ME00864B - Farmaceutski sastav koji sadrži inhibitore protonske pumpe - Google Patents
Farmaceutski sastav koji sadrži inhibitore protonske pumpeInfo
- Publication number
- ME00864B ME00864B MEP-2001-504A MEP2001504A ME00864B ME 00864 B ME00864 B ME 00864B ME P2001504 A MEP2001504 A ME P2001504A ME 00864 B ME00864 B ME 00864B
- Authority
- ME
- Montenegro
- Prior art keywords
- composition
- liquid carrier
- proton pump
- hydrophobic
- omeprazole
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract 4
- 229940126409 proton pump inhibitor Drugs 0.000 title abstract description 12
- 239000000612 proton pump inhibitor Substances 0.000 title abstract description 10
- 239000000203 mixture Substances 0.000 claims abstract description 42
- SUBDBMMJDZJVOS-UHFFFAOYSA-N 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole Chemical compound N=1C2=CC(OC)=CC=C2NC=1S(=O)CC1=NC=C(C)C(OC)=C1C SUBDBMMJDZJVOS-UHFFFAOYSA-N 0.000 claims description 21
- 229960000381 omeprazole Drugs 0.000 claims description 21
- 230000002209 hydrophobic effect Effects 0.000 claims description 13
- 239000007788 liquid Substances 0.000 claims description 13
- 239000002562 thickening agent Substances 0.000 claims description 11
- DNIAPMSPPWPWGF-UHFFFAOYSA-N monopropylene glycol Natural products CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 10
- 239000002610 basifying agent Substances 0.000 claims description 8
- -1 propylene glycol diesters Chemical class 0.000 claims description 8
- 235000015112 vegetable and seed oil Nutrition 0.000 claims description 8
- 239000008158 vegetable oil Substances 0.000 claims description 8
- 239000008159 sesame oil Substances 0.000 claims description 7
- 235000011803 sesame oil Nutrition 0.000 claims description 7
- CHHHXKFHOYLYRE-UHFFFAOYSA-M 2,4-Hexadienoic acid, potassium salt (1:1), (2E,4E)- Chemical compound [K+].CC=CC=CC([O-])=O CHHHXKFHOYLYRE-UHFFFAOYSA-M 0.000 claims description 5
- 125000004432 carbon atom Chemical group C* 0.000 claims description 5
- 239000003795 chemical substances by application Substances 0.000 claims description 5
- PHMQYKDOTWAOBI-UHFFFAOYSA-N decanoic acid;propane-1,2-diol Chemical compound CC(O)CO.CCCCCCCCCC(O)=O PHMQYKDOTWAOBI-UHFFFAOYSA-N 0.000 claims description 5
- 235000014113 dietary fatty acids Nutrition 0.000 claims description 5
- 239000000194 fatty acid Substances 0.000 claims description 5
- 229930195729 fatty acid Natural products 0.000 claims description 5
- 150000004665 fatty acids Chemical class 0.000 claims description 5
- WWZKQHOCKIZLMA-UHFFFAOYSA-M octanoate Chemical compound CCCCCCCC([O-])=O WWZKQHOCKIZLMA-UHFFFAOYSA-M 0.000 claims description 5
- 239000004302 potassium sorbate Substances 0.000 claims description 5
- 229940069338 potassium sorbate Drugs 0.000 claims description 5
- 235000010241 potassium sorbate Nutrition 0.000 claims description 5
- HZAXFHJVJLSVMW-UHFFFAOYSA-N 2-Aminoethan-1-ol Chemical compound NCCO HZAXFHJVJLSVMW-UHFFFAOYSA-N 0.000 claims description 4
- 239000004359 castor oil Substances 0.000 claims description 4
- 235000019438 castor oil Nutrition 0.000 claims description 4
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 claims description 4
- RYYKJJJTJZKILX-UHFFFAOYSA-M sodium octadecanoate Chemical compound [Na+].CCCCCCCCCCCCCCCCCC([O-])=O RYYKJJJTJZKILX-UHFFFAOYSA-M 0.000 claims description 4
- 150000003626 triacylglycerols Chemical class 0.000 claims description 4
- 150000004667 medium chain fatty acids Chemical class 0.000 claims description 3
- 241001465754 Metazoa Species 0.000 abstract description 10
- 201000010099 disease Diseases 0.000 abstract description 4
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract description 4
- 210000004211 gastric acid Anatomy 0.000 abstract description 3
- 238000009472 formulation Methods 0.000 description 14
