|
|
|
|
|
|
|
| |
Dry
Powder Inhalers
TwinCaps®
A simple, disposable low-cost dry powder inhaler with
high performance.
The Challenge: In 2006, Hovione was asked to
develop a disposable, pre-filled,low cost dry powder inhaler to deliver a
large dose of drug.
The solution: TwinCaps®, a two-component inhaler
with a single step to inhalation, currently in Phase III clinical trials for
an influenza drug.
TwinCaps® can deliver lactose-based or
particle-engineered powders, and Hovione has effective experience in both
types of formulations, from proof of concept, to optimization, robustness
and compatibility tests, scale-up, method validation, stability studies and
clinical supplies. |
|
 |
| |
|
Simple Operation |
|
 |
 |
|
1. Industrial filling. Two dose
compartments are filled
directly with drug powder… |
2. … and immediately closed by
inserting them into
the inhaler body. |
| |
|
 |
 |
|
3. In use, the patient pushes the
dose compartment
sideways and aligns the first dose
compartment
with the mouthpiece. |
4. With the inhaler ready for
use, inhalation can
take place. |
| |
|
 |
 |
|
5. For the second dose, the
patient pushes the dose compartment in
the other direction… |
6. … and inhales again. |
| |
|
|
Effective delivery |
|
 |
|
In
in-vitro tests, the minimum flow rate at
which TwinCaps® has been shown to
deliver 95% of the nominal dose is 20
litres per minute of airflow. Above 25
litres per minute, performance is
unaffected (data formulation dependent).
Drug payloads range from the microgram
range, employing lactose-based
formulations, up to 80 mg of active
using highly dispersible, engineered
particles. With two dose compartments,
nominal doses of up to 160 mg are
possible.
|
| |
|
Effective dispersion |
|
|
TwinCaps®
uses a patented dispersion mechanism in
which the dose compartment becomes a
highly turbulent chamber, maximizing
fine particle fractions. FPFs ranging
from 25% to 70% have been obtained, at
flow rates of 35 litres per minute (pressure
drop 4 KPa). |
 |
|
In the
NGI test illustrated above, a
reproducible, delivered dose of 58% was
obtained. The percentage of drug
deposited in stage 3 and below was 28%
in relation to the label claim, and 58%
in relation to the emitted dose,
possibly implying retained drug in the
inhaler is composed of larger particles.
|
| |
|
Applications |
|
TwinCaps®
is presently in Phase III for the
delivery of a long-acting neuraminidase
inhibitor for the cure and prevention of
influenza. This DPI is indicated for
applications where a pre-filled,
disposable, low-cost device is needed,
with extreme ease of use. Examples
include anti-virals and antibiotics for
lung infection, oncological drugs,
pulmonary hypertension drugs.
|
| |
|
Licensing and services |
|
TwinCaps®
is available for licensing.
Hovione can provide all formulation
development services as well as
TwinCaps® devices to GMP specifications.
As an integrated inhalation products
developer, Hovione possesses the most
complete service offering, from API
through particle design to formulation
development and clinical supplies, for
development, scale-up and industrial
manufacturing, including full analytical
support. |
| |
|
|
|
Inhalation technologies
About Hovione 
