Many reconstituted drugs are administered at home by the patient. Different technologies for reconstitution have gained approval and acceptance among pharmaceutical companies and their patients.

For patients who must manage chronic diseases — such as hemophilia, multiple sclerosis, rheumatoid arthritis, diabetes, and others — medication issues can present significant challenges regarding safety, ease of administration, cost, compliance, and other factors. Fortunately, continual advances and breakthroughs from pharmaceutical companies are delivering tremendous improvements in theform of more effective medications. However, these medications typically require frequent injections; depending on the nature of the disease and the patient’s individual condition, those injections could be weekly, daily, or even multipletimes a day.

In an effort to reduce health care costs and improve patient satisfaction, there has been a marked increase in patient self-administration of medications forchronic conditions. Many pharmaceutical companies are turning to home-deliveryand administration of these injectable medications, most of which are manufacturedand sold in lyophilized (or “freeze-dried”) form and require reconstitution,mixing, or transfer before administration. This reconstitution process can becomplex and introduce certain issues to consider.

WHY DO WE NEED RECONSTITUTION SYSTEMS?
Many new drugs, especially those developed by bio-pharmaceutical companies, are initially marketed in lyophilized form for two primary reasons: shelf-life and time-to-market. A lyophilized drug maintains its stability and potency over time, extending its shelf-life for prolonged storage. Some drugs marketed in lyophilized form may eventually be available as liquids, but lyophilizationprovides the fastest route to market for many drugs, and the only option forthose not stable in a liquid form.

These drugs — often packaged in a powdered form in vials —requirean additional preparation step prior to administration. That additional stepis the traditional reconstitution process. With traditional reconstitution, thereare two vials and one disposable syringe. One vial contains the lyophilized drugand the other contains the diluent (often water, but occasionally another liquid).The patient or caregiver must use the syringe to insert air into the vial containingdiluent, withdraw the diluent into the syringe, insert the diluent into the vial containing the lyophilized drug, mix the solution to create an injectable medication, and draw a measured dose back into the syringe for injection. Not surprisingly,this rudimentary reconstitution process presents several formidable challenges.

A Lack of Expertise – In most instances, reconstituted drugs are administered in non-clinical settings (typically at home) by patients or caregivers who are not trained health care professionals. While it’s far more convenient for patients who can avoid repeated trips to clinics and other facilities for routine injections, it can be a daunting experience to prepare and administer an injectable drug. Pharma companies need to ensure that the process is simple and safe.

Added Risks – Any drug that requires mixing presents complications and risks. For instance, a hemophiliac must be especially vigilant to prevent accidental needle sticks. There can be inadvertent contaminations or exposures to sometimes-toxic drugs (often resulting from so-called “spray-back”). And there’s a greater risk of inaccurate process — such as using improper concentrations, resulting in incorrect dosing.

Compliance Concerns – If the process is complicated, dosing accuracy may suffer. And if the process is difficult, unpleasant, or painful, it can become an impediment to patient compliance.

Waste – Pharmaceutical manufacturers often overfill the vial by as much as 35 percent to ensure that there is a sufficient quantity of the reconstituted drug to administer the correct dose. The overfill compensates for the inherent variability of the manual process, as well as the difficulty of removing the liquid completely from the vial. From the patient’s perspective, there’s a risk of mishandling or contamination that can necessitate throwing out very expensive drugs.

A number of newer, advanced products on the market can provide both professionals and non-professionals alike with safe, convenient, and easy-to-use systems for reconstituting and administering injectable drugs. These systems can be provided either as a total packaged solution or as components for specialized use.