Vetter: Choosing the Right Diluent to Help Maximize Success

Choose the Right Diluent to Help Maximize Success

The biologics market continues to rise, expecting to reach $250 billion by 2024. Due to the unstable nature and limited shelf life of many biopharmaceutical compounds, there is an increase in the demand for lyophilized drugs. With increasing costs of drug development and the rapidly increasing launch of parenteral lyophilized products, it is essential to make important decisions about the diluent. Most important, the choice of the diluent as part of the drug package should not affect or influence the efficacy of the drug.

Is There an Optimal Diluent Delivery System?

Several diluent delivery options are available on the market today including vials, prefilled syringes, or dual-chamber syringes. In traditional reconstitution using vials, a number of components are required — 2 vials (1 with the lyophilized drug and 1 with a diluent), a disposable syringe, and 2 needles. Experience and training are important with vials since there is the risk of needle stick injury to the person administering the drug. Prefilled diluent syringes, however, have a distinct advantage over vials since they eliminate components and process steps used in traditional reconstitution, reducing risks and opening up new opportunities for the product. These self-contained systems are simple and safe for patients to use since they minimize handling, decrease the potential for dosing errors, maintain a stable pH value, and even help protect against tampering.

Figure 1. Filling of sWFI syringes

Benefits of Prefilled Diluent Syringes

-Less components and fewer steps

-Precision, single-unit dosing

-Less risk of dosing error

-Product differentiation

Customer-Specific or Established Diluent Programs Are Available

Regardless of the choice of diluent or diluent delivery option chosen, proceeding with a customer specific diluent program or an established program will depend on important aspects that are critical for success. Of paramount importance is reducing the risk of interactions by minimizing the packaging material coming into contact with the diluent or a special treatment of the glass barrel. Other important aspects include packaging material preferences and the choice of an appropriate closure part.

An Established Diluent Program Can Offer Significant Advantages

-Faster time-to-market

-Reduced development costs

-One-stop-shop offer

-Distinctive quality

Customized Development Programs Also Have Distinct Benefits

-Flexibility in the selection of primary packaging material

-Availability of a broad range of filling formats

-Various diluent options

For more information about choosing the right diluent, please follow this link: Drug reconstitution: Choosing the right diluent or visit vetter-pharma.com.