WO2014115168A2 - Formes solvatées d'un nouveau type de cabazitaxel et son procédé de préparation - Google Patents

Formes solvatées d'un nouveau type de cabazitaxel et son procédé de préparation Download PDF

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Publication number
WO2014115168A2
WO2014115168A2 PCT/IN2014/000049 IN2014000049W WO2014115168A2 WO 2014115168 A2 WO2014115168 A2 WO 2014115168A2 IN 2014000049 W IN2014000049 W IN 2014000049W WO 2014115168 A2 WO2014115168 A2 WO 2014115168A2
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Prior art keywords
cabazitaxel
butyl alcohol
tertiary butyl
solvate
preparation
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PCT/IN2014/000049
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English (en)
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WO2014115168A3 (fr
Inventor
Kocherlakota Chandrashekhar
Banda Nagaraju
Pullagurla Manik REDDY
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Leiutis Pharmaceuticals Private Limited
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Publication of WO2014115168A2 publication Critical patent/WO2014115168A2/fr
Publication of WO2014115168A3 publication Critical patent/WO2014115168A3/fr

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    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D305/00—Heterocyclic compounds containing four-membered rings having one oxygen atom as the only ring hetero atoms
    • C07D305/14—Heterocyclic compounds containing four-membered rings having one oxygen atom as the only ring hetero atoms condensed with carbocyclic rings or ring systems
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions

