The technological temperature regime influences the consistency and viscosity
of emulsions. The temperature dependency of emulsion rheological properties have
been evaluated by using drawn rheogram curves which have depicted relationship
between shear rate and shear stress at different temperatures. The viscosity of test
sample № 5 of soft pharmaceutical composition based on SAD at 20 and 34 °С hasn't
been significantly deviated and has valuated 7,6 Pa-sec and 8,4 Pa-sec accordingly.
There was wide interval on the drawn rheograms, when viscosity values haven’t been
depended on shear rate. From data obtained one can concluded that viscosity values
included in area of rheological optimum for hydrophilic ointments and the developed
remedy had good consumer characteristics and technological properties.
One of the most important biopharmaceutical factors influenced the
pharmacokinetic of topical soft compositions are properties of auxiliary substances
which provides intensive active pharmaceutical ingredient releasing and absorption.
The surface active substance – Sodium Lauryl Sulfate has been used in 1 %
concentration as a absorption booster and co-emulsifier of Lanette® SX 60 in the
content of the pharmaceutical composition based on SAD. The influence of the
Sodium Lauryl Sulfate on the SAD releasing from the ointment emulsion base with
method of dialysis through semi-permeable membrane in vitro has been carried out.
As test samples we used ointment composition with 1 % of Sodium Lauryl Sulfate
and composition without it. It has been determined that active pharmaceutical
ingredient (SAD) has been released from ointment test samples begins in the first
hour of the experiment. However, test sample containing 1 % of Sodium Lauryl
Sulfate has shown more intensive and equitable active substance's realizing during
8 hours of the experiment, whereas test sample without sodium lauryl sulfate has
demonstrated slowing down of the SAD releasing from base after the 4
th
hour of
experiment.
Therefore, the additional pharmacotechnological researches such as
thermogravimetry analysis, rheological and biopharmaceutical tests have enabled to
justify in details the composition and technology of the topical pharmaceutical dosage
form based on SAD.
On the background of the executed technological and physicochemical researches
the manufacturing technology of SAD ointment has been elaborated. It consists of such
stages: preparing of the SAD solution in DMSO, preparing of the oil phase, preparing
of the aqueous phase, manufacturing of the emulsion ointment, cooling, packing and
labeling. After that the average sample of the prepared ointment from each
manufacturing batch has analytical checked.
After verification of medicines quality according to the analytical papers, SAD
ointment is transferred to the finished-storage products area when it has to be stored
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