Preparation of penicillin procaine
A process for preparing penicillin G procaine comprises the steps of introducing inactive ingredients into a first mixing tank and sterilizing the mixture of inactive ingredients in the first mixing tank. A procaine hydrochloride is dissolved in a second mixing tank, and the contents of the second mixing tank are added to the first mixing tank through a sterile filter. A solution of penicillin G potassium is introduced to the first mixing tank through a sterile filter, and the contents of the first mixing tank are mixed so that the procaine hydrochloride reacts with the penicillin G potassium forming penicillin G procaine. The resulting suspension is transferred through a homogenizer to a holding tank and penicillin G procaine is filled into a container.
1. A process for preparing a suspension of penicillin G procaine comprising the steps of:
introducing inactive ingredients into a first mixing tank;
sterilising the mixture of inactive ingredients in the first mixing tank;
dissolving procaine hydrochloride in a second mixing tank;
adding the contents of the second mixing tank to the first mixing tank through a sterile filter;
introducing a solution of penicillin G potassium to the first mixing tank through a sterile filter;
mixing the contents of the first mixing tank so that the procaine hydrochloride reacts with the penicillin G potassium forming penicillin G procaine;
transferring the resulting suspension through a homogeniser to a holding tank; and
filling the suspension of penicillin G procaine into a container.
2. A process as claimed in claim 1 wherein the suspension is transferred under nitrogen through the homogeniser.
3. A process as claimed in claim 1 wherein the homogeniser is orerated at a pressure of from 4,000 to 10,000 psi.
4. A process as claimed in claim 1 wherein the homogeniser is operated at a pressure of from 6,000 to 10,000 psi.
5. A process as claimed in claims 1 wherein the inactive ingredients are selected from one or more of the group consisting of water, methylparaben, lecithin, propylparaben, sodium carboxymethylcellulose and povidone.
6. A process as claimed in claim 1 wherein the mixture of inactive ingredients in the first mixing tank are heated to a temperature of from 55° C. to 65° C., then pH adjusted, and sterilised by heating to from 122° C. to 124° C. and subsequently cooled to about 25° C.
7. A process as claimed in claim 1 wherein procaine hydrochloride is dissolved in a mixture of water, sodium citrate, sodium formaldehyde and sulfoxylate in the second mixing tank.
8. A process as claimed in claim 1 wherein a solution of penicillin G potassium is prepared in a third mixing tank prior to delivery into the first mixing tank.
9. A process as claimed in claim 1 wherein the pH of the suspension is maintained between 5.0 and 7.5.