Clinical Evaluation of the Anesthetic Effect of Diphenhydramine in Quince Seed Mucilage Base

Abstract

Background & Aims: The topical anesthetic effects of diphenhydramine combined with ingredients such as aluminum and magnesium hydroxide have been used for many years in modern medicine. Due to the limited durability of anesthetic mouthwashes due to saliva secretion and the spreading use of herbal and natural medicines in pharmacotherapy, this study was designed to formulate diphenhydramine in the mucilage of quince seed and evaluate its in-vitro properties and clinical anesthetic effect. Methods: This research was a descriptive laboratory and double-blind clinical study on 4 formulations. Diphenhydramine in quince seed mucilage, diphenhydramine and aluminum magnesium hydroxide combination, diphenhydramine solution, and diphenhydramine elixir and aluminum magnesium hydroxide combination were administered to 12 healthy male volunteers. The age range of the participants was 20 to 30 years. All subjects signed informed consent forms. Diphenhydramine release from the formulations was assessed through cellulosic membrane in Franz diffusion cell. The clinical evaluation of the formulations on healthy volunteers was conducted through prescribing mouthwash use for 2 minutes and controlling the duration its effect in 10, 20, and 30 minutes after administration using a questionnaire. Data analysis was performed using Kruskal-Wallis and Mann-Whitney tests. Results: The duration of effect of diphenhydramine in quince seed mucilage base was at least 3 times longer than diphenhydramine solution and aluminum Mg and the diphenhydramine elixir and aluminum Mg combination. Clinical evaluation showed that the diffusion coefficient of diphenhydramine in the quince seed mucilage base was significantly different from that of the diphenhydramine solution and diphenhydramine and aluminum Mg combination (P < 0.010). However, it was not significantly different from the diphenhydramine elixir and aluminum Mg combination (P = 0.204). Conclusion: The results of in-vitro and clinical studies showed that diphenhydramine in mucilage of quince seed can sustain and control the release of diphenhydramine and can be administered instead of the diphenhydramine elixir and aluminum Mg combination.