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FUNGISOME™ - a Liposomal Lipid
complex of AmphotericinB is the latest addition to
the lipid formulations of AmphotericinB. Through
the clinical studies conducted at multiple centers,
it is established that FUNGISOME™ - is the most
effective and affordable drug for treatment of both
Systemic Mycosis and Kala-Azar.
FUNGISOME™ is a true liposomal preparation of
AmphotericinB in which lipid complex of liposomes
is constituted of lecithin and cholesterol. The
mixed lamellar preparation does not require
reconstitution. Ultrasonication is used for maximization of small unilamellar
vesicles (SUVs) by disruption of Multi lamellar
vesicles (MLVs) in the preparation.
Ultrasonic disruption of FUNGISOME™ changes MLVs to
SUVs.
Liposomes are microscopic vesicles made up of
concentric layers of fat and are proven to be
versatile controlled release carriers of Drugs and
Vaccines. AmphotericinB is the most potent wide
spectrum drug for treatment of Systemic Fungal
Infections. Systemic Mycosis - life threatening
fungal infections are frequent in patients with
diseases causing immune impairment. Majority of
patients are recipients of Transplants such as
Kidney or Bone Marrow and Cancer Patients undergoing
Radiotherapy or Chemotherapy. In addition, Systemic
Mycosis is also important concern in patients of
HIV, those subjected to invasive procedures such as
Dialysis and complicated Surgeries. Diabetics, Burn
victims and Neonates are also prone to immune
depression.
Conventional preparation of AmphotericinB which is
a suspension of the drug in a Bile Salt carries a
serious risk of Nephrotoxicity, Cardiotoxicity and
other adverse effects. Published literature
categorically states that Liposomal AmphotericinB
with cholesterol has given better result clinically
than other lipid formulation of Amphotericin B
without cholesterol. Lifecare's FUNGISOME™ is a
strategically designed targeted drug. It contains
sterol as Liposome constituent, necessary to prevent
interaction with Human cells and to raise
specificity to target Fungal cells thus making it
the safest formulation as proven by international
experience of Liposomal AmphotericinB of more than
a decade. FUNGISOME™ matches with the best of the
options in terms of therapeutic efficacy and the
treatment costs are as little as one tenth.
Diagrammatic representation of mechanism and
reduction in AmphotericinB toxicity to patients by
liposome targeted drug delivery to fungal cells.
FUNGISOME™ is also effective treatment of visceral leishmaniasis (VL) also known as Kala-Azar caused by
protozoan parasite Leishmania. Leishmaniasis is
presently endemic in all continents except
Australia. According to a WHO report of year 2000
there were 4 million existing cases of Kala-Azar
with pattern of 0.7 million additional new cases
every year. As much as 90% of the VL cases are in
five countries Bangladesh, Brazil, India, Nepal and
Sudan. India alone accounts for on fourth of the
total world wide incidents.
In India, Kala-Azar (VL) is common in the eastern
parts of the country mainly in Bihar and adjoining
parts of UP, Jharkhand, Uttaranchal, Orissa and
Bengal. Even in Kala-Azar FUNGISOME™ acts as a
targeted Drug. FUNGISOME™ is targeted to macrophage
cells wherein the parasite causing Kala-Azar
resides.
It is well known that both liposomes and a variety
of pathogens are engulfed by macrophages which
increases the effectiveness of drugs encapsulated in
liposomes. This is also the reason why liposomal
pharmaceuticals are believed to be suitable for
macrophage mediated diseases.
Liposomes engulfed in the macrophages. Liposomal
contents were detected by immuno-gold staining
procedure.
Electron micrographs modified from J.N. Verma,
N.M.Wassef, R.A. Wirtz, C.A. Atkinson, M.Aikawa, L.D.
Loomis and C.R. Alving. (1991) Biochimica et
Biophysica Acta, 1066,:299-238 with permission from
J.N. Verma.
FUNGISOME™ has undergone extensive safety,
preclinical and multi-center clinical studies at
government and private hospitals including KEM
Hospital, Tata Memorial Cancer Hospital, Jaslok
Hospital, Hinduja Hospital, Bombay Hospital, Nair
Hospital and Patna Medical College. All
the data at every stage of pre-clinical studies and
clinical trials have been duly submitted to the
Drugs Controller General of India (DCGI) and given
due approvals by the DCGI.
Availability of this effective, safe and affordable
anti-fungal FUNGISOME™ is a boon for patients who
until now had difficult option either unaffordable
and / or unsafe.
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