WO2007093021A1

WO2007093021A1 - Package, or drug kit, or drug smooth administration presentation for the treatment of hypertension, angina and others kinds of cardiovascular diseases.

Info

Publication number: WO2007093021A1
Application number: PCT/BR2006/000029
Authority: WO
Inventors: Moreira De Almeida Igor
Original assignee: Bayer Healthcare Ag
Priority date: 2006-02-17
Filing date: 2006-02-17
Publication date: 2007-08-23
Also published as: BRMU8603054U2

Abstract

This invention refers to a package, or drug kit, or drug smooth administration p cardiovascular diseases including in each outer carton, blister or similar one or more unit dosage forms of a angiotensin-ll antagonist 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 or as indicated in FIGURE 1. The package or drug kit form for oral treatment presentation is indicated for hypertension, angina and others kinds of cardiovascular diseases. Blood pressure control is important to reduce risks and/or to prevent cardiovascular diseases, such as angina, myocardial infarction, among others.

Description

PACKAGE, OR DRUG KIT, OR DRUG SMOOTH ADMINISTRATION PRESENTATION FOR THE TREATMENT OF HYPERTENSION, ANGINA AND OTHERS KINDS OF CARDIOVASCULAR DISEASES.

The present invention is presented under package or drug kit form or oral treatment presentation for hypertension, severe hypertension, hypertension associated to angina, angina and others kinds of cardiovascular diseases. 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 been known already, 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 (AC) inhibitors, anti-depressants, selective serotonin reuptake inhibitors, antihistamines, decongestants, biguanides, sulfonylureas, 3-hydroxy-3-methylglutaryl coenzyme A HMG Co 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, pjroxicam, 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 acetyl salicylic 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, severe hypertension, hypertension associated to angina, angina and others kinds of cardiovascular diseases.

The regular use of drugs to control blood pressure helps to prevent cardiovascular diseases development and to improve patient's life quality. In patients which it is difficult to control blood pressure, it is indicated the concomitant use of two antihypertensive drugs of distinct therapeutical classes in order to better reduce the blood pressure without increasing the side effects. The mentioned invention provides easiness on the combination use of these two antihypertensive drugs, 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. Both of them are indicated for hypertension treatment. 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 for the treatment of hypertension, severe hypertension, hypertension associated to angina, angina and others kinds of cardiovascular diseases, including in each outer carton, blister or similar one or more unit dosage forms of a angiotensin-ll antagonist 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.

Both of the drugs have, together, the whole of treating severe hypertension or hypertension associated to angina.

The active principles that aim at reducing or adjusting blood pressure in of angiotensin- ll antagonist, plain class are: telmisartan, losartan, ibersartan, candesartan, valsartan and olmesartan, or its mixtures, isomers, enantiomers or pharmaceutically acceptable salts thereof, on dosage unit between 10 mg and 1000 mg, preferably 20 mg, or 30 mg, or 60 mg, optionally associated with others synergic drugs, following medical orientation. Preferably angiotensin-ll antagonist agent is potassium losartan.

The active principles that aim at treating angina, as well as the reduction of blood pressure levels inside calcium antagonists, plain class are: amlodipine, nifedipine, verapamile, felodipine, nitrendipine, isradipine, nisoldipine, diltiazem, mibefradil, manidipine, lacidipine and lercandipine, its mixtures, isomers, enantiomers or pharmaceutically acceptable salts thereof, on dosage between 10 mg and 1000 mg, preferably 50 mg or 100 mg, optionally associated with others synergic drugs, following medical orientation,

Optionally angiotensin-II antagonist and / or calcium antagonist agents may be associated with others synergic drugs.

The active principles can be presented under tablets, coated tablet, capsules, soft gel capsules, or any other pharmaceutical form known by the man skilled in the art.

