SK4982000A3 - Pharmaceutical composition with a content of calcium or mixture of calcium and vitamin d or mixture of calcium and magnesium in a new formulation - Google Patents
Pharmaceutical composition with a content of calcium or mixture of calcium and vitamin d or mixture of calcium and magnesium in a new formulation Download PDFInfo
- Publication number
- SK4982000A3 SK4982000A3 SK498-2000A SK4982000A SK4982000A3 SK 4982000 A3 SK4982000 A3 SK 4982000A3 SK 4982000 A SK4982000 A SK 4982000A SK 4982000 A3 SK4982000 A3 SK 4982000A3
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- Slovakia
- Prior art keywords
- amount
- calcium
- weight
- mixture
- magnesium
- Prior art date
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- 239000011575 calcium Substances 0.000 title claims abstract description 51
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 title claims abstract description 48
- 229910052791 calcium Inorganic materials 0.000 title claims abstract description 48
- 239000000203 mixture Substances 0.000 title claims abstract description 43
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 title claims abstract description 15
- 239000011777 magnesium Substances 0.000 title claims abstract description 15
- 229910052749 magnesium Inorganic materials 0.000 title claims abstract description 15
- 229940046008 vitamin d Drugs 0.000 title claims abstract description 8
- 239000008194 pharmaceutical composition Substances 0.000 title abstract description 5
- 238000009472 formulation Methods 0.000 title description 7
- QYSXJUFSXHHAJI-XFEUOLMDSA-N Vitamin D3 Natural products C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C/C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-XFEUOLMDSA-N 0.000 claims abstract description 13
- 239000000843 powder Substances 0.000 claims abstract description 12
- 229930003316 Vitamin D Natural products 0.000 claims abstract description 7
- 235000019166 vitamin D Nutrition 0.000 claims abstract description 7
- 239000011710 vitamin D Substances 0.000 claims abstract description 7
- 150000003710 vitamin D derivatives Chemical class 0.000 claims abstract description 7
- 239000000725 suspension Substances 0.000 claims abstract description 5
- 239000007788 liquid Substances 0.000 claims abstract description 3
- 238000002156 mixing Methods 0.000 claims abstract description 3
- 239000002671 adjuvant Substances 0.000 claims abstract 2
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 27
- 229930006000 Sucrose Natural products 0.000 claims description 15
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 15
- 239000005720 sucrose Substances 0.000 claims description 15
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims description 14
- 229910000162 sodium phosphate Inorganic materials 0.000 claims description 14
- 239000001488 sodium phosphate Substances 0.000 claims description 14
- 235000011008 sodium phosphates Nutrition 0.000 claims description 14
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims description 14
- 229920000881 Modified starch Polymers 0.000 claims description 13
- 229910000397 disodium phosphate Inorganic materials 0.000 claims description 13
- 235000019800 disodium phosphate Nutrition 0.000 claims description 13
- 235000019426 modified starch Nutrition 0.000 claims description 13
- 150000003839 salts Chemical class 0.000 claims description 11
- 239000001509 sodium citrate Substances 0.000 claims description 9
- 239000004205 dimethyl polysiloxane Substances 0.000 claims description 8
- 235000013870 dimethyl polysiloxane Nutrition 0.000 claims description 8
- 229920000435 poly(dimethylsiloxane) Polymers 0.000 claims description 8
- 239000000796 flavoring agent Substances 0.000 claims description 7
- 235000019634 flavors Nutrition 0.000 claims description 7
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 7
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 6
- 239000000825 pharmaceutical preparation Substances 0.000 claims description 6
- 239000011734 sodium Substances 0.000 claims description 6
- 229910052708 sodium Inorganic materials 0.000 claims description 6
- 239000002245 particle Substances 0.000 claims description 5
- 239000000126 substance Substances 0.000 claims description 5
- 239000000979 synthetic dye Substances 0.000 claims description 5
- FJKROLUGYXJWQN-UHFFFAOYSA-N 4-hydroxybenzoic acid Chemical compound OC(=O)C1=CC=C(O)C=C1 FJKROLUGYXJWQN-UHFFFAOYSA-N 0.000 claims description 4
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims description 4
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 claims description 4
- 235000009470 Theobroma cacao Nutrition 0.000 claims description 4
- 239000013543 active substance Substances 0.000 claims description 4
- WPYMKLBDIGXBTP-UHFFFAOYSA-N benzoic acid Chemical compound OC(=O)C1=CC=CC=C1 WPYMKLBDIGXBTP-UHFFFAOYSA-N 0.000 claims description 4
- 239000011591 potassium Substances 0.000 claims description 4
- 229910052700 potassium Inorganic materials 0.000 claims description 4
- 229940090248 4-hydroxybenzoic acid Drugs 0.000 claims description 2
- 239000005711 Benzoic acid Substances 0.000 claims description 2
- 229910019142 PO4 Inorganic materials 0.000 claims description 2
- 229920002472 Starch Polymers 0.000 claims description 2
- AZDRQVAHHNSJOQ-UHFFFAOYSA-N alumane Chemical class [AlH3] AZDRQVAHHNSJOQ-UHFFFAOYSA-N 0.000 claims description 2
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims description 2
- 239000008122 artificial sweetener Substances 0.000 claims description 2
- 235000021311 artificial sweeteners Nutrition 0.000 claims description 2
- 235000010233 benzoic acid Nutrition 0.000 claims description 2
- 235000013539 calcium stearate Nutrition 0.000 claims description 2
- 239000008116 calcium stearate Substances 0.000 claims description 2
- 235000014113 dietary fatty acids Nutrition 0.000 claims description 2
- 150000002016 disaccharides Chemical class 0.000 claims description 2
- 150000002148 esters Chemical class 0.000 claims description 2
- BEFDCLMNVWHSGT-UHFFFAOYSA-N ethenylcyclopentane Chemical compound C=CC1CCCC1 BEFDCLMNVWHSGT-UHFFFAOYSA-N 0.000 claims description 2
- 239000000194 fatty acid Substances 0.000 claims description 2
- 229930195729 fatty acid Natural products 0.000 claims description 2
- 150000004665 fatty acids Chemical class 0.000 claims description 2
- 150000002772 monosaccharides Chemical class 0.000 claims description 2
- 239000000978 natural dye Substances 0.000 claims description 2
- 150000007524 organic acids Chemical class 0.000 claims description 2
- 235000005985 organic acids Nutrition 0.000 claims description 2
- 239000010452 phosphate Substances 0.000 claims description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims description 2
- 239000003755 preservative agent Substances 0.000 claims description 2
- 235000011962 puddings Nutrition 0.000 claims description 2
- 150000003377 silicon compounds Chemical class 0.000 claims description 2
- LIVNPJMFVYWSIS-UHFFFAOYSA-N silicon monoxide Chemical class [Si-]#[O+] LIVNPJMFVYWSIS-UHFFFAOYSA-N 0.000 claims description 2
- 229910052814 silicon oxide Inorganic materials 0.000 claims description 2
- 235000010199 sorbic acid Nutrition 0.000 claims description 2
- 239000004334 sorbic acid Substances 0.000 claims description 2
- 229940075582 sorbic acid Drugs 0.000 claims description 2
- 239000008107 starch Substances 0.000 claims description 2
- HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 claims description 2
- 229940038773 trisodium citrate Drugs 0.000 claims description 2
- 229940126601 medicinal product Drugs 0.000 claims 2
- 241000196324 Embryophyta Species 0.000 claims 1
- 244000240602 cacao Species 0.000 claims 1
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 24
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 14
- 229910000019 calcium carbonate Inorganic materials 0.000 description 12
- 238000002360 preparation method Methods 0.000 description 12
- 238000000034 method Methods 0.000 description 7
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 7
- 239000005913 Maltodextrin Substances 0.000 description 6
- 229920002774 Maltodextrin Polymers 0.000 description 6
- 208000001132 Osteoporosis Diseases 0.000 description 6
- 239000000679 carrageenan Substances 0.000 description 6
- 235000010418 carrageenan Nutrition 0.000 description 6
- 229920001525 carrageenan Polymers 0.000 description 6
- 229940113118 carrageenan Drugs 0.000 description 6
- 239000003814 drug Substances 0.000 description 6
- 238000000265 homogenisation Methods 0.000 description 6
- 229940035034 maltodextrin Drugs 0.000 description 6
- 235000005282 vitamin D3 Nutrition 0.000 description 6
- 239000011647 vitamin D3 Substances 0.000 description 6
- QYSXJUFSXHHAJI-YRZJJWOYSA-N vitamin D3 Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C\C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-YRZJJWOYSA-N 0.000 description 6
- 229940021056 vitamin d3 Drugs 0.000 description 6
- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 description 6
- 239000004480 active ingredient Substances 0.000 description 4
- 235000015165 citric acid Nutrition 0.000 description 4
- 239000002552 dosage form Substances 0.000 description 4
- 239000007938 effervescent tablet Substances 0.000 description 4
- 235000019441 ethanol Nutrition 0.000 description 4
- 235000011083 sodium citrates Nutrition 0.000 description 4
- 208000037147 Hypercalcaemia Diseases 0.000 description 3
- 244000299461 Theobroma cacao Species 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- 230000000148 hypercalcaemia Effects 0.000 description 3
- 229910052500 inorganic mineral Inorganic materials 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 239000011707 mineral Substances 0.000 description 3
- 230000002265 prevention Effects 0.000 description 3
- 206010067484 Adverse reaction Diseases 0.000 description 2
- 244000144730 Amygdalus persica Species 0.000 description 2
- 235000005979 Citrus limon Nutrition 0.000 description 2
- 244000131522 Citrus pyriformis Species 0.000 description 2
- 244000060011 Cocos nucifera Species 0.000 description 2
- 235000013162 Cocos nucifera Nutrition 0.000 description 2
- 208000029725 Metabolic bone disease Diseases 0.000 description 2
- 241001465754 Metazoa Species 0.000 description 2
- 206010049088 Osteopenia Diseases 0.000 description 2
- 235000006040 Prunus persica var persica Nutrition 0.000 description 2
- 230000006838 adverse reaction Effects 0.000 description 2
- UHZZMRAGKVHANO-UHFFFAOYSA-M chlormequat chloride Chemical compound [Cl-].C[N+](C)(C)CCCl UHZZMRAGKVHANO-UHFFFAOYSA-M 0.000 description 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 2
- OUHCLAKJJGMPSW-UHFFFAOYSA-L magnesium;hydrogen carbonate;hydroxide Chemical compound O.[Mg+2].[O-]C([O-])=O OUHCLAKJJGMPSW-UHFFFAOYSA-L 0.000 description 2
- 239000000546 pharmaceutical excipient Substances 0.000 description 2
- 230000003449 preventive effect Effects 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 208000010444 Acidosis Diseases 0.000 description 1
- 201000001320 Atherosclerosis Diseases 0.000 description 1
- 208000037260 Atherosclerotic Plaque Diseases 0.000 description 1
- 206010006956 Calcium deficiency Diseases 0.000 description 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 description 1
- 206010027417 Metabolic acidosis Diseases 0.000 description 1
- 206010027423 Metabolic alkalosis Diseases 0.000 description 1
- 208000001647 Renal Insufficiency Diseases 0.000 description 1
- 244000269722 Thea sinensis Species 0.000 description 1
- 244000290333 Vanilla fragrans Species 0.000 description 1
- 235000009499 Vanilla fragrans Nutrition 0.000 description 1
- 235000012036 Vanilla tahitensis Nutrition 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 238000005054 agglomeration Methods 0.000 description 1
- 230000002776 aggregation Effects 0.000 description 1
- 239000002216 antistatic agent Substances 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 229940043430 calcium compound Drugs 0.000 description 1
- 150000001674 calcium compounds Chemical class 0.000 description 1
- 150000001768 cations Chemical class 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000000326 densiometry Methods 0.000 description 1
- 230000008021 deposition Effects 0.000 description 1
- 229940061607 dibasic sodium phosphate Drugs 0.000 description 1
- 235000005911 diet Nutrition 0.000 description 1
- 230000000378 dietary effect Effects 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 210000003278 egg shell Anatomy 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 239000011888 foil Substances 0.000 description 1
- 239000007789 gas Substances 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 201000005991 hyperphosphatemia Diseases 0.000 description 1
- 230000001771 impaired effect Effects 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 201000006370 kidney failure Diseases 0.000 description 1
- 238000002386 leaching Methods 0.000 description 1
- XMGQYMWWDOXHJM-UHFFFAOYSA-N limonene Chemical compound CC(=C)C1CCC(C)=CC1 XMGQYMWWDOXHJM-UHFFFAOYSA-N 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 235000019359 magnesium stearate Nutrition 0.000 description 1
- 235000013336 milk Nutrition 0.000 description 1
- 239000008267 milk Substances 0.000 description 1
- 210000004080 milk Anatomy 0.000 description 1
- 239000007968 orange flavor Substances 0.000 description 1
- 239000008188 pellet Substances 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 238000007873 sieving Methods 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- 238000011287 therapeutic dose Methods 0.000 description 1
- 230000001052 transient effect Effects 0.000 description 1
- 235000013311 vegetables Nutrition 0.000 description 1
- 230000002861 ventricular Effects 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
- A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
Landscapes
- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Physical Education & Sports Medicine (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Rheumatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Inorganic Chemistry (AREA)
- Zoology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
Oblasť technikyTechnical field
Vynález z oblasti farmácie sa týka sa liečivého prípravku s obsahom vápnika, alebo zmesi vápnika a vitamínu D, alebo zmesi vápnika a horčíka pre dlhodobé perorálne užívanie na prevenciu a liečbu primárnej a sekundárnej osteoporózy a na korekciu hyperfosfatanémie pacientov v pokročilých štádiách renálnej insuficiencie.The invention in the field of pharmacy relates to a medicament comprising calcium, or a mixture of calcium and vitamin D, or a mixture of calcium and magnesium for long-term oral use, for the prevention and treatment of primary and secondary osteoporosis and for correcting hyperphosphatemia in patients with advanced renal insufficiency.