Definitions

  • the invention relates to novel solvate forms of dimethoxydocetaxel or 4-acetoxy-2a.- benzoyloxy-5p 20-epoxy- l -hydroxy-7p , ⁇ ⁇ -dimethoxy-9-oxotax-l l -en-13a-yl(2R,3S)- 3-tert-butoxycarbonylamino-2-hydroxy-3-phenylpropionate and methods ' for the preparation thereof.
  • Cabazitaxel is chemically described as ( ⁇ S,2S,3RAS, 7R,9S, ⁇ 0S, ⁇ 2R, ⁇ 55)-4-(Acetyloxy)- 15- ⁇ [(2R,3S)-3- ⁇ [(tert-butoxy) carbonyl]amino ⁇ -2-hydroxy-3-phenylpropanoyl]oxy ⁇ - 1 - hydroxy-9, 12-dimethoxy- 10, 14, 17, 17-tetramethyl- 1 1 -oxo-6-oxatetracyclo
  • Cabazitaxel is an antineoplastic agent belonging to the taxane class, exhibits anticancer and antileukemic properties and used for the treatment of hormone-refractory prostate cancer.lt is prepared by semi-synthesis with a precursor extracted from yew needles. Cabazitaxel is a microtubule inhibitor. It acts by binding to tubulin and promotes its assembly into microtubules while simultaneously inhibiting disassembly. This leads to the stabilization of microtubules, which results in the inhibition of mitotic and interphase cellular functions. Cabazitaxel has the following chemical structure:
  • Prostate cancer is a form of cancer that develops in the prostate gland in the male reproductive system. Most prostate cancers are slow growing; however, there are cases of aggressive prostate cancers. The cancer cells may metastasize (spread) from the prostate to other parts of the body, particularly the bones and lymph nodes.
  • Cabazitaxel is white to almost-white powder with a molecular formula of C45H57 O14.C3H6O and a molecular weight of 894.01 (for the acetone solvate) / 835.93 (for the solvent free). It is lipophilic, practically insoluble in water and soluble in alcohol.
  • JEVTANA Cabazitaxel is marketed in the US under the trade name JEVTANA by SANOFI AVENTIS US.
  • JEVTANA is available as single 60 mg injections for intravenous use.
  • JEVTANA (Cabazitaxel) Injection 60 mg/1.5 mL is a sterile, non-pyrogenic, clear yellow to brownish-yellow viscous solution and is available in single-use vials containing 60 mg Cabazitaxel (anhydrous and solvent free) and 1 .56 g Polysorbate 80. Each mL contains 40 mg Cabazitaxel (anhydrous) and 1 .04 g Polysorbate 80.
  • JEVTANA requires two dilutions prior to intravenous infusion.
  • JEVTANA injection should be diluted only with the supplied DILUENT (clear, colorless, sterile, and non-pyrogenic solution containing 13% (w/w) ethanol in water for injection, approximately 5.7 mL) for JEVTANA, followed by dilution in either 0.9% sodium chloride solution or 5% dextrose solution.
  • DILUENT clear, colorless, sterile, and non-pyrogenic solution containing 13% (w/w) ethanol in water for injection, approximately 5.7 mL
  • This formulation is indicated in combination with prednisone for the treatment of patients with hormone- refractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen.
  • U.S Patent No. 5438072 discloses new injectable form containing taxoids such as taxol, taxotere or derivatives.
  • U.S Patent No. 5847170 discloses Cabazitaxel and its process of preparation and pharmaceutical compositions containing them.
  • U.S. Patent Application No. 201 10144362 by Sanofi Aventis Pharma discloses various crystalline forms of dimethoxydocetaxel such as anhydrous form D, anhydrous form B, anhydrous form C, anhydrous form E, anhydrous form F, ethanolate form D, ethanolate form E, ethanolate form B, ethanol/water heterosolvate form F, monohydrated forms C and dihydrate form C and methods for preparing the same.
  • WO2012/1421 1 7 by Teva Pharmaceuticals discloses various solid state forms of Cabazitaxel such as crystalline Cabazitaxel form 1, Amorphous Cabazitaxel in a powdery, non-foamy form, crystalline Cabazitaxel form II, crystalline Cabazitaxel form III, crystalline Cabazitaxel form IV, crystalline Cabazitaxel form V and processes for preparation thereof.
  • Polymorphism the occurrence of different crystal forms, is a property of some molecules and molecular complexes.
  • a single molecule, like Cabazitaxel may give rise to a variety of polymorphs having distinct crystal structures and physical properties like melting point, thermal behaviors (e.g.
  • the primary object of the invention is to provide novel solvate forms of Cabazitaxel. Another object of the invention is to provide process for preparation of such novel solvate forms of Cabazitaxel.
  • the present invention provides novel solvate forms of Cabazitaxel, process for the manufacture thereof and pharmaceutical compositions comprising the said novel solvate forms of Cabazitaxel.
  • One aspect of the invention relates, to novel solvate forms of Cabazitaxel such as tertiary- butyl alcohol solvate form of Cabazitaxel.
  • Another aspect of the invention relates to novel solvate forms of Cabazitaxel comprising tertiary butyl alcohol or a mixture of tertiary-butyl alcohol and ethyl acetate and the process of preparation thereof.
  • Another aspect of the present invention relates to tertiary-butyl alcohol solvate form of Cabazitaxel preparation comprising mixture of solvents such as tertiary-butyl alcohol (TBA) and ethyl acetate (EA) in varied proportions.
  • TSA tertiary-butyl alcohol
  • EA ethyl acetate
  • Yet another aspect of the invention provides the lyophilization process by using a suitable solvent or mixtures of solvents to obtain the novel solvate form of Cabazitaxel.
  • Yet another aspect of the invention relates to pharmaceutical compositions of Cabazitaxel comprising novel solvate form of Cabazitaxel and method of preparation thereof.
  • Figure 1 shows a powder X-ray diffraction pattern ("Powder XRD” or "PXRD”) of novel solvate form (TBA Solvate form) of Cabazitaxel.
  • FIG. 2 shows a Differential Scanning Calorimetry ("DSC") thermogram of novel solvate(TBA Solvate form) form of Cabazitaxel
  • FIG 3 shows a Thermogravimetric analysis ("TGA") thermogram of novel solvate form(TBA Solvate form) of Cabazitaxel
  • Figure 4 shows a' H NMR spectrum of novel solvate form(TBA Solvate form) of Cabazitaxel
  • Figure 5 shows the Infrared Spectrum of novel solvate(TBA Solvate form)form of Cabazitaxel.
  • the invention provides tertiary-butyl alcohol solvate form of Cabazitaxel, processes for preparation and pharmaceutical compositions thereof.
  • a “solvate” may be defined as a compound formed by solvation, for example as a combination of solvent molecules with molecules or ions of a solute.
