DESIGN OF EXPERIMENTS-BASED OPTIMIZATION OF ORAL THIN FILM FORMULATION OF ESCITALOPRAM OXALATE FOR ENHANCED PATIENT COMPLIANCE

SUMANTH BHUKYA; JAYAPAL REDDY GANGADI; POLI REDDY PAPAGATLA

doi:10.22159/ijap.2025v17i4.53907

Authors

SUMANTH BHUKYA Faculty of Pharmaceutical Sciences, Motherhood University, Roorkee, Haridwar, Uttarakhand, India https://orcid.org/0009-0009-0171-0737
JAYAPAL REDDY GANGADI Faculty of Pharmaceutical Sciences, Motherhood University, Roorkee, Haridwar, Uttarakhand, India https://orcid.org/0000-0002-4380-7379
POLI REDDY PAPAGATLA Department of Pharmacology, Nalanda College of Pharmacy, Nalgonda, Telangana, India

DOI:

https://doi.org/10.22159/ijap.2025v17i4.53907

Keywords:

Escitalopram, Oral thin films, Central composite design, Dissolution, Patient Centric

Abstract

Objective: This study aimed to develop and optimize an Oral Thin Film (OTF) formulation of escitalopram oxalate to enhance patient compliance, improve drug acceptability, and facilitate rapid systemic absorption.

Methods: A Central Composite Design (CCD) under Response Surface Methodology (RSM) was employed to optimize the formulation. Polymer (300–500 mg) and plasticizer (100–300 mg) concentrations were selected as independent variables, and their effects on critical response parameters—tensile strength, folding endurance, disintegration time, and dissolution rate-were evaluated. The optimized OTF was characterized for thickness, disintegration, and dissolution behaviour.

Results: The optimal polymer and plasticizer concentrations were identified as 400 mg and 220 mg, respectively, yielding desirable film properties. The OTF thickness ranged from 0.48 to 0.57 mm, with formulations between 0.50 and 0.55 mm exhibiting the most favorable dissolution and disintegration profiles. The optimized OTF exhibited a tensile strength of 15.3 N/mm², folding endurance of 159 folds, and a disintegration time of 73 sec. Dissolution studies demonstrated 98% drug release within 10 min, confirming rapid dissolution for a fast onset of action.

Conclusion: The study successfully developed an optimized OTF formulation of escitalopram oxalate, supporting the global shift toward patient-centric drug delivery. The formulation enhances therapeutic outcomes by ensuring rapid systemic absorption and improved patient adherence.

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