Drug packaging materials plastic

The definition of a food additive in Section 201(s) of the Federal Food, Drug, and Cosmetic Act, as amended ( the Act ) refers to substances whose intended use results directly or indirectly in the substance becoming a component of food. The FDA refers to direct food additives as those added to a food to accomplish an intended effect. Indirect additives are those that unintentionally, though predictably, become components of food. Components of plastic packaging materials that can migrate to food are indirect additives. 

HDPE by itself is a safe plastic material on account of its chemical inertness and lack of toxicity . Film and containers made from HDPE are used on a large scale in food and drug packaging and HDPE has been used in prosthetic devices including hip and knee joint replacements. All these applications underscore polymer safety. If articles made of HDPE contain fillers, processing aids, and colorants, their toxic effects must be estimated separately. 

F. Pellerin, J. L. Kiger, and J. Caporal-Gauter, Synthetic organic colours in plastic packaging materials for pharmaceutical use, II Identification in plastics and detection of their release into drugs, Ann. Pharm. Fr., 32 421 (1974). 

Packaging Materials. As in the case of fibers, thermal analysis can easily distinguish between most polymeric films on the basis of the glass transition and the thermal history dependence of the melt and recrystallization (20, 21). From the analysis of thin films--as, for example, used in plastic bags recovered with drugs—it should be possible to identify by comparison the bag manufacturer and possibly the manufacturing lot. 

Some examples of plastic additives and parenteral drug administration devices used as packaging materials for sterile products can be seen in Tables 1 and 2. 

Due to the need to check for particles, fibers, and possible discoloration in drug solutions transparent and colorless packaging materials are desirable. Hence, uncolored glass and plastic, bottles and bags, are commonly used as primary packaging for parenteral. To attain photo protection without losing VIS controllability, transparent containers or covers are necessary. 

Some antioxidants possess antimicrobial properties, such as propyl gallate and butylated hydroxy anisole, which are somewhat effective against bacteria. Butylated hydroxy toluene has demonstrated some antiviral activity. Compatibility of antioxidants with the drug, packaging system and the body should be studied carefully. For example, tocopherols may be absorbed onto plastics ascorbic acid is incompatible with alkalis, heavy metals, and oxidizing materials such as phenylephrine, and sodium nitrite and propyl gallate forms complexes with metal ions such as sodium, potassium and iron. 

Containers used for topical administration include plastics, glass, and metals. Most topical preparations are packaged in plastic jars, metal tubes, glass jars or, in some cases, a combination of these materials. Suitable tests are performed to ensure that drug products do not leach or react with the proposed containers. The various types of topical formulations are discussed in Pharmaceutical Dosage Forms (1151) of the USP/NFP ... 

In contrast to the situation for food and drugs, FDA has no specific regulations for plastic packaging materials or their additives for use in cosmetic packaging. Such packaging regulations as there are for cosmetics deal with issues such as labeling and tamper evidence, which are outside the scope of this book. 

Many pharmaceutical manufacturers have now taken to packaging their drug product in plastic containers. The plastics used most in these applications are those manufactured from polyethylene and polypropylene, though other materials have also been used. Since both polyethylene and polypropylene contain extremely small amounts of additives (mostly as antioxidants and antistatic agents), the possibility of their release in sufficient concentrations to endanger to patient is negligible. 

One of the important requirements of any packaging material is that it should not release any component into the drug product. Preparation of containers free of any leachables such as monomeric component is especially important for the containers of ophthalmics, parenteral products, and any liquid products. It was shown that di(2-ethylhexyl) phthalate was released from the PVC bags and that caused haziness of the taxol solution (37), USP/NF offers the protocol of chemical, spectral, and water vapor permeation tests and tolerances for plastic containers (55). Among those, chemical test is designed to give a quantitative assessment of the extractable materials in both organic solvents and water. 

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