Novel Drug Reconstitution Systems Market, 2021-2030

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.

Reconstitution is the process, which involves mixing of dried therapeutic with a sterile diluent to reformulate it into liquid form before administration. It is multi-step process that involves the manual extraction and transfer of diluent from first vial to the second vial, containing the lyophilized product using syringe and transfer needle. After transferring, the contents are mixed until the final mixture is fully reconstituted. The process is usually performed by a trained healthcare provider or caregivers and requires the use of vial adaptors, vial-to-vial systems and advanced dual chamber reconstitution systems.

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