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    Aqueous Enteric Coating Polymer
    
    
    Aqueous Enteric Coat L30D is an aqueous dispersion of
    a neutral co-polymer which confirms to USP/NF specifications of Methacrylic
    Acid Co-Polymer, Type C. 
     
     Aqueous Enteric Coat L100D is spray dried powder of Aqueous Enteric Coat
    L30D dispersion. It is an anionic polymer which confirms to USP/NF
    specification of Methacrylic Acid Co-Polymer, Type C. 
 
    Use
    Enteric coating of tablets, pills, pellets,
    granules, and powders. 
    Features
    Appearance : Aqueous Enteric Coat L30D forms
    colourless and transparent film in presence of plasticizers, colour can be
    given with pigments. 
    Solubility : The Aqueous Enteric Coat L30D films formed are
    insoluble in pure water, in buffer solutions below pH 5.5 and natural
    gastric juices. Aqueous Enteric Coat L30D films are soluble in neutral to
    weakly alkaline region of the digestive tract, in intestinal fluids and
    buffer solutions above pH 5.5 
    Applications 
    
    
      - Enteric coating for resistance to gastric fluid, (to protect active
        drug from influence of acids, prevent irritation of gastric mucosa).
 
      - Film coating of tablets, pills for protecting the drug from
        surrounding environment, particularly air, moisture, light, thus
        retaining required stability. 
 
      - Masking unpleasant taste and odour, thus overcoming resistance to
        drug ingestion. Providing product identity for
        differentiation of products from manufacturing, storage to patient.
      
 
      - Imparting cosmetic elegance to product appearance, masking, any
        noticeable visible differences in tablet core from batch to batch. 
 
      - Reducing risk of interactions between incompatible ingredients. 
 
      - Improves mechanical integrity, eliminating possibility of abrasions
        chipping etc
 
 
      - Insulating hygroscopic cores. 
 
      - Isolating porous cores. 
 
      - Extending and improving keeping properties. 
 
    
 
    Advantages
    
    
      - It eliminates fire hazard in your factory. 
 
      - It eliminates toxicity inhaling for coater. 
 
      - It reduces cost of solvents and indirectly reducing your cost of
        production without compromising the quality. 
 
      - Miscible with water in any proportion. 
 
      - Less quantity required, hence reducing volume of dispersion for
        coating. 
 
      - Low temperature required for film forming. 
 
      - Exhibits excellent colour value. 
 
      - Stability over a broad temperature range. 
 
      - Marginal weight gain in tablets.
 
      - Hydrophobic. 
 
    
 
    Specification
    Aqueous Enteric Coat L30D
    
      - Appearance - White, milky liquid
 
      - Odour - Weakly aromatic. 
 
      - Content - 28.5 to 31.5% w/w dry polymer. 
 
      - Acid value - 300 - 330 mg KOH/mg dry polymer. 
 
      - Solubility - Water or organic alcohols, acetone. 
 
    
Aqueous Enteric Coat L100D
    
      - Appearance - Off white powder. 
 
      - Odour - Weakly aromatic. 
 
      - Content - 95% Min. dry polymer. 
 
      - Acid value - 300 - 330 mg KOH/gm dry. 
 
      - Solubility - Water or organic alcohols, acetones. 
 
    
 
    Toxicity 
    Aqueous Enteric Coat L30D is a high molecular weight
    polymer. It is not absorbed by body tissues and is totally safe for human
    oral consumption. Test for toxicological tolerance show that it does not
    have pronounced physiological action and is non-toxic. 
    Alternatives
    Solvent Enteric L100 solvent system can be adopted.
    Plasticizer
    Aqueous Enteric Coat L30D film is brittle in nature.
    To improve film elasticity use of plasticizer is strongly recommended. The
    recommended plasticizers are polyethylene glycol, triacetin, triethyl
    citrate etc
 usually 10% of plasticizer is sufficient, but if
    necessary, can be increased to 25% 
    Average Requirement 
    Aqueous Enteric Coat L30D : 135 gms. Enteric
    L30D per 1 kg. tablets for enteric coating.
    Aqueous Enteric Coat L100D : 40 gms. Enteric L100D per 1 kg. tablets
    for enteric coating. 
    Storage
    At low temperature below 400c and keep away from
    frost.
    Shelf Life 
    Two years for Aqueous Enteric Coat L30D & five
    years for Aqueous Enteric Coat L100D from the date of manufacturing. Keep
    the container in tightly closed condition. 
    Packing
    Aqueous Enteric Coat L30D : 5 kg, 20 kg, net
    in H.D.P.E. drum. 
    Aqueous Enteric Coat L100D : 5 kg, 20 kg, in corrugated box. 
    Certificate of Analysis
    
      
          | 
        
        
          
            | Test | 
            Specification | 
            Results | 
           
          
            | Description | 
            Milky White Liquid of Low Viscosity | 
            Milky White Liquid Of Low Viscosity | 
           
          
            | Solubility | 
            Soluble in Acetone Alcohol, IPA | 
            Soluble In I.P.A. & Acetone | 
           
          
            | Identification | 
            A. Complies 
             B. Complies | 
            Conforms | 
           
          
            | Viscosity Dry Polymers | 
            BETN 100 TO 200 | 
            120 Cps | 
           
          
            | pH | 
            BETN 2.0 TO 3.0 | 
            2.71 | 
           
          
            | Acid Value (mgKOH/gms dry substance) | 
            BETN 300 TO 330  | 
            310 | 
           
          
            | Residue on Ignition | 
            NMT 0.2% | 
            Conforms | 
           
          
            | Heavy Metals | 
            NMT 0.002% | 
            Conforms | 
           
          
            | Limit of monomers | 
            NMT 0.01% | 
            0.00246% | 
           
          
            | Coagulum Content | 
            The Weight Of The Residue Does Not Exceed 1000 Mg.
            (1%) | 
            Conforms | 
           
          
            | Assay for Methacrylic Acid Copolymers Content | 
            Bet'n 46.0 To 50.6% | 
            47.74% | 
           
          
            | Emulsion%Solid | 
            28.50 To 31.50% | 
            30.8% | 
           
          
            | Emulsion Viscosity | 
            Nmt 15 Cps | 
            06 Cps | 
           
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