
In 2018, seven out of ten top-selling prescription medicines were biologics. The liquid formulations of biologics are not much stable and tend to lose efficacy with time due to the changes in their pharmacokinetic and pharmacodynamic properties. Therefore, lyophilization of such drugs is essential before their storage. Around 50% of the biologics intended for parenteral administration are available in lyophilized form, which require reconstitution before administration.
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The traditional methods of drug reconstitution involve manual extraction and transfer of diluent for mixing the drug. As such, these methods are complex and associated with several concerns including, large number of steps, multiple containers, and medications errors, which made reconstitution of various lyophilized drugs and vaccines a challenge in commercialization of these drugs. This has led to the development of novel drug reconstitution systems, which enable simple and effective way of reconstitution and administration of lyophilized products.
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The reconstitution system offers multiple benefits to patients as well as biopharmaceutical and pharmaceutical companies, enabling them to store the lyophilized therapeutics in the container closure system.
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