Pharmaceutical Packaging from Drug Conception to Injection | Newsletter | Issue 10 | 2022

It is estimated that the pharmaceutical product packaging market will experience a growth rate at a compounded annual rate of 6.1% throughout the forecast period of 2020-2027. This growth comes with technological demands and market needs that are driving enhancements for development. There are 9 megatrends that define and affect the pharmaceutical product packaging market. These data vectors are the increase in chronic conditions and an aging populace, fast development in generics, improved medical care provisions, growing metropolitan populations as well as middle class, rising healthcare costs, stricter regulatory requirements, more biosimilars and biologics, self-medication, in addition to personalized medication, next generation vaccines and sustainability.

Market Influences

Drug packaging requirements are affected by the increasing demand for compounded drug products, growth in biological therapies (cell, gene), and advancements in vaccines as demonstrated through new mRNA technologies (COVID-19). Consequently, drug manufacturers are seeking solutions that are pre-validated and ready-to-use, to ensure that the quality of drug products including safety and effectiveness. When evaluating and selecting primary packaging options for injectable solutions, it is important to achieve optimal compatibility between container, close and drug product. New technologies are improving compounded drug security and also reducing drug/container interaction over the duration of its shelf life. High-quality container closure systems that satisfy governing requirements decrease the danger of leachables and extractables, ensure container closure seal integrity to maintain sterility and minimize risk of particulates. There are various attributes that must be defined and final drug product testing that have to be completed to have a validated packaging system.

These parameters include drug type; for example, a sensitive drug product will need an efficient primary packaging solution that minimizes drug/container correspondence, such as amber material to protect from UV exposure. The route of administration plays an essential function. Whether the drug product is injected intravenously or subcutaneously, at home or in a medical office setting, there are numerous variables that should be thought of prior to selecting the ideal fit for drug product packaging. In most cases, new compounded drugs are introduced to the market in a vial/cap; however, pre-fillable syringes benefit by streamline of administration.

The popular direction being pushed for therapies is where the patient can administer the medication themselves and the expanding biological therapy pipeline is driving development in both containment and shipment of injectables. From the manufacturer’s viewpoint, the most significant changes affecting packaging equipment at the manufacturing site are demand for smaller batch sizes. Small production lots require faster changeover from one compounded drug formulation to another, calling for flexible equipment, while pharmacy staff and drug products must be insulated from cross- contamination, particularly in primary packaging. Advanced isolator technology and if applicable, lyophilization technology, have improved sterile drug manufacturing consistency and improved quality. Lastly, digitalization has improved production reliability in advanced manufacturing operation technology systems and digital document control.

Other Trends Driving Change

Another key trend for pharmaceutical packaging is the increasing complexity of drug formulations. In many cases, these new complex drugs enter the market in smaller batches as the patient group is smaller, requiring compounding, as compared with FDA approved drugs. This is where pre-validated and ready-to-use containers come in to play. For the emerging custom compounded medicines with lower production volumes, the need for flexibility in both primary packaging container and lot size will, in many cases, be of a higher priority than optimized costs.

Personalized medicine and novel therapies are impacting the pharmaceutical industry in general as these drugs represent a particularly high financial value and are complex to produce, which challenges the filling technology in various ways. Small batches require high system flexibility as well as automation and safeguarded processes through standard operating procedures. Under these conditions and with these technologies, even small, very valuable batches can be processed very efficiently.

Packaging development has become an integral part of the compounded pharmaceutical drug development and manufacturing. The COVID-19 pandemic has strengthened the collaboration between the compounded pharmaceutical industry, packaging technology suppliers, and regulatory authorities, creating a solid network of solutions for speed and efficiency in drug development and supply of safe and effective medicines in the future.

MediZap offers pre-validated packaging solutions for E-Beam | X-Ray terminal sterilization that saves you both time and money for commercializing new sterile drug products.

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