BETAMETHASONE AND NEOMYCIN EYE/EAR DROPS
Betamethasone & Neomycin Sulphate Eye/Ear Drops are a combination drug of antibiotic and steroid medicine that is used when there is a risk of bacterial infection in or around the eye.
USES OF BETAMETHASONE & NEOMYCIN EYE / EAR DROPS
Betamethasone & Neomycin Sulphate Eye / Ear Drops are used to treat eye inflammation caused by bacterial infections.
DOSAGE FORM: OPHTHALMIC DOSAGE FORM
Neomycin Sulphate IP 0.5% w/v
Betamethasone Sodium Phosphate IP 0.1% w/v
Benzalkonium Chloride (as preservative) IP 0.02% v/v
Aqueous buffered vehicle q.s
- Eye irritation
- Eye pain
- Blurred vision
HOW TO USE
This medication is for external use only. It is advisable to take this medicine as per prescribed by your doctor. Follow the directions as given on the prescription label. For ear application- Hold the dropper close to the ear without touching it. Gently squeeze the dropper and place the medicine inside the ear. For eye application- Gently squeeze the dropper and place the medicine inside the lower eyelid. Wipe off the extra liquid.
HOW TO DO BETAMETHASONE & NEOMYCIN SULPHATE EYE / EAR DROPS WORK
Betamethasone & Neomycin Sulphate Eye / Ear Drops are combination drugs containing Betamethasone and Neomycin Sulphate. Betamethasone is a corticosteroid that helps in reducing swelling, itching, and redness of the skin. Neomycin Sulphate stops bacterial growth by preventing the synthesis of essential proteins.
EQUIPMENT TO BE USED FOR MANUFACTURING:
- Auto Clave with SS Transfer trolley
- Multi-Column Distillation Still
- Distill Water Storage Tank
- SS Batch Mixing Tank
- SS Pressure Vessel – 100 Ltr.
- SS Membrane Filtration Assembly (293 mm)
- SS Filling Vessel – 100 Ltr
- Auto Liquid Vial Filling, Stoppering & Sealing Machine
- Auto Vial Labelling Machine
Equipment to be sterilized :
- S.S Membrane Filter Assembly
- S.S Filling vessel
- S.S Filling syringes
- Sterile dress of the operator
- Pre Nitrogen Filling needles& POST- nitrogen-filling needles
- Silicon tubes
RAW MATERIALS USED IN MANUFACTURING
|S.NO.||INGREDIENTS||STD||Theoretical Quantity Req.||Overages %||Total Quantity Used|
|1.||BORIC ACID||I.P.||0.200||–||0.200 KGS|
|3.||BETAMETHASONE SODIUM PHOSPHATE||I.P.||100.000||15.000||115.000 GMS|
|4.||BENZYLKONIUM CHLORIDE||I.P.||0.02||–||0.02 KGS|
|6.||DI SODIUM HYDROGEN ORTHOPHOSPHATE||I.P.||0.280||–||0.280 KGS|
|7.||NEOMYCIN SULPHATE||I.P.||0.500||20.000||0.600 KGS|
|9.||SODIUM DI HYD. ORTHOPHOSPHATE||I.P.||0.066||–||0.066 KGS|
|10.||TRI SODIUM ORTHOPHOSPHATE||I.P.||0.040||–||0.040 KGS|
|11.||TWEEN – 80 (SD)||I.P.||0.010||–||0.010 LTRS|
- 10 ML PLASTIC VIALS WITH CAP & NOZZLE (PRE-STERILIZED)
- STICKER LABEL
- UNIT CARTONS
- OUTER CARTONS
- CORRUGATED BOX
MANUFACTURING PROCESS OF BETAMETHASONE & NEOMYCIN EYE / EAR DROPS:
I) Preparation of Solution:
- Take in Mixing Tank and take 70 Lt. of freshly prepared distilled water.
- Dissolve Boric Acid and Borax in 10 Ltr. of water and add to Batch Mixing Tank Stir it properly.
- Dissolve Betamethasone sodium phosphate and stir properly.
- Dissolve Di-Sodium Orthophosphate and monosodium orthophosphate & Tri-Sodium phosphate and add to the mixing tank stir it properly.
- Dissolve SMBS & EDTA in water and pour in BMT.
- Dissolve Benzylkonium Chloride in the mixing tank.
- Dissolve Neomycin Sulphate and add it to the mixing tank.
- Dissolve Tween – 80
- Adjust the pH to 7.1 (pH RANGE: 6.8 TO 7.2)
- Make up the volume to 100.00 Ltr.
- Shift the solution from the mixing tank to the pressure vessel and do membrane filtration.
Filtration is done with the membrane assembly by using the appropriate pre-filter and post-filter i.e. membrane – Pre Filter 1.5 µ & Membrane Filter 0.2 µ.
III) Aseptic Filing
After the process of washing, sterilization Filteration filing of Aseptic filing is carried out in the class 100 area under the laminar flow. The machine adjustment is carried out for the appropriate vials.
Butyl Bung Station Adjustment
Sealing Station Adjustment
VI) Volume variation is checked intermittently, volume prescribed 5ml, and volume filled 5.05 ml, percentage variation 10%.
- Pack the filled vials in a unit carton
- Pack such 24 cartoons in each outer carton
- Seal the outer carton with cello tape
- Pack the 24 outer cartons in the specified corrugated box to give a pack size of 24 x 24 x 10 ml.
- Seal the corrugated box with adhesive tape and label it properly by affixing the specified label
IN-PROCESS CONTROLS DURING THE MANUFACTURING OF EYE / EAR DROPS:-
The following in-process controls should be maintained during the processing.
- Check raw materials used for manufacturing purposes are all approved materials and have ‘released’ labels fixed on them.
- All weighed Raw materials should be counter-checked by Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of the Production Manager and QC/QA Manager.
- Physical characteristics of Raw materials like colour, odour, and consistency are checked before compounding.
- The final volume should be made as per Standard Operating Procedure.
- pH of the bulk should be checked and it should be within specified limits.
- Bulk samples should be sent for analysis to QC Department before starting the filling and sealing stage.
- Intermittently filled volume should be checked at 30-minute intervals by the Manufacturing Chemist and a record for the same should be kept in Batch Manufacturing Record.
- The net volume should be checked for all the filling nozzles and in no case, the net volume should be less than the volume claimed on the label. (Limit for volume variation: volume claimed + 5%.
- The labels and cartons should be checked thoroughly for proper batch coding.
- Intimation should be sent to QC Department for finished product sampling and testing.
- After the completion of labeling and packaging, the coded labels and cartons should be accounted for rejected printed material should be destroyed in the presence of the QC/QA Manager. Maintain the destruction of the same in the BMR.
- It will ensure that the filling or packing equipment has been properly cleaned.
- Filling or packaging of the next product should not commence until the ‘Line Clearance’ has been given by the IPQA.
- Carry out bubble test for checking the integrity of membrane filter as per SOP.