, the patient pro-
mance feature in the rational design and selection of a vides the energy to suck the drug from the device). This
pulmonary delivery system. Historically, MDIs have has prompted several companies to evaluate ways of pro-
achieved lung deposition of 5–15% of the delivered dose. viding energy in the inhaler, which is leading to the de-
Current DPIs have similar efficiency, but they have a num- velopment of several “active” DPIs, although none of these
ber of advantages over MDIs, including the fact that they are currently available commercially.
are breath-actuated and therefore require less coordination
than a conventional press-and-breathe MDI. Furthermore, Unit-Dose Devices
they do not contain chlorofluorocarbon propellants, which
have been implicated in atmospheric ozone depletion2 and With a single-dose DPI, a powder-containing capsule is
are being phased out. In addition, the more recently de- placed in a holder inside the DPI, the capsule is opened
veloped multi-dose DPIs have either a dose counter or within the device, and then the powder is inhaled. The
indicator that tells the patient how much medication re- spent capsule must be discarded after use and a new cap-
mains in the inhaler, which is another feature that differ- sule inserted for the next dose. The concept of the first
entiates DPIs from currently available MDIs. capsule-based device (the Spinhaler) was first described in
DPIs do, however, suffer from some inherent disadvan- the early 1970s, by Bell and colleagues,8 who had devel-
tages, including the fact that they require moderate inspira- oped this device for the administration of powdered so-
tory effort to draw the formulation from the device; some dium cromoglycate. Briefly, the drug mixture, which often
patients are not capable of such effort. Furthermore, there includes a bulk carrier to aid powder flow, is pre-filled into
is only a limited number of drugs available in a multi-dose a hard gelatin capsule and loaded into the device. After
format, with some drugs being available only in unit-dose activation of the device, which pierces the capsule, the
formats. These unit-dose devices are perceived as complex patient inhales the dose, which is dispensed from the vi-
and confusing for patients.3 In a recent review, Frijlink and brating capsule by means of inspired air. This product is
De Boer claimed that “well designed DPIs are highly ef- no longer available in the United States.
ficient systems for pulmonary drug delivery. However, A similar DPI (Rotahaler, GlaxoSmithKline), which has
they are also complicated systems, the performance of also been available for many years, delivers albuterol. With
which relies on many aspects, including design. . . , pow- the Rotahaler, the drug mixture is also in a hard capsule.
der formulation, and airflow generated by the patient.”4 The capsule is inserted into the device, broken open inside
This paper will review the currently available DPIs, fo- the device, and the powder is inhaled through a screened
cusing primarily on the United States market, evaluate the tube (Fig. 1).9,10 Again, this product is no longer available
key performance variables of these DPIs, including patient in the United States.
preferences, and provide some insights into potential fu- Although these single-dose devices have performed well
ture developments of DPIs for the delivery of agents to in clinical use for many years, the main criticism of them
treat respiratory diseases and systemic diseases. is the cumbersome nature of loading the capsule, which
might not be easily accomplished by a patient who is
Powder Inhalers Today undergoing an asthma attack and requires immediate de-
livery of the drug. This is clearly very relevant for devices
Today there are essentially 2 types of DPI: those in that deliver short-acting bronchodilators. In addition, el-
which the drug is packaged into discrete individual doses derly patients may not have the manual dexterity to ac-
(in a gelatin capsule or a foil-foil blister) and those that complish all the necessary maneuvers to take the capsule
contain a reservoir of drug from which doses are metered from the package, load it, and pierce the capsule in the
out.5 Both are now widely available around the world and device. However, despite the perception that unit-dose de-
are gaining broad acceptance as suitable alternatives to vices are not patient-friendly and are not easy to use, sev-
MDIs. There is clearly considerable interest in these de- eral introductions of single-dose DPIs have occurred over
vices, because they do not require chlorofluorocarbon pro- the last few years using similar designs (eg, Foradil Aerol-
pellant to disperse the drug and are therefore ozone-friendly. izer, made by Novartis/Schering-Plough, and Spiriva
Furthermore, DPIs obviate coordination of actuation and HandiHaler, made by Boehringer Ingelheim/Pfizer).11,12

