Novel Drug Reconstitution Systems: Emerging Options for the Reconstitution of Lyophilized Drugs

Lyophilization of Pharmaceuticals and Drug Reconstitution

In 2018, seven out of ten top-selling prescription medicines were biologics. The liquid formulations of biologics are not much stable and tend to loose 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 drug reconstitution before administration.

Need for Reconstitution Systems

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.

Overview of Reconstitution Systems

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.

Factors Affecting Drug Reconstitution

Dual Chamber / Multi Chamber Systems

These reconstitution systems consist of dual chamber or multi-chamber prefilled syringes / cartridges / infusion bags which enhance the portability, efficiency and optimum delivery of the lyophilized drugs. They enable the patients and caregivers to administer drugs without healthcare provider’s intervention and reduce the time required to reconstitute and inject the dose, in addition to minimizing the risk of dosing errors.

One Step Reconstitution Systems

The one step reconstitution systems capable of reconstituting a lyophilized / liquid drug and diluent, provides an innovative option to prefilled syringes and other containers that require significant development time. This system operates through less number of steps and utilizes the standard drug vial configurations for easy and complete drug withdrawal.

Conventional Reconstitution Devices

The conventional reconstitution devices such as, vial adaptors are considered a safe solution for transfer and reconstitution of drugs between vials and syringes. In addition, they are cost-effective and reduce the exposure to needle-stick injuries. Further, the closed systems are associated with benefits including, reduced hazardous drug exposure and the transfer of environmental impurities into the system is restricted.

Advantages of Drug Reconstitution Systems

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.

Growth Drivers and Challenges

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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