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

Heni Rachmawati Bernard Manuel Haryadi

doi:10.4172/2157-7439.1000187

Abstract

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.

Highlights

Protein which is major part of pharmaceutical biotechnology product is predicted to be used increasingly as a therapeutic agent in the future
It has been estimated that biotechnology products in the 20 years will take half of the world drug market [1]
Administration route of therapeutic proteins in particular for systemic treatment is still restricted to invasive route due to the low bioavailability of protein when given by non-invasive way

Summary

Introduction

Protein which is major part of pharmaceutical biotechnology product is predicted to be used increasingly as a therapeutic agent in the future. Administration route of therapeutic proteins in particular for systemic treatment is still restricted to invasive route due to the low bioavailability of protein when given by non-invasive way. This low bioavailability mainly due to enzymatic degradation, poor absorption and first-pass effect metabolism. Some advantages like ease of access, availability of tough mucosa tissue, avoidance of intensive first past effect and degrading enzymes, potential to improve bioavailability with rapid onset, and promising patients acceptance, convenience and adherence because the drug can be administered by themselves without help from paramedics

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Conclusion