R. Bodmeier et O. Paeratakul, THE DISTRIBUTION OF PLASTICIZERS BETWEEN AQUEOUS AND POLYMER PHASES IN AQUEOUS COLLOIDAL POLYMER DISPERSIONS, International journal of pharmaceutics, 103(1), 1994, pp. 47-54
The distribution of water-soluble (triethyl citrate and triacetin) and
water-insoluble (acetyltriethyl citrate, acetyltributyl citrate, dibu
tyl phthalate, dibutyl sebacate, diethyl phthalate and tributyl citrat
e) plasticizers between the aqueous and polymer phases in an aqueous c
olloidal ethylcellulose dispersion, Aquacoat(R), was determined. A sep
aration scheme was developed, which allowed the determination of the a
mounts of plasticizers dissolved and, in the case of water-insoluble p
lasticizers, also emulsified in the aqueous phase, and dissolved in th
e colloidal polymer particles. The plasticized ethylcellulose dispersi
on was separated by centrifugation and/or ultracentrifugation to obtai
n the various plasticizer-containing fractions. The plasticizer concen
tration in each phase was determined by a HPLC assay. The extent of th
e plasticizer partitioning was investigated with respect to the type (
water-soluble or water-insoluble) and concentration of the plasticizer
, and the solids content of the polymer dispersion. Water-insoluble pl
asticizers mainly partitioned into the polymer particles due to the hi
gher affinity towards the polymer phase, however, the amount of emulsi
fied plasticizer droplets increased with increasing plasticizer concen
tration after a plasticization time of 24 h. An 'association' coeffici
ent, which was obtained from the ratio of the plasticizer concentratio
n in the polymer to the concentration in the aqueous phase, was used t
o characterize the plasticizer partitioning. The fraction of plasticiz
er taken up by the colloidal polymer particles increased with increasi
ng solids content of the polymer dispersion. It is therefore recommend
ed to add the plasticizer to the undiluted dispersions followed by dil
ution to the desired solids content just prior to coating, rather than
first diluting the dispersion followed by addition of the plasticizer
.