RESPIRATORY CARE • OCTOBER 2005 VOL 50 NO 10 1305

 DRY POWDER INHALERS: AN OVERVIEW

to deliver both ␤ agonists (formoterol, terbutaline) and

combinations (formoterol and budesonide), in the United
States this device is only available to deliver the inhaled
corticosteroid budesonide (Pulmicort Turbuhaler).15
One of the drawbacks for the Turbuhaler, which may
have contributed to its limited acceptance in the United
States, is its variable delivery at different flow rates.5,16
This has also been the major criticism of several recently
developed reservoir-type DPIs17 and may limit their intro-
duction into the United States. It is, however, important to
note that Schering-Plough recently announced approval of
their reservoir DPI for the delivery of the inhaled cortico-
steroid mometasone (Asmanex Twisthaler).18
To address issues associated with multiple dosing and
consistent dose-to-dose delivery, in the late 1980s Glaxo
developed the Diskhaler,19 which was used to deliver a
range of drugs, including albuterol, beclomethasone, sal-
meterol, fluticasone, and the anti-viral agent zanamivir.
This device uses a circular disk that contains either 4 or 8
powder doses, which typically would be sufficient drug for
Fig. 1. Examples of unit-dose dry powder inhalers (DPIs). A: Ro-
1–2 days of treatment; the empty disk is then discarded
tahaler and Rotacap (contains albuterol). B: Diagram of Rotahaler.
C: Spiriva Handihaler. (Diagram from Reference 10, with permis- and a new disk is inserted in the device. The doses are
sion. Photograph C courtesy of Boehringer Ingelheim/Pfizer.) maintained in separate aluminum blister reservoirs until
just before inspiration. On priming the device, the alumi-
num blister is pierced and its contents drop into the dosing
The Foradil device has been poorly accepted since its chamber. This device had limited commercial success, pri-
introduction. This may be related to the need to store the marily because it held only a few doses per disk and was
capsules refrigerated. With the recently introduced Spiriva perceived as very cumbersome to load (Fig. 2).20 It was
Handihaler it is too early to evaluate the degree of patient used in the United States for the delivery of fluticasone
acceptance of this device, although it is complex and re- propionate to pediatric patients, although the product has
quires at least 7 distinct steps to deliver the dose. For some now been withdrawn. It was also used (in a modified form)
patients, 2 inhalations are required to completely empty to deliver the anti-influenza agent zanamivir, although,
the capsule and achieve the therapeutic dose, which adds again, the use was not widespread.
to the degree of complexity for the patient when using this Further improvements in patient convenience and ease
device. Furthermore, there have been recent reports3 of of use were incorporated into the next generation of multi-
patients ingesting the capsules instead of placing the cap- dose DPI, called the Diskus. This product was introduced
sule in the device and inhaling the contents. This is clearly in the late 1990s. Initially it delivered salmeterol or fluti-
not desirable. casone, but in 2001 a version was released that contains a
combination salmeterol-plus-fluticasone formulation (Ad-
Multi-Dose Devices vair Diskus). This is a true multi-dose device; it contains
60 doses (one month’s therapy) in a foil-foil aluminum
Given the inherent limitations of single-dose devices, in strip that is indexed, and the dose blister is only opened
the past decade or so there has been considerable focus on just prior to patient inspiration (Fig. 3).20,21 Consistent
developing multi-dose DPIs. The development of multi- performance,5 broad patient acceptance,22,23 and the grow-
dose DPIs was pioneered by the AB Draco company (now ing use of combination therapy (long-acting ␤ agonist plus
a division of AstraZeneca), with their Turbuhaler.13 This inhaled corticosteroid) for asthma have allowed the Diskus
device was truly the first metered-dose powder delivery to become the accepted standard multi-dose powder de-
system. The drug formulation is contained within a storage livery device (Fig. 4).
reservoir and can be dispensed into the dosing chamber by
a simple back-and-forth twisting action on the base of the Factors That Impact Performance
device. The device is capable of working at a moderate and Patient Acceptance
flow rate and also delivers carrier-free particles as well as
lactose-based formulations.14 Although the Turbuhaler is Currently available DPIs are all passive systems, mean-
widely available in Europe and Canada, and has been used ing that the patient must provide the energy to disperse the

