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EP3551171A1 - Compositions pharmaceutiques orales solides de ticagrelor - Google Patents

Compositions pharmaceutiques orales solides de ticagrelor

Info

Publication number
EP3551171A1
EP3551171A1 EP17821819.4A EP17821819A EP3551171A1 EP 3551171 A1 EP3551171 A1 EP 3551171A1 EP 17821819 A EP17821819 A EP 17821819A EP 3551171 A1 EP3551171 A1 EP 3551171A1
Authority
EP
European Patent Office
Prior art keywords
tablet
solid oral
oral pharmaceutical
pharmaceutical composition
weight
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP17821819.4A
Other languages
German (de)
English (en)
Inventor
Ali TÜRKYILMAZ
Ediz Yildirim
Irem KARABULUT
Ibrahim ATMACA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sanovel Ilac Sanayi ve Ticaret AS
Original Assignee
Sanovel Ilac Sanayi ve Ticaret AS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sanovel Ilac Sanayi ve Ticaret AS filed Critical Sanovel Ilac Sanayi ve Ticaret AS
Publication of EP3551171A1 publication Critical patent/EP3551171A1/fr
Pending legal-status Critical Current

Links

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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates

Definitions

  • the present invention relates to a solid oral pharmaceutical composition, comprising ticagrelor or a pharmaceutically acceptable salt thereof with at least one hydrophilic polymer.
  • Ticagrelor (trade name BRILINTA®) is a platelet aggregation inhibitor produced by AstraZeneca.
  • An antiplatelet drug is a member of a class of pharmaceuticals that decrease platelet aggregation and inhibit thrombus formation. They are effective in the arterial circulation, where anticoagulants have little effect. They are widely used in primary and secondary prevention of thrombotic cerebrovascular or cardiovascular disease.
  • Antiplatelet drug decreases the ability of blood clot to form by interfering with platelet activation process in primary haemostasis.
  • Antiplatelet drugs can reversibly or irreversibly inhibit the process involved in platelet activation resulting in decreased tendency of platelets to adhere to one another and to damaged blood vessels endothelium.
  • Ticagrelor is a cyclo-pentyltriazolo-pyrimidine that reversibly inhibits the P2Y 12 receptor which is a protein found mainly but not exclusively on the surface of blood platelets and which is an important regulator in blood clotting.
  • ticagrelor is (1 S,2S,3R,5S)-3-[7-[(1 R,2S)-2-(3,4-Difluorophenyl) cyclopropylamino]-5-(propylthio)-3H-[1 ,2,3]triazolo[4,5-d]pyrimidin-3-yl] -5-(2- hydroxyethoxy) cyclopentane-1 ,2-diol and its chemical structure is shown in the Formula 1 .
  • Ticagrelor Ticagrelor (BRILINTA ) is indicated to reduce the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction (Ml). For at least the first 12 months following ACS, it is superior to clopidogrel. It also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS.
  • the patent application no. EP2056832A1 discloses an oral pharmaceutical composition comprising ticagrelor and other excipients.
  • the composition is presented as enhancing the bioavailability through increasing the release of the active agent due to the formulation comprising at least two fillers and one single binder.
  • one of these fillers is dibasic calcium phosphate dehydrate which is commonly known by its abrasive properties. Considering these undesirable properties, the use of dibasic calcium phosphate dehydrate as a tablet excipient shall increase the required amount of lubricants (Handbook of Pharmaceutical Excipients, sixth edition, page 97).
  • the ratio of the lubricant given in the application which is preferably magnesium stearate, is in the range of 0.5-1 % by weight. This low ratio is likely to cause stability problems in the presence of dibasic calcium phosphate dehydrate.
  • the increase of the magnesium stearate amount shall reduce the dissolution rate and the promised enhanced bioavailability accordingly (Handbook of Pharmaceutical Excipients, sixth edition, page 405).
  • WO201 1076749A2 discloses a solid pharmaceutical composition of ticagrelor and asserts that ticagrelor particles having a particle size in the range of 1 pm to 150 pm exhibit beneficial effects in particular regarding an improved dissolution rate. However, it is stated that these effects are observable only if the ratio of ticagrelor is more that 50% by weight in the composition.
  • the composition also comprises at least one hydrophilic polymer and an anti-thrombotic agent, in particular acetylsalicylic acid.
  • a pharmaceutical composition of ticagrelor is suggested to solve the problems regarding stability and dissolution which occur in case of the use of the amorphous form of ticagrelor.
  • Ticagrelor has a low aqueous solubility (10 ⁇ g/mL in water) and this situation brings bioavailability and stability problems regarding decreases in the dissolubility of the tablet formulations.
  • ticagrelor has a low aqueous solubility (10 ⁇ g/mL in water) and this situation brings bioavailability and stability problems regarding decreases in the dissolubility of the tablet formulations.
