Parenterals can be complex to administer but Italian company Haemopharm Healthcare has developed an easy-to-use safety closure for needle-free parenteral vials that won Gold in the CPhI Pharma Innovation Awards. Haemopharm Healthcare is an Italian company that has been manufacturing flexible bags, parenteral delivery systems and medical devices since the 1970s. It also has specific expertise in the field of products for critical care, the life sciences, speciality healthcare and drug administration.
In addition to its manufacturing activities, Haemopharm has been investing in the research and development of new systems and solutions for drug delivery, many of which have been patented by the company.
Its award-winning needleless injection vial (NIV), for example, is a safety closure for parenteral drug vials and is the first needle-free system of its kind connecting a vial and a syringe without any intermediate components.
It is a closure for glass vials for injectable drugs or nutritional active principles, which are mostly sold as lyophilised or freeze-dried drugs, and which require reconstitution, mixing or transfer before administration to the patient. The closure has a hermetic seal, using a needle-free site on the vial seal that is perforable with a needle-free syringe, and which automatically recloses when the syringe is removed.
This device replaces both standard vials used with the conventional syringe with needle, and needle-free vial connector or adaptors that require another item to enable drug reconstitution and which are also very expensive.
This device replaces both standard vials used with the conventional syringe with needle, and needle-free vial connector or adaptors that require another item to enable drug reconstitution
The main innovation is the rubber top on the vial closure. In general, the rubber top on medicinal vials protects the contents from outside contamination. Needles pierce the rubber stopper easily, allowing access to the medication. When the medication is drawn from a rubber-topped vial, it is essential that proper procedures are followed to prevent contamination and ensure the correct dosage is administered to the patient. Moreover, the rubber top also needs to be secure for the care-giver and the patient in avoiding backflow and dangerous aerosol release from the vial, notably where toxic substances such as oncology drugs are concerned.
The innovation’s major strengths are:
- It requires no intermediates, i.e. no additional devices are required for reconstitution besides the syringe and the vial with the drug.
- The raw material, in addition to being compliant with USP class VI, is innovative with no elastic memory.
- The device is compliant with needle-free policies.
- It is cost competitive – not only from the point of view of the innovative material, which makes the vial price competitive, but also because of the absence of an expensive vial adaptor for the syringe, which also reduces the production cost.
- The absence of any intermediate devices also makes the NIV a more environmentally sustainable option, as fewer plastic disposable items will be wasted.
In addition to the standard design NIV, it is also possible to provide bespoke systems, either incorporating special design requests or personalisation, etc.
The hermetic closure is a mechanically and microbiologically closed system during and after multi-use, and therefore protects against contamination of the vial’s contents. Furthermore, it can be used for mixing multiple medications, where the rubber top needs to be accessed a few times, while maintaining completely its flexible and hermetic attributes.
It is a new product that does not require any investment in training or nursing personnel time, since its use and handling are simple and similar to common devices already universally in use.
Ease-of-use for care-givers is extremely important since reconstitution, mixing and administration procedures need to be simple to maintain dosing accuracy
Ease-of-use for care-givers is extremely important since reconstitution, mixing and administration procedures need to be simple to maintain dosing accuracy and reduce any unpleasantness or pain.
Consideration of the user’s experience and interface with drug delivery devices will continue to have a significant impact on the success of a product since they mostly have to be efficient and user-friendly and build patient preference and loyalty.
Preventing backflow
As mentioned above, the immediately reclosable seal avoids the backflow effect, preventing unwanted leakage of the drug or substance, which is critical in case of toxic drugs that may harm the nurse or the patient. It is known that during liquid injection into the medication vial in order to mix and reconstitute certain drugs, a layer of foam is formed inside the vial due to liquid pressure.
This layer impedes the full dose of medication from exiting the vial during administration and as a result, the patient does not receive the full medication dose required, leading to the need for more frequent administration of the drug to receive the necessary dose. This creates inconvenience for the patient and is also a waste of medication, which partially stays unused inside the vial.
Furthermore, some pharmaceutical companies often overfill the vial with medication to ensure that beyond the air bubbles in the vial, the patient still receives the correct dose. This also leads to waste of the active ingredients, which will eventually be thrown away with the vial.
NIV permits a larger amount of drug to be administered due to the wider injection point diameter (syringe tip versus needle), which causes significant reduction of air bubbles due to less liquid pressure inside the vial. In addition, there is less difficulty in removing the mixed drug in liquid completely from the vial since the syringe tip is much shorter than a needle inserted inside the vial.
All of these together accelerate the therapy and save precious time for the care-giver. Therefore the entire process of reconstitution, mixing and administration to the patient is shorter and there is also less failure due to suboptimal dose.
Sound security system
The first perforation of the rubber top is identified by the sound of a click. This is an important mechanism when multiple medications need to be mixed or in case the syringe needs to be inserted into the vial more than once. This ensures the integrity of the vial before use.
In conclusion, the NIV readily suits the ever-growing use of drug delivery systems for applications such as cancer treatment, antibiotics, clinical nutrition, etc. and therefore for many pharmaceutical companies, hospitals and clinics, and finally, patients. It is particularly suitable to the general trend of the clinical and medical world of moving towards a needle-free environment. It can be applied for any medication used in vial, containing a liquid, gel or powder substance.
It is innovative, combining two existing principles into a new one, creating completely safe handling of the device in absence of a needle, but strictly maintaining the sterility of the process and avoiding contamination to the patient due to the hermetically reclosable seal.
NIV offers a small but important variation of the product that does not require any critical change to pharmaceutical companies’ existing procedures, but as an upgrade gives an added value to their products, and as Haemopharm sees it, the best innovation is an alternative with no alternatives.
