Preparation and quality evaluation of lozenges with lidocaine hydrochloride as an active substance

Abstract

Relevance. Lidocaine is a local anaesthetic drug that is most effective when used topically. Because of it activity, while used on the skin or mucous membranes of the body, it is added to a wide variety of pharmaceutical formulations, such as creams, lotions, ointments, and patches, as well as in solutions and lozenges that treat sore throat symptoms (Khodadoost an et al., 2018, Donath et al., 2018). It is al ways important to model various novel pharmaceutical forms with lidocaine hydrochloride that would be more appealing to patients. Soft medicated lozenges are one of the most suitable pharmaceutical forms to use topically on the mouth mucous tissues. It is in pharmaceutical form, with the texture of soft candy, with a pleasant taste and smell. It is important to model novel pharmaceutical forms and ensure their quality parameters (Hemilä et al., 2022). The study aimed to evalute thequality of modelled lozenges with lidocaine hydrochloride as the active substance. Methodology The study was performed using organoleptic, physicochemical, and biopharmaceutical methods to evaluate the quality of modelled soft lozenges. The organoleptic properties of lozenges were evaluated by tasting, touching and smelling. The physicochemical properties, such as mass uniformity, were measured with the digital laboratory scale. The disintegration test was performed using the MRC Scientific Instruments apparatus to evaluate the time needed for the lozenges to disintegrate. The stability and organoleptic properties were assessed visually, as well as measuring the mass of the lozenges after two months while keeping lozenges in the refrigerator (2-8 degrees Celsius) temperature. All the experiments were carried out at least three times. The statistical analysis was performed using SPSS 25.0 software. Results Two batches of soft lozenges with different amounts of lidocaine hydrochloride were modelled during the research. The physical characterization of the lozenges has shown that all of the formulations were soft, with uniform edges, brown colour and with the smell of peppermint and thyme essential oils that were used in the composition. The taste was sweet because of honey which was used as the sweetener in the lozenges, and the anaesthetic feel was prominent because of the lidocaine hydrochloride. [...].