Lesson VI: Semi-Solid Dosage Form of Preparations

Lesson VI
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
solid Dosage  5. Gel

 6. Suppositories
Form
 7. Poultices
 8. Plasters
 Ointments
 Are semi-solid preparations for external application readily
applied to the skin.
 Serves as vehicles for some topical application of medical
substances.
 Use as protective for the skin, astringent.
 As an base for other preparations, it should be compatible with
common medicaments, stable easily removable with water,
absorptive ( able to absorb water and/or other liquids and able to
efficiently release incorporated medicament).
 Creams
 They are viscous emulsions of semi-solid consistency intended for

application to the skin or mucous membrane.
 They contain more than 20% water or volatile component and typically
less than 50% hydrocarbons, waxes or polyols as vehicle.
 They contain one or more drug substance dispersed in a suitable cream
base.
 The difference of cream from ointment: cream has high concentration of
water while ointment has high concentration of oil.
 Paste
 They are prepared by incorporating solids directly into a

congealed system by levigation with a proportion of base to form
thick and stiff mass.
 They contain high percentage of insoluble solids (usually 50% or
more) which are finely dispersed into a suitable vehicle.
 Jellies
 They are prepared by heating, using various kinds of polymer with
different concentration .
 They are used to mask the unpleasant taste of the drug.
 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.
 Poultices (Cataplasm, Compresses)

 They are made from fresh, crushed herbs (leaves) applied to the
skin.
 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
Mechanism of skin absorption or penetration

 Skin Penetration
 Factors influencing skin penetration:
 1. physiological and pathological condition of the skin
 2. physio-chemical properties of the active substances
 3. effect of vehicles and effect of additives
 Different approaches have been used to overcome the skin barrier

and improve drug delivery.
 Chemical enhancers are used to disturb the skin structure.
 The mechanisms of absorption depends on the type of enhancers
used.
Quiz 3 and 4
MT (45 points)
1. Oleaginous base
SEMI-SOLID 2. Absorption base
BASES 3. Emulsifying base

4. Water soluble base
 These are fats, fixed oils, hydrocarbon or silicones, which are
anhydrous, non-washable and does not absorb water.
OLEAGINOUS  They should not be applied to infected skin.
BASES  They are used as protectants, emollients, vehicles for hydrosable

drugs.
 Example: white petrolatum, white Ointment
 These are bases of anhydrous substances which have the property
of absorbing (emulsifying) considerable quantities of water but
still retaining their ointment like consistency.
 They are of two types:

 a. non-emulsified bases
ABSORPTION  It absorbs water and aqueous solution producing W/O emulsion.

 Examples: wool fat, wood alcohol, bees wax, and cholesterol
BASES
 b. water in oil emulsion
 This is capable of absorbing more water and has the properties of
non-emulsifying bases.
 Example: hydrous wool fat (lanolin)
 These are anhydrous, hydrophilic, absorb water and non-washable
with water.
EMULSIFYING  They have the same properties that of absorption bases.
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:
METHODS OF  1. Levigation method

 2. Fusion Method
PREPARATION  3. Emulsification Method
 3. Chemical Reaction Method
 Also called as Trituration. This is the most common. Using bases of
Levigation soft fats and oils. Powdered materials are sifted while solid
ingredients are heated to melt. Mix the mixtures on an ointment
Method slab with a spatula.
 This is carried out using porcelain dish placed over a water bath.
FUSION The ingredients of high melting point are heated first, followed by
the rest of ingredients in decreasing (melting points) order, with
METHOD constant stirring.
 Four steps involved:
 1. Preparation of oil
 The lipids are melted according to the order of melting points.
 2. Aqueous phases mixing
EMULSIFICATION  Mix aqueous phase with emulsifier
METHOD  3. mixing of phases they are mix under slow agitation, with
application of heat to dissolve nat 70 C.
 4. Emulsion Cooling
 With the use of homogenizer.
CHEMICAL
REACTION  it involves fusion and mechanical mixing.
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.
PACKAGING 3. Be easy to use, light weight.

Aluminum tubes should have special internal epoxy coatings.
Plastic tubes (low and high density). Low , are generally soft and
flexible and offer good moisture protection. While high density, are
relatively harder but offer high moisture protection.
Example: Polyethylene containers

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Lesson VI

solid Dosage  5. Gel

 They are viscous emulsions of semi-solid consistency intended for

 They are prepared by incorporating solids directly into a

 Poultices (Cataplasm, Compresses)

Mechanism of skin absorption or penetration

 Different approaches have been used to overcome the skin barrier

BASES 3. Emulsifying base

BASES  They are used as protectants, emollients, vehicles for hydrosable

 They are of two types:

ABSORPTION  It absorbs water and aqueous solution producing W/O emulsion.

METHODS OF  1. Levigation method

PACKAGING 3. Be easy to use, light weight.

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