- 239000000843 powder Substances 0.000 description 7
- 239000003814 drug Substances 0.000 description 4
- 238000002156 mixing Methods 0.000 description 4
- 208000008469 Peptic Ulcer Diseases 0.000 description 3
- 239000012051 hydrophobic carrier Substances 0.000 description 3
- 239000000546 pharmaceutical excipient Substances 0.000 description 3
- 235000013772 propylene glycol Nutrition 0.000 description 3
- 229960004063 propylene glycol Drugs 0.000 description 3
- FZTHHIGKHFQAKY-UHFFFAOYSA-N 1-octanoyloxypropan-2-yl decanoate Chemical compound CCCCCCCCCC(=O)OC(C)COC(=O)CCCCCCC FZTHHIGKHFQAKY-UHFFFAOYSA-N 0.000 description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 2
- 230000002378 acidificating effect Effects 0.000 description 2
- 150000001412 amines Chemical class 0.000 description 2
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 description 2
- 235000013539 calcium stearate Nutrition 0.000 description 2
- 239000008116 calcium stearate Substances 0.000 description 2
- 239000011248 coating agent Substances 0.000 description 2
- 238000000576 coating method Methods 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- JEIPFZHSYJVQDO-UHFFFAOYSA-N ferric oxide Chemical compound O=[Fe]O[Fe]=O JEIPFZHSYJVQDO-UHFFFAOYSA-N 0.000 description 2
- 229960005191 ferric oxide Drugs 0.000 description 2
- UQSXHKLRYXJYBZ-UHFFFAOYSA-N iron oxide Inorganic materials [Fe]=O UQSXHKLRYXJYBZ-UHFFFAOYSA-N 0.000 description 2
- 235000013980 iron oxide Nutrition 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 238000003756 stirring Methods 0.000 description 2
- DUXYWXYOBMKGIN-UHFFFAOYSA-N trimyristin Chemical compound CCCCCCCCCCCCCC(=O)OCC(OC(=O)CCCCCCCCCCCCC)COC(=O)CCCCCCCCCCCCC DUXYWXYOBMKGIN-UHFFFAOYSA-N 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 239000001993 wax Substances 0.000 description 2
- DMBUODUULYCPAK-UHFFFAOYSA-N 1,3-bis(docosanoyloxy)propan-2-yl docosanoate Chemical compound CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(OC(=O)CCCCCCCCCCCCCCCCCCCCC)COC(=O)CCCCCCCCCCCCCCCCCCCCC DMBUODUULYCPAK-UHFFFAOYSA-N 0.000 description 1
- WCOXQTXVACYMLM-UHFFFAOYSA-N 2,3-bis(12-hydroxyoctadecanoyloxy)propyl 12-hydroxyoctadecanoate Chemical compound CCCCCCC(O)CCCCCCCCCCC(=O)OCC(OC(=O)CCCCCCCCCCC(O)CCCCCC)COC(=O)CCCCCCCCCCC(O)CCCCCC WCOXQTXVACYMLM-UHFFFAOYSA-N 0.000 description 1
- MIDXCONKKJTLDX-UHFFFAOYSA-N 3,5-dimethylcyclopentane-1,2-dione Chemical compound CC1CC(C)C(=O)C1=O MIDXCONKKJTLDX-UHFFFAOYSA-N 0.000 description 1
- 235000019489 Almond oil Nutrition 0.000 description 1
- 244000223760 Cinnamomum zeylanicum Species 0.000 description 1
- 235000013162 Cocos nucifera Nutrition 0.000 description 1
- 244000060011 Cocos nucifera Species 0.000 description 1
- 244000000626 Daucus carota Species 0.000 description 1
- 235000002767 Daucus carota Nutrition 0.000 description 1
- 239000004097 EU approved flavor enhancer Substances 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 241000220225 Malus Species 0.000 description 1
- 235000011430 Malus pumila Nutrition 0.000 description 1
- 235000015103 Malus silvestris Nutrition 0.000 description 1
- 235000019483 Peanut oil Nutrition 0.000 description 1
- VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 description 1
- 208000007107 Stomach Ulcer Diseases 0.000 description 1
- 235000019486 Sunflower oil Nutrition 0.000 description 1
- GSEJCLTVZPLZKY-UHFFFAOYSA-N Triethanolamine Chemical compound OCCN(CCO)CCO GSEJCLTVZPLZKY-UHFFFAOYSA-N 0.000 description 1
- 208000025865 Ulcer Diseases 0.000 description 1
- 239000008168 almond oil Substances 0.000 description 1
- 230000000767 anti-ulcer Effects 0.000 description 1
- 239000003963 antioxidant agent Substances 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 235000013736 caramel Nutrition 0.000 description 1
