4. Contents
• Introduction
• Advantages of semisolid dosage form
• Ideal properties
• Classification
• Plant layout Qualitative Plant Layout for
semisolid
• Quantitative Plant Layout for semisolid
• Plant layout for manufacturing of suppository
• Specific requirements
• problems
5. Introduction
• Semi solid dosage form: Semisolid dosage forms
are products of semi-solid consistency and
applied to skin or mucous membranes for a
therapeutic or protective action or cosmetic
function.
• They may be medicated (containing therapeutic
agents) or non-mediacated (used for their
physical effects as protectants , lubriants and
emollients).
• Example:Ointmnets Creams Gels, Pastes Foams,
Suppositories Plasters, powders, solutions
6. Ideal properties of semi-solid dosage
forms:
• Physical properties:
a)Smooth texture
b) Elegant in appearance
c) Non dehydrating
d) Non gritty
e) Non greasy and non staining
f) Non hygroscopic.
• Physiological properties:
a) Non irritating
b) Miscible with skin
secretion
c) Have low sensitization
effect.
• Application properties:
a) Easily applicable with
efficient drug release
b) High aqueous wash ability.
7. Advantages of semisolid dosage form
Avoidance of first pass metabolism
Avoidance of gastro intestinal incompatibility
Predictable and extended duration of activity
Delivery via the skin route is an interesting
option because route is convenient and safe
Provide suitability for self administration
Enhance therapeutic efficacy of drugs
Avoiding the fluctuation in drug levels
Inter and intra patient variations
Maintain plasma concentration of potent drugs
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14. High speed Automatic Suppository Filling and Sealing Machine pharmaceutical
machineries
15.
16. Specific requirement for manufacturing of
topical preparation
• Manufacturing area under suitable AIR LOCK. Outside
air lock INSECTOCUTORS shall be installed.
• The air to this manufacturing area shall be filtered
through at least 20μ air filters and shall be air
conditioned.
• An EXHAUST SYSTEM of suitable capacity. NO RAGS OR
DUSTERS shall be used in process of cleaning & drying.
• Water used in compounding shall be PURIFIED WATER
IP Powders SUITABLY SIEVED, before use.
• Heating vehicles & base like petroleum jelly shall be
done in SEPARATE MIXING AREA.
• The temperature of manufacturing area shall NOT
EXCEED 30˚C.
17. Problems in suppositories
formulation
Weight and volume control: Various factors influence the weight of
the suppository, the volume of the suppository and the amount of
active ingredient in each suppository.
These factors include :
1. Concentration of the drug in the mass.
2. Volume of the mould cavity.
3. The specific gravity of the base
4. Volume variation between moulds.
5. Weight variation between suppositories due to the inconsistencies
in the manufacturing process.
The upper limit for the weight variation in suppositories is 5%.