iv. Ejection of tablet from the cavity
At the pilot-plant scale-up the compression characteristics of a tablet can only be
determined if trials run at tablet press speed same to that of speed in normal
8. Tablet coating: At laboratory-scale the tablet coating is done in conventional coating
pans. There are many changes in the coating technology due to new developments
of safety and environment regulations, new polymeric materials, coating types, etc.
Nowadays, the place of conventional sugar coating pan has taken by perforated
pans and fluidised bed coating columns. The development of new polymeric
materials gives way to aqueous sugar coating and aqueous film coating (Table 2.7).
Table 2.6: Scale-up considerations during compression
Name of equipment Scale-up considerations
High-speed tablet press Sticking to the punch surface
Interaction of press with granules is appropriate or not
Ejection of tablets (should be free from sticking)
Table 2.5: Scale-up considerations during particle size reduction
Name of equipment Scale-up consideration
Oscillating granulator Lubricants and glidants should be added at the size reduction
Hammer mill stage during scale-up
2.3 PILOT-PLANT SCALE-UP CONSIDERATIONS FOR ORAL LIQUIDS
Oral liquids can be defined as homogenous liquid preparations, mainly contain an
emulsion, a suspension or a solution (Fig. 2.4) having one or more active ingredients
in an appropriate base, i.e. liquid. They are for oral administration. These preparations
stabilizing agents, thickening agents, etc. During pilot-plant scale-up each and every
material and equipment is tested in the same amount and with same characteristics as
to be used at large-scale production. This is a pourable dosage form which displays
Newtonian or Pseudoplastic flow behaviour. This dosage form remains conforms to
Steps in Liquid Manufacturing Process
1. Planning of material requirements: In this step the calculation for material required
to manufacture a product is done. It consists of majorly three functions.
i. Taking inventory of components or material needed and on hand
ii. Identification of the needed components and materials
iii. Scheduling the production or purchase of needed materials and components
Fig. 2.4: Different types of oral liquids
Table 2.7: Scale-up considerations during tablet coating
Name of equipment Scale-up considerations
Perforated pans Type of materials (polymeric)
Fluidised bed coating columns Nature of material (hydrophilic or hydrophobic)
Safety and environmental guidelines
Temperature and humidity required
General Considerations and Pilot-Plant Considerations for Different Dosage Forms 19
2. Liquid preparation: It is done by suspending, dissolving or emulsifying active
ingredients and excipients as per master manufacturing formula which is prepared
in compliance with guidelines.
3. Filling and packing: Based on the characteristics of the liquid prepared
(photosensitive, volatile, microbial property, etc.), the container-closure system for
packaging is chosen. Labelling of the container will be done as per labelling
guidelines followed in the company.
4. Quality assurance: Qualitative and quantitative tests like identification, microbial
testing, stability testing, etc, for liquid preparation and packaging material, will be
done in accordance with validated analytical tests and with validated equipment.
This will be done to check whether the product is prepared and packed as per
Critical aspects of liquid manufacturing (Table 2.8)
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