PENGEMBANGAN FILM INTRAORAL MENGANDUNG NANOEMULSI PROTEIN DAN KARAKTERISASINYA

• Main Author: Manuel Haryadi, Bernard
• Format: Final Project
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/62196
• Institution: Institut Teknologi Bandung

The use of proteins as a therapy for patients is increasing recently. However, protein has limitation, both in stability and the invasive route of administration (by injection). Therefore, formulation to optimize the use of therapeutic proteins become the research focus of interest. The purpose of this study was to develop protein preparation given via intraoral route (oral cavity), namely intraoral films loaded protein nanoemulsion (IFPN). Nanoemulsion was prepared using SNEDDS method as previously research with composition of glyceryl monooleate (GMO), Cremophor RH-40, and polyethylene glycol (PEG 400), 1:8:1 respectively. The film was prepared by using different polymers and plasticizers with solvent casting technique. Characterization of protein nanoemulsion (PN) was determined by droplets size, size distribution represented by polydispersity index, zeta potential, entrapment efficiency, and pH. Characterization of IFPN was included pH and viscosity of the film-forming liquid, macroscopic of films, film thickness, film weight uniformity, folding endurance, disintegration time, dissolution time, tear resistance, tensile strength (TS), percent elongation (PE), elasticity modulus (EM), and film morphology by SEM. IFPN was formed by using carboxymethyl chitosan (CMCs) polymer solution and PN in the ratio 76:24, where PN contained solid dispersion of BSA (Bovine Serum Albumin)-soyPC (1:3) that equal to 0.1 % BSA in SNEDDS. IFPN formula of CMCs has sucessfully retained droplets that had been formed in the PN, where droplets size of PN was 17.60 ± 0.66 nm. More than 95% protein BSA was entrapped in SNEDDS. IFPN showed clear, transparent, and specific texture of CMCs films, thickness of 0.099 + 0.005 mm, weight 84.13 + 0.12 mg, folding endurance > 300 times, disintegration time of 32.67 + 1.53 seconds, dissolution time of 124.67 + 2.52 seconds, tear resistance of 6.71 + 0.42 N, 18.35 + 0.60 MPa TS, 34.23 + 2.00 % PE, and 241.77 + 55.42 MPa EM. IFPN was successfully developed with CMCs polymer and PG plasticizer. Critical factors for the development such as the type and ratio of film-forming polymer, plasticizer, drying condition, and the loading amount of BSA also influenced IFPN characteristics.