PACKAGE, OR DRUG KIT, OR DRUG SMOOTH ADMINISTRATION PRESENTATION FOR THE TREATMENT OF HYPERTENSION, CARDIOVASCULAR DISEASES AND DECREASE PLATELET AGGREGATION.

The present invention is presented under package or drug kit form or oral treatment presentation for treatment of hypertension, cardiovascular diseases and decrease platelet aggregation. Blood pressure control is important to reduce risks and/or to prevent cardiovascular diseases, such as angina, myocardial infarction, among others.

The types of packing or orientation kit for patients suffering from chronic dysfunctions and whose treatment involves administering of various types of active ingredients to be ingested in different quantities and at different times of the day, during the period of long-lasting treatment, had a quite facilitating effect, thus increasing the chances of continuation and termination of the treatment by the patient himself and the consequent success of same. Some types of packing or kit with such purpose have already been known, however, they are of a very specific character for each type of disease to be treated, because they are reproducing in a didactical and facilitating way for the patient, a method of medium term treatment.

Packaging system is just known. Document US 2002/0045184 is related to a drug packaging system comprising packaging material comprising therein combined prescription drug therapy comprising one or more unit dosage forms of a first drug, wherein said first drug and second drug are independently selected from a group consisting of non-steroidal anti-inflammatory drugs, proton pump inhibitors, calcium channel blockers, angiotensin converting enzyme (ACE) inhibitors, anti-depressants, selective serotonin reuptake inhibitors, antihistamines, decongestants, biguanides, sulfonylureas, 3-hydroxy-3-methy!glutaryl coenzyme A (HMG CoA) reductase inhibitors, anti-epileptic, and anti diabetics. Particularly, the invention comprises a nonsteroidal anti-inflammatory drug and said second drug comprises a proton pump inhibitor. As a proton pump inhibitor it is possible to select a drug from the group consisting of: omeprazole, lansoprazole, esomeprazole, pantoprazole, isomers, enantiomers or pharmaceutically acceptable salts thereof, preferably omeprazole. As a non-steroidal anti-inflammatory drug it is possible to select a drug from the group consisting of: naproxen, diclofenac, sulindac, oxaprozin, diflunisal, aspirin, piroxicam,

indomethacin, etodolac, ibuprofen, fenoprofen, ketoprofen, mefenamic acid, nabumetone, tolmetin, ketorolac, preferably diclofenac.

Document US 6273260 describes a packaging system for storing and dispering individual doses of medication on prescribed days wherein the individual dose of medication is an enteric fluoxetine pellet comprising: a) a core consisting of fluoxetine and one or more pharmaceutically acceptable excipients; b) an optional separating layer; c) an enteric layer comprising hydroxypropylmethylcellulose acetate succinate (HPMCAS) and one or more pharmaceutically acceptable excipients; d) an optional finishing layer.

Document BR 9609559 describes a packaging system for storing pills that are administered in a gradually increasing dosage during the period of treatment.

Document BR MU8302502 deals about a packaging system or kit of medicaments for the treatment of arteriosclerotic disease, comprising one or more anti-thrombocyte agents, that may be: simvastatin, atorvastatin, pravastatin, lovastatin, fluvastatin and rosuvastatin, preferentially the simvastatin and one or more agents, capable to meliorate the lipid profile of blood, like the acetyl salicylic acid, or ticlopidine, preferentially the acetylsalicylic acid.

Document BR MU8201733 deals about a packaging system or kit of medicaments, particularly for treating ulcerous gastro-intestinal problems, caused by the bacterium Helicobacter pylori, presenting one or more antibiotics like amoxicillin, erythromycin, metronidazole, tinidazole, preferentially amoxicillin and erythromycin and one or more inhibitors of the proton pump (IBP), like the lansoprazole, omeprazole, pantoprazole, rabeprazole, esomeprazole, preferentially the lansoprazole.

This invention is a matter of package, or drug kit, or drug smooth administering presentation for the treatment of hypertension, coronary disease chest pain and decrease platelet aggregation.

The regular use of drugs to control blood pressure helps to prevent cardiovascular diseases development and to improve patient's life quality. In patients with high blood pressure and coronary disease chest pain is recommended to take anti-hypertensive drugs and platelet aggregation inhibitor.

This invention describes a packaging system, or drug kit, or drug smooth administration presentation for the treatment of hypertension, cardiovascular diseases and decrease platelet aggregation, including in each outer carton, blister or similar one or more unit dosage forms of a platelet aggregation inhibitor agent and one or more unit dosage forms of a calcium antagonist agent, optionally associated with others synergic drugs wherein information are presented under clear orientation about active principles nature, dosage, day of week, period of the day when the drug must be taken, periodicity of the treatment and other technical information.

The mentioned invention provides easiness on the combination use of one antihypertensive drug and one platelet aggregation inhibitor drug, through its administration form that shows an additional benefit compared to the simple treatment. Hence, the invention's objectives are: a) to emphasize the importance of the administration of both drugs together; b) to enhance treatment adhesion; c) to guarantee that both drugs are taken.

The outer carton, blister or similar brings written information that facilitates the patient's adhesion and the drug/product handle. The outer carton, blister or similar contains two products: one anti-hypertensive of calcium antagonists, plain class and another one of platelet aggregation inhibitor class. First one is indicated for hypertension treatment, coronary disease and stable angina and the second to inhibit platelet aggregation in: instable angina, heart attack and others. The presentation aims at the functionality relating to one already available in the market.

