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					CONTOH FORMULASI
            Alpha-Methyldopa Tablets
                  (500 mg), DC
                  Formulasi   Dosis 1   Dosis 2

Alpha-Methyldopa              500 g     500 g

Avicel PH 101 [5]              54 g     200 g

Kollidon VA 64 [1]             20 g      30 g

Kollidon CL [1]                20 g      20 g

Talc [10]                      90 g       8g

Aerosil 200 [4]                 7g        1g

Magnesium stearate [2]          2g         -

Calcium arachinate [2]           -        1g
       Manufacturing (Direct compression)
• Pass magnesium stearate trough a 0.2 mm sieve and the
  other components
• through a 0.5 mm sieve, mix and press with high compression
• force (Formulation No. 1) and low compression force
  (Formulation No. 2).
       Tablet Properties      tablet 1     Tablet 2
       Weight                  93 mg       750 mg
       Diameter               12 mm        12 mm
       Form                   Biplanar    Biplanar
       Hardness                80 N         113 N
       Disintegration         < 1 min     1 – 2 min
       Friability              0,4 %        0,8 %
       Dissolution, 4 min      86 %           -
       Dissolution , 16 min    92 %           -
              Aminophylline Tablets
                    (90 mg)
               Formula                 Dosis 1   Dosis 2
Aminophylline, hydrous powder           90 g      90 g
(Knoll)
Potato starch [3]                       80 g        -
Corn starch [3]                           -         g
Kollidon VA 64 [1]                       3g        3g
Kollidon VA 64 [1].                      3g        3g
Water                                   30 g      27 g
Magnesium stearate [2]                   1g         -
Talc [10]                                4g         -
Polyethylene glycol 6000, powder [6]      -       10 g
    Manufacturing (Wet granulation)
-    Granulate mixture I with solution II, pass through a 0.8 mm sieve, dry,
• mix with III, pass through a 0.5 mm sieve and press to tablets with

• medium compression force.

           Tablet properties          Tablet 1               Tablet 2
        Weight                        179 mg                  180 mg
        Diameter                       8 mm                   8 mm
        Form                          Biplanar               Biplanar
        Hardness                        80 N                   72 N
        Disintegration                3 – 4 min              6 – 7 min
        Friability                     0,4 %                   0,4 %
Beta Carotene + Vitamin C + Vitamin E
          Chewable Tablets
     (10 mg + 500 mg + 250 mg)
                    Formula             Dosis

 Beta Carotene dry powder 10%           100 mg

 Ascorbic acid, crystalline (BASF)      250 mg

 Sodium ascorbate, crystalline          280 mg

 Vitamin E acetate dry powder SD 50     500 mg

 Sorbitol, crystalline [10]             600 mg

 Ludipress [1]                          500 mg

 Fructose                               350 mg

 Polyethylene glycol 6000, powder [6]   50 mg
 Manufacturing (Direct compression)

• Mix all components, pass through a sieve and
  press with high compression
• force.
               Properties        Tablet
      Weight                    2600 mg
      Diameter                   20 mm
      Form                      Biplanar
      Hardness                   122 N
      Disintegration (water)   15 – 20 min
      Friability                 0,4 %

				
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posted:4/25/2012
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Andi Widiyanto Andi Widiyanto CEO http://storiesme.com
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