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08 June 2009 SRTM University, NandedDept. of Pharmaceutics 2
Introduction
What is Pilot plant :
Defined as a part of the pharmaceutical
industry where a lab scale formula is transformed into a viable
product by the development of liable practical procedure for
manufacture.
R&D Production
Pilot Plant
Scale-up :
The art of designing of prototype using the data
obtained from the pilot plant model.
08 June 2009 SRTM University, NandedDept. of Pharmaceutics 3
Objectives of Pilot Plant
Find mistakes on small scale and make profit on
large scale.
To produce physically and chemically stable therapeutic
dosage forms.
Review of the processing equipment.
Guidelines for productions and process control.
Evaluation and validation.
To identify the critical features of the process.
To provide master manufacturing formula.
Production rates.
WEIGHING WEIGHING
WEIGHING
SIZING SIZING
SIZING
BLENDING GRANULATION
BLENDING
LUBRICATION DRYING
COMPACTION
COMPRESSION BLENDING
MILLING
COATING LUBRICATION
LUBRICATION
COMPRESSION
COMPRESSION
Colorants :
Various soluble synthetic dyes (coal tar dyes) and
insoluble pigments are used.
Not only play a role in identifying the product, but also
may play a role in improving patient compliance.
E.g., white, analgesia; lavender, hallucinogenic effects;
orange or yellow, stimulants and antidepressants.
08 June 2009 SRTM University, NandedDept. of Pharmaceutics 52
Opaquing agents :
Titanium dioxide may be included to render the shell
opaque.
Opaque capsules may be employed to provide protection
against light or to conceal the contents.
Preservatives :
When preservatives are employed, parabens are often
selected.
2. Thermal-setting formulations,