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 DRY POWDER INHALERS: AN OVERVIEW

Table 1. Resistance of 5 Dry Powder Inhalers

Resistance
Inhaler Manufacturer
(H2O/L/s)
Rotahaler GlaxoSmithKline 0.015
Spinhaler Sanofi-Aventis 0.016
Diskhaler/Diskus GlaxoSmithKline 0.032
HandiHaler Boehringer Ingelheim 0.042
Turbuhaler AstraZeneca 0.044

(Adapted from Reference 4.)

Table 1 shows that there are important differences in re-

sistance among the DPIs, and this difference in resistance
causes differences in drug delivery efficiency between these
devices.
The patient labeling for DPIs reveals some interesting
statistics. For example, with the Spiriva Handihaler,12 the
powder is delivered at a flow as low as 20 L/min. How-
ever, when tested under standardized in vitro conditions,
the HandiHaler delivers a mean of only 10.4 ␮g (or 58%
of the nominal dose) when tested at a flow of 39 L/min for
3.1 s (for a total of 2 L of inspired volume). For patients
with chronic obstructive pulmonary disease (mean forced
expiratory volume in the first second 1.02 L, 37.6% of
predicted), their median peak inspiratory flow through the
HandiHaler was only 30.0 L/min (range 20.4 – 45.6 L/min).
That relatively low flow impacts the amount of drug the
patient receives, and the patient instructions include a pro-
vision for a second inhalation if all the powder has not
been evacuated from the capsule.
Under standard in vitro test conditions, Advair Diskus1
Fig. 2. Relenza Diskhaler. (Photograph courtesy of GlaxoSmith-
Kline. Diagram from Reference 20, with permission.) delivers 93 ␮g, 233 ␮g, and 465 ␮g of fluticasone propi-
onate and 45 ␮g of salmeterol base per blister from the
100/50 ␮g, 250/50 ␮g, and 500/50 ␮g products, respec-
powder from the device. The performance of these devices tively, when tested at a flow of 60 L/min for 2 seconds. In
depends on both the formulation and the geometry of the contrast to the HandiHaler, adult patients with obstructive
air path in the device. Thus, frequently these delivery sys- lung disease and severely compromised lung function
tems tend to be compound-specific and, without substan- (mean forced expiratory volume in the first second 20 –
tial re-formulation efforts, are not used to deliver other 30% of predicted) achieved mean peak inspiratory flow of
compounds. Typical formulations in DPIs are either drug 82.4 L/min (range 46.1–115.3 L/min) through the Diskus.
alone (eg, budesonide in the Turbuhaler) or drug blended Furthermore, adolescents (n ⫽ 13, age 12–17 years) and
with a carrier, typically lactose (eg, formoterol in the Fo- adults (n ⫽ 17, age 18 –50 years) with asthma inhaling
radil Aerolizer). The requirement for specific DPI formu- maximally through the Diskus had a mean peak inspira-
lations is addressed in Hickey’s contribution to this Jour- tory flow of 122.2 L/min (range 81.6 –152.1 L/min). Among
nal Conference,24 but I will make some general observations pediatric patients with asthma inhaling maximally through
regarding current DPI products. the Diskus, mean peak inspiratory flow was 75.5 L/min
The particle size distribution, both in vitro and, more (range 9.0 –104.8 L/min) among the 4-year-old patient set
importantly, in vivo, depends on the patient’s ability to (n ⫽ 20) and 107.3 L/min (range 82.8 –125.6 L/min) among
pull a certain airflow through the device to create the shear the 8-year-old patient set (n ⫽ 20).1
force that disperses the particles. In general, a higher shear Thus, it is important that physicians recognize that these
leads to a higher percentage of smaller particles, which devices will deliver different amounts of drug to different
may be beneficial, depending on the drug being delivered. patients, and the lung delivery depends on patient factors,

