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As the number of drugs developed for self-administration has grown, devices that integrate a reconstitution step with the injection step have gained traction.

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As biological drugs continue to grow in terms of therapeutics and total prescriptions, the impact of specialty devices will increase. Who Should Read this Report Development. Executive Summary 2.

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Drug Reconstitution Market Dynamics. Integrated Devices for Reconstituting Injectables. Fax: Fax outside U. What You Will Learn What is the impact of lyophilized injectable drugs on today's therapeutic market, how are they packaged, and who markets them?

Index Reconstitution | WisdomTree

For some of these drugs and vaccines, lyophilization represents the fastest route to market, with pharmaceutical companies later planning their introduction in an alternative format as part of lifecycle management strategies. The supply of many biologics in a liquid form is impractical or impossible. Instability of liquid stable drugs at room temperature can require costly transportation and storage using refrigeration during the entire life of the product.

How to reconstitute PCC (Prothrombin Complex Concentrate)

Pharmaceutical companies may also have concerns that the pharmacokinetic and pharmacodynamic properties of certain biologics in a liquid stable format may diminish over time. For such biologics and other drugs or vaccines, their supply in a lyophilized or powder form requiring reconstitution at the point of delivery can represent the only feasible pathway to commercial launch. The majority of lyophilized drugs and vaccines are targeted for administration via IV infusion, intramuscular, or subcutaneous injection.

The traditional process for their reconstitution requires up to a dozen steps incorporating a syringe, a single- or multi-dose vial with the drug, a second vial or syringe with diluent, one blunt needle, and one narrow bore needle for injection. Vial access devices, vial adaptors, and vial-to-vial systems are also becoming common for use with some reconstitution therapies. Given the paramount importance of avoiding errors during the reconstitution of an accurate dose, the self-injection of such therapies has long been recognized as being unfeasible without a device that is extremely intuitive for the user.

The relative complexity of conventional reconstitution systems compared to other device categories used with liquid stable drugs has therefore largely restricted lyophilized drugs to injection by healthcare workers within the confines of hospitals and other secondary care sites. Even with extensive staff training, the process of reconstituting lyophilized products within healthcare facilities can involve some significant challenges.

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  • Vial Adaptors for Reconstitution Drug Market – Major Factors Driving the Industry?
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Inefficiencies include the need for facilities to purchase and stockpile multiple pieces of inventory and the lengthy preparation time required to reconstitute a therapy with the correct dose volume prior to injection. For mass vaccination programs in which an operator may be delivering dozens or even hundreds of injections per day, the length of time required to reconstitute a dose can become particularly cumbersome.

With the FDA placing an increasing focus on human factors in the approval of new drugs or formulations, pharmaceutical companies risk failure if data cannot be presented that demonstrates sufficient levels of reliability and dose accuracy during the reconstitution and injection process. The traditional process of reconstituting a lyophilized drug may also exacerbate the risk of needlestick injury for a healthcare worker, as syringes with attachable needles are typically used to draw a reconstituted dose from a vial.

To comply with needlestick prevention laws in within the US, Europe, and other international regions, healthcare workers will typically attach safety needles with needlestick prevention systems, such as a sliding sheath or hinged arm. Filter needles used for vial access lack safety features altogether. For fine needles used for injection, these ancillary safety products require post-removal activation of the safety mechanism, with the operators required to undertake a second manual action, such as placing their hands close to the needle after completion of injection.

An estimated two-thirds of all reported needlestick injuries involving safety products are caused by such manually activated products. Organizations, such as the Emergency Care Research Institute, also site a common practice amongst many healthcare workers to not activate the safety mechanism of such manual products, creating the risk of downstream injury, unsafe disposal, or syringe reuse.

For IV applications, there are many therapeutic drugs in which there are no suitable or sub-optimal system to seamlessly integrate reconstitution, dilution, and delivery. A shortage of easy-to-use drug reconstitution delivery systems has constrained market opportunities for the self-administration of many approved therapies by patients outside of healthcare facilities. In some cases, the lack of an effective reconstitution system has prevented the commercialization of promising injectable therapies in which a business case can only be made for patient self-injection.

Vial Adaptors for Reconstitution Drug Market – Major Factors Driving the Industry

Despite conventional reconstitution technologies being unable to fully address many of these unmet market needs, some pharmaceutical companies have sought to make their injectable therapies available for patient self-injection to address significant healthcare challenges.

One example of a lyophilized drug currently supplied in injection kits for reconstitution and use outside of healthcare facilities is glucagon. A selection of glucagon therapies are available by several manufacturers that that are targeted for use by the family members or other caregivers of patients requiring emerging treatment for severe hypoglycemia.

With current glucagon therapies beginning to fibrilize and become unstable shortly after entering into a liquid form, the only available option is to keep the drug in a lyophilized form where it can be kept on hand and stored at room temperate for up to 2 years. Supplied in emergency kits in a lyophilized vial and a syringe filled with diluent, such glucagon products must be rapidly reconstituted and injected by a caregiver who may have little to no prior experience or training.

On the basis of delivery mode, the market has been segmented injection and infusion.

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In addition, the regions have been further segmented by major countries from each region. These include the U. Key Players Mentioned in the Report are: The global vial adaptors for reconstitution drug market is consolidated in which relatively small number of companies accounted for majority market share. Major players operating in the global vial adaptors for reconstitution drug market are Baxter International Inc. Canada Europe U. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place. Contact Us.

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