Transcript Filtrum

FILTRUM
(0,45 g LIGNIN, TABS)
NEW GENERATION ENTEROSORBENT
Life free of toxins
FILTRUM
Lignin fibres of plant origin to neutralize wide
range of endo- and exogenous toxins and
pathogenic microorganisms in GI tract
INDICATIONS:
 Intoxication by poor food, alcohol, drugs.
Intoxication by detrimental substances accumulating
at hepatic and renal insufficiency.
 Acute intestinal diseases (dysentery, salmonellosis,
rota-virus infections etc.)
 Diarrhea syndrom of unspecified origin
Filtrum does not affect any tissues of the gastro-intestinal
tract, is does not accumulate in any organs and is entirely
eliminated from the intestines.
FILTRUM
COMPOSITION
Lignin is formed by removal of
water from sugars to create
aromatic structures.
These reactions are non reversible. There
are many possible monomers of lignin, and
the types and proportions depend on the
source in nature. Some typical monomers
are shown in the sketch :
The OH groups (either the alcoholic OH's on the
chains or the phenolic OH's on the aromatic
rings) can react with each other or with the
aldehyde or ketone groups. When an OH reacts
with another, an ether linkage is formed. As we
see, an OH reacts with an aldehyde to form a
hemiacetal. The reactions of OH groups with
ketones forms ketals. An early stage in the
condensation of various monomers to form lignin
is shown in the next sketch :
FILTRUM / LIGNIN
COMPOSITION
There are several
groups shown in
red that can react
further. Some will
simply extend the polymer
while others would establish
cross linking. The monomer
that is shaded in orange has
three of its functional groups
linked to other monomers, so it
is starting a branch or cross
link. The large lignin molecules
fill three dimensions and are
heavily cross linked.
Sometimes lignin is isolated as
a brown powder, but more
often it is a gummy mixture of
lignins with a wide range of
molecular weights.
Lignin resists attack by most
microorganisms, and anaerobic
processes tend not to attack the
aromatic rings at all. Aerobic
breakdown of lignin is slow and
may take many days. Lignin is
nature's cement along with
hemicellulose to exploit the
strength of cellulose while
conferring flexibility.
FILTRUM / LIGNIN
HISTORY AND BACKGROUND
1943 / Germany – original enterosorbent product Porlisan
(on the basis of lignin) appeared as anti-diarrhea product for
curing diarrhea syndrome of infection and non-infection nature
1970 / Russia – improved form of lignin was elaborated
(lignin powder with higher absorbtion properties)
1997 / Russia – tableted formulation of medical lignin
(Filtrum) was patented
There are many pores on the surface of
Filtrum-sorbent: micro-, mezo- and
macropores, which results in broad spectrum
of absorbtion activity – from heavy metal
ions to microbic cells and organic metabolits.
Prevalence of mezopores enables Filtrum to
neutralize middle- and long-chained
molecules including endo- and exotoxins.
FILTRUM vs Activated
Charcoal
FILTRUM®
Broad absorbtion spectrum
Activated Charcoal
Narrow absorbtion spectrum
Neutralizes bacteria and its toxins Low absorbtion of bacteria and its toxins
Binds gistamine and food allergens
Reparative effect of lignin
on intestinal mucous surface
Binds low spectrum of allergens
Negative influence on intestinal
mucous surface
FILTRUM
advantages in intoxication and
acute intestinal diseases segment
 Universal means of decreasing intoxication in case of intoxication of
different etiology (poor food, acute intestinal diseases, alchogol
overdosage etc.)
 Neutrolizes pathogenic microflora and its toxins
thus blocking the pathogenic mechanism (vs. loperamide)
 No negative effect on normal microflora
(vs. intestinal antiobiotics)
 Does not form resistant stamps in pathogenic
microflora.
 High safety profile.
 Can be used to prevent an assumed intoxication.
FILTRUM
Frequency of acute toxic infections symptoms
in people
Abdominal pain
77
Diarrhea
60
Nausea, vomitting
48
Meteorism, swelling
32
Anorexia
25
Fever
14
Other
2
0
10
20
30
40
50
60
70
80
90
100
%
FILTRUM
Intoxication and acute intestinal diseases
According to marketing
research 60% of people at
least once a year suffered from the
following symptoms:
1. Gastro-intestinal disorders caused by
“food poisoning”
2. Alimentary toxic infection
3. Intestinal infection
4. Gastro-intestinal disorder of unspecified
toxic origin
60%
FILTRUM
CLINICAL EVIDENCE
Treatment of acute intestinal infections
accompanied by diarrhea syndrome
Fig.1 Duration of main clinical symptoms in patients
with acute dysentery
Control group (basic therapy):
antimicrobials Furazolidon
(nitrofurans) and ciprofloxacin
(fluoroquinolones), and
pathogenetic therapy – parenteral
detoxification solutions (colloid
and salt solutions), astringents,
reparative drugs and
adrenomimetics.
