Journal of Aerosol Medicine and Pulmonary Drug Delivery,
Journal Year:
2024,
Volume and Issue:
unknown
Published: Dec. 9, 2024
Approved
drug
products
may
be
subject
to
change(s)
for
a
variety
of
reasons.
The
changes
include,
but
are
not
limited
to,
increase
in
batch
size,
alteration
the
product
constituent(s),
improvement
manufacturing
process,
and
shift
sites.
extent
pharmaceutical
testing
regulatory
pathway
timely
implementation
any
change
approved
and/or
process
depends
upon
nature
change.
U.S.
Food
Drug
Administration
(FDA)
has
published
guidelines
that
outline
its
expectations
Scale-Up
Postapproval
Changes
(SUPAC)
solid
oral
immediate
modified
release
(MR)
products,
semisolid
formulations.
However,
date,
no
such
have
been
issued
address
SUPAC
orally
inhaled
(OIDPs),
this
article
represents
seminal
contribution
direction.
It
is
hoped
it
will
inspire
contributions
from
relevant
multidisciplinary
experts
industry
agency
accomplishing
formal
OIDP
SUPAC.
OIDPs
complex
drug-device
combination
products.
Therefore,
conceptualization
these
warrants
consideration
effect
individual
components
(drug
substance,
formulation,
device)
as
well
compound
single
or
multiple
on
performance,
safety
efficacy.
This
provides
discussion
scientific
aspects
bases
development
OIDPs,
attempts
considerations
applicable
addressing
issues
related
context
human
drugs.
authors'
statements
should
viewed
recommendations
agency,
would
determined
case-by-case
evaluation
by
authorities.
European Journal of Pharmaceutical Sciences,
Journal Year:
2023,
Volume and Issue:
188, P. 106509 - 106509
Published: June 24, 2023
Pirfenidone
(PFND)
is
a
recommended
oral
drug
used
to
treat
idiopathic
pulmonary
fibrosis,
but
have
low
bioavailability
and
high
hepatotoxicity.
The
study,
therefore,
seeks
improve
the
therapeutic
activities
of
via
increased
reduced
associated
side
effects
by
developing
novel
delivery
system.
electrostatic
spray
technology
was
prepare
sustained
release
pirfenidone-loaded
microsphere
dry
powder
inhalation
with
PEG-modified
chitosan
(PFND-mPEG-CS-MS).
entrapment
efficiency,
loading,
in
vitro
cumulative
rate
(at
24
h
effect)
PFND-mPEG-CS-MS
were
77.35±3.01%,
11.45±0.64%,
90.4%,
respectively.
Carr's
index
17.074±2.163%
theoretical
mass
median
aerodynamic
diameter
(MMADt)
0.99±0.07
μm,
moisture
absorption
weight
gain
(Rw)
4.61±0.72%.
emptying
rate,
deposition
(fine
particle
fraction)
actual
(MMADa)
90%∼95%,
48.72±7.04%
3.10±0.16
MTT
bioassay
showed
that
mPEG-CS-MS
(200
μg/mL)
had
good
biocompatibility
(RGR
=
90.25%)
significant
inhibitory
activity
49.82%)
on
fibroblast
growth.
pharmacokinetic
data
revealed
t1/2
(5.02
h)
MRT
(10.66
prolonged
compared
free
PFND
(t1/2,
1.67
h;
MRT,
2.71
h).
pharmacodynamic
results
also
formulated-drug
group
slight
pathological
changes,
lower
lung
hydroxyproline
content,
hepatotoxicity
free-drug
group.
further
significantly
down-regulated
TGF-β
cytokines,
Collagen
I,
α-SMA
protein
expression
levels
drug.
findings
indicated
effect,
enhanced
bioavailability,
decreased
toxicity,
anti-fibrotic
activities.
Pharmaceutics,
Journal Year:
2024,
Volume and Issue:
16(6), P. 784 - 784
Published: June 8, 2024
Dry-powder
inhalers
(DPIs)
are
valued
for
their
stability
but
formulating
them
is
challenging
due
to
powder
aggregation
and
limited
flowability,
which
affects
drug
delivery
uniformity.
