WO2009153729A1

WO2009153729A1 - Parenteral medicament delivery device

Info

Publication number: WO2009153729A1
Application number: PCT/IB2009/052547
Authority: WO
Inventors: Roelf Kassies; Giovanni Nisato; Wilhelmus H. N. M. Van Mensvoort
Original assignee: Koninklijke Philips Electronics N.V.
Priority date: 2008-06-19
Filing date: 2009-06-16
Publication date: 2009-12-23

Abstract

Device for parenteral administration of a medicament, e.g. for transdermal or (sub)cutaneous administration of drugs without the use of a needle. The device (1, 21, 31) comprises a top side (3, 23, 33) with a support surface for supporting a patient's body part, e.g. a lower arm, at least one medicament reservoir (5, 6) with at least one jet dispenser comprising a nozzle (8, 28, 38) at the support surface. The support surface (3, 23, 33) can be curved to guide the body part to be in reach of the jet dispenser nozzle (8, 28, 38). The device can have a grip (25, 35) for further optimizing the positioning of the lower arm.

Description

Parenteral medicament delivery device

FIELD OF THE INVENTION

The present invention relates to a parenteral medicament delivery device, e.g., for transdermal, intradermal, subcutaneous, or intramuscular administration of a medicine.

BACKGROUND OF THE INVENTION

For the treatment of some diseases it is necessary to inject medication on a regular basis, e.g., daily. An example of such a disease is Multiple Sclerosis, where patients have to inject medication once per day to once per week, depending on the exact medication. However, many patients find it difficult and uncomfortable to inject themselves. Moreover, a needle can cause stick injuries, and amounts to contaminated sharp waste material.

As an alternative to injections by a needle, jet dispensers have been proposed, such as for instance in WO 03/028797 using a piezo-electric jet dispenser. The device is used for application on and subsequent absorption through the skin. The device is not useful for subcutaneous medicament delivery.

SUMMARY OF THE INVENTION

It is the object of the invention to come to a medicament delivery system which can be used without needles also for subcutaneous medicament delivery and which improves convenience and comfortability for the patient. The object of the invention is achieved with a device according to the invention for parenteral administration of a medicament, the device comprising a top side with a support surface for supporting a patient's body part, e.g., an arm, at least one medicament reservoir with at least one jet dispenser comprising a nozzle at the support surface. Accordingly, the device does not require the use of needles to inject the medication which addresses the issue of needle phobia. Instead it comprises one or multiple nozzles through which the medication is jetted to target the patient's skin. The patient can simply place his or her lower arm, or any other suitable body part, on the device, covering the injection nozzle(s). The device can be realized as a desk-top system. The support surface can be shaped or curved to guide the body part into a position where it is in reach of the jet dispenser nozzle. The device can be designed in such a way that the patients arm is automatically aligned into the proper position with respect to the nozzles. Optionally, spacers near the nozzle, e.g., about 1 - 2 mm high, can be used to keep the nozzle at a distance from the targeted patient body part during injection of the medicament and to prevent sealing of the nozzle by the skin.

The support surface can for example be an arm support comprising a hand grip at one of its ends. The nozzles are positioned in such a way that, when the patient grips the hand grip, a good contact surface between the support surface and the skin is obtained. Having the supported arm aligned in the proper position, the nozzles can be directed to one or more spots particularly suitable for injecting the medicament. The volar forearm can be particularly suitable for injection by high speed liquid jets as the stratum corneum, a main element in the mechanical barrier for jet penetration, is quite thin at that location. The grip can for example be provided with an activation member, such as a button or switch, to activate the jet dispensers. Alternatively, an activation member can be located on another part of the device and may for example be activated by the other hand of the patient.

Optionally, the support surface may contain sensors close to the nozzles to detect whether a good contact between the skin and the support surface is made prior to jet dispensing. These sensors can also function as a safety measure that prevents the possibility of medication dispensing when no body part is present. These sensors can be e.g. pressure sensors, skin impedance sensors, capacitive sensors or optical sensors.

Suitable examples of jet dispensers are for example thermal droplet jet dispensers, which are particularly suitable for low speed jetting, and piezoelectric droplet dispensers, which can also be used for high speed jetting (above 30 m/s). High speeds jet dispensers are particularly suitable for intradermal, subcutaneous or intramuscular administration, requiring the medicament to be shot through the skin barrier. Low speed injectors can be used for topical or transdermal administration, when the medicament passes the skin by diffusion. Optionally a combination of high speed and low speed jet dispensers can be used. The use of such inkjet-related technology jet dispensers, allows careful and accurate control of distribution of the medicament to the target. Exact dosing of the medicament can be achieved. In piezoelectric jet dispensers, an activating pulse induces movement of a piezoelectric transducer changing the volume of a chamber containing liquid to be jetted. The volume change of the chamber generates pressure for propelling a drop out of a nozzle. By adjusting the chamber configuration the velocity of the jetted drops can be increased. Passing the nozzles, the medicament can be accelerated to a velocity which is sufficient to penetrate the patient skin. To this end, the velocity can be increased to more than 30 m/s, e.g., to a velocity of 50 - 150 m/s. The jets can be generated by actuators located at each individual nozzle, e.g., by piezo actuators, or by a central pressure generating system in combination with electronically controlled valves.

