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Nutrition & Health
Pharma Ingredients & Services - Excipients
Tablet Overview

 Filler (Ludipress®)                 Coating (Kollicoat®)             Binder (Kollidon®)
 Increases volume, making tiny       Protects from moisture and        Glues the different tablet
 little tablets manageable           unpleasant taste                  ingredients together




Disintegrant (Kollidon® CL)                                       Solubilizer (Soluplus®)
Decreases the disintegration time                                 Assists to dissolve the drug; only
                                                                  dissolved drugs have an effect
          + H2O 
                                                                       Solubilizer +     drug 
Soluplus®
The Solid Solution
Soluplus®


What is the solubility challenge?

               Based on the material (CaCO3) the solubility
               of marble is about 10 µg/mL

               The solubility of itraconazole is
               about 1 ng/mL at pH 7


               The Venus De Milo is 10,000-times
               more soluble than itraconazole

               The volume of water to solubilize a
               dose = 200,000 L!


                                                              Amidon et al.
                                                              Brewster
Soluplus®


What is the solubility challenge?

 A solid is dissolved in another solid, forming
   a transparent, homogenous solid solution


   Examples:
    Metal oxides in glass
    Plasticizer in polymer

    Active agent in polymer
Soluplus®


The Solid Solution - Principle

 Polymer matrix acts as a solid solvent for drug molecules
 In the ideal case, drug is molecularly dissolved in the polymer
 Enhanced rate of dissolution and solubility of drug molecules
  compared to crystalline form

    Crystalline          Hot melt          Solid solution           Tablets
       drug              extrusion          “extrudate”



            + Temp.
            + Polymer
Soluplus®


The melt extrusion process
                                     feeder
                                                                material flow

                                                 BASF
                                                                      engine


        extrudate       die          barrel    screw(s)


                                                               BASF




                    Shaping      Mixing section            Feeding
                    section conveying, kneading, melting   section
Kollicoat® IR Coating Systems
      Create Your Own Colors!
Kollicoat® IR Coating Systems


You may know the challenge …




                                How to achieve a
                                 certain color?
Kollicoat® IR Coating Systems


Our customers challenged us …




                                ?
Kollicoat® IR Coating Systems


You may know the solution …




                                A set of colors + Color
                                  measuring device
Kollicoat® IR Coating Systems


We took the challenge …



    BASF‘s Base Colors

                                Combine base
                                   colors
Kollicoat® IR Coating Systems


Benefit more from the BASF‘s Systems
  Xfast®                        Modular System           Kollicoat® IR

                                          +
                                   =
  Easy redispersion             Reduced number           Low viscosity allows
                                of stock-keeping units   high solids contents

            Time*                       Time*                    Time*
           savings                     savings                  savings



                                    Cost savings                      *   up to 40%
For further information contact our enablers …

              http://www.pharma-ingredients.basf.com/

              pharma-ingredients@basf.com




14.02.2008                                                    14
                                                              14
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Nutrition & Health: Pharma Ingredients & Services - Excipients

  • 1. Nutrition & Health Pharma Ingredients & Services - Excipients
  • 2. Tablet Overview Filler (Ludipress®) Coating (Kollicoat®) Binder (Kollidon®) Increases volume, making tiny Protects from moisture and Glues the different tablet little tablets manageable unpleasant taste ingredients together Disintegrant (Kollidon® CL) Solubilizer (Soluplus®) Decreases the disintegration time Assists to dissolve the drug; only dissolved drugs have an effect + H2O  Solubilizer + drug 
  • 4. Soluplus® What is the solubility challenge? Based on the material (CaCO3) the solubility of marble is about 10 µg/mL The solubility of itraconazole is about 1 ng/mL at pH 7 The Venus De Milo is 10,000-times more soluble than itraconazole The volume of water to solubilize a dose = 200,000 L! Amidon et al. Brewster
  • 5. Soluplus® What is the solubility challenge?  A solid is dissolved in another solid, forming a transparent, homogenous solid solution Examples:  Metal oxides in glass  Plasticizer in polymer  Active agent in polymer
  • 6. Soluplus® The Solid Solution - Principle  Polymer matrix acts as a solid solvent for drug molecules  In the ideal case, drug is molecularly dissolved in the polymer  Enhanced rate of dissolution and solubility of drug molecules compared to crystalline form Crystalline Hot melt Solid solution Tablets drug extrusion “extrudate” + Temp. + Polymer
  • 7. Soluplus® The melt extrusion process feeder material flow BASF engine extrudate die barrel screw(s) BASF Shaping Mixing section Feeding section conveying, kneading, melting section
  • 8. Kollicoat® IR Coating Systems Create Your Own Colors!
  • 9. Kollicoat® IR Coating Systems You may know the challenge … How to achieve a certain color?
  • 10. Kollicoat® IR Coating Systems Our customers challenged us … ?
  • 11. Kollicoat® IR Coating Systems You may know the solution … A set of colors + Color measuring device
  • 12. Kollicoat® IR Coating Systems We took the challenge … BASF‘s Base Colors Combine base colors
  • 13. Kollicoat® IR Coating Systems Benefit more from the BASF‘s Systems Xfast® Modular System Kollicoat® IR + = Easy redispersion Reduced number Low viscosity allows of stock-keeping units high solids contents Time* Time* Time* savings savings savings Cost savings * up to 40%
  • 14. For further information contact our enablers … http://www.pharma-ingredients.basf.com/ pharma-ingredients@basf.com 14.02.2008 14 14 14