1. Capsule-based dry powder inhalers (DPIs) are commonly used to deliver medications for asthma and COPD. Popular DPI systems include Spiriva HandiHaler, Atrovent Aerohaler, and Foradil Aerolizer. 2. These DPIs contain capsules that hold the medication powder and are inserted into the inhaler device. Common inhalers are the Rotahaler, Spinhaler, and newer devices like the Rheohaler. 3. Continuous innovation has improved lung deposition of medication from DPIs from around 5% to over 20% now through optimizing the formulation, inhaler device design, and

1. Stuart Silverman – CEO & Founder

2. Major DPI Market Trends
and Perspectives

3. Double digit growth on DPI market
Western European Asthma/COPD market
Oral, injectable,inhaled drugs
CAGR 2008–2018: 4%*
2008 sales: $6.9 billion 2018 sales: $9.9 billion
*Source: 2009–2018 forecast = Datamonitor; 2004–08 sales data from MIDAS, IMS Health Western Europe: France,
Germany, UK, Spain, Italy
Worldwide DPI Market
Global Sales revenue $19 bn to $38 bn by 2015
( GIA report 2010)

4. Key Drivers for Choice of Inhalation Technology
Risk
Risk
•Innovation is long to be established
•Safe, well-known inhalation solution
•Technology mastering/in-house technology
Patient’s need
•Acceptability, convenience
•Familiarity of patient group with device
•Small / High volumes of drug
Differentiation
•Ability to get competitive advantage
•Patent protection
•Bring innovation, choice, diversity
Performance
•Technical performance (lung deposition, API protection)
•Ability to effectively deliver the dose
•Cost effectiveness

5. In the last six years Dry Powder Inhalers have continued to take share
from the MDI market, a trend that we expect to continue for several reasons
including patient preference and environmental impact.
DPI- A growing technology
*

6. 6
CapsulesBlister Reservoir
Weaknesses
•High dose variation
•No ability to see
remaining doses
Strengths
Accurate dosing
Pre-metered dose
Humidity protection
•All-in-one system
•COGs
•Multidose (no handling)
•No ability to see dose is
effectively taken
•More expensive than
capsules
•Control of inhaled dose
•Flexibility:
•number of doses,
•remaining dose, emptied
dose,
•Potential for combination
•API protection
•Multidose inhaler
•Easy to handle
•All-in-one system
•Handling
•Device and capsule are
separated
Perceived Strengths and Weaknesses of DPIs Technologies

7. Trends in capsule-based DPI systems
•Improving quantity of inhaled drug
•100% protection of active ingredient
•No humidity constraint
• API improvement for less side-effects
• Excipient-free
•Ability to combine different APIs
•Reduction of device size
•Improving handling
•Easier way of dispensing and
removing the capsule
•Pre-loaded system with several
capsules
•Ability to maintain cost low
•Recycling material
•Reusable / refill cartridge
•Colored / Imprinted capsule
•Same device for different
capsule/application
• Specific design to protect from copy
Performance User-Friendly
Eco-Friendly Differentiation

8. Two opposed trends in Inhalation Technology:
ComplexSimple
Product handling
Less manipulation in between 2 doses
Elderly patients, cognitive or physical
impairment
Fits naïve users
Simple devices cheap to develop
Fit developing market, large market
size with strong economic pressure
Being able to produce in very large
number very quickly (pandemic)
Patient convenience
Device attributes / technology
Extra attributes like counting dose, blocking
system to avoid accidental charge of the
next dose, cleanliness, monitoring dose
intake for compliance
Cost effectiveness
Complex device offering innovation
 Fits disease with few medications on the
market to be able to deliver an innovative
product both on API and delivery
mechanism

9. Current and future applications
Current Future
MDIs is the
historical
device for
inhalation
Asthma
COPD
 Relatively sophisticated users: Want multi-dose
solution, high number of dose, cost-effective
solution
 Naïve users: one unique dosage to smaller
number of dosage, need for simple device, easy
to use
DPIs is well
positioned
for future
application
Vaccines
Preferred
inhalation device
still to be
assessed
Biologics
 Naïve users who need convenient mode of
administration: alternative to injection, frequent usage,
sophisticated by easy to use device
Nasal routes
Central nervous system
Pain relief
Migraines
Macromolecules
Anti-viral

10. Summary of Capsule-
Based Delivery Systems

11. Summary of Capsule-based Devices
Spiriva® HandiHaler® (tiotropium bromide inhalation
powder) is an inhaled once-a-day maintenance
prescription treatment for bronchospasm (airway
narrowing) associated with chronic obstructive pulmonary
disease (COPD). Inhalation device: Handihaler
Atrovent is used to prevent bronchospasm, or
narrowing airways in the lungs, in people with
bronchitis, emphysema, or COPD (chronic
obstructive pulmonary disease). Inhalation
device: Aerohaler Multidose

12. Summary of Capsule-based Devices
Foradil relaxes the muscles in the walls of the
airways, allowing them to expand. Taken on a twice-
daily basis, it helps to control asthma in people who
need regular treatment with short-acting inhalers,
including people with nighttime asthma. Regular twice-
daily use can also relieve tightening of the airways in
people with Chronic Obstructive Pulmonary Disease,
including chronic bronchitis and emphysema.
Inhalation device: Aerolizer
Inhalation device:
Osmohaler:

13. Summary of Capsule-based Devices
This drug relaxes the smooth muscle in the
lungs and dilates airways to improve
breathing. It is used in the treatment of
asthma, chronic bronchitis, and emphysema.
VENTOLIN ROTACAPS for Inhalation are
indicated for the prevention and relief of
bronchospasm in patients 4 years of age and
older with reversible obstructive airway
disease and for the prevention of exercise-
induced bronchospasm in patients 4 years of
age and older. The VENTOLIN ROTACAPS
for Inhalation formulation is particularly useful
in patients who are unable to properly use the
pressurized aerosol form of albuterol or who
prefer an alternative formulation.
Inhalation device: Rotahaler and Spinhaler.

14. Summary of Capsule-based Devices
The inhalation capsule Avessa is available as
Rheocaps Avessa 100 mcg, Avessa 250 mcg,
Avessa 500 mcg, depending on the severity of
Asthma. Indian pharmaceutical major Ranbaxy
Laboratories Limited has launched Avessa
(Formoterol + Fluticasone) inhalation capsules in
India for the treatment of asthma. Ranbaxy
claims that this unique combination has been
launched for the first time in the world combining
the fastest acting Long Acting Beta 2 Agonist
Formoterol and the most potent inhaled
corticosteroid Fluticasone. The product is to be
used only with the Rheohaler - the world's first
capsule-based multi-dose dry powder inhaler,
Ranbaxy.
Inhalation device: FlowCaps® - Rheohaler
(developed by Hovione)
Inhalation device:
FlowCaps® -
Rheohaler (developed
by Hovione)

15. Continuous improvement in DPI systems
The key challenge for inhalation drug delivery systems is a
consistent and high lung deposition
The first DPI systems had ~5 % lung deposition which has
been increased by 4 – 5 times meanwhile
This has been achieved by optimization of
the formulation
the inhalation device
the inhalation capsule
Labiris & Dolovich 2003