Formulation and Physicochemical Characterization of
Buccoadhesive Films Containing Ketrolac
Fars K. Alanazi *, Ali A. Abdel Rhuman, Gamal M. Mahrous and Ibrahim A. Alsarra
Department of Pharmaceutics, College of Pharmacy,
King Saud University, P.O. BOX 2457, Riyadh 11451, Saudi Arabia.
*
To whom correspondence should be addressed.
Email: afars@ksu.edu.sa
Abstracts:
Ketrolac tromethamine, non-steroidal anti-inflammatory drug, were formulated in
buccoadhesive films to overcome the limitations in the currently available routes of
administration which in sequence will increase patients compliance. Films were
casted from organic and aqueous solvents using various bioadehsive polymers
namely:
ethyl
cellulose (EC), sodium
carboxy methyl
cellulose (CMC),
hydroxypropyl cellulose (HPC), hydroxylpropyl methyl cellulose (HPMC), carbopol
934. The prepared films were subjected to investigations for theirs physical and
mechanical properties, swelling behaviors, in vitro bioadhesion, and in vitro release.
Those properties were found to vary significantly depending on the preparation
method, the type of the polymer, combination of two polymers, and addition of both
plasticizer
(i.e.
polyethylene
glycol)
and
film
forming
agent
(i.e.
polyvinylpyrolidene). Formula (K10) containing Carbopol 0.5% and HPMC 0.5%
was selected to be the best formula because it shows good adhesion, acceptable pH,
and gives a reasonable ketrolac release ( about 85- 90% at 6 hours ). This formula was
subjected to in situe release and results indicated that concentration of ketorolac in the
oral cavity maintained above 4.0 g /ml for a period of at least 6 hours. This film
shows promising results for using ketrolac buccoadhesive route and thus it will be
subjected to clinical evaluation in future.
Key words: Ketrolac, Buccoadhesive, Ethyl cellulose (EC), Sodium carboxy methyl cellulose (CMC),
Hydroxypropyl cellulose (HPC), Hydroxylpropyl methyl cellulose (HPMC), Carbopol 934.