Formulation of Gentamycin Cream

LABELLED FORMULA

Gentamycin                                            0.1 % w/w
(As Sulphate)

BATCH SIZE                       :           40 Kg.

PRATICAL YIELD             :           2600 Tubes of 15 g

USUAL PACKING              :           15 g. Collapsible Tubes

 
FORMULASI

S.No.	Ingredients	Quantity
1	Gentamycin Base (as Sulphate)	*40,00 g.
2	Chlorocresol	40,00 g.
3	Sodium Acid Phosphate	135,65 g.
4	Phosphoric Acid	0,80 g.
5	White Soft Paraffin	6,00 Kg.
6	Liquid Paraffin	2,40 Kg.
7	Cetomacrogol 1000	0,90 Kg.
8	Cetostearyl Alcohol	2,88 Kg.
9	Distilled Water	2,88 Kg.
10	** 1 % Sodium Hydroxide Solution	Q.S.

            ** (For pH adjustment) 

              * Calculation for Gentamycin Sulphate

        1000 x 40                    = Gentamycin Sulphate
         Potency of Gentamycin Base

Manufacturing Process

Part I – Oil Phase

Charge white soft paraffin, liquid paraffin, cetomacrogol and cetomacrogol and cetostearyl alcohol to a suitable vessel. Heat to melt and maintain a temperature of 70^o – 75^o C

Part II – Aquous phase

Dissolve Sodium Acid Phosphate, Chlorocresol and Phosporic Acid in the Distiled Water and maintain a temperature of 65^o – 75^o C.

1.       Add oil phase to Aquous Phase and stir for 15 minutes, start cooling and cool to 45^o – 46^o C.

2.       Cool the batch by further cooling and attain a temperature of 40^o – 42^o C.

3.       Dissolve Gentamycin Sulphate in water and add to the batch at 42^o – 42^o C.

4.       Check the pH and adjust to 4.8 to 4.9 (limit 4.5 to 5.5).

5.       Send a sample to Q.C. for evaluation.