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Packaging system for pharmaceutical compositions and kit for intravenous administration

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Packaging system for pharmaceutical compositions and kit for intravenous administration


The invention refers to a new system for packaging pharmaceutical compositions comprising active principles that may be administered intravenously, in particular it concerns a system for packaging in bottles which makes it possible to ensure the complete transfer of the content of the bottle into the liquid for intravenous infusion and at the same time prevent any accidental contact with the active principle by the health-care personnel preparing said intravenous infusion, and a complete kit for intravenous administration.
Related Terms: Fusion Intravenous Active Principle Infusion Principles

Browse recent Infa S.a. patents - Mendrisio, CH
USPTO Applicaton #: #20140197062 - Class: 206438 (USPTO) -
Special Receptacle Or Package > For Body Treatment Article Or Material (i.e., "surgical" Or Therapeutic Type)



Inventors: Paolo Magri', Flavio Villani

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The Patent Description & Claims data below is from USPTO Patent Application 20140197062, Packaging system for pharmaceutical compositions and kit for intravenous administration.

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CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No. 12/443,058, filed Apr. 16, 2009, which is the U.S. national phase of International Application No. PCT/IB2007/002857, filed Sep. 28, 2007, which designated the U.S. and claims priority to Italian Application No. MI2006A001881, filed Sep. 29, 2006, and Italian Application No. MI2007A000635, filed Mar. 29, 2007, the entire contents of each of which are hereby incorporated by reference.

SUMMARY

OF THE INVENTION

The present invention refers to a new system for packaging pharmaceutical compositions comprising active principles that may be administered intravenously, in particular it concerns a system for packaging in bottles which makes it possible to ensure the complete transfer of the content of the bottle into the liquid for intravenous infusion and at the same time prevent any accidental contact with the active principle by the health-care personnel preparing said intravenous infusion. More particularly, the invention refers to a new system for packaging pharmaceutical compositions comprising Tacrolimus and other highly active drugs.

The invention concerns a kit for the parenteral administration of medicines which comprises said packaging system.

Technical Context

Some highly active drugs, such as anti-tumour, immunosuppressants, antiviral drugs, some hormone derivatives, are considered potentially dangerous for the health-care personnel who have to handle them at the time or administration. For this reason, in the United States, the NIOSH (National Institute for Occupational Safety and Health) publishes guidelines for protecting the health and safety of health-care workers (www.cdc.gov/niosh) and lists the dangerous active principles for which particular attention is required during administration, such as the use of gloves and eye protection when opening the drug package (vial or similar).

In many cases these drugs are administered intravenously, either because of the intrinsic characteristics of the active principle or when the patient\'s conditions do not allow them to be administered by mouth.

The pharmaceutical compositions intended for intravenous administration must be transferred from the pack in which they are sold into a suitable container holding the liquid for infusion. The transfer is generally made by taking said compositions (when possible already in a solution or to be dissolved or diluted with an appropriate solvent at the moment of use) by means of a syringe and injecting the liquid composition thus obtained into the container holding the liquid for infusion. This type of transfer presents several inconveniences, including the risk for the health-care personnel of accidental pricking or of contact with the drug which, as explained above, may be extremely toxic or dangerous. Said transfer also presents the risk of losing part of the drug to be administered, which often remains in the package, as it is difficult to extract a liquid completely with a syringe, for example from an ampoule. This possibility, which is quite frequent, may have extremely serious consequences. For this reason pharmaceutical companies tend to minimise the risk of administering too little with respect to the prescribed amount by means of “overdosing”, that is adding an extra quantity of active principle to the pharmaceutical composition too be sold. This overdosing is generally around 10%, but in some particular cases it may be as much as 20%. Besides the waste of active principles, often extremely expensive, this solution involves an opposite risk, that is the danger of administering to the patient an amount of drug higher than that necessary for the therapy. It can easily be understood that, especially for highly active drugs, this risk is unacceptable for the patient\'s health.

Another problem connected with the use of ampoules lies in the cost and complexity of production. The process for producing ampoules is in fact much more expensive than that of producing bottles and involves risks linked with the flammability of the solvents used as vehicles for the active principles.

Technology has recently developed means for trying to overcome at least part of the inconveniences listed above. In particular, connectors equipped with at least two perforating spikes (known as spikes) have been designed and marketed, suited to put directly into connection the container holding the liquid for infusion and the package of the pharmaceutical composition, which in this case is generally a bottle sealed with an appropriate rubber cap. These connectors therefore perforate the cap of the container holding the liquid for infusion on one side and the cap of the bottle holding the composition on the other and said composition can be transferred by means of the so-called wash-out of the bottle by the liquid for infusion which is pushed upwards by compression of the infusion container, which in this case is made of collapsible material. These means are marketed for example by the company B. Braun Melsungen AG, Germany.

