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WO2025079089A1 - Composition pharmaceutique de cabozantinib - Google Patents

Composition pharmaceutique de cabozantinib Download PDF

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Publication number
WO2025079089A1
WO2025079089A1 PCT/IN2024/052025 IN2024052025W WO2025079089A1 WO 2025079089 A1 WO2025079089 A1 WO 2025079089A1 IN 2024052025 W IN2024052025 W IN 2024052025W WO 2025079089 A1 WO2025079089 A1 WO 2025079089A1
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutical composition
cabozantinib
amount
present
pharmaceutically acceptable
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
PCT/IN2024/052025
Other languages
English (en)
Inventor
Ravi Kumar Nithiyanandam
Bala Krishnaiah MEDUM
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.)
MSN Laboratories Pvt Ltd
Original Assignee
MSN Laboratories Pvt Ltd
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 MSN Laboratories Pvt Ltd filed Critical MSN Laboratories Pvt Ltd
Publication of WO2025079089A1 publication Critical patent/WO2025079089A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A61K31/435—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
    • A61K31/47—Quinolines; Isoquinolines
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C57/00—Unsaturated compounds having carboxyl groups bound to acyclic carbon atoms
    • C07C57/02—Unsaturated compounds having carboxyl groups bound to acyclic carbon atoms with only carbon-to-carbon double bonds as unsaturation
    • C07C57/13—Dicarboxylic acids
    • C07C57/15—Fumaric acid
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D215/00—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems
    • C07D215/02—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom
    • C07D215/16—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
    • C07D215/20—Oxygen atoms
    • C07D215/22—Oxygen atoms attached in position 2 or 4

