Evaluation of Mechanical Properties and Volatile Organic Extractable to Investigate LLDPE and LDPE Polymers on Final Packaging for Semisolid Formulation.

Arianna Cozzi,Filippo Fangarezzi,Paola Perugini,Barbara Mannucci,Benedetta Briasco,Enrico Salvarani

doi:10.3390/pharmaceutics10030113

Abstract

Plastic material is used for a wide variety of commercial packaging due to being inexpensive, lightweight, and due to its resistance. In pharmaceutics, container-content compatibility studies are required for product authorization. Many guidelines and publications are available; however, the information is often only related to the raw materials used to produce packaging. During the manufacturing process, substances can be added to improve the product characteristics and performance, resulting in a processed material that is considerably different from the unprocessed material. In this study, the mechanical properties of low-density polyethylene (LDPE) and linear low-density polyethylene (LLDPE) specimens fabricated according to standard ISO 527 and specimens fabricated with the same materials, but obtained from final packaging, were evaluated. Furthermore, we examined the interaction between a semisolid formulation and LLDPE and LDPE as a final packaging, by subjecting two samples to accelerated degradation testing. Then, mechanical properties and volatile organic extractable were evaluated. Simulated solar radiation did not induce changes in the packaging mechanical properties and no extracts were detectable. The thermal shock strongly influenced the mechanical behavior, and interactions between packaging contents were identified. The present work underlines the difference between analyzing the standard ISO specimens versus samples obtained from final packaging in order to evaluate the packaging under real use conditions. An evaluation on the final packaging, instead on standard specimens, can provide information about the plastic material after the manufacturing process and the interaction between packaging and content.

Highlights

Packaging plays a key role in preventing spoilage, extending shelf life, and facilitating storage and transport, but the packaging has to fulfil more than these primary containment, preservation, and protection functions
Thickness of the linear low-density polyethylene (LLDPE) and low-density polyethylene (LDPE) specimens created according to International Organization for Standardization (ISO) 527 specifications [14] and LLDPE and LDPE dog-bone shaped specimens obtained from the final single-dose packaging containers were calculated to determine if the specimens were uniform
Results for the LDPE polymer showed that simulated solar radiation induced statistically significant changes in the mechanical characteristics of this polymer and induced some interactions between the formulation and the container detectable at the level of alterations of the mechanical properties of packaging composed of this polymer

Summary

Introduction

Packaging plays a key role in preventing spoilage, extending shelf life, and facilitating storage and transport, but the packaging has to fulfil more than these primary containment, preservation, and protection functions. Even if the packaging should preserve and protect the content from external physical, chemical, and microbiological hazard in order to maintain the safety, quality, and effectiveness of the product, studies about the interactions between the packaging material and the product contained have highlighted possible migration of chemical substances across the packaging sourced from the contained or the sorption of product ingredients by the packaging. The food sector is regulated by European Regulation No 1935/2004 for materials and articles intended to contact food, and Commission Regulation (EU) No 10/2011 is specific to food-contact plastic materials This regulation establishes a list of compounds authorized for use in plastic formulation and migration tests performed on food simulants because the packaging and the contained product are not two separated entities, but they may interact, especially in presence of varying environmental conditions. Penetration of content components into the packaging or migration of packaging substances into the product could produce significant variation in the packaging properties or affect product safety and efficacy

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Discussion

Conclusion