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SEMISOLID DOSAGES
Questions
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Characteristics
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Classification of SSDF
•on affinity to water: Hydrophobic (lypophilic) and Hydrophilic;
• on ability to absorb water and to the mechanism of absorption;
• on the class of dispersible system:
homogenous (solutions, alloys),
biphasic (emulsions of class are oil/water (o/w) and w/o,
suspensions, colloid dispersions)
and multiphase systems (plural emulsions of o/w/o and w/o/w,
and also the combined systems);
•on reological characteristics at the set temperature of storage and
usage;
• on a concentration and dispersible condition of auxiliary and/or
medicinal substances.
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Classification of semisolides
according to consistence
liniments
ointments gels creams pastes
ointments
homogeneous heterogeneous
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The main requirements to the semi-solid medicines
effectiveness safety
first of all they are defined by active substances
Hermetic packing,
Use of hydrophilic basis, absence of microbiological
Using water-soluble
absorption penetrators contamination, production Exclusion of basis
according to GMP possible
principles allergens
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!!! Ointment = basis + active substances
Requirements to ointment bases
•Ointment basis are the carrier of medicinal substance and provides
volume and necessary physical properties of ointment. The basis
ensuring maximal therapeutical effect should answer the following
requirements:
To have necessary structural - mechanical properties
To have absorbing ability,
To not change under action of external environment and not react
with medicinal substances, entered into it,
To not render irritating action on a skin and to promote
preservation of initial meaning of skin or mucous environment рН ,
To not be exposed microbe contamination.
The properties of a basis should correspond to the purpose of
ointment assignment.
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Auxiliary substances
soft bases (mineral oils, lanolin and other);
Substances increased the melting temperature and
viscosity of bases (paraffin, spermacet, hydrogenated
vegetable oils, beeswaxes, polyethylenglykol with high
molecular mass and other);
Hydrophobic e solvents (mineral and vegetable oils,
isopropylpalmitat, isopropylmiristat, polyalkilsiloksans,
Benzylbenzoath and other);
water and hydrophilic solvents (ethyl and isopropyl
alcohols, polyethylenglykols 200-600, propylenglykols,
propylencarbonate, glycerin, dymeksid and other);
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Auxiliary substances
emulsifying agents of o/w type (sodium laurilsulfate,
emulsifying agent № 1, twin, polyoxyethylenglykol ethers of
higher oily alcohols, cetilpyridin chloride, salts of higher fatty
acids, oxyethylated castor oil, polyoxyethylenglykol ethers of
stearinic acid and other);
emulsifying agents of w/o type (higher oily alcohols,
cholesterol, spens, glyceryl monooleate, a glyceryl
monostearat and other);
Gel-formers (karbomer, norgine and its salts, derivative
celluloses, polyethylene, poloxamers, polyethulenglkols 1500-
8000, bentonite, kaolin, colloid silex, Arabic gum, tragacanth,
gelatin and other);
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Auxiliary substances
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Technological process of ointment production:
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1
4 4
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Reactor-gomogenisator
3 types of mixers:
plate-and-frame,
turbine,
paddle
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Preparation of ointment
Discharge of intermediate
products (ointment, liniment, gel,
suppozitory mass) is carried out
under the pressure of filtered
compressed air or nitrogen into
the hermetically closed movable
capacities made from alloy
stainless steel, so-called “muller’s
barrels", of different capacity.
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Homogenization
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Packing of ointment
Screw machine
•Bunker with ointment (1),
screw (2), faucet for ointment
feeding (3) jet (4).
A faucet is closed at stated
intervals, and ointment from a jet
is pushed in a jar or tube. Packing
is carried out at times closing and
openings of faucet. Jars with the
packed up ointment close by caps.
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Packing of ointment
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Line for filling and packing of
tubes
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Quality control:
1. organoleptic property
2. Identification
3. Homogeneity
4. рН
5. microbial cleanness
6. quantitation
7. hermetic of tube
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Thank you
for your attention!
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