The mentioned drugs are already known in the market and are available in blisters, outer cartons or similar; however, they are commercialized on an independent way. It was developed a package or drug kit or drug smooth administration presentation of both drugs. The product has didactic, safe and clear information that facilitates use and handling of the drugs.

Both of the drugs have, together, the whole of treating hypertension, cardiovascular diseases and decrease platelet aggregation.

The active principles that aim reducing or adjusting blood pressure comprising calcium antagonists, plain class, may be selected from the group comprising: amlodipine, nifedipine, verapamil, felodipine, nitrendipine, isradipine, nisoldipine, diltiazem,

mibefradil, manidipine, lacidipine and lercandipine, its mixtures, isomers, enantiomers or pharmaceutically acceptable salts thereof. Unit dosage may vary from 10 mg to 1000 mg, optionally associated with others drugs, following medical orientation, preferably 20 mg, or 30 mg, or 60 mg per tablet unit. The active principles that aim at inhibiting platelet aggregation in instable angina, heart attack and others, may be selected from the group comprising: cilostazol, ticlopidine, acetylsalicylic acid, triflusal, dipyridamole, clopidrogel, abciximab, tirofiban, its mixtures, isomers, enantiomers or pharmaceutically acceptable salts thereof. Unit dosages may vary from 10 mg until 1000 mg, optionally associated with others drugs, following medical orientation, preferably 100 mg, or 200 mg, or 300 mg per tablet unit.

The active principles can be presented under tablets, coated tablet, capsules, soft gel capsules, or any other pharmaceutically or galenic forms known by the man skilled in the art. Said platelet aggregation inhibitor agent and / or calcium antagonist agent may be mixtures or associated with other synergic actives, like diuretics or others antihypertensives.

Package may comprise 28 or 14 or 7 tablets of a platelet aggregation inhibitor agents and 28 or 14 or 7 tablets of calcium antagonist agent, or any other amount suitable for the treatment period.

The invention is a packaging system, or a drug kit or a smooth administration presentation of both drugs in outer carton, blister or similar with one or more units of acetylsalicylic acid and one or more units of nifedipine, optionally associated with others drugs, with clear orientation about active principles nature, dosage, day of week, period of the day when the drug must be taken and periodicity of the treatment. The invention is a package, or a drug kit or a smooth administration presentation with 28 or 14 or 7 tablets of each active principle, or others amounts suitable for the treatment, with unit dosages for 10 mg to 1000 mg of each tablet or each active, acetylsalicylic acid or nifedipine, or others synergic drugs. Dosages of each unit respects medical orientation and are supported by clinical trials which validate the concomitant use of these products following the mentioned dosages.

The suggested administration is one tablet of each active principle per day or under medical orientation, during the period established by the doctor or health professional.

In a particular way of realization, the invention includes in each outer carton, blister or similar there are a dosage unit of nifedipine and a dosage unit acetylsalicylic acid, optionally associated with others drugs, presented under a clear and didactic way, which contains written technical and informative orientation about active principle, dosage, recommended dosage, day of week, period and periodicity. It may comprise 28 or 14 or 7 tablets of acetylsalicylic acid and 28 or 14 or 7 tablets of nifedipine for the treatment period, or any other amount suitable for the treatment. Acetylsalicylic acid unit dosage is 100 mg, or 200 mg, or 300 mg and nifedipine unit dosage is 20 mg, or 30 mg, or 60 mg.

Package, or drug kit, or drug smooth administration presentation for the treatment of hypertension, cardiovascular diseases and decrease platelet aggregation is indicated for instable angina, heart attack and others kinds of diseases. The following example aims at illustrating the invention or package, or drug kit or smooth administration presentation; however, it should not restrict the model draft.

Example 1 :

The FIGURE 1, attached, elucidates one of the outer carton of the package, according to the invention, as follow:

(1 ) Brand name of the product;

(2) Active principles names: nifedipine and acetylsalicylic acid, indication of the dosage and also optionally indication of the pharmaceutical form of the active, for example: enteric coated, CITS, etc; (3) Indication for the daily dosage. The outer carton contains 7 dosages, indicating one dosage per day;

The figure represents the outer carton, containing units of medicines, according to the TABLE 1 , below:

Acetylsalicylic acid tablets Nifedipine tablets quantity Days of treatment quantity and dosage and dosage

1 unit 1 unit

Monday

(100 mg or 200 mg or 300 mg) (20 mg or 30 mg or 60 mg)

1 unit 1 unit

Tuesday

(100 mg or 200 mg or 300 mg) (20 mg or 30 mg or 60 mg)

1 unit 1 unit

Wednesday

(100 mg or 200 mg or 300 mg) (20 mg or 30 mg or 60 mg)

1 unit 1 unit

Thursday

(100 mg or 200 mg or 300 mg) (20 mg or 30 mg or 60 mg)

1 unit 1 unit

Friday

(100 mg or 200 mg or 300 mg) (20 mg or 30 mg or 60 mg)

1 unit 1 unit

Saturday

(100 mg or 200 mg or 300 mg) (20 mg or 30 mg or 60 mg)

1 unit 1 unit

Sunday

(100 mg or 200 mg or 300 mg) (20 mg or 30 mg or 60 mg)

TABLE 1