Doteraiší stav technikyBACKGROUND OF THE INVENTION
Niektorí pacienti trpia nedostatkom vápnika napriek jeho dostatočnému prívodu potravou. Príčinou je narušené vstrebávanie v črevných bunkách.Some patients suffer from calcium deficiency despite a sufficient supply of calcium. The cause is impaired absorption in the intestinal cells.
Doteraz známe liekové formy s obsahom vápnika využívajú ako zdroj jeho chemicky definované terapeuticky akceptovateľné zlúčeniny a to vo forme hlavne šumivých tabliet, tabliet, roztokov, práškov a podobne, alebo ako zdroj slúžia upravené živočíšne a minerálne suroviny.Calcium-containing pharmaceutical formulations known hitherto use chemically defined therapeutically acceptable compounds as their source, in particular in the form of effervescent tablets, tablets, solutions, powders and the like, or as modified animal and mineral feedstocks.
Nevýhodou napr. u šumivých tabliet, je skutočnosť, že ich pacienti po dlhšom čase odmietajú, nakoľko tieto môžu okrem iného navodzovať posun v acidobázickej rovnováhe do metabolickej alkalózy, transport vápnika do krvného riečišťa je rýchly, a koncentrácia vápnika môže presiahnuť bezpečnú výšku so vznikom prechodnej hyperkalcémie, ktorá je nebezpečná z hľadiska vzniku a rozvoja aterosklerózy.The disadvantage of e.g. in effervescent tablets, the fact that patients refuse it over a long period of time as they may, among other things, induce a shift in acid-base balance to metabolic alkalosis, calcium transport to the bloodstream is rapid, and calcium concentration may exceed a safe height with transient hypercalcaemia it is dangerous for the development and development of atherosclerosis.
Pri použití nevhodne zvolenej zlúčeniny vápnika, napr. chloridu môže prípravok navodiť pri dlhodobom podávaní metabolickú acidózu, ktorá zvyšuje vyplavovanie vápnika z kostnej hmoty.When using an improperly selected calcium compound, e.g. Chloride may induce metabolic acidosis on prolonged administration, which increases the leaching of calcium from the bone mass.
Nevýhodou biopreparátov môže byť prítomnosť nežiaducich prímesí a neštandardnosť obsahu biologicky využiteľných katiónov.The disadvantages of biopreparations may be the presence of undesirable admixtures and abnormal content of bioavailable cations.
Ďalšou nevýhodou je časovo, surovinovo i energeticky náročná výroba.Another disadvantage is the time, raw material and energy intensive production.
Podstata vynálezuSUMMARY OF THE INVENTION
Podstatou liečivého prípravku podľa vynálezu je dávkovaná lieková forma, obsahujúca ako účinnú látku vápnik v množstve od 150 mg do 1500 mg s výhodou od 200 mg do 600 mg, alebo zmes vápnika s vitamínom D, pričom vitamín D je v množstve od 1001.U do 10001.U, s výhodou od 4001.U do 9001.U, alebo zmes vápnika a horčíka, pričom horčík je v množstve od 20 mg do 500 mg, s výhodou od 150 mg do 300 mg. Účinné látky obsahujúce vápnik a horčík sú mikronizované tak, že minimálne 80 % častíc má veľkosť menej ako 75 mikrometrov. Liečivý prípravok podľa vynálezu je vo forme instantného prášku, ktorý po pridaní tekutiny (vody, mlieka, čaju a pod.) vytvorí po krátkom zamiešaní pudingu podobnú suspenziu, tolerovanú pri užívaní pacientami, ktorí užívajú prípravky s popísanými účinnými látkami z preventívnych, alebo terapeutických dôvodov. Výhodou je presné dávkovanie účinných látok.The pharmaceutical composition according to the invention is based on a dosage form comprising as active ingredient calcium in an amount of from 150 mg to 1500 mg, preferably from 200 mg to 600 mg, or a mixture of calcium with vitamin D, wherein vitamin D is in an amount of 1001.U to 10001.U, preferably from 4001.U to 9001.U, or a mixture of calcium and magnesium, wherein the magnesium is in an amount of 20 mg to 500 mg, preferably 150 mg to 300 mg. The active ingredients containing calcium and magnesium are micronized so that at least 80% of the particles are less than 75 microns in size. The medicament according to the invention is in the form of an instant powder which, upon addition of a liquid (water, milk, tea, etc.), forms a suspension similar to that tolerated when used in patients receiving formulations with the active ingredients described for preventive or therapeutic reasons. . The advantage is the precise dosing of the active substances.
