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The Influence of Polymer Structure on the Physical Characteristic of Intraoral Film Containing BSA-loaded Nanoemulsion

Heni Rachmawati and Bernard Manuel Haryadi

Therapeutic protein has limitation, both in stability and invasive route of administration. Therefore, formulation to optimize the use of therapeutic protein becomes the research focus of interest. The purpose of this study was to develop nanoemulsion as a carrier system for a standard-model protein drug – bovine serum albumin (BSA). BSA-loaded nanoemulsion was then formulated into hydrophilic film for intraoral route. The influence of polymers was evaluated in relation to physical property of the film. Nanoemulsion was prepared using self assembly method with composition of Glyceryl monooleate (GMO), Cremophor RH-40 and Polyethylene glycol (PEG 400), with ratio of 1:8:1. The film was prepared using different polymers and plasticizers with solvent casting technique. Standard characterization of BSA nanoemulsion was including droplets size, size distribution, zeta potential, morphology, and entrapment efficiency. Physical properties of the film containing BSA nanoemulsion was included macroscopic of film, film thickness, film weight uniformity, folding endurance, tear resistance, Tensile strength (TS), percentage of elongation (PE), Elasticity modulus (EM) and film morphology. Based on all evaluated parameters, Carboxy methyl chitosan (CMCs) produced better film suitable for intraoral dosge form. Critical factors such as type and ratio of film-forming polymer, plasticizer, process and BSA concentration influenced the film characteristics.