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 DRY POWDER INHALERS: AN OVERVIEW

Fig. 3. Schematic of the Diskus powder inhaler. (From Reference 20, with permission.)

Fig. 4. Serevent Diskus (left) and Advair Diskus (right) powder inhalers. (Courtesy of GlaxoSmithKline.)

such as inspiratory flow, patient inhalation technique, and training with ease of use. In many device-handling stud-
device resistance. ies the simple conclusions are that patients find device
One of the key factors with DPIs is that the various A better than device B, although often the criteria eval-
DPIs require different techniques to achieve an appro- uated have been extremely subjective. In a recent study26
priate therapeutic dose, unlike MDIs, with which, in conducted in Germany and Holland, it was shown that
general, the inhalation technique is the same. Thus, ease in elderly patients (mean age 60 years), approximately
of use and clear, concise instructions are required. In a two thirds (n ⫽ 254) were able to use the Diskus suc-
recent publication by Melani and colleagues,25 some cessfully, without any problems, compared with less
interesting observations were made linking patient- than 30% of the patients using HandiHaler. This is at-

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 DRY POWDER INHALERS: AN OVERVIEW

tributable to the complex nature of the unit-dose system formulation from moisture effects. Hence, many of the
versus the simpler multi-dose system. In contrast, the DPIs now available have secondary packing (a foil over-
study by Melani et al25 showed that adherence to in- wrap) to protect them from moisture effects until just prior
structions was poorer with the Diskus and Turbuhaler to use.
than with another unit-dose device (the Aerolizer). In- Some years ago Brown28 alluded to the complexities
deed, in that study, which examined over 1,400 patients involved in the design and development of a DPI. In much
in Italy, the authors concluded that adherence to correct the same way as for an MDI, the combination of formu-
inhaler use was similar across DPIs and, indeed, be- lation (drug and carrier), the way that it is presented to the
tween the DPIs studied (Aerolizer, Turbuhaler, and Dis- device, and the design of the dosing device itself all con-
kus) and an MDI. This was attributed in part to appro- tribute to the overall performance of the dosage form. The
priate training prior to product use. Thus, one of the requirement to use micronized drug with small particles, to
critical factors in ensuring that patients receive the ap- achieve good aerodynamic properties of the dispersed pow-
propriate medication from the currently available pas- der, is confounded by the need to develop formulations
sive DPIs is the provision of appropriate training and that fill easily and accurately.29 It is also important that
device education by the health-care provider. changes in the physical nature of the formulation on trans-
portation and storage are studied and do not adversely
DPI Development affect the product performance.
The development of DPIs has traditionally linked a spe-
Historically, drug particles for inhalation have been pro- cific formulation to a particular device geometry that then
duced by a milling (micronization) process that creates creates a pneumatic dispersion of the powder to overcome
particles of 1.0 –3.0 ␮m (this is absolutely necessary for the interparticulate forces and create the aerosol.30 How-
inhalation). Of critical importance in the development of ever, in the past decade, the notion of producing particles
DPI products is the evaluation, optimization, and control of a specific size, density, and morphology has evolved,
of flow and dispersion (de-aggregation) characteristics of and has the potential to lead to important advances in