- 150000001734 carboxylic acid salts Chemical class 0.000 description 1
- 150000001735 carboxylic acids Chemical class 0.000 description 1
- 229940082500 cetostearyl alcohol Drugs 0.000 description 1
- 235000017803 cinnamon Nutrition 0.000 description 1
- 239000010630 cinnamon oil Substances 0.000 description 1
- 239000003086 colorant Substances 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 235000012343 cottonseed oil Nutrition 0.000 description 1
- 239000002385 cottonseed oil Substances 0.000 description 1
- ZBCBWPMODOFKDW-UHFFFAOYSA-N diethanolamine Chemical compound OCCNCCO ZBCBWPMODOFKDW-UHFFFAOYSA-N 0.000 description 1
- 239000002270 dispersing agent Substances 0.000 description 1
- 208000000718 duodenal ulcer Diseases 0.000 description 1
- 239000002662 enteric coated tablet Substances 0.000 description 1
- 239000000796 flavoring agent Substances 0.000 description 1
- 235000019634 flavors Nutrition 0.000 description 1
- 235000019264 food flavour enhancer Nutrition 0.000 description 1
- 235000003599 food sweetener Nutrition 0.000 description 1
- 230000027119 gastric acid secretion Effects 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 231100000029 gastro-duodenal ulcer Toxicity 0.000 description 1
- 239000000499 gel Substances 0.000 description 1
- 125000005456 glyceride group Chemical group 0.000 description 1
- 238000000265 homogenisation Methods 0.000 description 1
- GPRLSGONYQIRFK-UHFFFAOYSA-N hydron Chemical compound [H+] GPRLSGONYQIRFK-UHFFFAOYSA-N 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 239000003112 inhibitor Substances 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 210000000936 intestine Anatomy 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 229940126601 medicinal product Drugs 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- GLDOVTGHNKAZLK-UHFFFAOYSA-N octadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCO GLDOVTGHNKAZLK-UHFFFAOYSA-N 0.000 description 1
- 239000004006 olive oil Substances 0.000 description 1
- 235000008390 olive oil Nutrition 0.000 description 1
- 210000001711 oxyntic cell Anatomy 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 239000012188 paraffin wax Substances 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 239000000312 peanut oil Substances 0.000 description 1
- 208000011906 peptic ulcer disease Diseases 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 230000003389 potentiating effect Effects 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- CVHZOJJKTDOEJC-UHFFFAOYSA-N saccharin Chemical compound C1=CC=C2C(=O)NS(=O)(=O)C2=C1 CVHZOJJKTDOEJC-UHFFFAOYSA-N 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 150000004671 saturated fatty acids Chemical class 0.000 description 1
- 235000003441 saturated fatty acids Nutrition 0.000 description 1
- 235000013580 sausages Nutrition 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- 239000001632 sodium acetate Substances 0.000 description 1
- 235000017281 sodium acetate Nutrition 0.000 description 1
- 239000001509 sodium citrate Substances 0.000 description 1
- 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 1
- 235000011083 sodium citrates Nutrition 0.000 description 1
- 239000007909 solid dosage form Substances 0.000 description 1
- 239000003549 soybean oil Substances 0.000 description 1
- 235000012424 soybean oil Nutrition 0.000 description 1
- 241000894007 species Species 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000002600 sunflower oil Substances 0.000 description 1
- 230000009747 swallowing Effects 0.000 description 1
- 239000003765 sweetening agent Substances 0.000 description 1
- 230000009885 systemic effect Effects 0.000 description 1