The nozzles of the jet dispenser can have any suitably sized opening, e.g., having a diameter of 30 - 200 μm, for instance about 50 μm. Depending on the medication, the system is equipped with a formulation reconstitution unit. This can for example include a reservoir for lyophilized powder medicament and a separate reservoir for a diluent, to be mixed with the powder before use to reconstitute the injectable formulation. This reduces the time the patient has to spend on preparing the injection, e.g., for protein-based medicaments. Protein-based medicaments typically can be mixed with a diluent shortly before use. Protein-based medicaments are substances that use proteins that occur naturally in any living organism, to prevent and cure diseases or to restore, maintain or improve body functions. Such proteins can for example be cytokines, clotting factors, vaccines, anti-bodies and hormones, such as insulin.

The medicament reservoir can optionally comprise a temperature control unit to monitor the temperature of the stored medicament and, if necessary, to adjust the temperature. This way the device can store the medication in a sterile reservoir at the appropriate temperature. The temperature can for example be controlled by a cooling unit in the device.

Optionally, the medicament can comprise one or more penetration enhancers, such as water, alcohols (such as methanol, ethanol and 2-propanol); alkyl methyl sulfoxides (such as dimethyl sulfoxide, decylmethyl sulfoxide and tetradecylmethyl sulfoxide); pyrrolidones (such as 2-pyrrolidone, N-methyl-2-pyrroloidone and N-(2- hydroxyethyl)pyrrolidone); laurocapram; miscellaneous solvents such as acetone, dimethyl acetamide, dimethyl formamide, and tetrahyrdo fur fury 1 alcohol, and amphiphiles such as E- amino acids, surfactants, and fatty acids. Such enhancers are particularly useful if the device is used for administering a medicament by transdermal diffusion through the skin.

Optionally, the medicament reservoir can be provided with a memory for storing medicament delivery data. The number of injections and the dosage of medication injected can be stored. This information can for example be used by the treating doctor to monitor patient compliance. When the system is connected to the internet or any other suitable communications network, the data can be used in a remote monitoring and/or remote control system. To this end, the device can be provided with connection means, such as IEEE 1394 or USB contacts, or means for wireless communication, e.g. using Wi-Fi or Bleutooth technology. The device may further include a programming module, e.g., including a keyboard for entering dosage information, a display screen or indicators providing information about how much medicament remains in the reservoir or qualitative information about the medicament. The display can also provide an interface through which other information about the medications or their administration can be entered or consulted. The medication can be delivered in a single shot through one or more nozzles or through a series of repetitive shots through one or multiple nozzles. The latter method may reduce the sensations during injection and could be realized by piezo actuated jet injectors. Examples of medicaments that can be included in the reservoir of the device according to the invention include pharmaceutical compositions that are capable of parenteral delivery. Such medicaments include for instance insuline, dopamine receptor agonists, interferons, such as interferon-β, or therapeutic agents based on monoclonal antibodies. Examples of agents that are suitable for transdermal delivery include scopolamine, nitrates such as nitroglycerine, an antihypertensive or anti- adrenergic medicament such as clonidine, steroid hormones such as 17-beta-estradiol and testosterone, analgesics, such as the opioid analgesic fentanyl, and nicotine. Although the device of the present invention is particularly suited for parenteral delivery of medicaments, it can also be used for topical surface application of medicaments, such as antibiotics, corticosteroids, minoxidil or retinoids.

If so desired, the device can carry multiple medicament reservoirs, such as removable modules that contain different medicaments. Several modules may contain the same or different medicaments, for example components to be combined before or during delivery to modify one or both of the components, or to produce a desired effect. A programmed data processing unit such as a microprocessor can be used to coordinate release of the various medicaments, e.g., by controlling which combination of medicaments has to be administered at particular moments of the day or week.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be elucidated with reference to the figures wherein: Figure 1 : shows schematically a device according to the present invention; Figure 2A: shows in plan view a device according to the present invention; Figure 2B: shows in side view the device of Figure 2A; Figure 3: shows in perspective view a further possible embodiment of the device according ot the invention.

