Driving pulmonary Drug Delivery Forward - Amazon S3 · The lung provides an attractive drug...
Transcript of Driving pulmonary Drug Delivery Forward - Amazon S3 · The lung provides an attractive drug...
Driving pulmonary Drug Delivery Forward
Building on particle engineering expertise to optimize pulmonary drug delivery and bring advanced inhalation therapeutics to market
The lung provides an attractive drug absorption target for both local and systemic disease states and is increasingly utilized for the delivery of both small molecules and biotherapeutics. Dry powder inhalers (DPIs) are often a preferred drug delivery platform due to their inherent formulation flexibility and patient convenience.
Our core particle engineering expertise is complemented with extensive formulation and process development, specialized CMC/analytical, and encapsulation capabilities to provide integrated DPI product development from concept through the clinic and commercialization.
We provide unparalleled expertise in spray dry processing and jet milling for optimized particle engineering
Particle engineering is crucial to successful respiratory product design. At Capsugel, we have more than 20 years’ experience in advanced top-down and bottoms-up particle engineering techniques specific to inhalation applications, with specialized, proprietary equipment in place for all stages of product development.
Spray dry processing is finding increasing use in DPI applications due to its efficiency and flexibility vs. traditional milling and lactose blend approaches. Capsugel has unique capabilities in spray drying with a range of engineered inhalable product concepts developed to fit specific compound properties and target product profiles.
We provide extensive formulation and process development based on a rich legacy
Having formulated more than a thousand compounds, our scientists have encountered a myriad of API characteristics and delivery challenges. This has enabled Capsugel to optimize its formulation selection methodologies based on modeling, and optimize our process development and scale-up approaches. A comprehensive analytical platform with specialized CMC expertise is in place to support all aspects of inhalable product development.
Our full service offering includes state-of-the-art encapsulation for capsule-based DPI systems
Customized DPI capsules and encapsulation are additional Capsugel core competencies, with dedicated equipment in place for efficient, phase-appropriate capsule filling.
CRYSTALLINE API IN AMORPHOUS MATRIX
XCELODOSE® 600S FOR CLINICAL PHASE ENCAPSULATION
Learn how Lonza’s integrated inhalation product development and manufacturing can be tailored to meet your exact needs
PRODUCT CHARACTERIZATION
Performance
Stability
Release
ROBUST FORMULATION & PROCESS FOR CLINICAL TRIALS
MATERIALS
Precedented and GRAS
Materials science
PARTICLE ENGINEERING
300mg to >1kg scale
Development + cGMP
TARGET PRODUCT PROFILE
ACTIVE PRODUCT CONCEPT
FORMULATION/ PROCESS GUIDANCE
Compound physical properties
Biomodel guidance for formulation impact on PK/PD
Inhalation Product Development
Capsugel offers a full range of services, from POC and formulation identification to powder manufacture for clinical studies, cGMP manufacturing and capsule filling optimized for inhalation drug development.
Complete Inhalation Platform
ENCAPSULATION
Xcelodose® 600S
Harro Modu-C MS with 100k CPH
CAPSULE-BASED DPI DEVICE
Specialized capsules
FTO device
Specialized Dry Powder Inhaler capsules designed to meet the unique challenge of pulmonary delivery
By combining polymer science, engineering and formulation know-how, we are creating breakthroughs in capsules and encapsulation technologies that are changing the functional role of capsules in medical research, drug formulation and drug delivery. This unique capability has been utilized to develop specialized DPI capsules to optimize drug delivery to the lung.
Capsugel’s DPI capsules are customized to your specific application, achieving optimal and consistent performance by adjusting key design parameters including the capsule size and design, polymer/ gelling agents, moisture content, lubricant levels and weight tolerances.
The
info
rmat
ion
cont
aine
d he
rein
is in
tend
ed fo
r gen
eral
mar
ketin
g pu
rpos
es o
nly.
Whi
le L
onza
mak
es e
fforts
to in
clud
e ac
cura
te a
nd u
p-to
-dat
e in
form
atio
n, it
mak
es n
o re
pres
enta
tions
or w
arra
ntie
s, e
xpre
ss o
r im
plie
d, a
s to
the
accu
racy
or c
ompl
eten
ess
of th
e in
form
atio
n pr
ovid
ed h
erei
n an
d di
scla
ims
any
liabi
lity
for t
he u
se o
f thi
s pu
blic
atio
n. A
ll ac
cess
and
use
of t
he in
form
atio
n co
ntai
ned
here
in a
re a
t the
use
r’s o
wn
risk.
Lon
za m
ay c
hang
e th
e co
nten
t of t
his
publ
icat
ion
at a
ny ti
me
with
out n
otic
e bu
t doe
s no
t ass
ume
any
resp
onsi
bilit
y to
upd
ate
it. G
MC
N 2
0170
9007
©20
17 L
onza
. All
right
s re
serv
ed.
Enhanced Inhalation Therapeutics Through Spray Drying Technology
[email protected]: 800-706-8655Europe: +44 (0)1506 448080