International Journal of Drug Delivery Technology
Volume 14, Issue 3

Preparation of Mouth Dissolving Sublingual Film of Fixed Dose Combination of Hydrochlorothiazide and Losartan Potassium and Statistical Optimization of Film

Attal V*, Daniel K

Oriental University, Indore, Madhya Pradesh, India

Received: 08th March, 2024; Revised: 26th May, 2024; Accepted: 02nd August, 2024; Available Online: 25th September, 2024

ABSTRACT

Fast-dissolving films (FDFs) are innovative dosage forms offering advantages such as improved patient compliance, rapid onset of action, precise dosing, and favorable taste. Particularly beneficial for patients unable to swallow or require immediate drug absorption, FDFs dissolve rapidly in the mouth, releasing medication directly into the oral cavity. The sublingual application enhances drug delivery due to the high permeability of the sublingual mucosa, bypassing hepatic first-pass metabolism. This route is advantageous for drugs like losartan potassium (LP) and hydrochlorothiazide (HCZ), which benefit from enhanced bioavailability and faster onset of action. Preformulation studies included UV spectroscopy for λmax determination (LP: 282 nm, HCZ: 250 nm), DSC for thermal analysis (LP: 289.11°C, HCZ: 104.76°C), and solubility studies confirming LP’s solubility in acidic pH and HCZ’s increased solubility in pH 6.7 buffer. Compatibility studies using FTIR and DSC validated stability with excipients. Formulation optimization with HPMC E15 resulted in films with characteristics like film weight (145.66–167.0 mg), thickness (0.246–0.326 mm), folding endurance (898.0–1274.0), pH (6.0–6.70), disintegration time (77.66–174.6 s), tensile strength (77.04–141.90 g/cm²), and drug release profiles (LP: 68.78–96.22%, HCZ: 59.49–95.43% at 21 minutes). In summary, this study successfully developed LP and HCZ FDFs with optimized characteristics, demonstrating their potential in hypertension management and improving therapeutic outcomes.

Keywords: Fast dissolving films, Patient compliance, Rapid onset of action, Sublingual administration, Enhanced bioavailability, Formulation optimization.

International Journal of Drug Delivery Technology (2024); DOI: 10.25258/ijddt.14.3.13

How to cite this article: Attal V, Daniel K. Preparation of Mouth Dissolving Sublingual Film of Fixed Dose Combination of Hydrochlorothiazide and Losartan Potassium and Statistical Optimization of Film. International Journal of Drug Delivery Technology. 2024;14(3):1344-1352.

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