- OULAJFUGPPVRBK-UHFFFAOYSA-N tetratriacontyl alcohol Natural products CCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCO OULAJFUGPPVRBK-UHFFFAOYSA-N 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 229960005196 titanium dioxide Drugs 0.000 description 1
- 235000010215 titanium dioxide Nutrition 0.000 description 1
- 239000004408 titanium dioxide Substances 0.000 description 1
- UFTFJSFQGQCHQW-UHFFFAOYSA-N triformin Chemical compound O=COCC(OC=O)COC=O UFTFJSFQGQCHQW-UHFFFAOYSA-N 0.000 description 1
- 231100000397 ulcer Toxicity 0.000 description 1
- 239000002966 varnish Substances 0.000 description 1
- 239000011240 wet gel Substances 0.000 description 1
- 229940045860 white wax Drugs 0.000 description 1
Classifications
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
Landscapes
- Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Plural Heterocyclic Compounds (AREA)
Abstract
Predmetni pronalazak se odnosi na farmaceutsku formulaciju za oralnu primenu koja sadrži inhibitor protonske pumpe (proton pump inhibitor, PPI) i koja je pogodna za lečenje ljudi i životinja od oboljenja povezanih sa želudačnom kiselinom. Preciznije, sastav je pasta, i naročito je pogodan za unošenje inhibitora protonske pumpe u konje. Predmetni pronalazak se odnosi na farmaceutsku formulaciju za oralnu primenu koja sadrži inhibitor protonske pumpe (proton pump inhibitor, PPI) i koja je pogodna za lečenje ljudi i životinja od oboljenja povezanih sa želudačnom kiselinom. Preciznije, sastav je pasta, i naročito je pogodan za unošenje inhibitora protonske pumpe u konje.
Description
KRATAK OPIS PRONALASKA
Predmetni pronalazak se odnosi na poboljšanu formulaciju omeprazola u vidu paste, za oralnu primenu.
ISTORIJAT PRONALASKA
Omeprazol je potentan inhibitor lučenja želudačne kiseline koji deluje tako što inhibira H+-K+-ATP-azu, enzim uključen u završne korake proizvodnje vodonikovih jona u parijetalnim ćelijama, i koristi se za lečenje oboljenja povezanih sa želudačnom kiselinom, kao što su ulkusi želuca ili dvanaestopalačnog creva, kod ljudi. Peptički ulkusi se takođe javljaju i kod životinja, naročito kod konja. Iako etiologija gastroduodenalnih ulkusa kod konja nije jasna, izgleda da u nekim slučajevima stres ima važnu ulogu.
Omeprazol je izuzetno labilan u kiseloj sredini i zato formulacije za oralnu primenu imaju enetričnu oblogu. Izrada enterično obloženih formulacija je skupa i zahteva dosta vremena, kao i složenu tehnologiju i opremu. Još jedan nedostatak enterično obložene formulacije je njena osetljivost na vlagu.
W094/25070 objavljuje sastav za oralnu primenu koji sadrži inhibitor protonske pumpe u obliku enterično obloženih suvih čestica pomešanih sa suvim sredstvom za želatinizaciju, smesa se onda pre primene prevodi u gel nalik pasti. Ovaj sastav zahteva oblaganje eneteričnim omotačem, uz prethodno pomenute nedostatke udružene sa takvom formulacijom Štaviše, pošto takav vlažni gel nije stabilan tokom dugotrajnog skladištenja na sobnoj temperaturi, on ne može da se proizvodi i prodaje kao formulacija spremna za
upotrebu, nego mora da se priprema neposredno pre primene, što ga čini nepogodnim za korišćenje.
US Patent 5,708,017 opisuje formulacije inhibitora protonske pumpe u vidu paste koje uključuju inhibitor protonske pumpe, sredstvo za zgušnjavanje, sredstvo za bazifikaciju i hidrofobni uljasti tečni nosač.
DETALJAN OPIS PRONALASKA
Predmetni pronalazak daje poboljšanu formulaciju omeprazola u vidu paste koja uključuje:
(a) 1% do 60% m/m omeprazola,
(b) 0.1% do 2% m/m dva do četiri sredstva za bazifikaciju,
(c) 1% do 3% m/m sredstva za zgušnjavanje, i
(d) 30% do 95% m/m hidrofobnog uljastog tečnog nosača koji uključuje
(i) biljno ulje i
(ii) trigliceride masnih kiselina sa srednjom dužinom lanca - sa od 8-12 ugljenikovih atoma ili propilen-glikolne diestre masnih kiselina sa srednjom dužinom lanca -od 8-12 ugljenikovih atoma.