Definitions

  • RCCs More than 50% of RCCs are currently detected incidentally. However, some patients with RCC still present with clinical symptoms, such as flank pain, gross haematuria and palpable abdominal mass; metastatic symptoms like bone pain or lung nodules; or paraneoplastic syndromes, such as hypercalcaemia, unexplained fever, erythrocytosis or wasting syndromes. About 30% of patients with RCC have metastatic disease at the time of diagnosis, and a significant proportion of patients with localized disease.
  • RTKs hepatocyte growth factor receptor protein
  • VEGF vascular endothelial growth factor
  • Cabozantinib (S)-malate is chemically described as N-(4-(6,7-dimethoxyquinolin-4-yloxy) phenyl)-N'-(4-fluorophenyl) cyclopropane- 1,1- dicarboxamide, (2S)-hydroxybutanedioate.
  • the molecular formula is C28H24FN3O5 and the molecular weight is 635.6 Daltons as malate salt.
  • Cabozantinib (S)-malate salt is a white to off-white sold that is practically insoluble in water.
  • Liquid dosage forms would allow for such individualized and easy to swallow delivery to patients — however, the chemical and physical stability may cause limitations, and taste considerations may make it difficult to supply drugs in dissolved or dispersed form in liquid formulations.
  • First aspect of first embodiment of the present invention provides stable pharmaceutical compositions comprising cabozantinib, which comprises cabozantinib fumarate (2:1) and at least one pharmaceutically acceptable carrier.
  • Second aspect of first embodiment of the present invention provides stable pharmaceutical compositions comprising cabozantinib, which comprises cabozantinib fumarate (1 :1) and at least one pharmaceutically acceptable carrier.
  • Third aspect of first embodiment of the present invention provides stable pharmaceutical compositions comprising cabozantinib, which comprises cabozantinib (s)- malate (1: 1) and at least one pharmaceutically acceptable carrier.
  • Second embodiment of the present invention is to provide stable pharmaceutical compositions wherein the pharmaceutical composition comprising cabozantinib exhibits less intrapatient or interpatient variability in at least one pharmacokinetic parameter (i.e., Cmax, ti/2 and AUC) compared to the commercially available product when administered orally to human subjects.
  • First aspect of second embodiment of the present invention is to provide stable pharmaceutical composition wherein the pharmaceutical composition comprising solid oral dosage form or oral liquid dosage form or liquid or lyophilized injectable dosage form.
  • Third aspect of third embodiment of the present invention provides stable solid oral pharmaceutical composition wherein pharmaceutical compositions may preferably be obtained by direct compression, wet granulation or dry granulation.
  • First aspect of fourth embodiment of the present invention provide stable solid oral pharmaceutical composition comprising lower strengths of cabozantinib and one or more pharmaceutically acceptable excipients wherein the lower strength of cabozantinib is present in range of from about 2.5 mg to 15 mg (i.e.; 2.5mg, 5mg, lOmg, or 15mg) equivalent of cabozantinib free base.
  • Second aspect of fourth embodiment of the present invention provide stable solid oral pharmaceutical composition comprising higher strengths of cabozantinib and one or more pharmaceutically acceptable excipients wherein the higher strength of cabozantinib is present in the range of from about 80 mg to 200 mg (i.e.; 80mg, lOOmg, 120mg, 140mg, 160mg, 180mg or 200mg) equivalent cabozantinib free base.
  • Sixth embodiment of the present invention provides stable pharmaceutical composition
  • cabozantinib from about 20% w/w to about 40% w/w filler/diluent from about 40 %w/w to about 80%w/w binder from about 1% w/w to about 5% w/w disintegrant from about 1 %w/w to about 15%w/w lubricants from about 0.1 %w/w to about 5%w/w
  • Seventh embodiment of the present invention relates to a process for the preparation of stable solid dosage form comprising cabozantinib and one or more pharmaceutically acceptable excipients.
  • Eighth embodiment of the present invention provides stable ready-to-use or ready to dilute oral liquid dosage form comprising cabozantinib and one or more pharmaceutically acceptable excipients.
  • Ninth embodiment of the present invention provides stable ready-to-use or ready to dilute oral liquid dosage form comprising cabozantinib and one or more pharmaceutically acceptable excipients wherein said excipients are those which improve the stability of the said pharmaceutical composition.
  • First aspect of ninth embodiment of the present invention provides stable ready-to-use or ready to dilute oral liquid dosage form comprising cabozantinib, wherein, said stability improving excipients are one or more selected from a solubilizing agent, buffering agent, chelating agent, anti-oxidant, preservative, and pH adjusting agents and any other pharmaceutical excipients for improving stability.
  • said stability improving excipients are one or more selected from a solubilizing agent, buffering agent, chelating agent, anti-oxidant, preservative, and pH adjusting agents and any other pharmaceutical excipients for improving stability.
  • First aspect of tenth embodiment of the present invention provides stable ready-to-use or ready to dilute oral liquid dosage form comprising cabozantinib wherein, the diluent or solvent in liquid dosage form is aqueous solution, preferably water and more preferably purified water USP.
  • Second aspect of tenth embodiment of the present invention provides stable ready-to- use or ready to dilute oral liquid dosage form comprising cabozantinib wherein, the diluent or solvent in liquid dosage form is non-aqueous solution, wherein said non-aqueous solution is free from ethanol.
