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WO2022240279A1 - Comprimé dispersible contenant du déférasirox sous forme de dispersion solide - Google Patents

Comprimé dispersible contenant du déférasirox sous forme de dispersion solide Download PDF

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Publication number
WO2022240279A1
WO2022240279A1 PCT/MX2021/050023 MX2021050023W WO2022240279A1 WO 2022240279 A1 WO2022240279 A1 WO 2022240279A1 MX 2021050023 W MX2021050023 W MX 2021050023W WO 2022240279 A1 WO2022240279 A1 WO 2022240279A1
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WIPO (PCT)
Prior art keywords
microcrystalline cellulose
deferasirox
pharmaceutically acceptable
silicified microcrystalline
acceptable salts
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Ceased
Application number
PCT/MX2021/050023
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English (en)
Spanish (es)
Inventor
Miguel Ángel GARCÍA PÉREZ
Ricardo Zamora Ramírez
Jeny Vázquez Mendoza
Dora Elizabeth TOSCANO TOLENTINO
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Individual
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Individual
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Priority to PCT/MX2021/050023 priority Critical patent/WO2022240279A1/fr
Publication of WO2022240279A1 publication Critical patent/WO2022240279A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4196—1,2,4-Triazoles
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06—Antianaemics

Definitions

  • the present invention refers to a pharmaceutical composition in the form of a dispersible tablet, which comprises an iron chelating agent; wherein the iron chelating agent is deferasirox or its pharmaceutically acceptable salts in a pharmaceutically acceptable concentration of 125 mg to 500 mg per unit dose, in a solid dispersion with one or more diluting agents such as: a) silicified microcrystalline cellulose; b) a mixture with microcrystalline cellulose and up to 2% silicon dioxide, in combination with a disintegrating agent in an amount less than 10% and pharmaceutically acceptable excipients, where the ratio of the iron chelating agent deferasirox or its pharmaceutically acceptable salts, with silicified microcrystalline cellulose or a mixture of microcrystalline cellulose and up to 2% silicon dioxide, it is 1:1 to 4.62:1.
  • the human organism acts and is represented as a whole, in the organism each cell in particular regulates the availability of more than one element per entry (not per discharge), such as iron, which although it is an essential nutrient, in extreme abundance is potentially toxic.
  • iron which although it is an essential nutrient, in extreme abundance is potentially toxic.
  • One peculiarity of iron is that, unlike other nutrients, the body's ability to eliminate it is limited and is not subject to any regulation, so excess iron cannot be eliminated.
  • Secondary iron overload is a condition in patients with hemoglobinopathies, congenital hemolytic anemias, myelodysplasia or other disorders, commonly derived from increased iron absorption, by administration of exogenous iron as part of treatment or in patients who require recurrent blood transfusions, if iron overload is not promptly treated and adequately it can lead to more complications for the patient such as fibrosis, diabetes, among others that worsen their quality of life and can have a lethal result.
  • iron intake of the 5 to 15 mg recommended for your daily intake, 10% of these are absorbed. Iron absorption depends on the patient's diet, as well as the comorbidities that he presents at the time of his intake.
  • Treatment of iron overload currently consists of removing iron from patients by administration of iron chelating agents such as deferiprone or deferasirox and although there are other methods of treating this condition, chelating agents are preferred due to because they avoid the complication of the disorders that originally caused the overload, eliminating excess iron and reducing the risk of organ damage.
  • Deferasirox is an orally active chelator with high selectivity for iron(III). It is a tridentate ligand that binds iron with high affinity in a 2:1 ratio. The Deferasirox promotes the excretion of iron, mainly through the feces. Deferasirox has a low affinity for zinc and copper and does not produce consistently low serum concentrations of these metals.
  • This active principle presents problems at the time of compression, as well as poor flow characteristics that hinder the manufacturing process in solid pharmaceutical forms, in addition to affecting the quality of the product and, consequently, its therapeutic effectiveness.
  • Treatment with Deferasirox in practice is carried out by oral administration in tablets dispersed in a liquid such as water or natural juices, thus facilitating its ingestion by the patient and accelerating its absorption at a systemic level.
  • a liquid such as water or natural juices
  • the common use of beverages other than water can indirectly affect the properties of the active principle, particularly deferasirox, it presents hydrolysis due to acid stress, that is, in a beverage such as orange juice or lemonade, the pH of the medium affects on the stability of the active principle.
  • FIG. 1 Differential Scanning Calorimetry (DSC) corresponding to the following excipients or mixtures: A.1. Deferasirox (DF); A.2. Microcrystalline cellulose (CM); A.3. Silicon Dioxide (DS); A.4. Silicified microcrystalline cellulose (CMS); TO 5. Microcrystalline cellulose + Silicon dioxide (CM+DS); A.6. Deferasirox + Microcrystalline cellulose + Silicon dioxide (DF+CM-HDS); A.7. Deferasirox + Silicified microcrystalline cellulose (DF+CMS).