Omeprazol je objavljenu US Patent 4,255,432. Količina omeprazola u predmetnom pronalasku nije posebno kritična dok god lekoviti proizvod ostaje polučvrsti preparat; obično može da se toleriše do 60% m/m omeprazola. Poželjno, količina omeprazola je 50% m/m ili manje, i poželjnije, od 30 do 40% m/m.
Pogodna sredstva za bazifikaciju su na primer farmaceutski prihvatljive aminske baze kao što su monoetanolamin, dietanolamin, trietanolamin, i 1 i soli karbonskih kiselina kao što su natrijum-acetat, natrijum-citrat, kalijum-sorbat, natrijum-stearat i slično. Poželjno, jedno od sredstava za bazifikaciju je kalijum-sorbat, ijedno ili dva druga sredstva za bazifikaciju mogu da se odaberu između aminskih baza kao što je monoetanolamin i soli karbonske kiseline kao stoje natrijum-stearat. Sredstva za bazifikaciju su prisutna u količini dovoljnoj da se obezbedi ne-kisela sredina za omeprazol koji je labilan u kiseloj sredini, tipično, ukupna količina sredstava za bazifikaciju je od 0.1 do 2% m/m, i poželjno od 1 do 1.5% m/m
Sredstvo za zgušnjavanje može biti svaki farmaceutski prihvatljivi zgušnjivač koji je nerastvorljiv ili praktično nerastvorljiv u vodi, primeri uključuju silicijum-dioksid, voskove kao stoje ricinusov vosak ili hidrogenisano ricinusovo ulje, parafin, cetostearil-alkohol, i
slično. Poželjni hidrofobni zgušnjivač je hidrogenisano ricinusovo ulje. Količina sredstva za zgušnjavanje je približno 0.5% do 10% m/m konačnog sastava; poželjno, iznosi 1 do 2% m/m.
Hidrofobni uljasti tečni nosač uključuje (i) biljno ulje i (ii) trigliceride masnih kiselina sa srednjom dužinom lanca ili propilen-glikolne diestre masnih kiselina sa srednjom dužinom lanca. Primeri biljnih ulja obuhvataju bademovo ulje, ulje iz semena pamuka, maslinovo ulje, ulje kikirikija, suncokretovo ulje, susamovo ulje, i sojino ulje. Poželjno biljno ulje je susamovo ulje. Masne kiseline sa srednjom dužinom lanca su one koje imaju lanac dug osam do dvanaest ugljenikovih atoma; poželjno masne kiseline su zasićene masne kiseline. Poželjni trigliceridi i propilen-glikolni diestri su kaprinski/kaprilni trigliceridi i propilen-glikol kaprat/kaprilat (takođe označen i kao propilen-glikol oktanoat dekanoat). Kaprinski/kaprilni trigliceridi i propilen-glikol kaprat/kaprilat su komercijalno dostupni proizvodi koji se na tržištu nalaze pod zaštićenim imenom MigIyol® (Huls America, Ine., New Jersey). Poželjniji hidrofobni uljasti tečni nosač uključuje susamovo ulje i propilen-glikol kaprat/kaprilat (kao stoje Miglyol® 840). Hidrofobni nosač je prisutan u količini od približno 30% do 95% m/m, u zavisnosti od količine drugih ekscipijenata u pasti. Poželjno, hidrofobni nosač je prisutan u količini od 50 do 80% m/m. U hidrofobnom nosaču, odnos biljnog ulja prema trigliceridu može da bude u opsegu od 1:3 do 5:1; poželjno 1:1 do 2:1.
Predmetni sastav može da uključi dodatne sastojke koji se uobičajeno koriste u formulacijama u humanoj i veterinarskoj medicini. Na primer mogu da se dodaju sredstva za poboljšanje ukusa kao što su ukusi karamela, šargarepe, jabuke, cimeta i kobasice; sredstva za bojenje kao što su gvožđe-oksid, titanijum-dioksid, aluminijum-prirodni lakovi; zasladivači kao što su šećer, natrijum-saharin; prezervansi kao što su parabeni; antioksidanti kao što su BHT, BHA; disperzanti kao stoje kalcijum-stearat, i sredstva koja regulišu viskozitet kao što su beli vosak ili sintetski voskovi kao na primer gliceril-tribehenat, gliceril-trimiristat, hidrogenisani kokosovi gliceridi.
