Environmental Engineering Reference
In-Depth Information
Epaxal
®
(Berna Biotech Ltd, Berne Switzerland) and Inflexal
®
V (Berna Biotech
Espa˜a SA, Madrid, Spain) has been approved for intramuscular delivery
[
1
-
9
]. The potential for liposome breakdown following exposure to bile salts
makes it troublesome for oral delivery.
Globally research has led to the development of nanoliposomes that are currently
applied in clinical practice. Several micelle designed by encapsulating anti-cancer
drugs like paclitaxel (Micelle NK105), cisplatin (NK6004), and epirubicin
(NK-6300) carrying paclitaxel are currently under Phase 3 trial [
88
].
DepoDur (Almac Pharma Services Ltd), an extended-release injectable liposo-
mal formulation of morphine, exploiting DepoFoam drug formulation technology
(Pacira Pharmaceuticals, Inc.) was highly indicated for epidural administration for
the treatment of superior pain control following major surgery. The usage of
DepoDur in clinical trials decreases the dosage of systemically administered anal-
gesics like un-encapsulated morphine or intravenous administration of an opioid,
needed for the first 1-2 postoperative pain management [
5
].
The synergistic delivery of TLR4/TLR7 adjuvant into an anionic liposome to
trigger Th1 biased responses was pharmaceutically acceptable and will have a
straightforward path into human clinical trials [
28
].
The role of curcumin (diferuloyl methane) for cancer treatment has been limited
in its clinical use due to its low absorption and poor bioavailability. Encapsulation
of curcumin by nanoliposome or in a salmon
s lecithin liposome improved its
'
bioavailability as a therapeutic agent [
29
].
AeroEclipse II nebulizer formulated with pDNA complexed CLP like GL67A
(pDNA/GL67A) for slower aerosol delivery only during the inspiratory phase was
used as efficient lung gene therapy to many acute and chronic diseases, including
cystic fibrosis as part of phase IIa/b clinical studies [
75
].
The liposomal formulation of mifamurtide (immunomodulator with antitumor
effects mediated by activation of monocytes and macrophages) was Mepact
(Takeda Ireland Ltd, Wicklow, Ireland/Takeda Italia Farmaceutici S.p.A, Cerano,
Italy) used in children, adolescents, and young adults for the treatment of high-
grade, non-metastatic osteosarcoma after macroscopically complete surgical resec-
tion. Mepact was intravenously administered in conjunction with postoperative
multiagent chemotherapy to significantly increase overall survival of patients in
clinical trial [
5
,
89
,
90
].
The DexP, in comparison to commonly used corticosteroids, effectively
inhibited inflammation in childhood systemic inflammatory disorders like MAS
and was used as first-line therapy for MAS [
55
].
During clinical trials with gene therapy, safety is mainly concerned with the
immunogenicity of the viral carriers and their random integration into the host
genome. To improve clinical transplantation of hematopoietic stem/progenitor cells
(HSPCs) and CXC chemokine receptor 4 (CXCR4) gene delivery therapies in
leukemia, nonviral, and safer CLP agent IBAfect was used [
85
].
With safety as a primary concern for use of liposomes, the safety and pharma-
cokinetics of the combination therapy of LAmB and CAS in comparison to
conventional mono-therapy were investigated in a randomized, risk-stratified,
