A Comprehensive Review on Formulation and Evaluation of Medicated Chewing Gum

Abstract

Medicated chewing gum (MCG) is an advanced and innovative oral drug delivery system designed to release active pharmaceutical ingredients (APIs) during mastication for either local therapeutic action within the oral cavity or systemic absorption through the buccal mucosa. According to the European Pharmacopoeia, MCG is classified as a solid, single-dose preparation intended to be chewed but not swallowed. In recent years, MCG has gained substantial attention within pharmaceutical sciences due to its exceptional patient benefits, including improved patient compliance, ease of administration without water, rapid onset of action, and the critical ability to bypass hepatic first-pass metabolism and gastrointestinal degradation. MCG is currently successfully utilized across diverse clinical fields such as smoking cessation therapy, oral hygiene preservation, motion sickness management, acute pain relief, vitamin and nutritional supplementation, and the localized treatment of dental caries and oral infections. The formulation of MCG is sophisticated, universally involving an insoluble rubber-like gum base, plasticizers, softeners, fillers, intense and bulk sweeteners, flavoring agents, and the target active ingredients. This comprehensive review provides an in-depth examination of the historical perspective, fundamental release mechanisms, critical excipient selection, advanced manufacturing techniques (such as conventional melting, direct compression, and cryogenic freezing/grinding), stringent quality control evaluation parameters, and current therapeutic landscapes, while delineating future perspectives in this modern oral drug delivery field.

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