  • different forms of ticagrelor and different excipients are used to compose innovative formulations and to overcome some of these problems.
  • the challenge is to formulate a composition, some qualities of which won't reduce, while the others are improved.
  • a pharmaceutical composition comprising ticagrelor providing enhanced dissolution profile, stability and bioavailability at the same time.
  • the main object of the present invention is to obtain ticagrelor formulations eliminating all aforesaid problems and bringing additional advantages to the relevant prior art.
  • Another object of the present invention is to obtain ticagrelor formulations with high stability and bioavailability.
  • a further object of the present invention is to develop solid oral formulations of ticagrelor having an improved level of dissolution rate, solubility and permeability.
  • a further object of the present invention is to develop solid oral formulations of ticagrelor ensuring the bioequivalence.
  • another object of the present invention is to obtain a solid oral pharmaceutical composition which is substantially free of calcium salts and their derivatives. According to these objects, another object of the present invention is to obtain a solid oral pharmaceutical composition comprising ticagrelor and at least two binders.
  • Another object of the present invention is to provide a ticagrelor tablet comprising at least one film coating to protect the pharmaceutical composition against the moisture to maintain the stability.
  • a further object of the present invention is to improve a process for preparing the said ticagrelor tablet, comprising wet granulation method which is performed by granulating the active agent in the hydrophilic polymers and which increases the solubility thereby provides the bioequivalence.
  • the present invention relates to solid oral pharmaceutical compositions comprising ticagrelor or a pharmaceutically acceptable salt thereof as the active agent, wherein the composition is substantially free of calcium salts and their derivatives.
  • the composition is further free of starch and its derivatives.
  • the active agent is ticagrelor.
  • the amount of ticagrelor is between 5-60% by weight of the total composition. Preferably this amount is between 10-50% by weight of the total composition. More preferably ticagrelor is present between 20-40% by weight in the total composition.
  • ticagrelor is present in an amount of between 1 to 300 mg, preferably 10 to 240 mg and more preferably it is 20 to 120 mg.
  • the composition is in the form of coated tablet, trilayer tablet, bilayer tablet, multilayer tablet, orally disintegrating tablet, mini tablet, pellet, sugar pellet, buccal tablet, sublingual tablet, effervescent tablet, immediate release tablet, modified release tablet, film-coated tablet, gastric disintegrating tablet, pill, capsule, oral granule, powder, coated bead system, microsphere, tablet in tablet, inlay tablet, dragee, sachet, orally administrable film.
  • composition is preferably in the form of a film-coated tablet.
  • the composition further comprises at least one hydrophilic polymer.
  • the composition comprises at least one pharmaceutically acceptable excipient selected from binders, fillers, disintegrants, lubricants, glidants or mixtures thereof.
  • the solid oral pharmaceutical composition comprises at least two binders which are selected from the group comprising copovidone, copolyvidone, polyvinylpyrrolidone (PVP), povidone K30, carnauba wax, hydroxypropyl methyl cellulose (hypromellose, HPMC), pullulan, polymethacrylate, glyceryl behenate, hydroxypropyl cellulose (HPC), carboxymethyl cellulose (CMC), methyl cellulose (MC), hydroxyethyl cellulose, sodium carboxymethyl cellulose (Na CMC), ethyl cellulose, microcrystalline cellulose, polymetacrylates, polyethylene oxide, polyvinyl alcohol, polycarbophil, polyvinyl acetate and its copolymers, gelatin, xanthan gum, guar gum, alginate,
  • the solid oral pharmaceutical composition comprises two binders which are microcrystalline cellulose and hydroxypropyl methylcellulose.
  • the amount of microcrystalline cellulose is between 5-50%, preferably 10-40%, more preferably 20-30% by weight of the total composition.
  • the amount of hydroxypropyl methylcellulose is between 1 -20%, preferably 2-10% by weight of the total composition. Hydroxypropyl methylcellulose also takes part as a dissolution enhancer and it is selectively used as a binder for this purpose.
  • the ratio of ticagrelor to the total weight of binder is in the range of 2:1 to 0.5:1 and preferably 1 .5:1 to 0.7:1 and more preferably 1 .2:1 to 0.9:1 .
  • the ratio of microcrystalline cellulose to the hydroxypropyl methylcellulose is in the range of 10:1 to 2:1 and preferably 8:1 to 4:1 and more preferably 7:1 to 5:1 .
  • the solid oral pharmaceutical composition comprises at least one filler which is selected from the group comprising lactose monohydrate, lactose, mannitol, spray-dried mannitol, dextrose, sucrose, fructose, maltose, sorbitol, xylitol, inositol, kaolin, inorganic salts, polysaccharides, sodium chloride, dextrates, lactitol, maltodextrin, sucrose-maltodextrin mixture, trehalose, sodium carbonate, sodium bicarbonate or mixtures thereof.
