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Formula Baku Sediaan Gel

| August 2, 2012 | 0 Comments
  1. 1.            Drug Formulations manual Page 591-592, 2nd Ed. 1998

Diclofenac Gel

Labeled Formula

Diclofenac Diethylammonium Salt

Equivqlqnt to Diclofenac Sodium 1 % w/w

Batch size :150 kg

Practical Yield : 4850 tubes of 30 g

Formulation :

  1. Liquid paraffin                                                                     3,75 kg
  2. White Petrolatum Jelly                                                         5,00 kg
  3. Diclofenac Diethyammonium salt                                       1,74 kg
  4. Isopropyl alcohol                                                                 15,00 liters
  5. Propilen glycol                                                                     15 kg
  6. Carbopol 934 P                                                                    1,5 kg
  7. Sod. Hydroxiode 10 % solution (for pH adjustment)         q.s.
  8. Flavours (Lavender,Cologne)                                             300 mL
  9. Distillated water                                                                  q.s.

 

Manufacturing Proccess :

  1. Charge 110 liters distilled water to a 6,5 tank and suspend carbopol 934 P by adding slowly under homogenizer type stirrer wuth fast stirring.
  2. Prepare a solution of isopropyl alcohol, diethylamonium salt diclofenac and propylene glycols
  3. Add slowly solution of (2) to carbopol susupension of step (1)
  4. Melt white petrolatum jelly and mix liquid paraffin and add to the carbopol jelly mix well.
  5. Add sodium hydroxide 10% solution to adjust the pH to 7,0 add the flavours and mix well

Adjust the final weight with distilled water and mix well

 

 

 

  1. 2.            Proportion                                            %

Diclofenac Sodium                                2

Coconut fatty acid diethanolamid         2

Purified Water                                       60

Oleyl alcohol

D-sorbitol                                               20

Sodium polyacrilat                                 5

Propilenglycol                                        10

 

Prosedur pembuatan :

Dilofenak-Na dan coconut fatty acid dietanolamid dicampur kemudian ditambah purified water, dicampur dan diaduk dengan stirrer sampai larutan jernih menunjukkan bahawa dikofenak-Na telah larut semua. Oleyl alcohol dan D-sorbitol ditambahkan kdalam campuran di atas (selanjutnya disebut campuan A). campuran A disuspensikan dengan sodium poliakrilat dan propilenglikol dotambahkan kemudian. Aduk dengan stirer sampai terbentuk keonsistensi gel. Gel jernih karena diklofenak telah terlarut.

(www.patenstrom.us/patents)

 

  1. 3.            Cataplasm

Proportion                                              %

A              Diclofenak-Na                                  2

Coconut fatty acid diethanolamid    2

Purified Water                                  33,65

B  Gelatin an purified water                  3

D-Sorbitol                                         30

Salisic acid                                        2

D              Oleyl akcohol                                    1

Propilenglycol                                   7

Sodium polyacrilat                            5

CMC-Na                                          1

Polybutene                                        1

Tartaric acid                                      0,5

Al(OH)2                                            0,2

 

Prosedur pembuatan :

Bahan A dicampur sampai larutan dklofenak-Na jernih. Bahan B dipanaskan ditempat yang berbeda agar gelatin larut. Bahan A dan B dicampur, emudian bahan D ditambahkan sambil distirer sampai terbebtuk gel yang homogen.

(www.patenstrom.us/patent)

 

  1. 4.            Diclofenac Diethylamonium gel

Bahan                                        jumlah/kg (g)

Water purified                            465,53

Alcohol                                      500,00

Menthol                                      2,00

Diclofenac Diethylamonium      12,47

Carbopol 940                             8,00

Trolamin                                     12,00

 

Cara pembuatan :

1)      Aquadest dan alcohol dicampr dalam stenlis steel tank.

2)      Ditambahkan mentol ke dalam campuran (1), aduk selama 5 menit sampai tercampur homogen.

3)      (2)+ diklofenak detilamonium, campur selama 10 menit.

4)      Carbopol didispersikan, dicampur perlahan selama 1-2 jam atau sampai carbopol mengembang sempurna dalam larutan hidrokoloid.

5)      (4) + TEA dan dicampur selama 10 menit atau sampai terbentuk konsitensi gel.

6)      Masukkan ke dalam wadah yang seuai atau tube alumunium.

( Handbook of Pharmaceutical Manufacturing Formulation)

Category: Teknologi Farmasi

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