Sastav predmetnog pronalaska može da se pripremi dispergovanjem omeprazola u praškastoj formi u hidrofobni tečni nosač koji sadrži bilo koji drugi ekscipijent izuzev sredstva za zgušnjavanje. Smesi se zatim doda sredstvo za zgušnjavanje i mesa se dok se ne dostigne željena konzistencija. Sastav predmetnog pronalaska može takođe da se pripremi dispergovanjem ekscipijenata u hidrofobni uljasti tečni nosač, stoje praćeno dodavanjem sredstva za zgušnjavanje, i ako je potrebno naknadno, biljnog ulja da se postigne željena konzistencija; dobijenoj smesi se doda omeprazol u praškastoj formi i čitava smesa se dobro
meša da se omcprazol disperguje. Formulacija u vidu paste može da se upotrebi za punjenje doznih brizgalica, koje se koriste za direktnu primenu aktivnog leka kod životinje kojoj je potrebno lečenje.
Formulacije omeprazola u vidu paste, iz predmetnog pronalaska, imaju poboljšane odlike u odnosu na prethodno opisane formulacije omeprazola u vidu paste. Predmetne formulacije imaju bolje profile hemijske i fizičke stabilnosti i obezbeđuje višu bioraspoloživost leka.
Sastav predmetnog pronalaska je koristan u lečenju peptičkih ulkusnih oboljenja kod ljudi ili životinja. Može da se koristi za oralni unos omeprazola koji bi imao sistemsku aktivnost u životinjama. Sastav takođe može da se koristi za unos omeprazola kod ljudi sa teškoćama u gutanju čvrstih doznih oblika kao što su eneterično obložene tablete i kapsule. Sastav može da se primeni direktno u usta životinje, na primer konja kome je potrebna anti-ulkusna terapija; poželjno dozna brizgalica za pastu se koristi da se olakša primena leka. Konzistencija ove paste je takva da ne može lako da iscuri ili da se izbaci kada se jednom nađe na dorzalnoj strani životinjinog jezika. U pasti praktično neifia vazdušnih mehurića što povećava tačnost doziranja. Druga prednost ove formulacije je mogućnost primene individualizovanih doza.
Količina sastava koja se primenjuje može da varira u zavisnosti od određene vrste životinje koja treba da se leci, jačine bolesti, fizičkog stanja obolele životinje, i drugih faktora Lekar ili veterinar sa iskustvom u lečenju ulkusa može lako da odredi pravu dozu za specifičnog domaćina koji je podvrgnut lečenju. Generalno, može da se koristi dozni opseg od 0.2 mg/kg do 20 mg/kg.
Sledeći primer je dat da potpunije ilustruje pronalazak, i ne treba da se ni na koji način tumači kao ograničenje obima pronalaska.
PRIMER 1
Kalijum-sorbat (0.50 kg), kalcijum-stearat (2.50 kg), natrijum-stearat (0.25 kg), i žuti gvožđev oksid (0.50 kg) se dodaju u dvostruko konični blender i miksiraju se do disperznih praškova. Dobijem prašak se propusti kroz sito sa 60 okaca i samelje na velikoj brzini. Samleveni praškasti preblend se sakupi u polietilensku vrećicu da bi se koristio za izradu paste.
U mešalicu odgovarajuće veličine, sa vertikalnim vijkom, za polučvrstu pastu, dodaju se propilen-glikol oktanoat dekanoat (62.5 kg) i susamovo ulje (37.5 kg). Temperatura tečne smese se podesi na približno do 25°C, ako je potrebno, i vijak za mešanje se pokrene. Dok radi usitnjivač grudvica, u mešalicu se dodaju samleveni praškasti preblend, monoetanolamin (0.25 kg), i cimetovo ulje (0.75 kg). Posle toga, u mešalicu se doda hidrogenisano ricinusovo ulje (3.13 kg), i mesa se dok temperatura proizvoda ne dostigne 50±5°C. Vijak za mešanje i usitnjivač grudvica se zaustave i smesa se drži u sudu 30±5 minuta da se osigura završetak procesa želatinizacije.