  • a filler which is selected from the group comprising lactose monohydrate, lactose, mannitol, spray-dried mannitol, dextrose, sucrose, fructose, maltose, sorbitol, xylitol, inositol, kaolin, inorganic salts, polysaccharides, sodium chloride, d
  • the solid oral pharmaceutical composition comprises one filler which is mannitol.
  • the amount of mannitol is between 10-60%, preferably 15-50% and more preferably 30-40% by weight of the total composition.
  • the solid oral pharmaceutical composition comprises at least one disintegrant which is selected from the group comprising croscarmellose sodium, sodium carbonate, hydroxylpropyl cellulose (HPC), cross-linked polyvinylpyrrolidone (crospovidon), copovidon, polycarbophil, low-substitue poloxamer, sodium starch glycolate, alginic acid and alginates, ion-exchange resins, magnesium aluminum silica, sodium dodecyl sulphate, sodium carboxy methyl cellulose, docusate sodium, guar gum, polyacrylin potasium, sodium alginate, sodium glysin carbonate, sodium lauryl sulphate or mixtures thereof.
  • the solid oral pharmaceutical composition comprises one disintegrant which is croscarmellose sodium.
  • the amount of croscarmellose sodium is between 0.5-15%, preferably 3-10% by weight of the total composition.
  • the ratio of croscarmellose sodium to ticagrelor is in the range of 1 :2 to 1 :10 and preferably 1 :4 to 1 :8 and more preferably 1 :5 to 1 :6.
  • the ratio of croscarmellose sodium to the total weight of binder is in the range of 1 :2 to 1 :10 and preferably 1 :4 to 1 :8 and more preferably 1 :5 to 1 :6.
  • the solid oral pharmaceutical composition comprises at least one lubricant and at least one glidant which are selected from the group comprising sodium lauryl sulphate, sodium stearyl fumarate, colloidal silicon dioxide, magnesium stearate, zinc stearate, mineral oil, talc, polyethylene glycol, glyceryl monostearate, glyceryl palmitostearate, magnesium lauryl sulphate, fumaric acid, zinc stearate, stearic acid, hydrogenated natural oils, silica, paraffin or mixtures thereof.
  • lubricant sodium stearyl fumarate, colloidal silicon dioxide, magnesium stearate, zinc stearate, mineral oil, talc, polyethylene glycol, glyceryl monostearate, glyceryl palmitostearate, magnesium lauryl sulphate, fumaric acid, zinc stearate, stearic acid, hydrogenated natural oils, silica, paraffin or mixtures thereof.
  • the solid oral pharmaceutical composition comprises one lubricant which is sodium stearyl fumarate.
  • the amount of sodium stearyl fumarate is between 0.1 -5%, preferably 1 -3% by weight of the total composition.
  • the solid oral pharmaceutical composition comprises one glidant which is colloidal silicon dioxide.
  • the solid oral pharmaceutical composition comprises at least one coating layer to protect the composition against the moisture and maintain the stability.
  • Suitable coating ingredients are selected from the group comprising hydroxypropyl methylcellulose (hypromellose), hydroxypropyl cellulose, polyvinyl alcohol (PVA), polyethylene glycol (PEG), talc, polyvinyl alcohol-polyethylene glycol copolymers (Kollicoat IR), ethylcellulose dispersions (Surelease), polyvinylprolidone, polyvinylprolidone-vinyl acetate copolymer (PVP-VA) and all kinds of OpadryTM, pigments, dyes, titanium dioxide, iron oxide or polymethylmetacrylate copolymers (Eudragit) and mixtures thereof.
  • coating layer is Opadry Yellow which comprises hydroxypropyl methylcellulose, titanium dioxide, iron oxide yellow and polyethylene glycol.
  • the solid oral pharmaceutical composition comprises ticagrelor as active agent, microcrystalline cellulose and hydroxypropyl methylcellulose as binders, mannitol as filler, croscarmellose sodium as disintegrant, sodium stearyl fumarate as lubricant, colloidal silicon dioxide as glidant and a coating layer.
  • the composition comprises;
  • microcrystalline cellulose 5-50% by weight of microcrystalline cellulose
  • Example 1 Film-coated tablet formulation
  • Example 2 Film-coated tablet formulation
  • Polyethylene glycol powder (PEG 400) 6.25 The preparation method of the above mentioned pharmaceutical formulations essentially comprises 4 main stages. During the first stage, basic granule structure which can also be called as internal phase is formed by wet granulation. These basic granules comprise the active ingredient and some of the excipients. In the second stage, these granules are processed with lubricant and glidant to form an external phase on them and ameliorate the final tablet product properties such as stability, wettability and disintegration. Third stage includes compressing these granules into tablets. In the fourth stage, a coating layer is performed on these tablets against the moisture to maintain the stability.
  • first stage basic granule structure which can also be called as internal phase is formed by wet granulation. These basic granules comprise the active ingredient and some of the excipients. In the second stage, these granules are processed with lubricant and glidant to form an external phase on them and ameliorate the final tablet product properties such as stability,