the formulation. These typically consist of micronized drug pulmonary drug delivery. This advance was recently re-
blended with a carrier (eg, lactose). The properties of these viewed by Peart and Clarke31 and by Koushik and
blends are a function of the principal adhesive forces that Kompella.32 The underlying principle is that enhanced per-
exist between particles, including van der Waals forces, formance can be controlled by formulation changes (eg,
electrostatic forces, and the surface tension of adsorbed generating highly porous particles with large geometric
liquid layers.27 Particle size distribution of the drug and diameters but small aerodynamic diameters), an approach
the excipient (lactose) are optimized during early formu- characterized as “particle engineering.” These complex for-
lation development studies to ensure consistent aerosol mulations are then coupled with a simple delivery device.
cloud formation during subsequent clinical evaluation. This is clearly a subject of interest for formulation scien-
The efficiency of dispersion of DPI aerosols, relative to tists as they strive to develop more efficient powder de-
the various geometric diameters of the particles, may also livery systems.
be an important factor. Specifically, dispersion requires The goal of delivering micronized powders is a chal-
the powder to overcome interparticulate forces that bind lenging one. Because of their very nature, these types of
particles in bulk powder and to become entrained as single powders are highly cohesive. Their high inter-particulate
particles in the inhalatory air stream. Interparticulate forces forces make them difficult to de-aggregate: hence, the need
are dominated by the van der Waals force for particles in for high inspiratory flow and turbulent airflow within DPIs.
the respiratory size range. All other factors being equal, Inclusion of a carrier can aid in the de-aggregation pro-
the van der Waals force will decrease as the geometric cess, but it can also lead to problems with absorption of
particle size increases. Thus, in general terms, the proba- atmospheric moisture. The alternative approach to achiev-
bility of deposition in the deep lung is at odds with effi- ing efficient dispersion of these highly cohesive powders
ciency of dispersion for DPIs. is to provide an energy source for dispersion within the
Environmental factors, especially temperature and hu- device itself, and a number of companies are pursuing this
midity, are key factors that can impact DPI formulation approach. An outline review of some of these approaches
stability and performance. The impact of these are studied is provided below as part of a prediction of future DPI
in early development studies, and often the humidity ef- developments.
fects negatively impact the formulation (particularly for
lactose blends), making it more cohesive and therefore Future DPI Developments
more difficult to disperse. This will be to some extent
dependent on the device/formulation combination, and typ- The delivery of powdered medication for the treatment
ically reservoir devices have a poorer ability to protect the of lung ailments has been known for centuries, is well

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 DRY POWDER INHALERS: AN OVERVIEW

Table 2. Aerosol-Dispersion Mechanisms of Dry Powder Inhalers

Mechanism Inhaler Manufacturer

Venturi effect Easyhaler Orion

Impact bodies Clickhaler Innovata Biomed (IB)

CertiHaler SkyePharma

Discharge channels Turbuhaler AstraZeneca

Twisthaler Schering Plough

Cyclone chambers Pulvinal Chiesi

Airmax Ivax
Novolizer Viatris
Taifun LAB International
(formerly Focus
Inhalation)

Pressurized air* Inhance Nektar

Aspirair Vectura

Battery powered* (Inhaler names not Microdose Technologies

yet released) Oriel Therapeutics

*Active powder inhaler (Adapted from Reference 4.)

