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How to Choose Pharmaceutical Packaging Materials?

publication date: Apr 18, 2022

The packaging materials used for pharmaceutical tablets are in direct contact with the pharmaceuticals. Therefore, as a pharmaceutical manufacturer, when selecting packaging materials, it is necessary to understand some properties and characteristics of packaging materials and containers, to ensure the efficacy and quality of medicines.

 

What are the common pharmaceutical packaging materials?

 

Glass: Glass has the advantages of being moisture-proof, easy to seal, transparent and relatively stable in chemical properties. To ensure the quality of medicines, Pharmacopoeia stipulates that ampoules and large infusion bottles must be made of hard neutral glass, and containers made of brown glass should be used when containing medicines that are easily deteriorated by light.

 

Plastic: Plastic has the advantages of firm packaging, easy sealing, bright color, lightweight, and low price.

 

Paper products: Paper products have a wide range of sources, low cost, and certain moisture-proof properties after being painted with moisture-proof coatings. The packaging volume can be manufactured according to needs, and paper packaging can be recycled. Hence, it is one of the most widely used packaging materials today.

 

Metal: Commonly used metals for packaging are black iron, galvanized iron, tinplate, aluminum foil, etc. They have good pressure resistance, sealing and performance, but the cost is relatively high.

 

Wood: It has pressure resistance and is a commonly used outer packaging material. Due to the consumption of forest resources, it is gradually replaced by materials such as paper and plastic.

 

Composite material: Composite material is a newcomer in packaging materials. It is a packaging material made of plastic, paper, aluminum foil and other multi-layer composites. Commonly used are paper-plastic composite materials, aluminum foil-polyethylene composite materials, aluminum foil-polyester ethylene and so on. These composite materials have good mechanical strength, biological corrosion resistance, vacuum retention, and compression resistance.

 

Rubber products: They are mainly used for bottled medicines as various bottle stoppers.

 

In general, the past decade has witnessed an increased use of various composite materials. The applications of specialty packaging materials such as PTFE, silicone resins, polyester laminates or foamed polyurethane are on the rise.

 

Plastic bottle packaging

 

How to choose the most appropriate bottle packaging materials? Due to the many specifications of medicinal plastic bottles ranging from small dozens of milliliters to large thousands of milliliters, there are many options for pharmaceutical manufacturers when selecting plastic bottles. The following principles should be adhered to when choosing plastic bottles:

 

Select the main raw materials and auxiliary formulations of plastic bottles

Since there are many kinds of main raw materials available for selection, it is necessary to select the comprehensive properties of the raw materials. Generally, high-density polyethylene and polypropylene bottles are used for tablets. If transparency is required, PET bottles can be used. If medicines need higher barrier properties, light-blocking and opaque, brown PET bottles are used. The better barrier properties are PEN bottles. Liquid dosage forms generally use polypropylene bottles or polyester bottles as the main raw materials.

 

Body and cap tightness, water vapor permeability

Airtightness and water vapor permeability are two important technical indicators of medicinal plastic bottles, and they play a crucial role in drug stability.

 

Quality Assurance System

Auditing suppliers has become an essential part of purchasing plastic bottles. Through the audit, it is possible to make a comprehensive and correct assessment of the production plant's facilities, technical equipment, and comprehensive quality level.

 

Stability and compatibility of plastic bottles

The selection of plastic bottles, especially the selection of new plastic bottles (or new materials and new processes) for new drugs, should be carried out first to investigate the stability and compatibility between plastic bottles and drugs. The penetration, dissolution, adsorption, chemical reaction and denaturation of drugs and plastic bottle materials must be determined through scientific testing. CD Formulation can test the types of containers that need to be evaluated, including plastic bottles, glass vials, stoppers, and raw plastics (resin pellets, sheet, etc.). In a usual drug packaging test project, the following factors should be tested, including identification, solution appearance, UV absorbance, pH, total organic carbon, bioreactivity tests for polyethylene, polypropylene, polyethylene terephthalate, cyclic olefins and plasticized polyvinyl chloride, as well as chemical safety assessments.


 

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