Princípom výroby takto popisovanej liekovej formy je, že vyvážená zmes mikronizovaných účinných a pomocných látok je pripravovaná buď jednoduchým miešaním, alebo v prípade potreby ďalšieho strojného spracovania, granulovaním zmesou vody a etanolu, zložená z 30 až 80 % hmotn. vody a 20 až 70 % hmotn. etanolu, s výhodou 60% hmotn. vody a 40 % hmotn. etanolu a nasledovným vysušením komorovo, vákuovo, vo vznose, alebo mikrovlnným žiarením pri teplote 30 až 60 °C s výhodou 35 až 45 °C.The principle of manufacturing the dosage form so described is that a balanced mixture of micronized active and excipients is prepared either by simple mixing or, if necessary, further processing, by granulating a mixture of water and ethanol, composed of 30 to 80% by weight. % water and 20 to 70 wt. % ethanol, preferably 60 wt. % water and 40 wt. ethanol and subsequent drying by ventricular, vacuum, fluid, or microwave radiation at a temperature of 30 to 60 ° C, preferably 35 to 45 ° C.
Takto pripravená zmes, vhodne adj astovaná po terapeutických dávkach do jednorázového obalu tvoreného teplom zvarovateľnou kombinovanou foliou zamedzujúcou prechodu pár a plynov, je stabilná chemicky aj fyzikálne a umožňuje jednoduchú manipuláciu pri príprave suspenzie pre terapeutické alebo preventívne užitie pacientom.The composition thus prepared, suitably adjuvanted in therapeutic doses into a disposable heat-sealable combination film preventing vapor and gas passage, is stable chemically and physically and allows easy handling in preparing a suspension for therapeutic or preventive use by patients.
Lieková forma podľa tohto vynálezu obsahuje okrem mikronizovaných účinných látok zo skupiny terapeuticky akceptovateľných solí vápnika, horčíka, poprípade iných zdrojov ako sú upravené vaječné škrupiny, vápenaté schránky živočíchov, alebo nerastné minerály a vitamíny, ďalšie pomocné látky zodpovedajúce za možnosť vytvorenia pacientmi tolerovateľnej gelovitej suspenzie podobnej pudingu. Týmito sú:In addition to micronized active ingredients from the group of therapeutically acceptable salts of calcium, magnesium, or other sources such as modified eggshells, calcium livers of animals, or mineral minerals and vitamins, the dosage form of the present invention contains other excipients responsible for forming a patient-tolerable gel suspension similar to pudding. These are:
a) Farmaceutický akceptovateľné deriváty škrobu s výhodou diškrobfosfát v množstve od 5 do 40 % hmotn. s výhodou od 15 do 25 % hmotn..a) Pharmaceutically acceptable starch derivatives, preferably di-starch phosphate in an amount of from 5 to 40 wt. preferably from 15 to 25 wt.%.
b) Mono a/alebo disacharidy, s výhodou sacharózy, v množstve od 10 do 80 % hmotn. s výhodou od 20 do 40 % hmotn..b) Mono and / or disaccharides, preferably sucrose, in an amount of from 10 to 80 wt. preferably from 20 to 40 wt.%.
c) Látky rastlinného pôvodu schopné vytvárať s vodou xerogély, s výhodou karragenan v množstve 0,1 až 1,0 % hmotn. s výhodou 0,2 až 0,6 % hmotn..c) Substances of vegetable origin capable of forming xerogels with water, preferably carragenan in an amount of 0.1 to 1.0 wt. preferably 0.2 to 0.6 wt.%.
d) Farmaceutický použiteľné soli kyseliny fosforečnej ako je hydrogénfosforečnan sodný v množstve od 0,05 do 0,45 % hmotn., s výhodou od 0,1 do 0,35 % hmotn. a fosforečnan sodný v množstve od 0,2 do 2,0 % hmotn., s výhodou od 0,7 do 1,4 % hmotn..d) Pharmaceutically usable salts of phosphoric acid such as sodium hydrogen phosphate in an amount of from 0.05 to 0.45% by weight, preferably from 0.1 to 0.35% by weight. and sodium phosphate in an amount of from 0.2 to 2.0% by weight, preferably from 0.7 to 1.4% by weight.
e) Látky upravujúce chuť a vôňu prípravku zo skupiny prírodných a prírodné identických aróm v množstve od 0,1 do 5 % hmotn., s výhodou od 0,5 do 1 % hmotn., zo skupiny umelých sladidiel v množstve od 0,035 do 0,20 % hmotn., s výhodou od 0,05 do 0,15 % hmotn., zo skupiny farmaceutický použiteľných organických kyselín, s výhodou kyseliny citrónovej v množstve od 0,1 do 4 % hmotn., s výhodou od 0,8 do 1,8 % hmotn. a ich solí, s výhodou trinatriumcitrátu v množstve od 0,05 do 2,0 % hmotn., s výhodou od 0,1 do 0,5 % hmotn., kakaový prášok v množstve od 1 do 30 % hmotn., s výhodou od 10 do 20 % hmotn..e) The flavorants of the composition from the group of natural and naturally identical flavorings in an amount of from 0.1 to 5% by weight, preferably from 0.5 to 1% by weight, of the group of artificial sweeteners in an amount of 0.035 to 0; 20% by weight, preferably from 0.05 to 0.15% by weight, of the group of pharmaceutically usable organic acids, preferably citric acid, in an amount of from 0.1 to 4% by weight, preferably from 0.8 to 1% %, 8 wt. and salts thereof, preferably trisodium citrate in an amount of from 0.05 to 2.0 wt%, preferably from 0.1 to 0.5 wt%, cocoa powder in an amount of from 1 to 30 wt%, preferably from 10 to 20 wt.
f) Vzhľad upravujúce látky zo skupiny povolených prírodných a syntetických farbív v množstve od 0,001 do 0,005 % hmotn., s výhodou od 0,002 do 0,004 % hmotn..f) Appearance conditioners from the group of permitted natural and synthetic dyes in an amount of from 0.001 to 0.005% by weight, preferably from 0.002 to 0.004% by weight.
g) Technologický proces uľahčujúce látky, ktoré zamedzujú nežiadúcej aglomerácii častíc a antistatický pôsobiace látky zo skupiny oxidov kremíka v množstve od 0,1 do 7,0 % hmotn., klzné látky zo skupiny horečnatých,vápenatých a hlinitých solí vyšších mastných kyselín, s výhodou stearát vápenatý, alebo horečnatý v množstve od 0,1 do 0, 7 % hmotn., s výhodou od 0,2 do 0,4 % hmotn., alebo látky zo skupiny organických zlúčenín kremíka, s výhodou dimetylpolysiloxan v množstve od 0,07 do 0,9 % hmotn., s výhodou od 0,1 do 0,5 %.hmotn..g) Technological process facilitating substances which prevent undesirable agglomeration of particles and antistatic agents from the group of silicon oxides in an amount from 0.1 to 7.0% by weight, glidants from the group of magnesium, calcium and aluminum salts of higher fatty acids, preferably calcium or magnesium stearate in an amount of from 0.1 to 0.7% by weight, preferably from 0.2 to 0.4% by weight, or a substance from the group of organic silicon compounds, preferably dimethyl polysiloxane in an amount of from 0.07 % to 0.9% by weight, preferably from 0.1 to 0.5% by weight.
