Non-Sterile Manufacture PPT M.M.P

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NON-STERILE MANUFACTURE

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. Absorption bases - 1) Non emulsified 2) Emulsified


b. Water soluble bases -. Polyethylene glycols etc.

c. Hydrocarbon bases – Soft paraffin, hard paraffin,


liquid paraffin etc.

d. Water miscible bases – emulsifying wax, white soft


paraffin.
The ointments are prepared by two methods

a. Fusion method
b. Incorporation method

Other additives in ointment


c. preservatives- Organic mercurials, quaternary
ammonium compounds, benzoic acid is generally
used.
d. Antioxidants-BHA, BHT, Ethyl or propyl gallates
Emulsions
Types of emulgents-
1.Synthetic emulgents –
a) Anionic surfactants – e.g. sodium, potassium or
ammonium salt of oleic acid & stearic acid
b) Cationic surfactants- cetrimide
c) Non-ionic surfactants- Glycol and glycerol esters.
2.Natural products- acacia, tragacanth etc
3. Finely divided solids – Clays, bentonite, silica gel etc.
Requirements
1. Mixing tanks
2. Kettle, steam, gas
3. A suitable powder driven mixer
4. Storage tank or pots
5. A colloid mil or suitable emulsifier
6. A triple roller mill or ointment mill
7. Liquid filling equipment
8. Jar or tube filling equipment
Suppositories
There are two main type of bases
1.Fatty or oleaginous bases- e.g. Theobroma oil
(cocoa butter)

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

2. Water soluble bases-


Two main type of bases are:
a) Glycerogelatin base b) Polyethylene glycol base
a) Glycerogelatin base:
It is used in the preparation of vaginal suppositories

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.

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