Flow Chart and Manufacturing Procedure of Dextromethorphan Hydrobromide, Chlorphenamine Maleate & Phenylephrine Hydrochloride Flavoured Dispersible Tablets

Flow Chart and Manufacturing Procedure of Dextromethorphan Hydrobromide, Chlorphenamine Maleate & Phenylephrine Hydrochloride Flavoured Dispersible Tablets

Bill of Material

*Given quantity of Dextromethorphan Hydrobromide and Chlorphenamine Maleate complex is based on assay (ODB) of Chlorphenamine Maleate in the complex = 100.00 % W/W, L.O.D =   0.00   % W/W

**Given quantity of Phenylephrine Hydrochloride complex is based on assay

(ODB) = 100.00 % W/W, L.O.D   =     0.00   % W/W

# Taken 1.0 % extra to compensate loss during processing.

@ Taken 2.0 % to compensate for loss during processing`

• Manufacturing Procedure :
  • Manufacturing procedure in brief comprise of following steps:
    • Step – I:-MILLING : Mill Citric Acid Monohydrate through comminuting mill fitted with 5 mm perforated sieve at hammer forward orientation and at medium  speed and sift through   vibro sifter fitted with sieve of mesh size 100 & divide in two lots (2.0 + 1.0 kg).
    • Step – II:-SIFTING : Sift Dextromethorphan Hydrobromide and Chlorphenamine Maleate complex , Phenylephrine Hydrochloride complex, Mannitol , Silica, Colloidal Anhydrous, Indion 294 ,  Talc, Magnesium Stearate, Croscarmellose Sodium, Pharmaburst B2 through Vibro Sifter fitted with sieve of mesh size 40 collect the sifted material in IPCs.
    • Step – III:-SIFTING : Sift  Sunset Yellow Colour Lake through Vibro Sifter fitted with sieve of mesh size 100 collect the sifted material in IPCs.
    • Step – VI:Take Citric Acid Monohydrate (2.0 kg) from step- I and manually mix with the bulk of step – III  for 2-3 minutes.
    • Step – V:DRY MIXING : Perform dry mixing  of  materials of step – II & step -IV  in Blender’s bin. ( mix for  10 minutes at 6 rpm)
    • Step – VI:SLUGGING : Slug the mass of step – V in Roll-Compactor, adjust and record Feed screw rate (rpm) and speed of rollers (rpm) and weigh the slugs.
    • Step – VII: DESLUGGING : Mill the mass of step – VI by Multimill/ Comminuting mill fitted with 3.0 mm Screen at knife forward orientation and at slow speed
    • Step – VIII: SIFTING :Sift the milled mass through Vibro Sifter fitted with sieve of mesh size 16 and pass the retention through comminuting mill fitted with 3.0 mm Screen at knife forward orientation and at slow speed , repeat the above process till all the material of step- VII passed through sieve of mesh size 16 .
    • Step – IX:SIFTING :
    • a) Sift the material of step – VIII through Vibro Sifter fitted with sieve of mesh size                         60,collect and weigh the retention.
    • b) If the retention of step IXa is more than or equal to  80 % proceed for lubrication step.

If the retention percentage is less than 80 % then repeat process  steps (7.1.6 to 7.1.8) for  retention  until retention  % is equal or more than  80 % ,if it is equal or more  80 % then directly proceed for next  step

• Step – X:SIFTING/LUBRICATION OF GRANULES :
• a) Sift Colour Lake of Sunset Yellow through Vibro Sifter fitted with sieve of mesh size 100
• b) Sift Silica, Colloidal Anhydrous , Orange Flavour , Aspartame, Talc, Magnesium Stearate, Croscarmellose Sodium  through Vibro Sifter fitted with sieve of mesh size 40.
• c) Geometrically mix Citric acid monohydrate of step -I with step -X a&b manually for 3-5 minutes.
• d) Geometrically mix the granules  of step X c with step – IX then transfer  the bulk  to Blender’s Bin and    Blend for 10 minutes at 6 rpm.

• Step – XI: WEIGHING :Weighing of lubricated granules is done  by using a calibrated balance and calculate the actual  .
• SAMPLING : Inform to IPQA Department through In-process Analytical Request  to collect the sample of blended granules of step – XI, IPQA personnel  send the sample to Quality Control Department for testing as per In-process Specification.
• Step – XII:COMPRESSION : After getting approval from IPQA Department, compress the lubricated blend of step XI, into tablets of required specification using 37 station compression machine fitted with round  dies, plain punches  (12.00 ± 0.05 mm).

                                                  COMPRESSION PARAMETERS

Description : Orange coloured , round, plain, flavoured uncoated  tablets.

Average Weight : 600 mg

Uniformity of  mass : Individual mass of 20 tablets should not deviate by more than 5.0 % of the average weight.

Friability  : NMT 2.0 %w/w

Diameter : 12.00 ± 0.05 mm

Thickness : 4.60 ± 0.20 mm

Disintegration time : Not more than 3 minutes

Uniformity of Dispersion :  Shall Comply with the test

Hardness   : 30 – 60 N

• IPQA CHECKS : Carry out in-process control /check as per SOP.
• SAMPLING : Inform to IPQA Department through In-process Analytical Request to collect the sample of tablets for analysis as per approved in process specification.   
• WEIGHING : Collect the Compressed tablets in HDPE containers lined with double poly ethylene bags & weigh and calculate the  final yield of Compressed Tablet.                      

PACKAGING : After getting approval from IPQA Department, pack the approved tablets of step XII as per  approved BPR.

Critical Process Steps and Process Parameters for Validation with Justification:

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