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Working with Hovione
Communication with the customer in
the early development stages is usually performed on a weekly
basis, via telephone conferences and e-mailed information,
with Hovione issuing interim reports at regular intervals
and a final report at the study completion. Additionally,
face-to-face meetings are scheduled when requested. The pricing
of our services is transparent.
Proof
of concept
If the drug has not been developed for inhalation purposes,
we assess whether this is likely to be successful using
simple and economic techniques. This is usually performed
in two weeks. |
The
feasibility study
Hovione experiments with particle size reduction techniques,
starting with jet mill micronization provided the API
is able to withstand this treatment. A design-of-experiment
methodology then follows to identify the most promising
excipient grades and blending techniques. DUSA as well
as Cascade impactor testing are also performed and experimental
batches are manufactured. The formulations with the highest
deposition performance will be placed under ICH accelerated
environmental conditions to determine their stability.
This process typically takes between four and six weeks
to complete. |
The
extended feasibility study
In order to improve deposition characteristics –
reducing powder retention in the device and/or increasing
the fine particle fraction – an extended study may
follow lasting up to 3 months, followed by a 6 months
accelerated stability study. The process starts in the
chemistry phase, if applicable, and is followed by the
particle size reduction techniques Hovione developed.
A number of candidate formulations are selected for further
stability studies. The final goal of the extended stability
study is to produce a high-performance, stable formulation. |
Formulation
robustness and stability studies
Once a formulation has been selected, Hovione can carry
out a full robustness and stability programme. Alternatively,
we can identify a third party laboratory which can carry
out this task, according to a protocol developed by us
and under our supervision. |
Preparing
for manufacturing
Hovione has extensive experience in the conception and
design of equipment for high-speed inhaler filling, with
very high levels of precision (RSD < 3%). We can fill
small batches of capsules or inhalers for clinical batches,
for phases I and II as well as commercial-size batches,
both performed in clean room controlled environments. |
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Inhalation technologies
About Hovione 
