University of Alicante

The main objective of the invention is to provide a single-piece connector between a dropper bottle and a pharmaceutical vial that maintains the appropriate properties of the substances or components of the medicine throughout the entire process, until the final dosage by the patient or user assisting the patient, and that also keeps the medicine sterile throughout the entire shelf life of the container in the home environment.

For this purpose, the present invention is adapted to standard pharmaceutical vials (with cap and metal seal) and standard commercial eye drop dropper bottles. In this way, it allows the sealed vial cap to be pierced by pressure, and the solid components of the vial and liquids of the dropper bottle to be mixed aseptically and finally transferred to the eye drop dropper bottle, which is what the user ultimately uses to administer the drops to the eye.

This device will enable the pharmaceutical industry to market medicines that are not stable in solution for ocular administration in the form of eye drops, as they can be reconstituted aseptically by the end user when required without the need for any additional materials.

This device, consisting of a single piece, is composed of the following parts (see Figure 1):

• Needle end: This part of the device contains the rigid needle that pierces the sealing membrane of the pharmaceutical vial, allowing the liquid to be transferred to the vial. The needle has two internal cylindrical holes that allow the liquid to enter and the air to escape, facilitating the mixing of the components without creating a vacuum during the process.

• Outer flap: The outer flap consists of four flaps that allow for a secure fit to the vial. These flaps open slightly, facilitating the attachment of the device to the pharmaceutical vial. This design ensures that the device remains firmly connected, preventing unwanted movement during the transfer and mixing process.

• Internal tabs: The internal tabs work together with the outer flap to provide an additional locking system, preventing the vial and device from moving or disconnecting during the transfer process.

• Threaded end: This end of the device has an internal thread onto which the dropper bottle is assembled. This threaded mechanism ensures a secure connection between the bottle and the device.

• Device body: The main structure of the device, providing its shape, connects both parts (vial and dropper bottle), ensuring that the transfer of liquid is carried out in a controlled and sterile manner.

Figure 1: View of the connection device

The device works as follows: the liquid is contained in the dropper bottle and the freeze-dried powder in the pharmaceutical vial. The dropper bottle is attached to the device, and once joined, the vial is pierced. When the vial is pierced, the liquid is introduced from the dropper bottle into the vial by pressing the latter. Once the liquid is inside the vial, the entire assembly (bottle, device and vial) is shaken to mix the two compounds. After the mixture has formed, the assembly is turned, placing the vial on top and the bottle on the bottom. In this position, the dropper bottle is pumped, allowing the mixture to be extracted from inside the vial. When the mixture has been completely transferred to the dropper bottle, the device is unscrewed from the bottle, and the vial and device are discarded, leaving only the dropper bottle with the mixture inside.

MAIN ADVANTAGES OF THE TECHNOLOGY

The numerous advantages of the device are worth highlighting:

• Creation of sterile physiological solutions using a sealed system; the mixture obtained is transferred to a dropper bottle ready for use.

• It allows solutions to be created for patients (domestic use), not just for healthcare personnel (clinical use), thus making them more accessible.

• It reduces the workload of healthcare personnel and the pharmacy service.

• Ease of use and, therefore, time savings, leaving behind the use of needles/syringes to perform this type of transfer.

• It allows for the urgent and immediate availability of eye medications, without the delays of preparation in the pharmacy service.

• The flaps on the device offer a degree of flexibility, making it easier to fit onto the vial. However, the needle needs to be more rigid to prevent it from bending or breaking when piercing the vial membrane.

• In addition, specific kits with clear instructions will be developed to ensure that the process is carried out correctly and safely at home.

INNOVATIVE ASPECTS

Both the design and manufacturing process of the device have been optimised so that it can be produced using a 3D printer which, together with the use of three-dimensional models, has become an alternative manufacturing process to the conventional one (plastic moulding or injection). Its application within the biomedical sector opens up endless possibilities for improving the quality of life of patients and healthcare personnel.

This new form of production, already used in many sectors, is perfect for short runs as it offers great flexibility and the possibility of customisation. In addition to the low cost of materials and equipment required, it also offers rapid manufacturing.

The technology is currently at the laboratory stage, the result of the work carried out and the collaboration of a large number of healthcare specialists who have adjusted the dimensions and characteristics of the device.

It is primarily aimed at the pharmaceutical sector or laboratory equipment manufacturers seeking to improve the work of healthcare personnel and the treatment of patients with certain medicines.

We are seeking companies interested in developing a prototype, validating it and exploiting it (through licensing agreements) or in designing other new devices.

• Patent title: “Dispositivo de conexión para generación de solución estéril en frasco goteador a partir de vial farmacéutico con medicamentos en forma de polvo o liofilizados”

• Application number: P202531213

• Application date: 19/12/2025