days
4,5
4
3,5
3
2,5
2
1,5
1
0,5
0
,
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ve
fe
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os
lo
oo
st
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ce
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Russian State Medical University (Moscow, 2001)
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no
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Filtrum group = standard
therapy +Filtrum
FILTRUM
Fig.2 Duration of main clinical symptoms in patients
with gastrointestinal form of salmonellosis
days
Standard therapy (control group):
parenteral and oral rehydration by
salt solutions and adrenomimetics
4
3,5
3
2,5
2
1,5
1
0,5
0
xia
or
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an
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lo
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Filtrum group: standard therapy
+ Filtrum
Russian State Medical University (Moscow 2001)
FILTRUM
Fig.3 Duration of main clinical symptoms in
patients with alimentary toxic infections
days
Standard therapy (control group):
parenteral and oral rehydration
by salt solutions and adrenomimetics
4
3
Filtrum group: standard therapy +
Filtrum
2
1
0
er
ef v
se
ol o
ol
ts o
n
ai
p
al
in
m
do
b
a
ss
nr e
de
et n
Russian State Medical University, 2001
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FILTRUM
Сlinical evidence
Conclusion 1:
DOSAGES:
 Children under 6 months 1/4 tablet 3-4 times a day
 6 months - 1 year - 1/3
tablet 3-4 times a day
 1-3 years - 1/2 - 1 tablet 3
times a day
 4-7 years - 1 - 1,5 tablets 3
times a day
 over 7 years - 2 tablets 3-4
times a day
1-1,5 hours before or 1-1,5
hours after meal
Filtrum is highly effective for treatment of
acute intestinal infections accompanied by
diarrhea syndrome, e.g. acute dysentery,
gastrointestinal form of salmonellosis and,
particularly, gastroenteritic form of
alimentary toxic infection. Filtrum therapy
results in shortening of the major clinical
signs statistical decrease (in days) over
30%.
Conclusion 2:
Filtrum can be recommended as a drug of
choice for patients with mild alimentary
toxic infections and salmonellosis as well
as a component of combined therapy of
moderate and severe dysentery,
salmonellosis and alimentary toxic
infections
FILTRUM
Efficacy in combined treatment of acute intestinal
infections in children
Patients characteristics
Characteristic Filtrum
(n=61)
Control
(n=58)
Age (years)
4.220.79
3.420.44
Disease
3.340.36
duration (days)
2.450.2
Etiology: Klebsiella,
Salmonella,
Campilobacter,
Rotaviruses,
Thoroviruses, Norwalk
viruses, Unspecified
Filtrum STI addition to basic therapy of acute
intestinal infections in children had beneficial
effect on general toxicity and resulted in
alleviation of fever, intoxication, nausea and
vomiting and in improvement of appetite
Research Institute of Pediatric Infections (St.Petersburg, 2003)
FILTRUM
Fig.1 Duration of general infection symptoms in
study and control patient groups
Days
4,5
4
Fever
3,5
3
Vomiting
2,5
Fatigue
2
1,5
Poor appetite
1
0,5
0
Filtrum
Control
(rehydration, diet)
Research Institute of Pediatric Infections (St. Petersburg, 2003)
FILTRUM
Fig.2 Duration of local infection symptoms
Control
Filtrum
Days
0
0,5
1
1,5
Abdominal pain
Loose stool
Undigested food remnants in feces
2
2,5
3
Tenderness
Mucus in feces
Research Institute of Pediatric Infections (St.Petersburg, 2003)
3,5
4
4,5
FILTRUM
Clinical evidence
conclusion:
addition of intestinal
sorbent Filtrum to
standard therapy of
acute intestinal
infections significantly
enhances treatment efficacy and results in a
quicker clinical recovery. Good tolerability and
significant therapeutic effect on the course of
acute intestinal infections in children, including
infants, allows giving Filtrum a positive opinion
and recommendation towards a wider
promotion of the drug into clinical practice
Research Institute of Pediatric Infections (St.Petersburg, 2003)
FILTRUM
Positioning:
key messages aspects
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First aid natural means for protecting organism from
alimentary intoxication
Multipurpose non-drug means for decreasing acute
intoxication of different nature (food, intestinal
infections, alcohol)
Universal anti-”Travellers diarrhea” protector
Convenient first aid supplement – always at hand in
case of unexpected acute intoxication
Strengthens effect of the standard therapy in case of
acute intestinal disorders
Accelerates rehabilitation after food intoxication
FILTRUM
R & D prospects
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Product improvement for children audience: confectionery,
various tastes
Different formulations: caplets, capsules, sache, gel, paste
Combination with additives giving detoxifying synergy
effect for specific niche demands
Modifying absorption spectrum to increase neutralization of
toxic or microbe agents of definite parameters and
properties
Search for new enterosorbents with unique properties
beneficial for health and treatment
FILTRUM
Representação no Brasil:
R. Dr. Cândido Espinheira, 350 – 13° andar – Cj. 132
CEP 05004-000 – São Paulo/SP
Fone 55 11 3676-0546 / FAX 55 11 3676-0559
[email protected]