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La présente invention concerne une composition pharmaceutique orale solide, comprenant du ticagrelor ou un sel pharmaceutiquement acceptable de celui-ci avec au moins un polymère hydrophile.
EP17821819.4A 2016-12-07 2017-12-06 Compositions pharmaceutiques orales solides de ticagrelor Pending EP3551171A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2016/17983A TR201617983A2 (tr) 2016-12-07 2016-12-07 Ti̇cagrelorun kati oral farmasöti̇k bi̇leşi̇mleri̇
PCT/EP2017/081626 WO2018104363A1 (fr) 2016-12-07 2017-12-06 Compositions pharmaceutiques orales solides de ticagrelor

Publications (1)

Publication Number Publication Date
EP3551171A1 true EP3551171A1 (fr) 2019-10-16

Family

ID=60582496

Family Applications (2)

Application Number Title Priority Date Filing Date
EP17821819.4A Pending EP3551171A1 (fr) 2016-12-07 2017-12-06 Compositions pharmaceutiques orales solides de ticagrelor
EP17205587.3A Withdrawn EP3332769A1 (fr) 2016-12-07 2017-12-06 Compositions pharmaceutiques orales solides de ticagrelor

Family Applications After (1)

Application Number Title Priority Date Filing Date
EP17205587.3A Withdrawn EP3332769A1 (fr) 2016-12-07 2017-12-06 Compositions pharmaceutiques orales solides de ticagrelor

Country Status (4)

Country Link
EP (2) EP3551171A1 (fr)
EA (1) EA201991287A1 (fr)
TR (1) TR201617983A2 (fr)
WO (1) WO2018104363A1 (fr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020021110A1 (fr) 2018-07-27 2020-01-30 Krka, D.D., Novo Mesto Composition pharmaceutique de ticagrélor
WO2021080529A1 (fr) * 2019-10-26 2021-04-29 Santa Farma İlaç Sanayi̇ A.Ş. Formulations pharmaceutiques solides comprenant du ticagrelor
EP4058025A4 (fr) * 2019-11-13 2023-08-02 Santa Farma Ilaç Sanayi A.S. Compositions pharmaceutiques comprenant du ticagrelor
WO2023057879A1 (fr) * 2021-10-04 2023-04-13 Neurim Pharmaceuticals (1991) Ltd. Procédés et produits pour traiter des sujets atteints de troubles du spectre autistique
CN117503707B (zh) * 2022-08-05 2024-08-23 哈尔滨市康隆药业有限责任公司 一种掩味微球及其制备工艺和应用

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI482772B (zh) 2006-08-21 2015-05-01 Astrazeneca Ab 適合口服且包含三唑并[4,5-d]嘧啶衍生物之組合物
ES2550033T3 (es) 2009-12-23 2015-11-04 Ratiopharm Gmbh Forma de dosificación farmacéutica sólida de ticagrelor
CZ2012705A3 (cs) * 2012-10-16 2014-04-23 Zentiva, K.S. Pevná orální farmaceutická formulace obsahující ticagrelor
WO2015001489A1 (fr) 2013-07-01 2015-01-08 Ranbaxy Laboratories Limited Compositions pharmaceutiques de ticagrélor
WO2015110952A1 (fr) * 2014-01-21 2015-07-30 Wockhardt Limited Compositions pharmaceutiques orales solides comprenant du ticagrelor ou un sel de ce dernier

Also Published As

Publication number Publication date
EP3332769A1 (fr) 2018-06-13
WO2018104363A1 (fr) 2018-06-14
TR201617983A2 (tr) 2018-06-21
EA201991287A1 (ru) 2019-10-31

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