  • DSC Differential Scanning Calorimetry
  • FIG. 1 B Comparative Differential Scanning Calorimetry (DSC) corresponding to the following solid mixtures or dispersions: B.1. Comparison of Silicified Microcrystalline Cellulose (CMS) VS Microcrystalline Cellulose + Silicon Dioxide (CM-HDS); B.2. Comparison Deferasirox + Silicified Microcrystalline Cellulose (DF+CMS) VS Deferasirox + Microcrystalline Cellulose + Silicon Dioxide (DF+CM+DS).
  • CMS Silicified Microcrystalline Cellulose
  • CM-HDS Silicon Dioxide
  • B.2 Comparison Deferasirox + Silicified Microcrystalline Cellulose (DF+CMS) VS Deferasirox + Microcrystalline Cellulose + Silicon Dioxide (DF+CM+DS).
  • CMS microcystalline cellulose
  • DF Silicified microcystalline cellulose
  • CMS Silicified microcystalline cellulose
  • CCS Silicified microcrystalline cellulose
  • Dissolution profile with respect to the composition of the commercial product, for the following compositions: A. Dissolution profile of composition E 4.2; B. Dissolution profile of composition E 4.3; C. Dissolution profile of composition E 4.4; D. Dissolution profile of composition E 4.5; E. Dissolution profile of composition E 4.6; F. Dissolution profile of composition E 4.7; G. Dissolution profile of composition E 4.8.
  • the object of the present invention is to provide a high quality and stabilized pharmaceutical composition in the form of a dispersible tablet, such that it comprises an iron chelating agent, this iron chelating agent being deferasirox or its pharmaceutically acceptable salts in a pharmaceutically acceptable concentration of 125 mg to 500 mg per dose unit, in a solid dispersion with: a) silicified microcrystalline cellulose; or b) a mixture with microcrystalline cellulose and up to 2% silicon dioxide, in combination with a disintegrating agent in an amount less than 10% and pharmaceutically acceptable excipients, where the ratio of deferasirox or its pharmaceutically acceptable salts, with the microcrystalline cellulose Silicified or the mixture of microcrystalline cellulose and up to 2% silicon dioxide, is 1:1 to 4.62:1.
  • the present invention refers to a pharmaceutical composition stabilized from a solid dispersion in which the deferasirox compound or its pharmaceutically acceptable salts is molecularly dispersed in silicified microcrystalline cellulose; or in a mixture of microcrystalline cellulose with up to 2% silicon dioxide.
  • Solid dispersion refers to any composition of solids that has at least two components.
  • the solid dispersion includes the compound of formula 1 (Deferasirox or its pharmaceutically acceptable salts); preferably dispersed among at least one other component that may be a matrix or an inert solid-state vehicle, for example, a polymer.
  • the solid dispersion includes the compound of formula 1 molecularly dispersed with a polymer, the embodiment wherein the polymer is silicified microcrystalline cellulose or a mixture of microcrystalline cellulose with up to 2% silicon dioxide being preferred.
  • “Molecularly dispersed” refers to the random distribution of the compound of formula I with a polymer, with a physical, chemical or physicochemical interaction between the compound of formula I and the polymer.
  • the compound of formula 1 can be dispersed in a matrix formed by a polymer in its solid state, so as to "immobilize” the compound, preferably in the form of a Compound:Polymer complex.
  • “Compound:Polymer Complex” refers to the physicochemical incorporation of a compound of Formula 1 into a polymer, wherein the compound and the polymer interact with each other.
  • Disintegrating agent refers to the substance or substances that facilitate the disintegration of a tablet or other pharmaceutical form upon contact with an aqueous medium or with gastrointestinal fluids. For the purposes of this document, it will be referred to interchangeably as a disintegrating agent or superdisintegrating agent.
  • Dispersible tablet refers to that pharmaceutical form in the form of a tablet or tablet intended to be dispersed in an aqueous medium for subsequent administration.
  • the aqueous medium can be water, natural juices, juices with artificial flavors, carbonated drinks, among other liquids for human consumption.
  • “Pharmaceutical composition” refers to a product for pharmaceutical use that comprises the ingredients (active ingredients and pharmaceutically acceptable excipients) in the specified amounts, as well as any product that results directly and indirectly from the combinations of the ingredients in the specified amounts. .
  • “Pharmaceutically acceptable excipient, vehicle or carrier” refers to diluents, adjuvants, excipients or carriers, all of which are well known in the art.
  • Treating refers to reversing, alleviating, inhibiting the progress of, or preventing the disorder or condition to which the term applies, or one or more symptoms or disorders associated with such disorder or condition.
  • “Therapeutically effective amount” refers to an amount of a compound/medicine according to the present invention that is safe and effective to produce the desired therapeutic effect.
  • Patient or “patient in need” means a human or non-human mammal afflicted or likely to be afflicted with the disorders or conditions to which the term applies, or one or more symptoms or disorders associated with such disorders or conditions.
  • the patient is preferably a human.
  • Stability refers to the ability of a drug, a medication contained in a container-closure system made of a certain material, to maintain, during the time of storage and use, the established quality specifications.
