Abstract
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 Sjogren's syndrome (SS). Materials and methods: Hydroxypropylmethylcellulose (Methocel K4MCR) films were prepared in 1% acetic acid and pilocarpine was added under magnetic stirring. The pH and thickness, as well as diffusion uniformity and kinetics of drug release per cm 2 were evaluated by spectrophotometry. The films were tested sublingually in 40 patients with Sjogren's 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±0.00152 μm, and a diffusion uniformity of 91% per cm 2 . Use of the films resulted in an increase in salivary flow in both primary and secondary Sjogren's 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.
Highlights
Prolonged drug delivery in the oral cavity offers many advantages, such as reducing adverse effects
The objective of this study was to evaluate the stimulation of salivary flow by the use of pilocarpinereleasing films, as well as their effects on the symptoms of xerostomia and adverse effects in patients with Sjögren’s syndrome
Patients were excluded from the study who presented with another factor inducing hyposalivation that may have affected the outcome, such as: head and neck radiation therapy, history of Hepatitis C, Human Immunodeficiency Virus (HIV), pre-existing lymphoma, sarcoidosis, subjects with graft-versus-host disease, diabetes mellitus, and patients with a history of anticholinergic and parasympathomimetics drug use in the previous 4 months
Summary
Prolonged drug delivery in the oral cavity offers many advantages, such as reducing adverse effects. 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 Sjögren’s syndrome (SS). The films were tested sublingually in 40 patients with Sjögren’s syndrome for a period of two weeks Changes in their salivary flow were evaluated by analyzing samples of total saliva. In previous research it has been demonstrated that the local use of bioadhesive films
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