This combination makes it possible to avoid the inconvenience related to the risk of accidental pricking or of contact with the drug for health-care personnel, but it does not actually solve the problem of the complete transfer of the pharmaceutical composition into the liquid to be administered by infusion, nor the problem of overdosing of the drug.

In fact, in pharmaceutical compositions for infusion, in particular those including the highly active drugs mentioned above, the active principles are often dissolved using lipophilic substances and they do not dissolve easily in conventional liquids for infusion; it has been verified that the transfer by “washing out” the bottle with the liquid for infusion, which is of necessity composed of an aqueous solution mixable with said lipophilic substances, is often incomplete.

OBJECTS OF THE INVENTION

The object of the present invention is to overcome all the inconveniences of the known technique, providing a system for packaging in bottles pharmaceutical compositions comprising active principles that may be administered intravenously and a complete kit for its use, which makes it possible to ensure the complete transfer of the content of the bottle into the liquid for intravenous infusion and which is safe for the health-care personnel who have to administer it.

Another object of the present invention is to reduce the costs and the dangers indicated above, connected with the production of ampoules.

Another object of the present invention is to provide a system for packaging in bottles Tacrolimus and other drugs that may be administered intravenously and a complete kit for its use, which at the same time makes it possible to safeguard the health of the health-care personnel and to administer the exact quantity of the necessary active principle, reducing both the waste of expensive drugs and the risk of overdosing for the patient.

It has surprisingly been observed that the size of the bottle is of critical importance for the correct transfer of the pharmaceutical composition that it contains into the container for infusion. It has in fact been found that the identification of a suitable size of the bottle is indispensable for the “washing out” described above to be effective for the complete transfer of the drug.

The authors of the present invention have highlighted, for the first time, the fundamental role played by the size of the bottle for the efficacy of the transfer of the pharmaceutical composition to be transferred into a liquid for infusion using the system described above, with particular reference to Tacrolimus and other drugs dissolved in lipophilic substances and that do not dissolve easily in the liquids for infusion. This critical aspect had never been considered before in the prior art.

It has now unexpectedly been observed that the washing out of a bottle of the type described above, containing a pharmaceutical composition to be administered in a liquid for intravenous infusion, is much more effective when the size of said bottle is calculated in such a way as to allow a large empty volume, that is if it is not almost entirely filled with the pharmaceutical composition. This observation is in sharp contrast with the current practices of pharmaceutical technology, which tend to leave very little empty volume inside the package of a pharmaceutical composition, above all if of a liquid type. For example, the active principle Tacrolimus is sold in ampoules with a capacity of only 2 ml, which contain 1 ml of pharmaceutical composition, so they are half full.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 shows a particularly advantageous embodiment of the kit of the invention, at the moment of transfer of the pharmaceutical composition from the dosage unit (b) to the container (a) by means of a connector with two spikes (c).

DESCRIPTION OF THE INVENTION

So, according to one of its aspects, the invention concerns a packaging system for holding a pharmaceutical composition to be administered in a liquid for intravenous infusion, characterised in that said packaging system is a bottle which comprises said pharmaceutical composition and an empty volume of more than 80% of the total volume of the bottle, preferably ranging from 80% to 99%, advantageously from 80% to 95%, for example which is around 85% of the total volume of the bottle.

According to the present invention, the term “pharmaceutical composition” means a drug formulated with one or more pharmaceutically acceptable vehicles, ready for transfer into the liquid for intravenous infusion. So, in the case of drugs which require pre-dilution with a cosolvent prior to transfer into the liquid for intravenous infusion, for example docetaxel, the term “pharmaceutical composition” means the mixture of the concentrate with the cosolvent.

According to the present invention, the term “liquid for intravenous infusion” means any conventional solution for intravenous infusion, for example a saline physiological solution or a physiological solution containing glucose.

According to the present invention, the term “bottle” means a container holding a pharmaceutical composition, closed with a rubber cap, which may be pierced with needles or conventional piercing spikes. These bottles are available on the market in different sizes.

According to the present invention, the dimensions of the bottle are defined as “capacity”, where the term “capacity” indicates the volume of the bottle available as generally indicated by the manufacturer and not the “to the brim” volume of the bottle. So, according to the present invention, when mentioning for example a 7 ml bottle, it means a bottle that the manufacturer declares has a capacity of 7 ml but which, when “brim full”, contains even more than 8 ml, for example 8.4.

According to an advantageous embodiment of the invention, said bottle shall be made of glass, transparent or amber-coloured depending on the light-sensitivity of the active principle, and preferably it shall have an opening of the DIN/ISO type (about 22 mm), a characteristic which allows good compatibility with the majority of conventional connectors.

According to the present invention, the term “empty volume” (or also head space) means the volume inside the bottle not occupied by the pharmaceutical composition. The empty volume percentages are given here in terms of a percentage with respect to the capacity of the bottle, in such a way that the sum of the percentage of the volume of the composition and of the percentage of the empty volume is always 100%.

