It is estimated that between 2011 and 2015, there will be more than 130 patented drugs with an estimated value of more than $100 billion. At that time, Chinese pharmaceutical enterprises can make full use of the huge market space of generic drugs released by the expiration of patent drugs and realize the independent production of patented drugs.
With the rapid development of China's pharmaceutical market, a series of problems have followed, such as drug production pollution, low level of drug supervision and information management, and the biotechnology industry still at the middle and low end. Among them, compliance with the regulatory standards for packaging and drug contaminant migration should become one of the key concerns of Chinese pharmaceutical enterprises.
Although glass containers are effective in preventing chemicals from entering the container, many next-generation pharmaceutical containers and delivery systems, especially those that require extrusion, are typically made of plastics such as low-density polyethylene (LPE), high-density polyethylene (HPE), and polypropylene (PP). Plastic containers have the advantages of convenient operation, low cost and not easy to break.
However, label inks, natural paints, topcoats, additives, paper or film coatings, and even chemicals from the container itself can seep into the container and cause contamination or chemical reactions to the drugs in the container. Pollutant migration is the highest possibility of substances in ink solvents, UV inks, topcoat and natural paint.
Potential threats to China's drug market Packaging is designed to keep medicines and personal care products clean and prevent direct contamination, particularly in plastic packaging, where pore density is lower than in glass packaging, where chemicals are more likely to seep into medicines.
With the use of more convenient plastic packaging in the pharmaceutical industry, Chinese pharmaceutical companies should be aware of the potential risks of changing container materials from glass to plastic, and should also be concerned about the potential health risks to consumers in the event of the migration of chemicals on pharmaceutical packaging.
If this happens, the effectiveness of the drug may be reduced and harmful chemical reactions may occur if unnecessary chemicals are ingested. These problems may lead to the decline of consumer confidence in the brand, which in turn leads to the loss of market share of pharmaceutical companies. Only by ensuring that all drug packaging meets industry regulatory requirements, pharmaceutical companies can guarantee the safety of their products.
China has pointed out in the Twelfth Five-Year Development Plan of the Pharmaceutical Industry that it is necessary to strengthen the development and application of new pharmaceutical auxiliary materials and packaging materials, improve the quality and performance of medicines, and ensure the safety of medicines. In addition, the compatibility research and safety evaluation of pharmaceutical packaging materials and drugs will be carried out step by step, and the evaluation procedures and methods of pharmaceutical packaging materials will be established to ensure the safety and effectiveness of pharmaceutical packaging materials.