  • First aspect of eleventh embodiment of the present invention provide stable ready-to- use or ready to dilute oral liquid dosage form comprising lower strengths of cabozantinib and one or more pharmaceutically acceptable excipients wherein the lower strength of cabozantinib present in said ready-to-use or ready to dilute oral liquid dosage form ranges from 2.5 mg to 15 mg (i.e.; 2.5mg, 5mg, lOmg or 15mg) equivalent of cabozantinib free base.
  • Second aspect of eleventh embodiment of the present invention provide stable ready- to-use or ready to dilute oral liquid dosage form comprising higher strengths of cabozantinib and one or more pharmaceutically acceptable excipients wherein the higher strength of cabozantinib present in said ready-to-use or ready to dilute oral liquid dosage form ranges from 80 mg to 200 mg (i.e.; 80mg, lOOmg, 120mg, 140mg, 160mg, 180mg or 200mg) equivalent of cabozantinib free base.
  • Thirteenth embodiment of the present invention provides stable dosage form comprising parenteral dosage form, selected from but are not limited to i.v. lyophilized powder formulation or i.v. liquid injectable formulation of cabozantinib and one or more pharmaceutically acceptable excipients.
  • First aspect of thirteenth embodiment of the present invention provides stable dosage form comprising parenteral dosage form, selected from but are not limited to i.v. lyophilized powder formulation or i.v. liquid injectable formulation of cabozantinib, wherein cabozantinib used for the preparation of the present invention is amorphous, or in crystalline forms, or in mixture of amorphous and crystalline form. Crystalline forms may be anhydrous, solvate or hydrate forms.
  • Third aspect of thirteenth embodiment of the present invention provides stable parenteral pharmaceutical composition prepared by specialized techniques like and not limited to “Lyophilization” or “Freeze drying”.
  • First aspect of fourteenth embodiment of the present invention provides stable dosage form comprising parenteral dosage form, selected from but are not limited to i.v. lyophilized powder formulation or i.v. liquid injectable formulation of cabozantinib and one or more pharmaceutically acceptable excipients wherein said solubility and stability improving excipients are one or more selected from, but not limited to a solubilizing agent, buffering agent, stabilizing agent, chelating agent, anti-oxidant, preservative, bulking agent, surfactant / detergent and pH adjusting agents and any other pharmaceutical excipients for improving stability.
  • solubility and stability improving excipients are one or more selected from, but not limited to a solubilizing agent, buffering agent, stabilizing agent, chelating agent, anti-oxidant, preservative, bulking agent, surfactant / detergent and pH adjusting agents and any other pharmaceutical excipients for improving stability.
  • Third aspect of the fifteenth embodiment of the present invention relates to a process for the preparation of i.v. lyophilized powder formulation or i.v. liquid injectable formulation of cabozantinib by using a processes well known in the art for the preparation of I.V liquid or lyophilized injections, such as mixing cabozantinib and other required pharmaceutically acceptable excipients in a solvent and adjust the pH of the solution to required pH, and optionally lyophilize and terminally sterilize before aseptically fill into vial or ampule.
  • Second aspect of sixteenth embodiment of the present invention provide stable parenteral dosage form selected from but are not limited to i.v. lyophilized powder formulation or i.v. liquid injectable formulation of cabozantinib and one or more pharmaceutically acceptable excipients wherein the higher strength of cabozantinib present in said parenteral dosage form ranges from 80 mg to 200 mg (i.e.; 80mg, lOOmg, 120mg, 140mg, 160mg, 180mg or 200mg) equivalent of cabozantinib free base.
  • cabozantinib refers to cabozantinib free base or its pharmaceutically acceptable salts such as fumarate salt or S -malate salt or hydrochloride salt and its solvate or hydrate thereof.
  • any crystalline form or amorphous form of cabozantinib may be used for manufacturing of the inventive pharmaceutical compositions of the present invention.
  • the said fumarate salt may be 2:1 or 1:1 or said S-malate salt may be 1:1.
  • terapéuticaally effective amount of a compound as used herein means an amount sufficient to cure, alleviate or partially arrest the clinical manifestations of a given disease and its complications. An amount adequate to accomplish this is defined as “therapeutically effective amount”. Effective amounts for each purpose will depend on the severity of the disease or injury as well as the weight and general state of the subject. It will be understood that determining an appropriate dosage may be achieved using routine experimentation, by constructing a matrix of values and testing different points in the matrix, which is all within the ordinary skills of a trained physician.
  • “Pharmaceutically acceptable carrier” or “pharmaceutically acceptable excipient” or “pharmaceutically acceptable inactive ingredient” as used herein includes any and all solvents, dispersion media, coatings, antibacterial and antifungal agents, isotonic and absorption delaying agents and the like. The use of such media and agents for pharmaceutically active substances is well known in the art. Except in so far as any conventional media or agent is incompatible with the active ingredient, its use in the therapeutic compositions of the invention is contemplated. Supplementary active ingredients can also be incorporated into the compositions.
  • the term “about” as used herein will compensate for variability allowed for in the pharmaceutical industry and inherent in pharmaceutical products, such as differences in product strength due to manufacturing variation and time-induced product degradation.
