Polisule Ointa

7/30/2019 Polisule Ointa

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POLICRESULENOINTMENT

Composi

Strength Each gm of Ointment contains

Policresulen concentrate equivalent toPolicresulen 50mg and

Cincochaine Hydrochloride 10mg

in an ointment base.

Category Treatment of Hemorrhoids

. Manufacturing Formula (Batch Size 60 Kg )

Sr. No Composition Overage % Qty/Batch

(kg/lts)

1 Policresulen 50% w/w Aqueous solution IH 5.000

2 Cincochaine Hydrochloride BP 0.500

3 Polawax 20.515

4 Polyethylene Glycol 400 20.515

5 Cremophor A6 1.500

6 Xanthan Gum IP 0.150

7 Calcium Hydroxide IP *0.500

8 Butylated HydroxyanisoleIP 0.050

9 Disodium Edetate IP 0.005

10 Purified Water IP 1.265

Manufacturing Process

1. Transfer,

Policresulen 50% w/w solution in a HDPE container, Add.

Calcium Hydroxide 0.500 kg.

dissolve by agitation.

Maintain the temperature below 500c throughout neutralization by using ice bath.

2.Transfer

Polawax 20.515 kg.

Cremophor A6 1.500 kg.


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Start heating by opening steam inlet valve. Close the steam inlet valve when

Temperature reaches to 65 50c. Disperse.

Xantan Gum 0.150 kg.

Under stirring. Continue stirring till it disperses.

3. Transfer

Polyethylene Glycol 400 20.515 kg.

In oil phase vessel and start heating by opening steam inlet valve. Add &

Dissolve the following under stirring.

Butylate Hydroxyanisole 0.050 kg

Close the steam inlet valve when temp reaches to 75 2 0c

4. Transfer step 3.0 to main mixing tank.

1. Transfer step 2.0 to main mixing tank and stir at high speed and cool to 48-520c.

2. Transfer step 1.0 to main mixing tank under stirring at high speed for 15 min.

3. Check the pH, (1+10 dilution using distilled water at 200c)

Adjust pH using 20% w/v sodium hydroxide solution until pH is 4.20.2 &

further with 2% w/v sodium solution until pH is 4.5 +0.1 and note the qty.

Required of sodium hydroxide, also note the qty. of Purified Water usedIf pH is above 5.0 then adjust it to 4.50.1 using Policresulen solution.

Note the quantity of policresulen used.

4. Transfer

Purified water 0.50 kg.

In a suitable SS vessel, dissolve

Disodium Edetate 0.005 kg.

Cincochaine Hydrochloride 0.500 kg.

Filter through 100 mesh nylon cloth.

5. Transfer step 8.0 to main mixing tank under stirring at high speed. Rinse the

vessel with purified water and transfer the rinsing to main mixing tank. Note the

Qty. of purified water used up to step. 9.0


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6. Add remaining purified water calculated by taking into consideration the potency

of policresulen and excess sodium hydroxide of policresulen used and total

purified water used up to step No. 8. Note quantity of purified water added.

7. Stir at high speed with homogenization for 5 min.

8. Cool to 28-320c under stirring at high speed & check the pH. Range 4.4-5.0.

9. Store the bulk in SS storage tank/HDPE containers.

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Polisule Ointa