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EP3731837A2 - Combinaison contenant de la linagliptine et de la metformine - Google Patents

Combinaison contenant de la linagliptine et de la metformine

Info

Publication number
EP3731837A2
EP3731837A2 EP18913688.0A EP18913688A EP3731837A2 EP 3731837 A2 EP3731837 A2 EP 3731837A2 EP 18913688 A EP18913688 A EP 18913688A EP 3731837 A2 EP3731837 A2 EP 3731837A2
Authority
EP
European Patent Office
Prior art keywords
solid oral
pharmaceutical composition
oral pharmaceutical
weight
composition according
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
EP18913688.0A
Other languages
German (de)
English (en)
Other versions
EP3731837A4 (fr
Inventor
Ali TÜRKYILMAZ
Nur PEHLIVAN AKALIN
Merve ERGUN DONMEZ
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 EP3731837A2 publication Critical patent/EP3731837A2/fr
Publication of EP3731837A4 publication Critical patent/EP3731837A4/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
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K31/13—Amines
    • A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • 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
    • A61K31/52—Purines, e.g. adenine
    • A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

Definitions

  • the present invention relates to a solid oral pharmaceutical composition
  • a solid oral pharmaceutical composition comprising linagliptin, metformin and at least one pharmaceutically acceptable excipient. Further the present invention provides a method for the preparation of said composition.
  • Diabetes mellitus is a group of disorders of carbohydrate metabolism in which the action of insulin is diminished or absent through altered secretion, decreased insulin activity or a combination of both factors.
  • Type 1 and Type 2 There are two main types of diabetes; Type 1 and Type 2:
  • Type 1 diabetes occurs because the insulin-producing cells of the pancreas (beta cells) are damaged. In Type 1 diabetes, the pancreas makes little or no insulin, so sugar cannot get into the body's cells for use as energy. People with Type 1 diabetes must use insulin injections to control their blood glucose.
  • Type 2 diabetes the pancreas makes insulin, but it either doesn't produce enough, or the insulin does not work properly. This diabetes occurs most often in people who are over 40 years old and overweight. Type 2 diabetes may sometimes be controlled with a combination of diet, weight management, and exercise. However, treatment also may include oral glucose-lowering medications or insulin injections.
  • Linagliptin is used for type 2 or non-insulin dependent diabetes. It is a selective, orally administered, xanthine based dipeptidyl peptidase-4 (DPP-4) inhibitor used as an adjunct to diet and exercise to improve glycemic control. DPP-4 inhibitors work by blocking the action of DPP-4, an enzyme which destroys the hormone incretin.
  • DPP-4 inhibitors work by blocking the action of DPP-4, an enzyme which destroys the hormone incretin.
  • DPP-4 inhibitors work by blocking the action of DPP-4, an enzyme which destroys the hormone incretin.
  • GLP-1 glucagon-like peptide-1
  • GIP glucose-dependent insulinotropic peptide
  • Linagliptin works by binding to DPP-4 and preventing it from breaking down the GLP-1 and GIP. This increases the levels of these hormones in the body and so increases their effect on controlling blood sugar.
  • linagliptin 8-[(3R)-3-aminopiperidin-1 -yl]-7-but-2-yn-1 -yl)-3- methyl-1 -[(4-methylquinazolin-2-yl)methyl]-3,7-dihydro-1 H-purine-2,6-dione and its chemical structure is shown in the Formula I.
  • Metformin is antidiabetics having an orally-administrated biguanide structure.
  • Metformin hydrochloride is a white to off-white crystalline compound and it is freely soluble in water and practically insoluble in acetone, ether and chloroform.
  • Oral doses of metformin are generally recommended in the range of 500 to 2500 mg a day and a single dose may vary from 500 to 850 mg. It is used singly or in combination with sulfonylureas, alpha- glucosidase inhibitors, or insulin.
  • metformin hydrochloride is 1 ,1 -dimethylbiguanide hydrochloride, has the following chemical structure of Formula II.
  • US patent publication 201 1206766 discloses pharmaceutical composition comprising linagliptin and metformin HCI and one or more pharmaceutical excipients, and a nucleophilic and/or basic agents for stabilizing said linagliptin against degradation. Furthermore, the patent discloses use of a basic amino acid L-arginine, which may be suitable for stabilizing.
  • the present invention is aimed to obtain a stable combination formulation with synergistic effect for use in the treatment of type-2 diabetes so, this invention provides more effective treatment and at the same time, provide therapeutic effect in a shorter time.
  • the present invention is aimed to ensure good content uniformity without the addition of significant side effect.
  • Another object of the present invention is to eliminate problems and bringing additional advantages to the relevant prior art.
