Presentation on theme: "FILTRUM (0,45 g LIGNIN, TABS)"— Presentation transcript:
1 FILTRUM (0,45 g LIGNIN, TABS) NEW GENERATION ENTEROSORBENTLife free of toxins
2 FILTRUM INDICATIONS: Intoxication by poor food, alcohol, drugs. Lignin fibres of plant origin to neutralize wide range of endo- and exogenous toxins and pathogenic microorganisms in GI tractINDICATIONS: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 originFiltrum does not affect any tissues of the gastro-intestinal tract, is does not accumulate in any organs and is entirely eliminated from the intestines.
3 FILTRUMCOMPOSITIONLignin 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 :
4 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.
5 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 nature1970 / Russia – improved form of lignin was elaborated (lignin powder with higher absorbtion properties)1997 / Russia – tableted formulation of medical lignin (Filtrum) was patentedThere 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.
6 FILTRUM vs Activated Charcoal Broad absorbtion spectrumNarrow absorbtion spectrumNeutralizes bacteria and its toxinsLow absorbtion of bacteria and its toxinsBinds gistamine and food allergensBinds low spectrum of allergensNegative influence on intestinal mucous surfaceReparative effect of ligninon intestinal mucous surface
7 advantages in intoxication and acute intestinal diseases segment FILTRUMadvantages in intoxication and acute intestinal diseases segmentUniversal 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.
8 FILTRUMFrequency of acute toxic infections symptoms in people%
9 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 infection3. Intestinal infection4. Gastro-intestinal disorder of unspecified toxic origin60%
10 FILTRUMCLINICAL EVIDENCE Treatment of acute intestinal infections accompanied by diarrhea syndromeFig.1 Duration of main clinical symptoms in patients with acute dysenteryControl group (basic therapy): antimicrobials Furazolidon (nitrofurans) and ciprofloxacin (fluoroquinolones), and pathogenetic therapy – parenteral detoxification solutions (colloid and salt solutions), astringents, reparative drugs and adrenomimetics.Filtrum group = standard therapy +FiltrumRussian State Medical University (Moscow, 2001)
11 FILTRUMFig.2 Duration of main clinical symptoms in patients with gastrointestinal form of salmonellosisStandard therapy (control group): parenteral and oral rehydration by salt solutions and adrenomimeticsFiltrum group: standard therapy FiltrumRussian State Medical University (Moscow 2001)
12 FILTRUMFig.3 Duration of main clinical symptoms in patients with alimentary toxic infectionsStandard therapy (control group): parenteral and oral rehydration by salt solutions and adrenomimeticsFiltrum group: standard therapy FiltrumRussian State Medical University, 2001
13 FILTRUM Сlinical evidence Conclusion 1: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 infectionsDOSAGES:Children under 6 months - 1/4 tablet 3-4 times a day6 months - 1 year - 1/3 tablet 3-4 times a day1-3 years - 1/2 - 1 tablet 3 times a day4-7 years ,5 tablets 3 times a dayover 7 years - 2 tablets 3-4 times a day1-1,5 hours before or 1-1,5 hours after meal
14 FILTRUMEfficacy in combined treatment of acute intestinal infections in childrenPatients characteristicsEtiology: Klebsiella, Salmonella, Campilobacter, Rotaviruses, Thoroviruses, Norwalk viruses, UnspecifiedCharacteristicFiltrum (n=61)Control (n=58)Age (years)3.420.444.220.79Disease duration (days)3.340.362.450.2Filtrum 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 appetiteResearch Institute of Pediatric Infections (St.Petersburg, 2003)
15 FILTRUMFig.1 Duration of general infection symptoms in study and control patient groupsDays(rehydration, diet)Research Institute of Pediatric Infections (St. Petersburg, 2003)
16 FILTRUM Fig.2 Duration of local infection symptoms Days Research Institute of Pediatric Infections (St.Petersburg, 2003)
17 FILTRUMClinical 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 practiceResearch Institute of Pediatric Infections (St.Petersburg, 2003)
18 FILTRUM Positioning: key messages aspects First aid natural means for protecting organism from alimentary intoxicationMultipurpose non-drug means for decreasing acute intoxication of different nature (food, intestinal infections, alcohol)Universal anti-”Travellers diarrhea” protectorConvenient first aid supplement – always at hand in case of unexpected acute intoxicationStrengthens effect of the standard therapy in case of acute intestinal disordersAccelerates rehabilitation after food intoxication
19 FILTRUMR & D prospectsProduct improvement for children audience: confectionery, various tastesDifferent formulations: caplets, capsules, sache, gel, pasteCombination with additives giving detoxifying synergy effect for specific niche demandsModifying absorption spectrum to increase neutralization of toxic or microbe agents of definite parameters and propertiesSearch for new enterosorbents with unique properties beneficial for health and treatment
20 FILTRUM Representação no Brasil: R. Dr. Cândido Espinheira, 350 – 13° andar – Cj. 132CEP – São Paulo/SPFone / FAX