The present invention is a package, or a drug kit or a smooth administration presentation of both drugs in outer carton, blister or similar with one or more units of losartan and one or more units of nifedipine, 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 tablets of each active principle, or any other amount suitable for the treatment or under medical orientation, with dosages from 10 mg to 1000 mg of each tablet; the 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. Package may comprises 28 or 14 or 7 tablets of calcium antagonist agents and 28 or 14 or 7 tablets of angiotensin-II antagonist agents, or any other amount suitable for the treatment period.

As a particular way of realization of the present invention a package, or drug kit, or drug smooth administration presentation for the treatment of hypertension, severe hypertension, hypertension associated to angina, angina and others kinds of cardiovascular diseases comprising included in each outer carton, blister or similar a dosage unit of losartan, preferably potassium losartan or its pharmaceutically acceptable salts and a dosage unit of nifedipine or its pharmaceutically acceptable salts, 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 comprises 28 or 14 or 7 tablets of losartan and 28 or 14 or 7 tablets of nifedipine, or any other amount suitable for the treatment period. Nifedipine dosage units is 50 mg or 100 mg and losartan dosage units is 20 mg or 30 mg or 60 mg. Units of drugs for daily administration: one unit of losartan 50 mg or 100 mg and one unit of nifedipine 20 mg or 30 mg or 60 mg for a treatment period of 28 or 14 or 7 days or under medical orientation.

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, corresponding to: Nifedipine and potassium Losartan, indication of the dosage and also optionally indication of the pharmaceutical form of the active; (3) Indication for the daily dosage. The outer carton contains 7 dosages, indicating one dosage per day;

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

n ._«. * *_> ~*~ _♦ Losartan tablets Nifedipine tablets quantity

Days of treatment _{quantjty and d(?sage} "_{and ddsage}

Mnnrtev 1 unit 1 unit iv oπαay ^_{50 mg Qr 1 0Q mg}^ ^_{Q mg Qr 3Q mg Qr 6Q mg}^

Tuesday ^{1 unit 1 unit} ^y (50 mg or 100 mg) (20 mg or 30 mg or 60 mg)

W vveedunπees&duadvy _{(5Q mg} ¹ _Q ^u _f ⁿ .,^it _{Q0 mg) (2Q mg Qr 3} ¹ _Q ^u _m ^πi _g ^t _{Qr 6Q mg}^

_Th . 1 unit 1 unit πursαay ^_{50 mg QΓ 1 OQ mg}^ ^_{20 mg Qr 3Q mg Qr 6Q mg}^

_F . . 1 unit 1 unit ^y (50 mg or 100 mg) (20 mg or 30 mg or 60 mg) o . . 1 unit 1 unit ^y (50 mg or 100 mg) (20 mg or 30 mg or 60 mg)

Sundav ^{1 un}^ ^{1 unit} ^y (50 mg or 100 mg) (20 mg or 30 mg or 60 mg)

TABLE 1

Claims

1. Package, or drug kit, or drug smooth administration presentation for the treatment of hypertension, angina and others kind of cardiovascular diseases including in each outer carton, blister or similar one or more unit dosage forms of a angiotensin-ll antagonist 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.

2. Package, or drug kit, or drug smooth administration presentation for the treatment of hypertension, angina and others kind of cardiovascular diseases according to claim 1 wherein said anti-hypertensive agents of angiotensin-ll antagonist may be selected from the group comprising: telmisartan, losartan, ibersartan, candesartan, valsartan and olmesartan, or its mixtures, isomers, enantiomers or pharmaceutically acceptable salts thereof.

3. Package, or drug kit, or drug smooth administration presentation for the treatment of hypertension, angina and others kind of cardiovascular diseases according to claim 2 wherein angiotensin-ll antagonist agent is losartan.

4. Package, or drug kit, or drug smooth administration presentation for the treatment of hypertension, angina and others kind of cardiovascular diseases according to claim 3 wherein angiotensin-ll antagonist agent is potassium losartan.

5. Package, or drug kit, or drug smooth administration presentation for the treatment of hypertension, angina and others kind of cardiovascular diseases according to claims 1 or 2 wherein said angiotensin-ll antagonist agent unit dosage for I O mg to 1000 mg.