h) Konzervačné látky, ako je kyselina sorbová v množstve od 0,01 do 0,04 % hmotn., jej soli, s výhodou sodná a draselná v množstve od 0,01 do 0,05 % hmotn., kyselina benzoová v množstve od 0,006 do 0,02 % hmotn., jej soli, s výhodou sodná v množstve od 0,01 do 0,03 % hmotn., estery kyseliny p-hydroxybenzoovej v množstve odh) Preservatives such as sorbic acid in an amount of 0.01 to 0.04 wt%, salts thereof, preferably sodium and potassium in an amount of 0.01 to 0.05 wt%, benzoic acid in an amount of 0.006 to 0.02 wt.%, A salt thereof, preferably sodium in an amount from 0.01 to 0.03 wt.%, Esters of p-hydroxybenzoic acid in an amount of from
0,001 do 0,08 % hmotn., s výhodou od 0,01 do 0,06 % hmotn. a ich soli, s výhodou sodné a draselné v množstve od 0,001 do 0,08 % hmotn..0.001 to 0.08 wt.%, Preferably from 0.01 to 0.06 wt. and salts thereof, preferably sodium and potassium in an amount of from 0.001 to 0.08% by weight.
Príklady uskutočnenia vynálezuDETAILED DESCRIPTION OF THE INVENTION
Predmet vynálezu je objasnený v príkladoch bez toho,aby sa na ne obmedzoval.The subject matter of the invention is illustrated in the examples without being limited thereto.
Príklad 1Example 1
a) Farmaceutický prípravok, ktorý obsahuje v 1 dávke:(a) Pharmaceutical preparation containing in one dose:
b) Spôsob jeho prípravy.(b) Method for its preparation.
Mikronizovaný uhličitan vápenatý sa mieša vo vhodnom zariadení spolu so sacharózou a škrobovým derivátom, pridá sa karragenan, znovu sa mieša. V inom miešacom zariadení sa zmieša hydrogénfosforečnan sodný, fosforečnan sodný, kyselina citrónová, citronan sodný, ktoré sú upravené sitovaním cez sito s veľkosťou oka 1,0 mm. Po dosiahnutí homogenity sa táto zmes pridá do predošlej časti. Obidve zmesi sa spolu miešajú minimálne 20 minút a po zhomogenizovaní sa nakoniec pridá dimetylpolysiloxan v zmesi s maltodextrínom a prášková pomarančová aróma. Po dosiahnutí homogenity potvrdenou analýzou sa zmes adjustuje do jednodávkových vrecúšok s kombinovanej fólie s výhodou PP/Al/PE po 3,000 g. Takto vyrobená 1 dávka obsahuje 500 mg biologicky využiteľného vápnika.The micronized calcium carbonate is mixed in a suitable apparatus together with sucrose and a starch derivative, carragenan is added and mixed again. In another mixer, sodium hydrogen phosphate, sodium phosphate, citric acid, sodium citrate are mixed by sieving through a sieve with a mesh size of 1.0 mm. Once homogeneous, the mixture is added to the previous portion. The two mixtures are mixed together for at least 20 minutes and after homogenization, dimethyl polysiloxane is finally added in a mixture with maltodextrin and a powdered orange flavor. After homogeneity by confirmed analysis, the mixture is adjusted into single-dose sachets with a combined film, preferably PP / Al / PE of 3,000 g each. The 1 dose thus produced contains 500 mg of bioavailable calcium.
Príklad 2Example 2
a) Farmaceutický prípravok, ktorý obsahuje v 1 dávke :(a) Pharmaceutical preparation containing in one dose:
Uhličitan vápenatý................Calcium carbonate ................
Sacharóza..............................Sucrose ..............................
Škrobový derivát..................Starch derivative ..................
Karragenan...........................Carrageenan ...........................
Hydrogénfosforečnan sodný,Sodium hydrogen phosphate,
Fosforečnan sodný................Sodium phosphate ................
Kakaový prášok...................Cocoa powder...................
b) Spôsob jeho prípravy(b) Method for its preparation
Mikronizovaný uhličitan vápenatý sa mieša vo vhodnom zariadení s dopredu preosiatym škrobovým derivátom, sacharózou, karragenanom, hydrogénfosforečnanom sodným, fosforečnanom sodným a kakaovým práškom cez sito s dĺžkou strany oka 1,25 mm až do dosiahnutia homogenity. Táto zmes sa zvlhčí potrebným množstvom zmesi etylalkoholu a vody, kým sa nedosiahne potrebné zozmenie . Granulovina sa vysuší na vlhkosť neprevyšujúcu 2,5 % hmotn., upravia sa jej častice na velkosť vyhovujúcu adjustácii a plní sa do jednodávkových vrecúšok s kombinovanej fólie PP/A1/PE po 3,0000 g. Takto vyrobená 1 dávka obsahuje 500 mg biologicky využiteľného vápnika.The micronized calcium carbonate is blended in a suitable apparatus with a pre-screened starch derivative, sucrose, carragenate, sodium hydrogen phosphate, sodium phosphate and cocoa powder through a sieve with a mesh side length of 1.25 mm until homogeneity. This mixture is moistened with the necessary amount of a mixture of ethanol and water until the required browning is achieved. The granules are dried to a moisture content not exceeding 2.5% by weight, the particles are sized to a suitable size and filled into single-dose sachets of PP / A1 / PE combination film of 3.0000 g each. The 1 dose thus produced contains 500 mg of bioavailable calcium.
Príklad 3Example 3
a) Farmaceutický prípravok, ktorý obsahuje v 1 dávke :(a) Pharmaceutical preparation containing in one dose:
b) Spôsob jeho prípravy.(b) Method for its preparation.