  • Bioavailability refers to the proportion of a drug that is absorbed into the general circulation after administration of a drug and the time it takes to do so.
  • the present invention provides a pharmaceutical composition in the form of a dispersible tablet comprising a compound of formula I known as deferasirox or its pharmaceutically acceptable salts, in a pharmaceutically acceptable amount, preferably in concentrations of 125 mg to 500 mg per dose unit, in a solid dispersion with a polymer.
  • the polymer is selected from cellulose derivatives.
  • Polymers according to the present invention include, but are not limited to: cellulose acetate, microcrystalline cellulose, silicified microcrystalline cellulose, ethylcellulose, hydroxyethylcellulose, hydroxypropylmethylcellulose, hydroxypropylcellulose, cellulose phthalate, cellulose acetate phthalate, ethylcellulose phthalate, phthalate hydroxyethylcellulose, hydroxypropylmethylcellulose phthalate, hydroxypropylcellulose phthalate, methylcellulose phthalate, methylcellulose, cellulose succinate, ethylcellulose succinate, hydroxyethylcellulose succinate, hydroxypropylmethylcellulose succinate, hydroxypropylcellulose succinate and methylcellulose succinate.
  • the preferred polymer to be used in the composition object of the present invention is selected from: a) silicified microcrystalline cellulose; or b) a mixture with microcrystalline cellulose and up to 2% silicon dioxide.
  • an additional alternative modality of the present invention corresponds to a high-quality, stabilized pharmaceutical composition in the form of a dispersible tablet, such that it comprises deferasirox or its pharmaceutically acceptable salts in a concentration of 125 mg to 500 mg per dose unit.
  • the solid dispersion of the present invention can be obtained by the preparation methods widely known as melt extrusion, spray drying and solution evaporation, however, from the present invention, it is possible to generate the solid dispersion can be obtained by a wet granulation with a aqueous solvent and one or more binding agents in pharmaceutically acceptable amounts.
  • the compound of formula I is molecularly dispersed in a polymer such that a Compound:Polymer complex is obtained.
  • the present invention comprises a pharmaceutical composition in the form of a dispersible tablet comprising a compound of formula I known as deferasirox or its pharmaceutically acceptable salts, in a pharmaceutically acceptable amount, preferably in concentrations of 125 mg to 500 mg per unit. of doses, in a solid dispersion with a polymer, wherein said polymer is selected from: a) silicified microcrystalline cellulose; or b) a mixture with microcrystalline cellulose and up to 2% silicon dioxide; and wherein the dispersion comprises the formation of a Compound:Polymer complex.
  • a compound of formula I known as deferasirox or its pharmaceutically acceptable salts in a pharmaceutically acceptable amount, preferably in concentrations of 125 mg to 500 mg per unit. of doses, in a solid dispersion with a polymer, wherein said polymer is selected from: a) silicified microcrystalline cellulose; or b) a mixture with microcrystalline cellulose and up to 2% silicon dioxide; and wherein the dispersion comprises
  • the ratio of the compound of formula I or its pharmaceutically acceptable salts, with a) silicified microcrystalline cellulose, or b) the mixture of microcrystalline cellulose and up to 2% silicon dioxide is preferably 1:1 to 4.62:1, and in a preferred mode, it is 1:1 to 1.92:1, with 1.15:1 being the most preferred mode.
  • a preferred method for preparing the solid formulation comprising the solid dispersion of the compound of formula I is by way of non-limiting example, the following: sieving the compound of formula I; mixing with the polymer, with one more diluents and one or more pharmaceutically acceptable disintegrating agents; add a binding agent solution for subsequent wet granulation; the resulting granules are dried at a temperature above 40°C for a sufficient time for drying; sift the granules and incorporate excipients that facilitate dispersion or improve its flow, as well as other excipients in pharmaceutically acceptable amounts; and, finally, perform the compression of the mixture.
  • the amount of disintegrant contained in the final formulation directly influences its stability and dissolution.
  • An alternative modality of the present invention comprises that the amount of disintegrating agent represents a factor both for the stability of the dispersion and for the dissolution characteristics, the amount required for its correct operation being less than 10% of disintegrating agent with respect to the total weight of the formulation.
  • Disintegrating agents include, but are not limited to: alginic acid, sodium alginate, starch, sodium carboxymethyl starch, partially hydrolyzed starch, calcium carboxymethyl cellulose, sodium carboxymethyl cellulose, microcrystalline cellulose, croscarmellose sodium , crospovidone, sodium starch glycolate, hydroxypropyl cellulose, polyacryline potassium, and cross-linked polyvinylpyrrolidone.
  • Preferred disintegrating agents can be present in an amount of less than 10% by weight, with respect to the total weight of the formulation and can be used to improve the ability of the formulation to break into smaller fragments when in contact with a liquid, so that preference water.
