APV FOCUS GROUP DRUG DELIVERY
APV FOCUS GROUP DRUG DELIVERY
APV FOCUS GROUP DRUG DELIVERY
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Inhalation Technologies<br />
FORMULATION CHALLENGE SKYEPHARMA SOLUTION<br />
Robust and reproducible dosing<br />
Long room temperature shelf life (≥ 2years)<br />
SkyePharma formulation and device<br />
technologies aim to achieve this<br />
SkyeProtect TM SkyeDry TM , and SkyeStabe TM<br />
technologies<br />
Moisture protection SkyeProtect amd SkyeDry<br />
Breath actuation vs. active drug dispersion<br />
Flow rate independent dosing with breath actuated<br />
devices<br />
Efficient lung deposition<br />
Target delivery to specific lung regions, e.g. deep<br />
lung deposition for systemic uptake<br />
SkyeHaler TM DPI is breath actuated; MDI is<br />
active dispersion, which can be coupled to<br />
breath actuation, e.g. BAI<br />
SkyeHaler DPI achieves this via a threshold<br />
flow rate and medium resistance<br />
SkyeFine TM when necessary<br />
ISS-P TM nanotechnology<br />
Products: There are twelve products approved in the areas of oral, inhalation and topical delivery and additional<br />
products submitted for approval that incorporate the Group’s proven proprie-<br />
tary technologies. The Group’s products are marketed throughout the world by leading pharmaceutical<br />
companies.<br />
Approved Products<br />
LICENSEE/ PRODUCT<br />
PARTNER NAME<br />
INHALATION<br />
GENERIC NAME INDICATION MARKETED<br />
®<br />
AstraZeneca Pulmicort HFA-MDI Budesonide Asthma yes<br />
ORAL<br />
®<br />
sanofi-aventis Xatral OD/<br />
Alfuzosin BPH yes<br />
Uroxatral ®<br />
GlaxoSmithKline<br />
®<br />
Requip<br />
Once-a-day<br />
Ropinirole Parkinson’s disease yes<br />
GlaxoSmithKline Paxil CR Paroxetine Depression yes<br />
Sciele Pharma<br />
(Shionogi)<br />
Sciele Pharma<br />
(Shionogi)<br />
Triglide ®<br />
Sular ®<br />
Madopar DR ®<br />
Roche Levodopa +<br />
Benserazide<br />
Cornerstone<br />
Therapeutics<br />
ZYFLO CR ®<br />
Fenofibrate Lipid disorders yes<br />
Nisoldipine Hypertension yes<br />
Parkinson’s disease yes<br />
Zileuton Asthma yes<br />
Coruno ®<br />
Therabel Molsidomine Angina yes<br />
Ratiopharm diclofenac-<br />
®<br />
ratiopharm uno<br />
Diclofenac Pain/inflammation yes<br />
Lodotra ®<br />
Horizon Europe Prednisone Rheumatoid arthritis yes<br />
TOPICAL<br />
Solaraze ®<br />
Nycomed/Almirall Diclofenac Actinic keratosis yes<br />
<strong>APV</strong> Drug Delivery Focus Group Newsletter – 3/2011 Page 4 of 14
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