  • the term allows for any variation which in the practice of pharmaceuticals would allow the product being evaluated to be considered pharmaceutically equivalent or bioequivalent to the recited strength. In another embodiment the term allows for any variation within ⁇ 10% of the recited strength or concentration of the formulation.
  • the disintegrating agents suitable for use in the present formulations include which facilitate the breakup of a tablet when it is placed in aqueous environment.
  • Disintegrants once in contact with water or gastric juice, swell, hydrate, change in volume or form to produce a disruptive force that opposes the efficiency of the binder/s causing the compressed table to break apart.
  • the disintegrants are selected from maize starch, potato starch, carboxymethylstarch, sodium starch glycolate, croscarmellose sodium, crospovidones, sodium carboxymethylcelluloses, sodium alginate, microcrystalline cellulose, methacrylic acid copolymer, potassium polacrilin.
  • the most preferred disintegrant in a present pharmaceutical composition is one or more selected from croscarmellose sodium and crospovidone.
  • Lubricants are used in the tablet formulation to reduce the friction during the compression stages and to prevent the sticking of the tablet to the punch faces.
  • Lubricant is selected from stearic acid (calcium stearate and magnesium stearate), vegetable oils(corn oil), mineral oils, polyethylene glycol, inorganic salts (such as sodium chloride), organic salts (sodium benzoate, sodium acetate), and polyvinyl alcohols.
  • the most preferred lubricant is magnesium stearate.
  • Sweetening agents illustratively include glucose, fructose, sucrose, xylitol, tagatose, sucralose, maltitol, isomaltulose, IsomaltTM (hydrogenated isomaltulose), lactitol, sorbitol, erythritol, trehalose, maltodextrin, polydextrose, and the like.
  • Suitable natural or synthetic flavoring agents can be selected from standard reference books, for example Fenaroli's Handbook of Flavor Ingredients, 3rd edition (1995).
  • suitable natural flavors include almond, anise, apple, apricot, bergamot, blackberry, blackcurrant, blueberry, cacao, caramel, cherry, cinnamon, clove, coffee, coriander, cranberry, cumin, dill, eucalyptus, fennel, fig, ginger, grape, grapefruit, guava, hop, lemon, licorice, lime, malt, mandarin, molasses, nutmeg, mixed berry, orange, peach, pear, peppermint, pineapple, raspberry, rose, spearmint, strawberry, tangerine, tea, vanilla, wintergreen, etc.
  • tutti-frutti or bubblegum flavor a compounded flavoring agent based on fruit flavors.
  • Presently preferred flavoring agents include anise, cinnamon, cacao, orange, peppermint, cherry (in particular wild cherry), grape, bubblegum, vanilla, and mixed berry.
  • Flavoring agents can be used singly or in combinations of two or more.
  • Chelating agents include preservative and anti-oxidants, and agents that enhance sterility.
  • Exemplary chelating agents include ascorbic acid, ascorbyl palmitate, BHA, BHT, citric acid, EDTA and its salts, erythorbic acid, fumaric acid, malic acid, propyl gallate, sodium ascorbate, sodium bisulfate, sodium metabisulfite, sodium sulfite, parabens (such as methylparaben, ethylparaben, propylparaben, butylparaben and their salts), benzoic acid, sodium benzoate, potassium sorbate, vanillin, and the like.
  • wet granular material step 5 was loaded into dryer and dried to get LOD between 3.50 % -4.50%.
  • step 6 dried granules obtained from step 6 were milled by using Comill fitted with 32 G Screen at slow speed.
  • step 11 magnesium stearate of step 10 was added to the materials from step 9 and lubricated for 5 min.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne des compositions pharmaceutiques stables nouvelles/inventives comprenant du cabozantinib ou des sels pharmaceutiquement acceptables de celui-ci, et au moins un excipient pharmaceutiquement acceptable. De préférence, les sels pharmaceutiquement acceptables de cabozantinib sont choisis parmi le fumarate de cabozantinib (2 : 1) ou le fumarate de cabozantinib (1 : 1) ou le S-malate de cabozantinib (1 : 1) ou le chlorhydrate de cabozantinib. En outre, la présente invention concerne des procédés de fabrication, des procédés pour leur administration, et l'utilisation de compositions nouvelles/inventives de la présente invention pour la prévention, le traitement ou la prophylaxie de troubles chez des patients humains comprenant des patients pédiatriques et des patients gériatriques en ayant besoin.
PCT/IN2024/052025 2023-10-09 2024-10-09 Composition pharmaceutique de cabozantinib Pending WO2025079089A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN202341067661 2023-10-09
IN202341067661 2023-10-09

Publications (1)

Publication Number Publication Date
WO2025079089A1 true WO2025079089A1 (fr) 2025-04-17

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2024/052025 Pending WO2025079089A1 (fr) 2023-10-09 2024-10-09 Composition pharmaceutique de cabozantinib

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8877776B2 (en) * 2009-01-16 2014-11-04 Exelixis, Inc. (L)-malate salt of N-(4-{[6,7-bis(methyloxy) quinolin-4-yl]oxy}phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide
US10159666B2 (en) * 2014-03-17 2018-12-25 Exelixis, Inc. Dosing of cabozantinib formulations
WO2022177983A1 (fr) * 2021-02-19 2022-08-25 Slayback Pharma Llc Compositions pharmaceutiques de cabozantinib

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8877776B2 (en) * 2009-01-16 2014-11-04 Exelixis, Inc. (L)-malate salt of N-(4-{[6,7-bis(methyloxy) quinolin-4-yl]oxy}phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide
US10159666B2 (en) * 2014-03-17 2018-12-25 Exelixis, Inc. Dosing of cabozantinib formulations
WO2022177983A1 (fr) * 2021-02-19 2022-08-25 Slayback Pharma Llc Compositions pharmaceutiques de cabozantinib

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