Uz rashlađivanje vodom, preostalo susamovo ulje (49.6 kg) se doda u mešalicu. Vijak za mešanje i usitnjivač grudvica se pokrenu na dva minuta da se materijal disperguje i zatim se zaustave. U mešalicu se doda omeprazolni prašak (92.5 kg), u 8-10 porcija; posle
dodavanja svake porcije mešalica se uključi na onoliko vremena koliko je dovoljno da se ovlaži veći deo praha i zatim se isključi da bi se dodala sledeća porcija. Pošto se doda sav omeprazol, mešanje se nastavi dodatnih 10 minuta kako bi se omeprazol potpuno dispergovao; potom se uključi usitnjivač grudvica i mešanje se nastavlja dodatnih 10 minuta da bi se osigurala potpuna homogenizacija. Dobijena pasta se koristi za pakovanje u brizgalice.
Claims (11)
1. Farmaceutska formulacija za oralnu primenu, naznačena time, što uključuje. (a) 1% do 60% m/m omeprazola, (b) 0.1 % do 2% m/m od dva do četiri sredstva za bazifikaciju, (c) 1% do 3% m/m sredstva za zgušnjavanje, i (d) hidrofobni uljasti tečni nosač koji uključuje (i) biljno ulje i (ii) trigliceride masnih kiselina sa srednjom dužinom lanca - sa od 8-12 ugljenikovih atoma ili propilen-glikolne diestre masnih kiselina sa srednjom dužinom lanca - od 8-12 ugljenikovih atoma.
2. Sastav iz Zahteva 1, naznačen time, što je pomenuto sredstvo za zgušnjavanje hidrogenisano ricinusovo ulje.
3. Sastav iz Zahteva 1, naznačen time, što pomenuti hidrofobni tečni nosač uključuje propilen-glikol kaprat/kaprilat i biljno ulje
4. Sastav iz Zahteva 1, naznačen time što je pomenuti hidrofobni tečni nosač uključuje susamovo ulje i trigliceride masnih kiselina sa srednjom dužinom lanca ili propilen-glikolne diestre masnih kiselina sa srednjom dužinom lanca.
5. Sastav iz Zahteva 1, naznačen time, što pomenuti hidrofobni tečni nosač uključuje propilen-glikol kaprat/kaprilat i susamovo ulje.
6. Sastav i Zahteva 1, naznačen time; što je jedno od pomenutih sredstava za bazifikaciju kalijum-sorbat.
7. Sastav iz Zahteva 1, naznačen time, što su sredstva za bazifikaciju kalijum-sorbat, natrijum-stearat i monoetanolamin.
8. Sastav iz Zahteva 1, naznačen time, što je količina omeprazola 30 do 40% m/m
9. Sastav iz Zahteva 1, naznačen time, što je ukupna količina sredstava za bazifikaciju od 1 do 1.5% m/m.
10. Sastav iz Zahteva 1, naznačen time, što je količina hidrofobnog uljastog tečnog nosača 30% do 90% m/m.
11. Sastav iz Zahteva 1, naznačen time, što je količina hidrofobnog uljastog tečnog nosača 50% do 80% m/m.
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| PCT/US2000/004170 WO2000050038A1 (en) | 1999-02-23 | 2000-02-18 | Pharmaceutical composition containing proton pump inhibitors |
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| US6489346B1 (en) | 1996-01-04 | 2002-12-03 | The Curators Of The University Of Missouri | Substituted benzimidazole dosage forms and method of using same |
| US5840737A (en) | 1996-01-04 | 1998-11-24 | The Curators Of The University Of Missouri | Omeprazole solution and method for using same |
| US6852739B1 (en) | 1999-02-26 | 2005-02-08 | Nitromed Inc. | Methods using proton pump inhibitors and nitric oxide donors |
| MXPA02011608A (es) * | 2000-05-30 | 2003-10-06 | Merial Ltd | Metodos para la prevencion de ulceras. |
| CN100536844C (zh) | 2000-12-07 | 2009-09-09 | 尼科梅德有限责任公司 | 包含酸不稳定活性成分的糊剂形式的药物制剂 |
| DE10061135C1 (de) * | 2000-12-07 | 2002-11-07 | Byk Gulden Lomberg Chem Fab | Pharmazeutische Zubereitung in Form einer Paste enthaltend einen säurelabilen Wirkstoff |
| KR20030059318A (ko) | 2000-12-07 | 2003-07-07 | 알타나 파마 아게 | 산 불안정성 활성 성분을 포함하는 현탁액 형태의 약학 제제 |