  • Formulations that are suitable for oral administration to a patient in need thereof include units such as tablet, dispersible tablet, bilayer tablet, soft gelatin capsules, hard gelatin capsules, capsule containing one or more tablets. or capsules, powder, granules, among other pharmaceutical forms known in the state of the art. Taking into account the characteristics of the treatment for which the therapeutic activity of the compound of formula I is directed, a formulation in the form of a dispersible tablet is preferred.
  • pharmaceutically acceptable excipients are, for example: diluents, binders, agents to increase solubility, anti-adherents, lubricants, surfactants, sweeteners, flavoring agents, coloring agents.
  • Diluting agents in accordance with the present invention include, but are not limited to: kaolin, microcrystalline cellulose, silicified microcrystalline cellulose, lactose, such as anhydrous lactose or lactose monohydrate, sugars, such as dextrose, maltose, sucrose, glucose, fructose or maltodextrin, sugar alcohols, such as mannitol, maltitol, sorbitol, xylitol, cellulose, or starch.
  • Preferred diluting agents can be present from 1 to 80% by weight, with respect to the total weight of the formulation and can be used to increase or decrease the weight of the bulk volume, as well as to form a suitable pharmaceutical dosage form according to the amounts of the active ingredients.
  • Binding agents include, but are not limited to: acacia, alginic acid, polyvinyl alcohol, pregelatinized starch, compressible sugar, carboxymethylcellulose, calcium carboxymethylcellulose, sodium carboxymethylcellulose, ethylcellulose, ethylhydroxyethylcellulose, gelatin, glucose liquid, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, methylcellulose, methacrylic acid compounds, polyacrylates and polyvinylpyrrolidone.
  • the preferred binding agents can be present from 0 to 15% by weight, with respect to the total weight of the formulation and can be used to ensure the required mechanical resistance.
  • Lubricating agents in accordance with the present invention include, but are not limited to: calcium stearate, magnesium stearate, mineral oil, stearic acid, fumaric acid, sodium stearyl fumarate, zinc stearate, and polyethylene glycol.
  • Preferred lubricating agents can be present from 0.1 to 10% by weight, with respect to the total weight of the formulation and can be used to reduce static friction, sliding friction and rolling friction.
  • Release agents in accordance with the present invention include, but are not limited to: silicon dioxide and talc.
  • Preferred anti-adherent agents can be present from 0.1 to 10% by weight, with respect to the total weight of the formulation and can be used to improve fluidity.
  • Agents to increase solubility, surfactants, coating materials, sweeteners, flavoring agents, coloring agents or other excipients pharmaceutically acceptable they can be present in the amounts necessary according to their functions and characteristics of the formulation to be developed.
  • the present invention is useful for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in adults and children (from two years of age).
  • Example 1 Composition of the commercial product. Deferasirox.
  • the commercial product EXJADE® of 500 mg and 125 mg is used, which is in the form of a dispersible tablet.
  • the tablets are round, flat and white with a diameter of 12 mm for the 125 mg dose and 20 mm for the 500 mg dose.
  • the components of said composition are presumed to be: Deferasiox, lactose monohydrate, crospovidone, microcrystalline cellulose, polyvidone K-30, magnesium stearate, silicon dioxide and sodium lauryl sulfate.
  • Example 2 Differential Scanning Calorimetry (DSC) of the excipients.
  • CM Microcrystalline cellulose
  • CMS microcrystalline cellulose
  • CM+DS Microcrystalline cellulose + Silicon dioxide
  • CMS silicified microcrystalline cellulose
  • CM+DS Microcrystalline cellulose + Silicon dioxide
  • Example 3 Differential Scanning Calorimetry (DSC) of the solid dispersion.
  • DSC Differential Scanning Calorimetry
  • Example 4 Compositions in dispersible tablet form with different excipients.
  • compositions in dispersible tablet form containing deferasirox in solid dispersion with a polymer were prepared using microcrystalline cellulose, silicified microcrystalline cellulose and mixtures of microcrystalline cellulose with silicified microcrystalline cellulose, to evaluate their performance.
  • compositions were made as follows:
  • Example 5 Evaluation of the performance of the compositions.
  • composition E 4.4 Evaluation of the composition E 4.4.
  • the powder continues to flow well and the tablets look good despite the fact that the hardness has dropped a bit compared to the previous test.
  • the dissolution profile was more adjusted with that in previous tests.
  • the dissolution profile is observed in figure 3C.
  • Example 4 Determination of interaction Deferasirox:silicified microcrystalline cellulose
  • silicified microcrystalline cellulose formed by means of wet granulation, it was evaluated by calorimetry. differential scanning, resulting in the interaction between the active ingredient and the silicified polymer. The result can be seen in figure 4.
  • composition E 4.8 from Example 2, the accelerated stability study was carried out, keeping the samples at a temperature of 40°C ⁇ 2°C, with a relative humidity of 75% ⁇ 5% for a period of 6 months, obtaining the following results:
  • composition E 2.8 from Example 2 the long-term stability study was carried out, keeping the samples at a temperature of 30°C ⁇ 2°C, with a relative humidity of 65% ⁇ 5% for a period of 12 months. , obtaining the following results:

