Introduction: Prolonged
drug delivery in the
oral cavity offers many advantages, such as reducing
adverse effects .
Pilocarpine is an FDA-approved parasympathomimetic
drug for the
treatment of glandular hypofunction; however, its
adverse effects limit its use.
Objective: To evaluate the stimulation of salivary flow by the use of
pilocarpine -releasing
films , as well as their effects on the symptoms of
xerostomia and
adverse effects in
patients with Sjõgrens
syndrome (SS). Materials and
methods: Hydroxypropylmethylcellulose (
Methocel K4MCR)
films were prepared in 1 percent
acetic acid and
pilocarpine was added under
magnetic stirring. The
pH and thickness, as well as
diffusion uniformity and
kinetics of
drug release per cm2 were evaluated by
spectrophotometry . The
films were tested sublingually in 40
patients with Sjõgrens
syndrome for a period of two weeks. Changes in their salivary flow were evaluated by analyzing samples of total
saliva . Additionally,
patients were screened for symptoms of
xerostomia and
adverse effects .
Results: The
films had a
pH of 2.91 +/- 0.035, a thickness of 0.06866 +/- 0.00152μm, and a
diffusion uniformity of 91 percent per cm2. Use of the
films resulted in an increase in salivary flow in both primary and
secondary Sjõgrens
syndrome , but this increase was only significant in primary SS.
Conclusion: Films showed optimal physicochemical properties for their
administration , and proved effective in stimulating salivary flow without causing
adverse effects during their
administration .