| WO2004012659A2 (en) | 2002-08-01 | 2004-02-12 | Nitromed, Inc. | Nitrosated proton pump inhibitors, compositions and methods of use |
| GB2394895A (en) * | 2002-11-06 | 2004-05-12 | Cipla Ltd | Proton pump inhibitor composition in paste form |
| WO2005000269A1 (en) * | 2003-06-26 | 2005-01-06 | Cipla Limited | Pharmaceutical formulations comprising a proton pump inhibitor |
| US8993599B2 (en) | 2003-07-18 | 2015-03-31 | Santarus, Inc. | Pharmaceutical formulations useful for inhibiting acid secretion and methods for making and using them |
| US8906940B2 (en) | 2004-05-25 | 2014-12-09 | Santarus, Inc. | Pharmaceutical formulations useful for inhibiting acid secretion and methods for making and using them |
| WO2006026829A1 (en) * | 2004-09-09 | 2006-03-16 | Metelli Pty Ltd | Stable paste composition of enteric coated acid labile active agent and use thereof |
| CN101500553B (zh) * | 2006-07-25 | 2012-04-18 | 维克塔有限公司 | 联合使用小分子二羧酸的衍生物与ppi用于抑制胃酸分泌的组合物和方法 |
| US8309138B2 (en) | 2007-02-16 | 2012-11-13 | Aska Pharmaceutical Co., Ltd. | Pharmaceutical composition comprising microparticle oily suspension |
| ES2552723T3 (es) | 2008-05-06 | 2015-12-01 | Dexcel Pharma Technologies Ltd. | Formulación de bencimidazol estable |
| CA2768024A1 (en) | 2009-07-20 | 2011-01-27 | Vetegen, Llc | A stable pharmaceutical omeprazole formulation for oral administration |
| WO2012106058A2 (en) | 2011-01-31 | 2012-08-09 | New Market Pharmaceuticals | Animal treatments |
| US10064849B2 (en) | 2012-05-02 | 2018-09-04 | New Market Pharmaceuticals | Pharmaceutical compositions for direct systemic introduction |
| WO2013165468A1 (en) | 2012-05-02 | 2013-11-07 | New Market Pharmaceuticals | Pharmaceutical compositions for direct systemic introduction |
| ES2717029T3 (es) * | 2013-10-18 | 2019-06-18 | Norbrook Lab Ltd | Composiciones de pasta inhibidora de la bomba de protones |
| GB2524351B (en) * | 2013-10-18 | 2016-12-14 | Norbrook Lab Ltd | Proton Pump Inhibitor Paste Compositions |
| HRP20231051T1 (hr) | 2015-12-08 | 2023-12-22 | Luoda Pharma Limited | Postupci i pripravci namijenjeni liječenju želučanog vrijeda |
| WO2017145146A1 (en) | 2016-02-25 | 2017-08-31 | Dexcel Pharma Technologies Ltd. | Compositions comprising proton pump inhibitors |
| US10076494B2 (en) | 2016-06-16 | 2018-09-18 | Dexcel Pharma Technologies Ltd. | Stable orally disintegrating pharmaceutical compositions |
| CA3033065A1 (en) * | 2016-08-11 | 2018-02-15 | Adamis Pharmaceuticals Corporation | Drug compositions |
| US11564910B2 (en) | 2017-12-08 | 2023-01-31 | Adamis Pharmaceuticals Corporation | Drug compositions |
| ES2723873B1 (es) * | 2018-03-01 | 2020-05-13 | Hernan Ma Carmen Batanero | Medicamento combinado con omeprazol y vitamina B12 |
| CN112972481A (zh) * | 2021-03-18 | 2021-06-18 | 华农（肇庆）生物产业技术研究院有限公司 | 药物组合物及其制备方法和应用 |
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| US4255432A (en) | 1979-09-06 | 1981-03-10 | Syntex (U.S.A.) Inc. | 8-[2-3-Indolyl)ethyl]-1-oxa-3-,8-diazaspiro[4.5]decan-2-ones, pharmaceutical compositions thereof and methods of use thereof |
| DK130287D0 (da) | 1987-03-13 | 1987-03-13 | Benzon As Alfred | Oralt praeparat |
| SE9301489D0 (sv) | 1993-04-30 | 1993-04-30 | Ab Astra | Veterinary composition |
| US5708017A (en) * | 1995-04-04 | 1998-01-13 | Merck & Co., Inc. | Stable, ready-to-use pharmaceutical paste composition containing proton pump inhibitors |
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