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.
VDAs target the endothelial cells of tumor blood vessel that are involved in processes like migration, adhesion, cohesion, and proliferation which further alternates the shape of the endothelial cells, break the cell-to-cell junctions, thereby, leading to loss of cohesion and ultimately resulting in ischemia and tumor necrosis. They have shown greatest effect in combination with conventional chemotherapy or other modes of treatment that selectively target and attack cancer cells. Presently, there are multiple small molecule VDAs, which have been / are being developed for the treatment of a variety of oncological conditions, including colorectal cancer, glioblastoma, hepatocellular carcinoma, lung cancer, melanoma and ovarian cancer.
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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.
The shortage of easy-to-use drug reconstitution delivery systems has limited the market opportunities in the past. However, with the introduction of novel drug reconstitution systems, delivery of lyophilized drugs has become convenient. Such systems provide better treatment options to patients, save time and labor of caregivers. Owing to the various benefits offered by novel drug reconstitution systems, and the growing pipeline of biologics and lyophilized formulations, adoption of novel drug reconstitution systems is anticipated to increase, and this segment of the pharmaceutical industry is likely to witness significant developments in the coming years.
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