Professional Documents
Culture Documents
Dosage Forms
Tablets (1 of 2)
• Molded tablets
• introduced to be used as hypodermic tablets for the extemporaneous
preparation of solutions for injection.
II. Technology
A. Improve drug stability
i. Reduce influence of moisture/atmosphere
ii. Prolong shelf life
B. Avoid dust formation
PH-PHR 316: Pharmaceutical Manufacturing (with Quality Assurance and cGMP)
Reasons for Coating
III. Marketing
A.Avoid bad taste
B.Improve product identity
C.Improve appearance and acceptability
5. Polishing
• beeswax, carnuba wax, candelila wax or hard paraffin wax
Controlled &
Acceptable by
reproducible
patient
release of API
Sufficient
Stable mechanical
strength
10/6/20
PH-PHR 316: Pharmaceutical Manufacturing (with Quality Assurance and cGMP) 53
Dry Granulation
• Involves the compaction of the components of a tablet
formulation into slugs followed by milling (to produce granular
material) & screening (to separate the desired fraction), prior to
final compression into a tablet
10/6/20
PH-PHR 316: Pharmaceutical Manufacturing (with Quality Assurance and cGMP) 55
Wet Granulation
• involves the wet massing of
the powders, wet sizing or
milling, & drying.
10/6/20
PH-PHR 316: Pharmaceutical Manufacturing (with Quality Assurance and cGMP) 56
Fluid-bed Granulation
• Granules possess greater porosity and the granule surface is
covered by a film of binding agent
Wet
Dry screening Weighing Mixing Granulation Drying
screening
Combining Addition of
Dry screening IPQC tests Tumbling Compression
goods & fines lubricant
10/6/20
PH-PHR 316: Pharmaceutical Manufacturing (with Quality Assurance and cGMP) 66
Components of a Tablet Press
1. Hopper
2. Dies
3. Punches
4. Cam Tracks
5. Feed Shoe
6. Upper & lower turrets
7. Die table
Particle Size
Mixing Granulation Drying
Reduction