Lesson VI: Semi-Solid Dosage Form of Preparations
Lesson VI: Semi-Solid Dosage Form of Preparations
SEMI-SOLID DOSAGE
FORM OF
PREPARATIONS
They are dermatological preparations intended to be applied
externally on the skin to produce local or systemic effect.
Properties:
1. Smooth texture
2. Elegant appearance
3. non-dehydrating
Semi-solid Dosage
Form 4. non-greasy and non-staining
5. Non-irritating
6. Do not alter skin membrane / skin functioning
7. Miscible with skin secretions
8. Have low sensitization effect
9. Easily applicable with efficient drug release.
10. High aqueous wash ability.
1. Ointments
2. Creams
3. Pastes
Types of Semi- 4. Jellies
Gel
They are prepared by precipitation from a solution of aluminum
chloride with a solution of sodium phosphate.
The particle size of the precipitate which is important factor in its
absorption is governed by several factors.
They are actually suspensions in water medium of insoluble drugs in
hydrated form.
If they are left undisturbed for some time, they become gelatinous
or semi-solids with some amounts of water separating on standing.
Suppositories
These drug preparations are meant for insertion into the body
cavities other than mouth.
They may be inserted into the rectum, vagina or urethra.
Plasters (Patches)
A drug formulation containing one or more active substances
intended for external use and possessing the ability to adhere to
the skin.
STRUCTURE OF THE SKIN
The skin is the largest organ of the body.
Human skin is, on average, 0.5mm thick and ranging from
0.05mm to 2mm in eyelid.
The skin is thick on the hands and soles of the feet ana thin on the
other parts of the body.
The Three Major Layers of the Skin
1. Epidermis
2. Dermis
3. Subcutaneous Tissues
BASES They are used as emollients, cleansing creams, vehicles for solid,
liquid, and non-hydrolysable drugs.
Examples: cold cream, hydrous lanolin, rose water ointment
Non- oily, greaseless base, non-staining, stable, and does not
WATER support the growth of molds because the there is little water. They
are completely soluble in water.
SOLUBLE Example:
BASES Polyethylene glycol, polyoxyl 40 stearate, polysorbates
Selection must be based on:
a. Dermatological Factors
Absorption and penetration effect on the skin
Miscibility with skin secretion and serum
SELECTION
Compatibility with the skin secretions
OF Non-irritant ease of application and removal
APPROPRIATE
BASE b. Pharmaceutical factors
Stability solvent properties
Emulsifying properties
Consistency
FOUR METHODS OF SEMISOLID DOSAGE FORM
PREPARATIONS:
METHOD
1. Minimum Fill
To compare the weight or volume of the product filled into each container
with their labeled weight or volume-content conformity. This is applied only
to those containers that contain not more than 150g or mL preparation.
The USP recommends that the average net content of 10 containers should
not be less than the labeled amount. If the product weight is <60g or mL,
the net content of any single container should not be less than 90% of the
EVALUATION labeled amount. Between 60 and 150g or mL the net content of any single
container should not be less than 95% of the labeled amount. If these limits
OF SEMI- are not met, the test is repeated with an additional 20 containers.
2. Water Content
SOLID The presence of minor quantities of water may alter the microbial, physical
DOSAGE and chemical stability of ointments and creams. Titrimetric methods are
usually performed for determining the water content. The maximum
FORM allowable limit of water in ointment preparations varies between 0.5 and
1.0%
3. Metal Particles
Only for Ophthalmic preparations, the presence of metal particles will
irritate the corneal or conjunctival surfaces of the eye.. The number of such
particles in 10 tubes should not exceed 50, with not more than 8 particles in
any individual tube. If these limits are not met, the test is repeated with an
additional 20 tubes.
Leakage Test
LEAKAGE TESTS This test evaluates the intactness of the ointment tube and its
seal. Ten sealed containers are selected and their exterior surfaces
FOR are cleaned. They are horizontally placed over absorbent blotting
OPHTHALMIC paper and maintained at 60-63 C for 8 hours. The test passes if
leakage is not observed from any tube. If leakage is observed, the
PREPARATIONS test is repeated with an additional 20 tubes. The test passes if not
more than 1 tube shows leakage out of 30 tubes.
STERILITY TEST
FOR Ophthalmic semisolids should be free from anaerobic and aerobic
bacteria and fungi. Sterility tests are therefore performed by
OPHTHALMIC membrane filtration technique or direct inoculation techniques.
PREPARATIONS
An ideal container should:
1. protect the product from the external atmosphere such as heat,
humidity and particulates.
2. Be non-reactive with product components.