Mikronizovaný uhličitan vápenatý sa mieša vo vhodnom farmaceutickom zariadení a predom preosiatym škrobovým derivátom, sacharózou, karragenanom, hydrogénfosforečnanom sodným, fosforečnanom sodným cez sito s dĺžkou strany oka 1,25 mm až do dosiahnutia homogenity. Táto zmes sa počas miešania postupne zvlhčuje potrebným množstvom zmesi etylalkoholu a vody a zozmí sa. Granulovina sa vysuší vo vznose pri teplote privádzajúceho vzduchu 50 °C až kým nedosiahne zbytkovú vlhkosť max. 2,0 % hmotn.. Suchá zmes sa prenesie do miešacieho zariadenia, pridá sa potrebné množstvo vanilkovej práškovej arómy a farbiva a mieša sa do dosiahnutia homogenity. Týmto je zmes pripravená k adjustácii do jednodávkových vrecúšok z kombinovanej fólie po 3,0000 g. Týmto spôsobom vyrobená dávka obsahuje 500 mg biologicky využiteľného vápnika.The micronized calcium carbonate is mixed in a suitable pharmaceutical device and previously screened starch derivative, sucrose, carragenate, sodium hydrogen phosphate, sodium phosphate through a sieve with a side length of 1.25 mm to homogeneity. This mixture is gradually wetted with the necessary amount of a mixture of ethyl alcohol and water while stirring and the mixture is eaten. The pellet is dried in the air at an air supply temperature of 50 ° C until a residual moisture of max. The dry mixture is transferred to a mixer, the necessary amount of vanilla powder flavor and color is added and mixed until homogeneous. Thus, the mixture is ready for adjustment into single-dose bags of composite foil of 3.0000 g each. The dose produced in this way contains 500 mg of bioavailable calcium.
Príklad 4Example 4
a) Farmaceutický prípravok, ktorý obsahuje v 1 dávke :(a) Pharmaceutical preparation containing in one dose:
b) Spôsob jeho prípravy(b) Method for its preparation
Mikronizovaný uhličitan vápenatý sa mieša vo vhodnom farmaceutickom zariadení so sacharózou, pridá sa karragenan a ďalej sa mieša. Po dokonalej homogenizácii sa postupne pridáva hydrogénfosforečnan sodný, fosforečnan sodný, kyselina citrónová, citrát sodný, ktoré sú predtým upravené cez sito s veľkosťou strany oka 1,25 mm. V špeciálnom zariadení pre homogenizáciu malých množstiev sa narieďuje colekalciferol s vopred pripravenou zmesou v pomere 1 : 50. Nariedený colecalciferol sa prenesie do vopred pripravenej zmesi a zmieša sa intenzívnym miešaním do dosiahnutia homogenity. K zmesi sa potom postupne pridávajú žlté syntetické farbivo, broskyňová prášková aróma., maltodextrin a dimetylpolysiloxan . Po zhomogenizovaní je zmes pripravená k adjustácii do kombinovanej trojvrstvej fólie PP/A1/PE po 3,0000 g, čo je jedna dávka a táto obsahuje 500 mg biologicky využiteľného vápnika a 800 I.U. vitamínu D3.The micronized calcium carbonate is mixed with sucrose in a suitable pharmaceutical device, carragenan is added and further stirred. After complete homogenization, sodium hydrogen phosphate, sodium phosphate, citric acid, sodium citrate, which are pretreated through a sieve with a mesh side size of 1.25 mm, are gradually added. In a special device for homogenizing small amounts, colecalciferol is diluted with a pre-mix in a ratio of 1: 50. Yellow synthetic dye, peach powder flavor, maltodextrin and dimethylpolysiloxane are then gradually added to the mixture. After homogenization, the blend is ready for adjustment into a PP / A1 / PE triple layer film of 3.0000 g, a single dose containing 500 mg of bioavailable calcium and 800 I.U. of vitamin D3.
Príklad 5Example 5
a) Farmaceutický prípravok,ktorý obsahuje v 1 dávke :(a) Pharmaceutical preparation containing in one dose:
b) Spôsob jeho prípravy(b) Method for its preparation
Mikronizovaný uhličitan vápenatý sa mieša vo vhodnom farmaceutickom zariadení so sacharózou, pridá sa karragenan a ďalej sa mieša. Po dokonalej homogenizácii sa postupne pridáva hydrogénfosforečnan sodný, fosforečnan sodný, kyselina citrónová, citrát sodný, ktoré sú predtým upravené cez sito s veľkosťou strany oka 1,25 mm. V špeciálnom zariadení pre homogenizáciu malých množstiev sa narieďuje colecalciferol s vopred pripravenou zmesou v pomere 1 : 50. Nariedený colecalciferol sa prenesie do vopred pripravenej zmesi a zmieša sa intenzívnym miešaním do dosiahnutia homogenity. K zmesi sa potom pridá prášková kokosová aróma . Po zhomogenizovaní je zmes pripravená k adjustácií do kombinovanej trojvrstvej fólie PP/A1/PE po 3,0000 g, čo je jedna dávka a táto obsahuje 500 mg biologicky využiteľného vápnika a 800 I.U. vitamínu D3.The micronized calcium carbonate is mixed with sucrose in a suitable pharmaceutical device, carragenan is added and further stirred. After complete homogenization, sodium hydrogen phosphate, sodium phosphate, citric acid, sodium citrate, which are pretreated through a sieve with a mesh side size of 1.25 mm, are gradually added. In a special device for homogenizing small amounts, colecalciferol is diluted with a pre-mix in a ratio of 1: 50. The powdered coconut flavor is then added to the mixture. After homogenization, the mixture is ready for adjustment into a PP / A1 / PE triple layer film of 3.0000 g, which is a single dose and contains 500 mg of bioavailable calcium and 800 I.U. of vitamin D3.