In
this
study,
the
incorporation
of
L-leucine
(LEU)
into
hot-melt
extrusion
(HME)
was
proposed
enhance
dispersibility
while
simultaneously
maintaining
high
aerodynamic
performance
inhalable
microparticles.
This
study
explored
using
LEU
in
HME
improve
maintain
Formulations
with
crystalline
itraconazole
(ITZ)
were
made
via
co-jet
milling
followed
by
jet
milling.
The
ratio
varied,
comparing
solubility,
homogenization,
enhancements.
HME,
ITZ
solubility
increased,
crystallinity
decreased.
Higher
ratios
formulations
reduced
contact
angle,
enhancing
mass
median
diameter
(MMAD)
size
synergistically.
Achieving
a
maximum
extra
fine
particle
fraction
33.68
±
1.31%
enabled
stable
deep
lung
delivery.
shows
that
combined
effectively
produces
particles,
promising
improved
dispersion
Journal of Controlled Release,
Journal Year:
2024,
Volume and Issue:
373, P. 410 - 425
Published: July 24, 2024
Dry
powder
inhalers
(DPIs)
are
widely
employed
to
treat
respiratory
diseases,
offering
numerous
advantages
such
as
high
dose
capacity
and
stable
formulations.
However,
they
usually
face
challenges
in
achieving
sufficient
pulmonary
drug
delivery
minimizing
excessive
oropharyngeal
deposition.
This
review
provides
a
new
viewpoint
address
these
by
focusing
on
the
role
of
swirling
flow,
crucial
yet
under-researched
aspect
that
induces
strong
turbulence.
In
review,
we
comprehensively
discuss
both
key
classic
designs
(tangential
inlet,
chamber,
grid
mesh,
mouthpiece)
innovative
inhalers,
exploring
how
induced
flow
initiates
dispersion
promotes
efficiency.
Valuable
design
considerations
effectively
coordinate
with
formulations
patients
also
provided.
It
is
highlighted
delicate
manipulation
essential
maximize
benefits.
By
emphasizing
its
potential
application,
this
offers
promising
insights
for
advancing
DPI
technology
optimizing
therapeutic
outcomes
inhaled
therapy.
Journal of Aerosol Medicine and Pulmonary Drug Delivery,
Journal Year:
2024,
Volume and Issue:
unknown
Published: Dec. 9, 2024
Approved
drug
products
may
be
subject
to
change(s)
for
a
variety
of
reasons.
The
changes
include,
but
are
not
limited
to,
increase
in
batch
size,
alteration
the
product
constituent(s),
improvement
manufacturing
process,
and
shift
sites.
extent
pharmaceutical
testing
regulatory
pathway
timely
implementation
any
change
approved
and/or
process
depends
upon
nature
change.
U.S.
Food
Drug
Administration
(FDA)
has
published
guidelines
that
outline
its
expectations
Scale-Up
Postapproval
Changes
(SUPAC)
solid
oral
immediate
modified
release
(MR)
products,
semisolid
formulations.
However,
date,
no
such
have
been
issued
address
SUPAC
orally
inhaled
(OIDPs),
this
article
represents
seminal
contribution
direction.
It
is
hoped
it
will
inspire
contributions
from
relevant
multidisciplinary
experts
industry
agency
accomplishing
formal
OIDP
SUPAC.
OIDPs
complex
drug-device
combination
products.
Therefore,
conceptualization
these
warrants
consideration
effect
individual
components
(drug
substance,
formulation,
device)
as
well
compound
single
or
multiple
on
performance,
safety
efficacy.
This
provides
discussion
scientific
aspects
bases
development
OIDPs,
attempts
considerations
applicable
addressing
issues
related
context
human
drugs.
authors'
statements
should
viewed
recommendations
agency,
would
determined
case-by-case
evaluation
by
authorities.