According to a preferred aspect of the present invention, said empty volume is chosen as a function of the solubility of the active principle and/or of the composition. According to a preferred aspect of the present invention, said pharmaceutical composition is a pharmaceutical composition comprising a highly active drug dissolved in a lipophilic substance.

According to a preferred aspect of the present invention, said pharmaceutical composition is a pharmaceutical composition comprising a highly active drug dissolved in a lipophilic substance.

According to a particularly preferred embodiment of the invention, said pharmaceutical composition is a pharmaceutical composition comprising a drug chosen among immunosuppressants, anti-tumour drugs and hormones.

According to a particularly preferred embodiment of the invention, said pharmaceutical composition is a pharmaceutical composition comprising a drug chosen among tacrolimus, cyclosporine, alkylating agents (carmustine, busulfan), docetaxel, paclitaxel, teniposide, pentamidine and valrubicin.

According to another of its aspects, the invention concerns a packaging system for a pharmaceutical composition to be administered in a liquid for intravenous infusion characterised in that said packaging is a bottle having a capacity between 5 and 10 ml and said pharmaceutical composition comprises as active principle tacrolimus in a pharmaceutically acceptable oily vehicle.

According to a particularly preferred embodiment of this last aspect of the invention, said pharmaceutical composition comprises 5 mg of tacrolimus dissolved in 1 ml of solvent composed of 200 mg of polyoxyethylenated hydrogenated castor oil (HCO-60) and ethanol, for example absolute ethanol or anhydrous ethanol USP 80.0% v/v, q.s. to 1 ml.

According to a particularly preferred embodiment of the invention, said pharmaceutical composition comprises from 0.1 to 0.5 mg, preferably about 0.25 mg of citric acid, 5 mg of tacrolimus dissolved in 1 ml of solvent composed of 200 mg of polyoxyethylenated hydrogenated castor oil (HCO-60) and ethanol, for example absolute ethanol or anhydrous ethanol USP 80.0% v/v, q.s. to 1 ml.

According to another particularly preferred embodiment the pharmaceutical compositions comprising as active principle 5 mg of tacrolimus, with or without citric acid, are contained in a bottle having a capacity from 6 to 9 ml, advantageously of 7 ml, the empty space therefore amounting to 85.7%.

If necessary or desired, the pharmaceutical compositions may be packed according to the system of the invention in an inert atmosphere, for example in an atmosphere of nitrogen, argon or CO2.

For the use of the packaging system of the invention, the bottle in used in combination with connectors provided with at least two perforating spikes (known as spikes), suited to put the inside of the bottle directly in contact with the container holding the liquid for infusion. The container for infusion shall be made of collapsible material and advantageously compatible with the pharmaceutical composition and the active principle to be administered, for example in a material other than PVC if oily vehicles are used or drugs incompatible with PVC.

According to the present invention, the term “collapsible material” means a material that may be manually compressed to make the liquid for infusion come out through the spikes of the connector described above.

FIG. 1 shows a particularly advantageous embodiment of the kit of the invention, at the moment of transfer of the pharmaceutical composition from the dosage unit (b) to the container (a) by means of a connector with two spikes (c).

In practice, a container holding a liquid for infusion as defined above is engaged on one end of a connector equipped with at least two spikes, one of which penetrates inside the rubber cap of said container; then a bottle of the packaging system of the invention, after removal of the metal cap usually present on top of the rubber cap, is engaged, upside down, on the other end of the above-mentioned connector, causing the perforation of the rubber cap.

By applying a light pressure on the container in collapsible material, the liquid for infusion passes through the two spikes and flows into the bottle, “washing it out” (FIG. 1).

If the packaging system of the invention has been conveniently realised, that is suitably choosing the capacity of the bottle, only one wash is sufficient to transfer more than 99% of the active principle contained in said bottle. Always in optimal conditions, if two washes are performed, practically 100% of the active principle is certainly transferred.

The connectors used in combination with the packaging system of the invention are known to the technique and available on the market, for example sold by the company B. Braun Melsungen AG, Germany.

According to a preferred embodiment, said spikes have a length such that they do not penetrate much inside said bottles, to avoid leaving any residual volume of pharmaceutical composition mixed with solution for infusion inside the bottle itself

The containers holding the liquid for infusion made of collapsible material are known and marketed by many companies. These containers may be in the shape of bags or bottles.

So, according to one of its aspects, the present invention concerns a kit for the parenteral administration of drugs which comprises at least:

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Key IP Translations - Patent Translations


stats Patent Info
Application #
US 20140197062 A1
Publish Date
07/17/2014
Document #
14178999
File Date
02/12/2014
USPTO Class
206438
Other USPTO Classes
International Class
61J1/05
Drawings
2


Fusion
Intravenous
Active Principle
Infusion
Principles


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