  • Another object of this present invention is to provide stable dosage form with desired dissolution profiles.
  • the term“combination” means that when drugs are administered together, a combined action is obtained which is higher than the individual actions of the respective drugs when they are used separately.
  • using a lower dose of each drug to be combined according to the present invention will reduce the total dosage.
  • linagliptin refers to not only linagliptin, but also its other pharmaceutically acceptable salt, pharmaceutically acceptable solvates, pharmaceutically acceptable hydrates, pharmaceutically acceptable enantiomers, pharmaceutically acceptable derivatives, pharmaceutically acceptable polymorphs or pharmaceutically acceptable prodrugs thereof.
  • the linagliptin is present as amorphous linagliptin, crystalline linagliptin having polymorphic form A, crystalline linagliptin having polymorphic form B and crystalline linagliptin having polymorphic form C or mixtures of thereof.
  • metalformin refers to not only metformin, but also its other pharmaceutically acceptable salt, pharmaceutically acceptable solvates, pharmaceutically acceptable hydrates, pharmaceutically acceptable enantiomers, pharmaceutically acceptable derivatives, pharmaceutically acceptable polymorphs or pharmaceutically acceptable prodrugs thereof.
  • combining more than one molecule in one dosage form increases the patient’s compliance.
  • this combination is increasing the patients’ quality of life, combining more than one molecule in one dosage form also reduces side effects.
  • the solid oral pharmaceutical composition comprises linagliptin and metformin.
  • a crystalline linagliptin having polymorphic form A and/or crystalline linagliptin having polymorphic form B is used form of linagliptin.
  • the amount of linagliptin in the total composition is between 0.05% and 10.0%, preferably 0.05% and 5.0% or 5.0% and 8.0% or 8.0% and 10.0% by weight.
  • a pharmaceutically acceptable polymorphs of metformin is used and the amount of metformin in the total composition is between 70.0% and 90.0%, preferably 70.0% and 75.0% or 75.0% and 81 .0% or 81 .0% and 90.0% by weight.
  • the pharmaceutically acceptable excipients are selected from disintegrants, binders, fillers, lubricants, coating agents or mixtures thereof.
  • the advantages of the present invention are even more significant, as the problem of homogeneity is even more likely to occur when two active substances are incorporated in one final dosage form, especially when two actives is used very different regarding the amount. Improved content uniformity efficiently contributes to a marked increase in bioavailability. Improved content uniformity also favors to avoid toxicity in the otherwise possible event that the amount of drug substance would be too high.
  • Linagliptin is used small proportion that can lead to considerable problems during the manufacture of the composition with regard to the uniformity of the content of active agent in the individual composition units. Because of problems uniformity of the content, the active substance may interact with several excipients. It reflects that content uniformity play important role in the dissolution of the drug. Using the right disintegrant is ensured uniformity of the content.
  • Suitable disintegrants are selected from the group comprising sodium starch glycolate, low-substituted hydroxypropyl cellulose, cross-linked polyvinyl pyrrolidone, cross-linked sodium carboxymethylcellulose, alginates, gums, cross-linked calcium carboxymethylcellulose, sodium carboxymethylcellulose, ion-exchange resins or mixtures thereof.
  • the amount of disintegrant in the total composition is between 0.5% and 10.0% by weight, preferably 2.0% and 8.0% by weight, more preferably 3.0% and 6.0% by weight.
  • linagliptin are not very stable compounds.
  • amine group containing linagliptin may react with many excipients or impurities of excipients.
  • disintegrant especially sodium starch glycolate
  • the disintegrant is sodium starch glycolate, is also known as superdisintegrant, and the amount of sodium starch glycolate in the composition is between 2.0% and 8.0% by weight, preferably 3.0% and 6.0% by weight.
  • Suitable binders are selected from group comprising povidone, hydroxylpropyl cellulose, hydroxypropyl methyl cellulose, methyl cellulose, carboxymethyl cellulose, polyethylene glycol, polyvinyl alcohol, polyvinyl acetate, polyvinylpyrrolidone, sugars, glucose syrups, natural gums, guar gum, tragacanth gum, pregelatinized starch, gelatins, pullulan, agar, alginate, sodium alginates, glycyrrhizin, polymetacrylates, collagen, hyaluronic acid, pectin, carrageenan, carbomer, poloxamer, polyacrylamide, aluminum hydroxide, benthonite, laponite, cetostearyl
  • the amount of binder in the total composition is between 0.1% and 10.0% by weight.
  • the binder is povidone.
  • povidone and sodium starch glycolate provides desired short disintegration time in composition.
