Formulation and Evaluation of Pregabalin Buccal Film: A Research

Author

Sanjay Kumar E, Sarathi S, Sasikala E, Shobana S, Malarvizhi K, Dr. J. Karthi, Dr. S. Swarnalatha


Abstract

 Pregabalin is a widely prescribed α2δ-subunit ligand of voltage-gated calcium channels used in the management of neuropathic pain, fibromyalgia, partial-onset seizures and generalized anxiety disorder. Despite its high oral bioavailability (≥90%), conventional oral therapy requires frequent daily dosing owing to its short elimination half-life (~6.3 h), which can compromise patient compliance, particularly in geriatric and paediatric populations. The buccal mucosa offers an attractive alternative site for systemic drug delivery because it bypasses hepatic first-pass metabolism and gastrointestinal enzymatic degradation, while its rich vascularity supports rapid drug absorption. The present work reports the formulation of a mucoadhesive buccal film of pregabalin by the solvent casting technique using hydroxypropyl methylcellulose (HPMC) and chitosan as film-forming and mucoadhesive polymers, propylene glycol as plasticizer, mannitol as diluent/pore-former, and peppermint oil as a flavouring agent. The prepared films were evaluated for physicochemical, mechanical, mucoadhesive and in vitro release characteristics in accordance with standard pharmacopoeial and literature-reported methods. This article consolidates the drug and excipient profiles, formulation rationale, evaluation methodology and a review of twenty contemporary studies on mucoadhesive buccal and related transmucosal delivery systems, and discusses the findings in the context of the existing literature. The buccal film approach is presented as a promising, patient-friendly alternative dosage form capable of improving the bioavailability, onset of action and compliance associated with pregabalin therapy.



Keywords

Pregabalin; Buccal film; Mucoadhesive drug delivery; Solvent casting; HPMC; Chitosan; Neuropathic pain; Bioavailability.



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References


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