Non-Sterile Manufacture PPT M.M.P
Non-Sterile Manufacture PPT M.M.P
Non-Sterile Manufacture PPT M.M.P
Methods of granulation
Wet granulation
Dry granulation
Direct compression
Requirements of equipments for the mfg
of pills and compressed tablets
a. Granulating section-Disintegrator, powder and
mass mixer
b. Tableting section-tablet machine and counter
c. Coating section-coating pan, polishing pan
heater etc,
Manufacture of powders-
Mixing of powders-
Powders are mixed by the method of Spatulation,
trituration, shifting, mechanical mixers
• Capsules
• Filing of capsules- mixing and blending
equipment, capsule filling unit, capsule counters.
• Soft gelatin capsules-
1) Preparation- prepared from gelatin to
which glycerin or sorbitol is added to render it
elastic
2) Plate method
3)Rotary die method
Facilities required for mfg of Tablets,
Powders, and capsules
• Granulation- provision of stainless still scoops,
vacuum cleaner, sinks for washing , facility foe
weighing product ,etc
• Dry blending – dust control and personnel
protection is by suitable clothing is necessary.
• Compression – facilities for measuring thickness,
hardness , weight , QC lab, disintegration an
friability apparatus.
Manufacture of liquid orals
• Solutions-
• Syrup-
• Elixirs
Requirements:
• Mixing and storage tanks
• Portable mixer
• Filter press
• Vacuum or gravity filter
• Water still or Deionizer
The area required for the mfg. of these is 30 sq. meters
Manufacture of externals
• Preparation of ointment
Ointment bases-
a. Fusion method
b. Incorporation method
Advantages-
i. Non-irritating
ii. Melts at 30-60 degree c.
iii. Miscible with any ingredients
Disadvantages-
1. On cooling it does not contract sufficiently and
problem of adherence to mould occurs.
2. It may become rancid on storage.
3. The water absorbing ability is poor.
4. It is expensive
Disadvantages:
1. Unpredictable solution time.
2. The dehydrating effect of the base causes irritation
to the rectal or vaginal mucosa.
3. Preservatives are required in the formulation to
prevent microbial contamination, which results in
incompatibility.
4. The suppositories have laxative effect.
b) Polyethylene glycol base : (PEG base)
These materials have wide range of melting points
& solubilities. Hence it is possible to prepare
suppositories of varying heat stability and dissolution
rates.