DETAILED DESCRIPTION OF EMBODIMENTS

Figure 1 shows schematically a desk top device 1 for parenteral administration of a medicament. The device 1 comprises a housing 2 with a top side 3 with a support surface for supporting a patient's underarm, and a bottom side 4. The device 1 comprises a first reservoir 5 containing a lyophilized powder medicament, and a second reservoir 6 containing a diluent. Both reservoirs 5, 6 are in communication with a formulation reconstitution unit 7 where the powder is mixed and suspended or solved into the diluent. A line leads from the reconstitution unit to an array of nozzles 8, where the reconstituted medicament is jetted out off the device 1 under the control of jet injection control unit 9. The device 1 further contains a delivery information storage unit 10, which can be connected to a communication network, and a temperature control unit 11 for controlling the temperature of medicament in the medicament reservoir.

Under right angels with the view shown in Figure 1, the top surface is curved to form a guiding surface for positioning a patients arm in the proper way to ensure effective targeting of the nozzles. The support surface also comprises a hand grip (not shown) at one of its ends. Gripping the hand grip puts the arm of the patient in the optimized position.

A further possible embodiment of a desk top medicament delivery device 21 is shown in Figures 2 A and 2B. The device 21 comprises a flat bottom surface 24 which can rest on a desk or table or any other suitable place. The top side 23 forms a curved surface suitable for receiving a lower arm of a patient and for guiding the arm to a preferred position to optimize contact between the patient's arm skin and a nozzle 28 located in the area of the curved surface 28. The curved arm support area may be padded for the patient's comfort and convenience. Sensors 29 are used to determine if the contact between the skin and the nozzle is sufficient. At one end of the device 21 is a hand rest 25 shaped like a computer mouse. On top of the hand rest 25 are two control buttons 26. When the patient lays his or her arm in the curved surface, his or her hand rests on the hand rest 25. The patient can then activate the device 21 by pushing one of the control buttons 26 and the nozzles 28 will inject the medicament.

Figure 3 shows a further alternative embodiment of a desk top device 31. The device 31 comprises a longitudinal housing 32 with a flat bottom surface which can rest on a desk or table in a stable position. As with the embodiment of Figures 2A and 2B, the top side 33 forms a curved surface suitable for receiving a lower arm of a patient and for guiding the lower arm to a preferred position to optimize contact between the patient's arm skin and a nozzle 38 located in the area of the curved surface 33. The curved arm support area 33 may be padded for the patient's comfort and convenience. Sensors 39 are used to determine if the contact between the skin and the nozzle is sufficient. At one end of the device 31 is a hand grip 35 which can be gripped by the patient when his or her lower arm is in the preferred position on the curved surface 33. At the thumb side, the grip is provided with a control button. When the patient grips the hand grip 35, he or she can activate the device 31 by pushing control button 36 and the nozzle 38 will inject the medicament.

While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive. The invention is not limited to the disclosed embodiments. Other variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed invention, from a study of the drawings, the disclosure, and the appended claims. In the claims, the word "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality. A single processor or other unit may fulfill the functions of several items recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. Any reference signs in the claims should not be construed as limiting the scope.

Claims

CLAIMS:

1. Device for parenteral administration of a medicament, the device (1, 21, 31) comprising a top side with a support surface (3, 23, 33) for supporting a patient's body part, at least one medicament reservoir (5, 6) with at least one jet dispenser comprising a nozzle (8, 28, 38) at the support surface.

2. Device according to claim 1 wherein the support surface (3, 23, 33) is curved to guide the patient's body part to be in reach of the nozzle (8, 28, 38).

3. Device according to claim 1 or 2 wherein the support surface (23, 33) is an arm support comprising a hand grip (25, 35) at one of its ends.

4. Device according to claim 1 wherein the device comprises a temperature control unit (11) for controlling the temperature of medicament in the medicament reservoir.

5. Device according to claim 1 wherein the medicament reservoir comprises a reconstitution unit (7) for reconstitution of the medicament.

6. Device according to claim 1 wherein the device comprises a memory (10) for storing medicament delivery data.

7. Device according to claim 6 wherein the device comprises a connection port for connection to a communication network allowing remote reading of the delivery data and remote medicament release control.

8. Device according to claim 1 wherein at least a part of the jet dispensers is a high speed jet dispenser for jet velocities of at least 30 m/s.

9. Device according to claim 1 wherein at least a part of the at least one jet dispensers is a piezoelectric dispenser.

10. Device according to claim 1 wherein the device comprises multiple medicament reservoirs for storing different medicaments and a microprocessor for coordinating release of the various medicaments.

11. Device according to claim 1, 2 or 3 wherein the support surface (23, 33) contains one or more skin contact sensors (29, 39) close to the nozzles for detecting contact between the skin of a patient's body part and the support surface.