Príklad 6Example 6
a) Farmaceutický prostriedok, ktorý obsahuje v 1 dávke :(a) A pharmaceutical composition comprising, per dose:
Magneziumhydroxidkarbonát ...............0,7880 g 26,26 %Magnesium hydroxide carbonate ............... 0,7880 g 26,26%
Uhličitan vápenatý...................................0,6237 g 20,79 %Calcium carbonate ................................... 0.6237 g 20.79%
Sacharóza.................................................0,9749 g 32,50 %Sucrose ................................................. 0.9749 g 32.50%
Škrobový derivát......................................0,4682 g 15,61 %Starch derivative ...................................... 0,4682 g 15,61%
b) Spôsob jeho prípravy(b) Method for its preparation
Mikronizovaný hydroxidkarbonát horečnatý sa zmieša vo vhodnom zariadení s polovičným množstvom sacharózy a škrobového derivátu.Pridá sa karragenan, zmes sa dokonale premieša a pridá sa zbytok sacharózy a škrobového derivátu. Po dokonalej homogenizácii sa k tejto zmesi pridá predtým zhomogenizovaná zmes hydrogénfosforečnanu sodného, fosforečnanu sodného, kyseliny citrónovej a citrátu sodného s upravenou veľkosťou častíc cez sito s veľkosťou strany oka 1,0 mm. Po zhomogenizovaní týchto zmesí sa postupne pridáva dimetylpolysiloxan, maltodextrín a prášková citrónová aróma. Po dosiahnutí homogenity potvrdenou analýzou sa zmes adjustuje do jednodávkových vrecúšok s kombinovanej trojvrstvej fólie po 3,000 g. Takto vyrobená 1 dávka obsahuje 200 mg biologicky využiteľného horčíka a 250 mg biologicky využiteľného vápnika.The micronized magnesium hydroxide carbonate is mixed in a suitable machine with half the amount of sucrose and starch derivative. Carragenan is added, mixed thoroughly and the rest of sucrose and starch derivative are added. After complete homogenization, a previously homogenized mixture of dibasic sodium phosphate, sodium phosphate, citric acid and sodium citrate with adjusted particle size is added to this mixture through a 1.0 mm sieve. After homogenizing these mixtures, dimethyl polysiloxane, maltodextrin and powdered lemon flavor are added sequentially. After homogeneity by confirmed analysis, the mixture is adjusted into single-dose sachets with a combined 3-layer film of 3,000 g each. The 1 dose thus produced contains 200 mg of bioavailable magnesium and 250 mg of bioavailable calcium.
Klinické zhodnotenieClinical evaluation
Podávanie vápnika je nevyhnutnou súčasťou každej liečby, alebo prevencie vzniku osteoporózy, pričom je potrebné zabezpečiť príjem 400 až 8001.U vitamínu D denne.Calcium administration is an essential part of any treatment or prevention of osteoporosis, with an intake of 400 to 8001.U of vitamin D daily.
V monocentrickej otvorenej kontrolovanej klinickej štúdii bola dokázaná obdobná biologická dostupnosť vápnika po jednorazovom podaní prípravku podľa vynálezu oproti štandardnému prípravku vo forme šumivej tablety, pričom bola zistená výrazne vyššia kalcinémia po 1 hodine po podaní šumivej tablety. Postupné narastanie kalcinémie, ktoré nepresiahne hornú hranicu normy je veľmi žiadúce zvlášť u staršej populácie, kde je hyperkalcinémia spojená s rizikom ukladania vápnika do aterosklerotických plátov.In a monocentric, open-label, controlled clinical study, a similar bioavailability of calcium was observed after a single administration of the formulation of the invention over a standard effervescent tablet formulation, with significantly higher calcinemia at 1 hour after the effervescent tablet. A gradual increase in calcinemia that does not exceed the upper limit of the norm is highly desirable, especially in the elderly population, where hypercalcaemia is associated with the risk of calcium deposition in atherosclerotic plaques.
V monocentrickej otvorenej nekontrolovanej tolerančnej klinickej štúdii u dospelých pacientov s osteoporózou, alebo s nedostatočným príjmom vápnika v potrave bola dokázaná výborná tolerancia a bezpečnosť prípravku podľa tohto vynálezu. Dvojmesačné podávanie sledovaného prípravku podľa vynálezu štatisticky významne zvýšilo kalcinémiu v celom súbore 76 pacientov s osteopéniou alebo s osteoporózou dokázanou denzitometricky a s nedostatočným príjmom vápnika.In a monocentric, open-label, uncontrolled tolerance clinical study in adult patients with osteoporosis or with insufficient dietary calcium intake, excellent tolerance and safety of the formulation of the present invention has been demonstrated. The two-month administration of the investigated formulation of the invention statistically significantly increased calcinemia in the whole group of 76 patients with osteopenia or with densitometric evidence of osteoporosis and with insufficient calcium intake.
Charakteristika klinických štúdií s prípravkom kalcia podľa vynálezuCharacteristics of clinical studies with the calcium preparation of the invention
Priemyselná využiteľnosťIndustrial usability
Vynález je využiteľný vo farmaceutickom priemysle pri výrobe liečivých prípravkov na liečbu a prevenciu osteoporózy.The invention is useful in the pharmaceutical industry in the manufacture of medicaments for the treatment and prevention of osteoporosis.
Claims (3)
Priority Applications (10)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SK498-2000A SK284948B6 (en) | 2000-04-06 | 2000-04-06 | Pharmaceutical composition with a content of calcium or mixture of calcium and vitamin D or mixture of calcium and magnesium in a new formulation |
| PCT/SK2001/000004 WO2001076610A1 (en) | 2000-04-06 | 2001-03-15 | Pharmaceutical composition with a content of calcium or mixture of calcium and vitamin d or mixture of calcium and magnesium in a new formulation |
| MDA20020265A MD2722B2 (en) | 2000-04-06 | 2001-03-15 | Pharmaceutical composition containing calcium carbonate or mixture thereof with magnesium hydroxycarbonate or with vitamin D, used for prophylaxis or treatment of osteoporosis |
| CZ20023292A CZ303069B6 (en) | 2000-04-06 | 2001-03-15 | Therapeutical preparation containing calcium or a mixture of calcium and vitamin D or a mixture of calcium and magnesium in a novel medicament formulation |