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  • Life Sciences & Earth Sciences (AREA)
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Abstract

La présente invention concerne une composition pharmaceutique sous forme de comprimé dispersible qui comprend un agent chélateur du fer, ledit agent chélateur de fer étant le déférasirox ou ses sels pharmaceutiquement acceptables dans une concentration acceptable allant de 125 mg à 500 mg par unité de dose, dans une dispersion solide avec a) de la cellulose microcristalline silicifiée ; ou b) un mélange avec de la cellulose microcristalline et jusqu'à 2% de dioxyde de silicium, en combinaison avec un agent désintégrant dans une quantité inférieure à 10% et des excipients pharmaceutiquement acceptables, la relation du déférasirox ou de ses sels pharmaceutiquement acceptables, avec la cellulose microcristalline silicifiée ou le mélange de cellulose microcristalline et jusqu'à 2% de dioxyde de silicium allant de 1:1 à 4.62:1.
PCT/MX2021/050023 2021-05-10 2021-05-10 Comprimé dispersible contenant du déférasirox sous forme de dispersion solide Ceased WO2022240279A1 (fr)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007045445A1 (fr) * 2005-10-19 2007-04-26 Novartis Ag Comprimes dispersibles contenant du deferasirox
WO2019108157A1 (fr) * 2017-11-28 2019-06-06 Biofarma Ilac Sanayi Ve Ticaret A.S. Formulation de comprimé entaillé sous une forme dispersible comprenant du déférasirox

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007045445A1 (fr) * 2005-10-19 2007-04-26 Novartis Ag Comprimes dispersibles contenant du deferasirox
WO2019108157A1 (fr) * 2017-11-28 2019-06-06 Biofarma Ilac Sanayi Ve Ticaret A.S. Formulation de comprimé entaillé sous une forme dispersible comprenant du déférasirox

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
ANONYMOUS: "Exjade - SUMMARY OF PRODUCT CHARACTERISTICS", EUROPA.EU, 28 August 2006 (2006-08-28), XP093014755, [retrieved on 20230117] *

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