Formulation and evaluation of orodispersible films of atropine sulfate for sialorrhe

Abstract

Excess oral secretions or sialorrhea is a common problem affecting children and adults with neurological disorders, as well as those approaching the end of life because of a variety of underlying illnesses. Systemic anticholinergic medications are often prescribed in an attempt to improve quality of life and reduce complications. Atropine is a racemic mixture of d‐hyoscyamine and l-hyoscyamine. It is a competitive antagonist of the muscarinic receptors, thereby inhibiting the effect of acetylcholine, a major neurotransmitter of the parasympathetic nervous system, also innervating the submandibular glands.  It blocks the muscarinic receptors in the salivary glands and leads to reduced saliva production. Orodispersible films are solid dosage forms, which disintegrate or dissolve within a minute when placed in the oral cavity. In the current study atropine sulphate orodispersible films are formulated by solvent casting method using pullulan and HPMC E 15 polymer combination. The prepared formulations were evaluated using different parameters and they exhibited acceptable physical characteristics with good flexibility, folding endurance, tensile strength and percentage elongation. All the formulations quickly disintegrated and released the drug.  Therefore, orodispersible films can be considered potentially suitable for the immediate release of drug atropine sulfate for reducing excess of salivation.