PILOT PLANT SCALE UP FOR CAPSULES

PILOT PLANT SCALE UP

PILOT PLANT SCALE UP FOR CAPSULES

HGC are filled with - dry powder blend / granule mix/pellets

The processed powder blend:

·         Sufficient cohesiveness

·         Particle size distribution

·         Bulk density

·         Compressibility

·         Promote good flow characteristics

·         Formation of compacts of the right size

Capsule filling methods

Indirect filling

Dosing disk                  

Dosator

Capsule filling machine – Zanasi

Dosator

Dosator- hollow tube with plunger to eject the capsule plug

Dosator                                           Dosing tube and Piston

Dosing Disk

Dosing Disk- tamping pins form compacts on the die plate uses a disk with holes and tamping pins to form a plug

Problems encountered in scale up

With both the systems the common issues are

• Bulk density

• Powder flow

• Compressibility

• Lubricant distribution

Inadequate lubrication àPlugs stick to dosator, plunger surfaces / die walls à Weight variation

Over lubrication à Soft plugs will not be completely transferred to capsule body àWeight variation

Over lubrication à Delays capsule disintegration and dissolution àReduced bioavailability

• Size and type of equipment used in blending, granulating, drying, sizing and lubrication of capsule granules or powder mixtures

• Environmental conditions inside the production unit

Environmental conditions?????

• Humidity has a significant effect on the moisture content of granules and on empty gelatin capsules

• Problems often occur in encapsulation rooms as humidity is not adequately controlled

Granulation moisture content à influences à Chemical and physical stability of the finished product

Granulation moisture content à If not controlled à Machine problems of flow

                                                                                           à Sticking during material transfer and filling

Empty gelatin capsules à influences à Storage conditions of 15-25 oC Relative humidity between 35-65%

Empty gelatin capsules à If not controlled à Changes in physical dimensions of capsule shells- Problems in filling

Processing room humidity àinfluences à between 45-55%

Processing room humidity àIf not controlled àHigh humidity- capsules swell because of moisture absorption

èLow humidity- capsules become brittle

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