Preformulation Studies of Varenicline for Formulation and Development of a Novel Orally Disintegrating Film

Abstract

Objective: The major goal of pre-formulation research is to create a drug delivery system that is stable, elegant, safe, and effective by determining the drug's kinetic profile, the formulation's compatibility with various excipients, and the physico-chemical characteristics of new drug molecules. This could offer crucial support for executing formulation design or the need for the molecular change. Therefore, in the current study, studies on Varenicline (VAR)'s appropriateness for oral formulation were conducted. Similar to cytisine, VAR functions as a partial nicotine receptor agonist. It blocks alpha-4-beta-2 nicotinic acetylcholine receptor subtypes and is a partial agonist. Through partial agonism, VAR reduces the urge and withdrawal symptoms associated with quitting efforts by inhibiting the dopaminergic activation brought on by smoking. It stops nicotine from stimulating the mesolimbic dopamine pathway, which is linked to nicotine addiction. Methods: The authenticity of VAR was established by DSC and FTIR spectra. A UV spectrophotometric method was employed for determination of VAR in bulk and active pharmaceutical ingredient (API). Results: The authenticity of VAR was established by DSC and FTIR spectra. For the determination of VAR in bulk API (active pharmaceutical ingredient), a UV spectrophotometric approach was used. In the concentration range of 5–40 g/ml, the UV technique was linear. The lower% CV values of intraday and interday variability indicate the proposed methodology's robustness. The higher regression coefficient value(0.999) indicates the methodology is robust. Conclusions: The outcome of the physico-chemical experiments of drug molecule indicates suitability of oral route. Additionally, at different conditions like solid as well as liquid state, the drugmoleculewasobservedstable.