  • the weight ratio of povidone of sodium starch glycolate is between 1 :5 and 5:1 , preferably between 1 :4 and 4:1.
  • Suitable fillers are selected from group comprising microcrystalline cellulose, lactose monohydrate, starch, mannitol, dibasic calcium phosphate, tribasic calcium phosphate, trehalose, isomalt, sodium carbonate, sodium bicarbonate, calcium carbonate or mixtures thereof.
  • Suitable lubricants are selected from group comprising sodium stearyl fumarate, magnesium stearate, polyethylene glycol, sodium lauryl sulphate, magnesium lauryl sulphate, fumaric acid, glyceryl palmitostearate, hydrogenated natural oils, zinc stearate, calcium stearate, silica, talc, stearic acid, polyethylene glycol, paraffin or mixtures thereof.
  • Suitable coating agents are selected from the group comprising polymethacrylates, hydroxypropyl methylcellulose, triacetin, glycerol triacetin, talc, lactose monohydrate, hydroxypropyl cellulose, polyvinyl alcohol (PVA), polyethylene glycol (PEG), polyvinyl alcohol-polyethylene glycol copolymers (Kollicoat® IR), ethylcellulose dispersions (Surelease®), polyvinylprolidone, polyvinylprolidone-vinyl acetate copolymer (PVP-VA), all kinds of Opadry®, pigments, dyes, titanium dioxide, macrogol, coloring agent or mixtures thereof.
  • PVA polyvinyl alcohol
  • PEG polyethylene glycol
  • Kollicoat® IR polyvinyl alcohol-polyethylene glycol copolymers
  • Surelease® ethylcellulose dispersions
  • PVP-VA polyvinylprolidone
  • PVP-VA polyvinylprolidone
  • Suitable coloring agents are selected from the group comprising ferric oxide, titanium dioxide, Food, Drug & Cosmetic (FD&C) dyes (such as; FD&C blue, FD&C green, FD&C red, FD&C yellow, FD&C lakes), ponceau, indigo Drug & Cosmetic (D&C) blue, indigotine FD&C blue, carmoisine indigotine (indigo Carmine); iron oxides (such as; iron oxide red, yellow, black), quinoline yellow, flaming red, carmine, carmoisine, sunset yellow or mixtures thereof.
  • FD&C Food, Drug & Cosmetic
  • the formulation is free of basic amino acid.
  • solid oral pharmaceutical composition is in the form of tablet, capsule, pastilles, strip.
  • the solid oral pharmaceutical composition is tablet form.
  • the solid oral pharmaceutical combination is formulated as tablets comprising compressed tablets, coated or uncoated tablets, inlay tablet, multilayer tablets, inlay tablet, mini tablets, bilayer tablet, buccal tablets, sublingual tablets, effervescent tablets, immediate release tablets, modified release tablets, film- coated tablets, orally disintegrating tablets, gastric disintegrating tablets, chewable tablet, dispersing tablet, lozenges.
  • the solid oral pharmaceutical combination is formulated as film coated tablet or bilayer tablet.
  • the solid oral pharmaceutical combination is tablet form.
  • Tablet comprises of at least one type of particle, for example; mini-tablet, pellets, core, agglomerates, granules, powder, liposomes, sphericles or mixtures thereof.
  • each type of particle comprises at least one active agent.
  • the solid oral pharmaceutical combination is tablet-in-tablet or core-in-tablet.
  • the solid oral pharmaceutical combination is capsule form.
  • Capsule comprises of at least one type of particle, for example; capsule, mini-tablet, pellets, agglomerates, granules, powder, liposomes, sphericles or mixtures thereof.
  • the combination is mini-capsule in capsule wherein the mini capsule comprises at least one active agent.
  • Mini-capsule is located within a capsule.
  • the combination is mini-tablets in capsule wherein a mini-tablet comprises at least one active agent.
  • Mini-tablets is located within a capsule.
  • the combination is pellet in capsule wherein pellet comprises at least one active agent.
  • Pellets are located within a capsule.
  • the combination is granule in capsule wherein granule comprises at least one active agent.
  • Granules are located within a capsule.
  • the composition comprises; a) 0.05 - 10.0% by weight of linagliptin
  • compositions of invention can be developed into solid oral dosage form comprising immediate release, extended release, sustained release, controlled release, modified release and delayed release or combination thereof.
  • Process for preparing the solid oral pharmaceutical composition comprises the following steps; a) Mixing linagliptin, metformin, microcrystalline cellulose and sodium starch glycolate b) Granulating povidone with water-ethanol mixture (70% ethanol) on a separate tank c) Mixing step (a) mixture and step (b) mixture
  • Example 1 Film coated tablet comprising linagliptin and metformin
  • Example 2 Film coated tablet comprising linagliptin and metformin
  • Example 3 Film coated tablet comprising linagliptin and metformin
  • a process for preparing the solid oral pharmaceutical composition in example 2 and example 3 comprises the following steps: a) Mixing linagliptin, metformin, microcrystalline cellulose and sodium starch glycolate b) Granulating povidone with water-ethanol mixture (70% ethanol) on a separate tank c) Mixing step (a) mixture and step (b) mixture