documented,33 and is addressed by Anderson in her con-

tribution to this conference.34 Despite this extensive his-
tory, and in part fuelled by a need for alternative pulmo- Fig. 5. Prototype of the Nektar PDS (“pulmonary delivery system”)
for Exubera. The device slides open and closed like a telescope,
nary delivery methods, as the MDI is undergoing
for compact carrying and portability. The patient opens the device,
environmental challenge, innovative ways to deliver drugs inserts the foil blister (which contains the powdered medicine),
to the lungs continue to be pursued today. As can be seen and pumps the handle, which compresses a small amount of air
from the previous discussion, the goal of de-aggregating inside the device. When the patient pushes the button, the com-
highly cohesive powder for delivery to the lung in a pow- pressed air is released at high velocity, which aerosolizes the pow-
der and sends the aerosol into the chamber, where it is a station-
dered form is a challenging one.30 The small dose size
ary cloud. The patient then inhales the aerosol from the chamber.
required for many of these potent drugs is a confounding The patient receives the medicine first, followed by a volume of air,
factor in developing optimal DPIs. Nevertheless, today it which helps push the drug deep into the lung. (Courtesy of Nektar
is estimated that annually approximately 100 million multi- Therapeutics.)
dose DPIs are used, on a global basis. This compares with
approximately 400 million MDIs. Most of the DPIs con-
tain lactose-based formulations. There has been some con- nia) are probably too bulky to be fully portable. Others are
cern raised about the use of lactose carriers in asthma pursuing smaller and more compact options. A review of
patients who have lactose intolerance,35 although the in- the full range of these delivery systems is beyond the
cidence of this is believed to be small. scope of this paper, but there are a couple of subjects
As has been discussed by others,4,30 there are only a worth exploring.
limited number of mechanisms for dispersing powdered A multi-dose reservoir device is now under review
drugs (Table 2). Many of these devices are now available with the United States Food and Drug Administration
commercially, although only the Turbuhaler is currently for the delivery of formoterol (Foradil Certihaler, Skye-
available in the United States. Pharma, San Diego, California; Novartis, East Hanover,
Much interest has been focused recently on developing New Jersey).36 This would be a major advance, as it
delivery systems that de-aggregate the powder,30 –32 as this would provide a second long-acting ␤ agonist in a multi-
effectively minimizes formulation-development work. dose powder form. In addition, the first use of an active
Some of these systems are extremely complex in operation DPI is currently being sought for the delivery of pul-
and may prove difficult to achieve in everyday operations. monary insulin (Exubera, Pfizer/Sanofi-Aventis, li-
In addition, some designs that have already been achieved censed from Nektar Therapeutics, Fig. 5). The device
(eg, Inhance device for the delivery of 1 mg or 3 mg of uses an air pump system that disperses the insulin pow-
inhaled insulin, Nektar Therapeutics, San Carlos, Califor- der into a spacer chamber, from which the patient can

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 DRY POWDER INHALERS: AN OVERVIEW

then inhale. Approval of such a device will pave the REFERENCES

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Discussion probably about 10% or less, will not MacIntyre: I was struck by Tony’s
be able to use Diskus or other DPIs. [Hickey] comment during his presen-
Amato:* Do you think if Advair was That doesn’t answer your question di- tation that there will probably not be
introduced as an MDI, it would be as rectly, but I think there is probably a generic DPIs. But you showed 2 de-
popular as the DPI is? Is its popularity preference in some places for Diskus vices that are being used as generic
related more to the device or to the drug? or other DPIs over MDI, but the MDI DPIs. Help me reconcile those 2 state-
is going to be around for a while. ments. Can you build a “generic” DPI
Atkins: As to whether the device or and then find a product to disperse
the drug drives physician choice, I Smaldone: I think a lot of it has to with it?
think it is usually the drug. I can tell do with the market. In the United States
you that, in France, with fluticasone there was no heavy competition for Hickey: It’s a question of how you
at the same price per dose, patients the combination product. My answer consider generic products to perform.
preferred Diskus over HFA MDI, 65% to Mike’s question would be that an If you do it based on performance,
to 35%. Another aspect is that some MDI version of Advair probably which is how the Europeans are look-
small percentage of the population, would have been as popular. If you ing at it, then it’s possible. If you do it
compare the Diskus against the MDI, based on componentry equivalence,
the Diskus might win, but if the Dis- which is the way we look at it in the
* Michael T Amato, American Respiratory Care
kus wasn’t there, I don’t think the com- United States, it’s absolutely impossi-
Foundation, Irving, Texas; Monaghan Medical/ pany would have been any less suc- ble, because all these devices are dif-
Trudell Medical International, Syracuse, New York. cessful with an MDI version. ferent.

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