| PL01357777A PL357777A1 (en) | 2000-04-06 | 2001-03-15 | Pharmaceutical composition with a content of calcium or mixture of calcium and vitamin d or mixture of calcium and magnesium in a new formulation |
| EP01914325A EP1274447A1 (en) | 2000-04-06 | 2001-03-15 | Pharmaceutical composition with a content of calcium or mixture of calcium and vitamin d or mixture of calcium and magnesium in a new formulation |
| AU2001239668A AU2001239668A1 (en) | 2000-04-06 | 2001-03-15 | Pharmaceutical composition with a content of calcium or mixture of calcium and vitamin d or mixture of calcium and magnesium in a new formulation |
| EEP200200584A EE200200584A (en) | 2000-04-06 | 2001-03-15 | Pharmaceutical preparations containing calcium or a mixture of calcium and vitamin D or a mixture of calcium and magnesium in a new preparation |
| RU2002130196/15A RU2002130196A (en) | 2000-04-06 | 2001-03-15 | PHARMACEUTICAL COMPOSITION CONTAINING CALCIUM OR CALCIUM AND VITAMIN MIXTURE OR CALCIUM AND MAGNESIUM MIXTURE |
| BG107227A BG107227A (en) | 2000-04-06 | 2002-10-29 | Pharmaceutical composition with a content of calcium or mixture of calcium and vitamin d or mixture of calcium and magnesium |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SK498-2000A SK284948B6 (en) | 2000-04-06 | 2000-04-06 | Pharmaceutical composition with a content of calcium or mixture of calcium and vitamin D or mixture of calcium and magnesium in a new formulation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| SK4982000A3 true SK4982000A3 (en) | 2001-10-08 |
| SK284948B6 SK284948B6 (en) | 2006-03-02 |
Family
ID=20435843
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SK498-2000A SK284948B6 (en) | 2000-04-06 | 2000-04-06 | Pharmaceutical composition with a content of calcium or mixture of calcium and vitamin D or mixture of calcium and magnesium in a new formulation |
Country Status (10)
| Country | Link |
|---|---|
| EP (1) | EP1274447A1 (en) |
| AU (1) | AU2001239668A1 (en) |
| BG (1) | BG107227A (en) |
| CZ (1) | CZ303069B6 (en) |
| EE (1) | EE200200584A (en) |
| MD (1) | MD2722B2 (en) |
| PL (1) | PL357777A1 (en) |
| RU (1) | RU2002130196A (en) |
| SK (1) | SK284948B6 (en) |
| WO (1) | WO2001076610A1 (en) |
Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7067150B2 (en) * | 2002-04-16 | 2006-06-27 | Scepter Holdings, Inc. | Delivery systems for functional ingredients |
| ES2517244T3 (en) | 2004-05-11 | 2014-11-03 | Egalet Ltd. | Inflatable pharmaceutical form comprising gellan gum |
| UA95093C2 (en) | 2005-12-07 | 2011-07-11 | Нікомед Фарма Ас | Method for the preparation of calcium-containing compound |
| JP2012522011A (en) * | 2009-03-26 | 2012-09-20 | パルマトリックス，インコーポレイテッド | Pharmaceutical formulations and methods for treating respiratory tract infections |
| KR101639098B1 (en) | 2009-03-26 | 2016-07-12 | 풀매트릭스 오퍼레이팅 컴퍼니, 인크 | Dry powder formulations and methods for treating pulmonary diseases |
| EP2464346A1 (en) | 2010-08-30 | 2012-06-20 | Pulmatrix, Inc. | Treatment of cystic fibrosis using calcium lactate, leucine and sodium chloride in a respiraple dry powder |
| RU2017144619A (en) | 2010-09-29 | 2019-02-20 | Пулмэтрикс, Инк. | CASES OF SINGLE-VALVE METALS OF DRY POWDERS FOR INHALATIONS |
| US20150136130A1 (en) | 2012-02-29 | 2015-05-21 | Pulmatrix, Inc. | Inhalable dry powders |
| CA2907566C (en) | 2013-04-01 | 2023-08-22 | Pulmatrix, Inc. | Tiotropium dry powders |
| JO3456B1 (en) | 2015-05-13 | 2020-07-05 | H Lundbeck As | ferrotioxetine pyroglutamate |
| RU2726438C2 (en) * | 2018-11-14 | 2020-07-14 | Федеральное государственное бюджетное образовательное учреждение высшего образования "Ставропольский государственный медицинский университет" Министерства здравоохранения Российской Федерации (ФГБОУ ВО СтГМУ Минздрава России) | Method for production of a dry high protein milk mixture for prevention of osteopenia in children and adolescents with gee's disease |
| CN109453126A (en) * | 2018-12-07 | 2019-03-12 | 浙江核力欣健药业有限公司 | A kind of calcium carbonate D3Composition of chewable tablets and preparation method thereof |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4650669A (en) * | 1985-07-30 | 1987-03-17 | Miles Laboratories, Inc. | Method to make effervescent calcium tablets and calcium tablets produced thereby |
| CA1297035C (en) * | 1987-12-29 | 1992-03-10 | Warner-Lambert Canada Inc. | Chewable, non-gritty calcium citrate tablet |
| US5296476A (en) * | 1989-09-08 | 1994-03-22 | Henderson Esther G | Skin care compositions |
| DE69331528T2 (en) * | 1992-12-23 | 2002-10-31 | Abbott Laboratories, Abbott Park | MEDICAL FOOD FOR THE NUTRITIONAL SUPPLEMENT IN METABOLIC DISEASES OF INFANTS / KIDS |
| US5637313A (en) * | 1994-12-16 | 1997-06-10 | Watson Laboratories, Inc. | Chewable dosage forms |
| US6241997B1 (en) * | 1998-03-16 | 2001-06-05 | Smtm Group. Llc | Chewable calcium supplement and method |
-
2000
- 2000-04-06 SK SK498-2000A patent/SK284948B6/en not_active IP Right Cessation
-
2001
- 2001-03-15 MD MDA20020265A patent/MD2722B2/en unknown
- 2001-03-15 WO PCT/SK2001/000004 patent/WO2001076610A1/en not_active Ceased
- 2001-03-15 AU AU2001239668A patent/AU2001239668A1/en not_active Abandoned
- 2001-03-15 CZ CZ20023292A patent/CZ303069B6/en not_active IP Right Cessation
- 2001-03-15 PL PL01357777A patent/PL357777A1/en not_active Application Discontinuation
- 2001-03-15 RU RU2002130196/15A patent/RU2002130196A/en unknown
- 2001-03-15 EE EEP200200584A patent/EE200200584A/en unknown
- 2001-03-15 EP EP01914325A patent/EP1274447A1/en not_active Withdrawn
-
2002
- 2002-10-29 BG BG107227A patent/BG107227A/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| BG107227A (en) | 2003-05-30 |
| PL357777A1 (en) | 2004-07-26 |
| CZ303069B6 (en) | 2012-03-21 |
| RU2002130196A (en) | 2004-03-27 |
| WO2001076610A1 (en) | 2001-10-18 |
| AU2001239668A1 (en) | 2001-10-23 |
| SK284948B6 (en) | 2006-03-02 |
| EE200200584A (en) | 2004-04-15 |
| EP1274447A1 (en) | 2003-01-15 |
| MD20020265A (en) | 2003-05-31 |
| MD2722B2 (en) | 2005-03-31 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MM4A | Patent lapsed due to non-payment of maintenance fees |
Effective date: 20190406 |