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Diabetes (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne une composition pharmaceutique orale solide comprenant de la linagliptine, de la metformine et au moins un excipient pharmaceutiquement acceptable. La présente invention concerne également un procédé de préparation de ladite composition.
EP18913688.0A 2017-12-25 2018-12-21 Combinaison contenant de la linagliptine et de la metformine Pending EP3731837A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2017/21505A TR201721505A2 (tr) 2017-12-25 2017-12-25 Li̇nagli̇pti̇n ve metformi̇n i̇çeren kombi̇nasyon
PCT/TR2018/050857 WO2019194773A2 (fr) 2017-12-25 2018-12-21 Combinaison contenant de la linagliptine et de la metformine

Publications (2)

Publication Number Publication Date
EP3731837A2 true EP3731837A2 (fr) 2020-11-04
EP3731837A4 EP3731837A4 (fr) 2021-06-30

Family

ID=67900634

Family Applications (1)

Application Number Title Priority Date Filing Date
EP18913688.0A Pending EP3731837A4 (fr) 2017-12-25 2018-12-21 Combinaison contenant de la linagliptine et de la metformine

Country Status (3)

Country Link
EP (1) EP3731837A4 (fr)
TR (1) TR201721505A2 (fr)
WO (1) WO2019194773A2 (fr)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP7689825B2 (ja) * 2020-12-18 2025-06-09 日本ジェネリック株式会社 熱安定性に優れたリナグリプチン含有医薬組成物
WO2022173406A1 (fr) * 2021-02-15 2022-08-18 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Procédé pour formulations de linagliptine ou d'un sel pharmaceutiquement acceptable de celle-ci
JP2022171507A (ja) * 2021-04-30 2022-11-11 日本ジェネリック株式会社 安定性に優れたリナグリプチン含有製剤
CN117858703A (zh) * 2021-07-22 2024-04-09 新梅斯托克公司 用于制备包含利格列汀和盐酸二甲双胍的药物组合物的方法
WO2023075826A1 (fr) * 2021-10-28 2023-05-04 The Texas A&M University System Compositions de metformine stable et de produits médicamenteux similaires à contrôle d'impuretés nitroso
WO2023163510A1 (fr) * 2022-02-23 2023-08-31 주식회사 제뉴원사이언스 Formulation d'un complexe pharmaceutique à libération contrôlée de médicament comprenant de la linagliptine ou un sel de qualité pharmaceutique de celle-ci et de la metformine ou un sel de qualité pharmaceutique de celle-ci

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2011295837B2 (en) 2010-09-03 2015-06-18 Astrazeneca Uk Limited Drug formulations using water soluble antioxidants
WO2014080383A1 (fr) * 2012-11-26 2014-05-30 Ranbaxy Laboratories Limited Composition pharmaceutique d'inhibiteurs de la dipeptidyl-peptidase-iv (dpp-iv) en association avec d'autres antidiabétiques
EP2848242A1 (fr) * 2013-09-12 2015-03-18 Sanovel Ilac Sanayi ve Ticaret A.S. Formulations orodispersibles de Linagliptin
WO2015107536A2 (fr) * 2013-12-09 2015-07-23 Intas Pharmaceuticals Limited Combinaison de doses fixes contenant de la linagliptine et de la metformine hcl
WO2015110962A1 (fr) * 2014-01-21 2015-07-30 Wockhardt Limited Compositions pharmaceutiques orales solides comprenant une combinaison de doses fixes de metformine et de linagliptine ou de leurs sels

Also Published As

Publication number Publication date
WO2019194773A2 (fr) 2019-10-10
WO2019194773A3 (fr) 2019-12-12
TR201721505A2 (tr) 2019-07-22
EP3731837A4 (fr) 2021-06-30

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