6. Package, or drug kit, or drug smooth administration presentation for the treatment of hypertension, angina and others kind of cardiovascular diseases according to claim 5 wherein said angiotensin-ll antagonist agent unit dosage is 50 mg oM OO mg.

7. Package, or drug kit, or drug smooth administration presentation for the treatment hypertension, angina and others kind of cardiovascular diseases according to claim 1 wherein said calcium antagonist agent may be selected from the group comprising: amlodipine, nifedipine, verapamil, felodipine, nitrendipine, isradipine, nisoldipine, diltiazem, mibefradil, manidipine, lacidipine and lercandipine, or its mixtures, isomers, enantiomers or pharmaceutically acceptable salts thereof.

8. Package, or drug kit, or drug smooth administration presentation for the treatment hypertension, angina and others kind of cardiovascular diseases according to claim 7 wherein said calcium antagonist agent is nifedipine or its pharmaceutical acceptable salts.

9. Package, or drug kit, or drug smooth administration presentation for the treatment hypertension, angina and others kind of cardiovascular diseases according to claims 1 or 7 wherein said calcium antagonist agent unit dosage for 10mg - 1000 mg.

10. Package, or drug kit, or drug smooth administration presentation for the treatment hypertension, angina and others kind of cardiovascular diseases according to claims 1 or 7 wherein said calcium antagonist agent unit dosage is 20 mg, or 30 mg, or 60 mg.

11. Package, or drug kit, or drug smooth administration presentation for the treatment hypertension, angina and others kind of cardiovascular diseases according to claim 1 wherein the drug units presented in outer carton, blister or similar feature may be: tablets, enteric coated tablets, capsules, soft gel capsules, or any other pharmaceutical forms known by the man skilled in the art.

12. Package, or drug kit, or drug smooth administration presentation for the treatment hypertension, angina and others kind of cardiovascular diseases according to claim 1 comprising 28 or 14 or 7 tablets of calcium antagonist agents and 28 or 14 or 7 tablets of angiotensin-II antagonist agents, or any other amount suitable for the treatment period.

13. Package, or drug kit, or drug smooth administration presentation for the treatment hypertension, angina and others kind of cardiovascular diseases including in each outer carton, blister or similar one or more unit dosage forms of losartan or its pharmaceutically acceptable salts and one or more unit dosage form's of nifedipine or its pharmaceutically acceptable salts, plain or 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.

14. Package, or drug kit, or drug smooth administration presentation for the treatment hypertension, angina and others kind of cardiovascular diseases according to claim 12 comprising potassium losartan.

15. Package, or drug kit, or drug smooth administration presentation for the treatment hypertension, angina and others kind of cardiovascular diseases according to claim 12, wherein unit dosage forms of actives are daily, being taking: one or more dosage units of losartan for 10 mg until 1000 mg and one one or more dosage units of nifedipine for 10 mg until 1000 mg.

16. Package, or drug kit, or drug smooth administration presentation for the treatment hypertension, angina and others kind of cardiovascular diseases according to claim 12 comprising 28 or 14 or 7 tablets of losartan and 28 or 14 or 7 tablets of nifedipine, or any other amount suitable for the treatment period.

17. Package, or drug kit, or drug smooth administration presentation for the treatment hypertension, angina and others kind of cardiovascular diseases according to claim 12 comprising losartan unit dosage for 50 mg or 100 mg.

18. Package, or drug kit, or drug smooth administration presentation for the treatment hypertension, angina and others kind of cardiovascular diseases according to claim 12 comprising nifedipine units dosage for 20 mg or 30 mg or 60 mg.

19. Package, or drug kit, or drug smooth administration presentation for the treatment hypertension, angina and others kind of cardiovascular diseases according to all precedents claims comprising daily drug units: one unit of losartan 50 mg or 100 mg and one unit of nifedipine 20 mg or 30 mg or 60 mg for a treatment period of 28 or 14 or 7 days or under medical orientation.