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Flow Chart and Manufacturing Procedure of Nimesulide Tablets

Flow Chart and Manufacturing Procedure of Nimesulide Tablets

Bill of Materials

Ingredient Pharmacopoeial Status Pharmaceutical role
Nimesulide Ph.Eur Active
Lactose Monohydrate Ph.Eur. Diluent
Croscarmellose Sodium Ph.Eur Disintegrant
Silica, Colloidal Anhydrous Ph.Eur. Glidant
Maize Starch Ph.Eur Diluent
Povidone (K-30) Ph.Eur. Binder
Docusate Sodium Ph.Eur. Surfactant
Polysorbate 80 Ph.Eur. Surfactant
Hydrochloric Acid,Concentrated Ph.Eur. pH Adjusting agent
Water, purified Ph.Eur Vehicle for binder
Magnesium Stearate Ph.Eur. Lubricant

List of Process Equipment’s

S.No. Equipment Name Capacity
    1. Vibro Sifter 50-250Kg/Hrs.
    2. Stationary Hydraulic Lift 150 kg/cycle
    3. RMG 250Ltrs..
    4. S.S Jacketed kettle 100Ltrs/ cycle.
    5. FBP 120 kg/cycle
    6. Sifter cum MultiMill 100-250 Kg/cycle
    7. FBD Bowl Tipper 250kg/ cycle
    8. Electronic Balance 1500kg
    9. Conta Blender 600-1200 Ltrs
  10. Compression Machine 61 station. 120,200-300,000/Hr.
  11. Blister Packing Machine 250 PDA Max 250 Strips/Min
  12. HSAjet TCU Printer online
13. BOPP Tapping Machine online

Equipment’s / Instruments used for In-process checks

The following calibrated equipment’s / Instruments are used for in-process checks.

S. No. Equipment /Instrument Name
1.        Analytical weighing Balance
2.        Halogen Moisture Analyser
3.        Friability Test Apparatus
4.        Hardness Tester
5.        Vernier Caliper
6.        Disintegration Test Apparatus

Manufacturing Procedure.

Manufacturing procedure in brief comprise of following steps:

Step – I : SIFTING : Sift Silica, Colloidal Anhydrous, Maize Starch, Croscarmellose Sodium, through Vibro Sifter fitted with sieve of mesh size 60 collect the sifted material in IPCs.

Step – I : SIFTING : Sift Nimesulide, Lactose Monohydrate through Vibro Sifter fitted with sieve of mesh size 20 collect the sifted material in IPCs.

Step – III : DRY MIXING : Perform dry  mixing  of  sifted materials of step I & II  in RMG.(mix for 10 minutes, mixer at slow speed and chopper off ).

Step – IV : BINDER PREPARATION:

Step – IVa:Take S.S containers, add Hydrochloric Acid in Water, Purified & measure pH (by calibrated pH meter ) . pH should be between 2.5-3.5.

Step – IVb: In S.S jacketed kettle (80 to 90 °C) dissolve Docusate Sodium, Povidone (K-30) and  Polysorbate 80 in hot Water,  purified with continues stirring to obtain a clear solution.

Step – IV c:  Add bulk of Step – IVb [temperature  of bulk should be between (50 to 60 °C )] to Step – IVa and mix.

Step – V : WET GRANULATION :  Add binder solution of Step – IVc to the dry mix Step – III , slowly  and mix   at mixer slow speed for 3 minutes and knead the mass for 2-4 minutes at mixer fast speed . Add more  Water, Purified, if required to achieve the granulation end point.

Step – VI: DRYING : Dry the wet mass of step V in Fluidized Bed Processor at an inlet air Temp. of 75±5°C till LOD in the range of 1.0- 3.0 % w/w is achieved.

Step –VII:  DRY MILLING:  Mill the dried granules of Step – VI through sifter cum multimill using 2.0 mm screen for sifter and 2.0 mm screen for miller with knives forward orientation at slow speed , collect the granules in Blender’s Bin.

Step –VIII:  WEIGHING OF GRANULES :Weighing of  granules is done  by using a calibrated balance and calculate the actual  yield..

Step –IX: SIFTING OF POST GRANULATION INGREDIENTS:

Sift Magnesium Stearate, Silica, Colloidal Anhydrous, Croscarmellose Sodium through Vibro Sifter fitted with sieve of mesh size 40.

Step –X: BLENDING/ LUBRICATION  : Add the lubricants of Step –IX to Blender’s Bin of Step –VII and mix for 10 minutes at rpm 8.

Step –XI: WEIGHING :Weighing of  lubricated granules is done  by using a calibrated balance and calculate the actual  yield..

Step –XII: SAMPLING : Inform to IPQA Department through In-process Analytical Request  to collect the sample of blended granules  of Step –X, IPQA personnel  send the sample to Quality Control Department for testing as per In-process Specification.

Step –XIII: COMPRESSION : After getting approval from IPQA Department, compress the lubricated blend of Step –X ,into tablets of required  specification using 61 station compression machine fitted with  dies and 9.5 mm round, Biconcave Punches,. Dedust the tablet by using tablet dedusting machine.

 COMPRESSED TABLET SPECIFICATIONS

Description                               : Pale yellow coloured, Round, Biconvex, uncoated tablets.

Average Weight                        : 350 mg

Thickness                                  : 4.6 ± 0.20 mm

Diameter                                   : 9.6 ± 0.05 mm

Hardness                                   : 50 – 100 N

Friability                                    : NMT 1.0 %w/w

Disintegration Time                  : NMT 15 minutes

Uniformity of Weight               : Individual weight of 20 tablets should not deviate by more than 5 % of the average weight.

Step –XIV: IPQA CHECKS : Carry out in-process control /check as per SOP.

Step –XV: SAMPLING :  Inform to IPQA Department through In-process Analytical Request to collect the sample of tablets for analysis as per approved in process specification.

Step –XVI: WEIGHING : Collect the Compressed tablets in HDPE containers  lined with double poly ethylene bags & weigh and calculate the  final yield of Compressed Tablet.

Step –XVII: PACKAGING : After getting approval from IPQA Department, pack the approved tablets of Step –XIII as per  approved BPR.

 

 

 

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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