(T1130-08-48) Orally Dissolving Films (ODFs): A Modern Solution for Convenient Drug Delivery

Purpose: As consumer expectations evolve and the demand for more patient-friendly medication formats grows, innovation in drug delivery systems has become essential. Orally Dissolving Films (ODFs) have emerged as a cutting-edge solution, particularly for individuals experiencing pill fatigue or those who struggle with swallowing such as children, the elderly, or patients with dysphagia. ODFs are ultra-thin, flexible strips that dissolve quickly when placed on the tongue, requiring no water. They are designed to deliver active ingredients whether pharmaceutical or nutritional directly through the oral mucosa, offering a fast and efficient route into the bloodstream.  While examples of ODFs containing nutraceutical and pharmaceutical active ingredients exist in the marketplace today, most of them are very simple, containing just one of two active ingredients set in a polysaccharide-based matrix film ¹.The aim of this study was to develop and optimize an ODF formulation containing a synergistic blend of active ingredients that support energy and mental alertness in a strategic combination of natural and synthetic excipients to achieve a balance between controlled actives release and rapid onset of action.

Methods: A series of formulations were developed using the solvent casting technique which allow the adjustment of polymer concentration, solvent type, and drying conditions and suitable for heat-sensitive Vitamins as the drying temperatures are generally lower. The optimized formulation included Synthetic Polymer HPMC Headcel 60HD4000 (2%) and Natural Polymer High Methoxyl Rapid set Pectin (10%) , Polyethylene Glycol (1%) , Lactose Monohydrate (2%) and Sodium Starch Glycolate (1%). Active Ingredients and flavors: Delivering of dosages (100% DV) based on 200mg ODF. Vitamin B2 (as Riboflavin 1.6mg), Vitamin B6 (as Pyridoxine HCL 2mg), Vitamin C (as Ascorbic acid 50mg) and Caffeine (Caffeine Anhydrous). Sour Cherry was used as the flavoring agent, and Vitamin B2 served as the colorant, imparting a yellow hue to the final film. Two methods were evaluated for incorporating the active ingredients. Formula 1: Addition of actives and PEG before being added to the polymer mix. Formula 2: Actives dissolved in water with PEG, then mixed into the polymer mix. In both methods, water was used as the primary solvent for blending all components. The process map given as in Fig 1. Post drying the films were cut into 2x2cms postage stamp size strips. As though both methods gave promising results Formula 2 was selected for further testing parameters. Characterization and testing the final formula 2 films were evaluated using the following techniques: Thickness Uniformity: Measured using a Positector 6000 thickness gauge. Mechanical Properties: Puncture/Penetration test Assessed via Texture Profile Analysis (TPA). Assay of Active Ingredients: UV-VIS absorbance using GENESYS 10S. Films (200 mg) were compared against standard solutions of each raw material. FT-IR Spectroscopy was used to analyze both raw materials and the final dry formula 2 films to confirm chemical integrity and compatibility. Stability testing conducted at in a temperature-controlled chamber at 45 ⁰C for 4-weeks tested per assay

Results: Visually, the films from both formulas appeared uniform and exhibited a smooth finish. The final films from Formula 2 maintained a consistent thickness within the target range of 80-100 microns with weight of the film less than 100mg. Mechanical testing using a Texture Analyzer, demonstrated that the films possessed excellent mechanical strength (Fig 2). Analytical evaluations confirmed the identity and consistency of the films: FT-IR spectroscopy revealed that the spectral profiles of the films matched those of the individual raw materials (Fig 3). UV-VIS absorbance overlays showed alignment further validating the formulations (Fig 3). Additionally, the films exhibited excellent disintegration performance, dissolving completely in water within 30 seconds. Stability profile showed intact actives and identical to the control.

Conclusion: The project delivered a patient-friendly ODF which can deliver 100% DV actives in 200mg strip. The dosage can be adjusted based on the requirement. Through systematic formulation using a combination of synthetic and natural polymers, along with carefully selected excipients, the final films achieved desirable mechanical strength, uniformity, and rapid disintegration. Both formulation methods produced films that met critical quality attributes. Analytical techniques such as FT-IR and UV-Vis spectroscopy confirmed the presence and stability of active ingredients, ensuring the integrity of the final product. The films’ ability to dissolve within 30 seconds, supports the purpose. This study supports the potential of ODFs as a versatile platform for delivering vitamins, nutraceuticals, and pharmaceutical actives.

References: 1. Orodispersible Thin Film: A new patient-centered innovation: Author links open overlay panel Maram Suresh Gupta, Tegginamath Pramod Kumar, Devegowda Vishakante Gowda
Journal of Drug Delivery Science and Technology: Volume 59, October 2020, 101843

Process map for manufacturing and visual representation of ODFs

Physical attributes - Weight, strength and Thickness of ODFs

Analytical specifications - Assay and Integrity