Parenteral formulations packaging

Table 20 presents the A1 level in parenteral formulations, collected by different authors in different countries. Not all of them mention glass packaging as responsible for A1 contamination, but it seems to have been the major source. These data also confirm that the nature of the formulation components plays a key role in selective A1 leaching. 

Parenterally formulated biopharmaceuticals are typically packaged in glass containers with rubber/synthetic elastomeric closures. Pharmaceutical glass is composed primarily of silicon dioxide tetrahedron which is modified with oxides such as sodium, potassium, calcium, magnesium, aluminum, boron, and iron [45],The USP classifies glass formulations as follows ... 

B Disadvantages. Gabapentin is absorbed by an active process that saturates at higher doses. This may require more frequent daily dosing for patients who need doses greater than 3600 mg/day. Doses exceeding the 3600 mg/day maximum listed in the package insert may be required in some patients to achieve seizure remission. There is no parenteral formulation. 

With parenteral formulations, limitations on shelf-life can be based on the time needed for formation of microbial impurities. For many such formulations, biostats are added to prevent or at least slow microbial growth. Once these are consumed, growth can occur. For other formulations, packaging integrity over time may determine propensity for microbial growth. 

The diversity of radionucHde half-life and chemical nature of commonly used radiopharmaceuticals demands a variety of formulation matrices, packaging containers, and storage conditions. The containers, ingredients, and processes used in these products must meet the stringent requirements for parenteral pharmaceuticals, as well as provide safe conditions for storage, handling, and disposal of the radioactive material. 

Current good manufacturing practices (CGMPs) indicate that a parenteral manufacturer should confirm supplier certification on packaging components. The following characteristics are usually monitored for a specific elastomeric formulation ... 

Packaging components for parenteral products are generally composed of three items glass/plastic containers, elastomeric closures, and plastic bags. Selection of the packaging components depends on the compatibility between the formulation and the packaging material and on any special requirement of the formulation. 

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