  • Well known solvent molecules include water, alcohols and other polar organic solvents. Suitable solvents include the following but are not limited to methanol, ethanol, n-propanol, isopropanol, n-butanol, isobutanol, t-butanol, ethyl acetate and other lower alkanols, glycerine, acetone, Ethoxy ethanol dichloromethane, Dimethyl sulphoxide (DMSO), Dimethyl acetate (DMA), dimethyl formamide (DMF), isopropyl ether, methyl ethyl ketone, acetonitrile, toluene, N-methylpyrrolidone (NMP), tetrahydrofuran (THF), tetrahydropyran, water, other cyclic mono-,
  • polyethylene glycol polypropylene glycol, propylene glycol
  • solvents such as tertiary butyl alcohol (t-butanol), and ethyl acetate optionally in the presence of water in varied proportions may be used.
  • Powder X-ray Diffraction (PXRD) method
  • Scan range 3 - 40 degrees 2-theta
  • Step size 0.0167 degrees
  • Sample holder zero background silicon plate.
  • DSC Differential Scanning Calorimetry
  • DSC measurements were performed on a Differential Scanning Calorimeter: TA instruments; (Q20) in Aluminum crucibles 40 with pin-holed lids were used for sample preparation. Typical sample weight was between 1 and 5 mg.
  • TGA Thermo gravimetric analysis
  • TGA measurements were performed on a Thermogravimetric analyzer: TA instruments (Q50).
  • Infrared spectra measurement was performed on a PerkinElmer instrument (Spectrum one: model). 2-3 mg sample was taken and mixed with 250mg of KBr and a pellet was made which is used for the IR analysis.
  • the present invention also relates to a process of manufacture of Cabazitaxel tertiary butyl alcohol solvate.
  • Cabazitaxel tertiary butyl alcohol solvate (TBA Solvatre) is prepared by dissolving Cabazitaxel in a mixture of ethyl acetate and tertiary butanol in varied ratios, preferably 1 : 4 ratioand raising the temperature to 85-92 °C followed by cooling to 0-5°C.
  • the solvate form is prepared by lyophilization from a solution.
  • the solvate form is prepared by lyophilization from a mixture of t- butanol/ethyl acetate in the presence of water.
  • Lyophilization also called freeze-drying refers to a process that uses low temperature and pressure to remove a solvent, from a liquid formulation by the process of sublimation (i.e., a change in phase from solid to vapor without passing through a liquid phase). Lyophilization helps stabilize drug by reducing the solvent component or components to levels that no longer support chemical reactions or biological growth. Since drying during lyophilization takes place at a low temperature, chemical decomposition is also reduced.
  • the freeze-drying process comprises steps of freezing, annealing, primary drying and secondary drying under various conditions such that the bulking agent is maintained in a substantially amorphous state or is maintained in a substantially crystalline state.
  • the primary goal of the freezing process is to solidify at least the solvent component of the formulation.
  • the liquid formulation is therefore cooled to a sufficiently low temperature to allow for solidification of at least the solvent component.
  • An annealing process results in the removal of solvent crystals smaller than a critical size and generation of larger solvent crystals. Annealing also reduces freezing-induced drying rate heterogeneity.
  • the solvent is removed from the liquid formulation by a process of sublimation.
  • the solvate forms obtained are characterized by suitable analytical techniques known in the art.
  • Another aspect of the present invention is to provide pharmaceutical compositions of Cabazitaxel comprising: a)Cabazitaxel tertiary butyl alcohol solvate; and b) a pharmaceutically acceptable carrier.
  • One embodiment of the invention relates to a parenteral compositioncompnsing: a)Cabazitaxel tertiary butyl alcohol solvate; and b) a pharmaceutically acceptable carrier.
  • Pharmaceutically acceptable carrier or adjuvants can be selected from complexing agents, preservatives, anti-oxidants; stabilizers, tonicity modifiers, buffering agents and any other suitable adjuvants thereof.
  • Stabilizing agents are typically added to a formulation to improve stability of the protein formulation, for example, by reducing denaturation, aggregation, deamidation and oxidation of the protein during the freeze-drying process as well as during storage.
  • Suitable stabilizers include the following, but are not limited to Saccharides, including monosaccharides such as glucose, disaccharides such as sucrose (glucose+fructose), lactose (glucose+galactose), maltose (glucose+glucose), and trehalose (alpha-D- glucopyranosyl alpha-D-glucopyranoside), and polysaccharides such as dextran (polysaccharide containing glucose monomers and the like.
  • Surfactants also act as suitable stabilizers such as polyoxyethylenesorbitanmonolaurate (Tween.TM. 20, Tween.TM. 80), pluronic F-68, Triton.TM. X- 100, and sodium dodecyl sulfate (SDS), polysorbate or any other suitable surfactant can be selected. Cyclodextrins can also be used as a stabilizer. Preferably stabilizers could be surfactants in suitable proportion.
  • Tonicity modifiers are those pharmaceutically acceptable inert substances that can be added to the formulation to provide an isotonity of the formulation.
  • Tonicity modifiers suitable for this invention include the following, but are not limited to mannitol, dextrose, sucrose, glycine, glycerol, sodium chloride, salts and amino acids and the like.
  • Tonicity modifier can also be a component of diluent used for dilution of the prepared parenteral formulation.
  • Buffers are typically included in pharmaceutical formulations to maintain the pH of the formulation at a physiologically acceptable pH.
  • the desirable pH for a formulation may also be affected by the active agent.
  • suitable buffers include but are not limited to buffers derived from an acid such as phosphate, aconitic, citric, tartaric, aleic, glutaric, malic, succinic, carbonic acid, alkali or alkaline earth salt of one of these acids, Tris buffer, glycine, histidine buffers, meglumine, Sodium acetate, Ammonium acetate, and other acetates or any suitable buffer thereof.
  • pH adjusting agents such as, but are not limited to sodium hydroxide, sodium carbonate, sodium bicarbonate, potassium hydroxide, ammonium carbonate, hydrochloric acid, citric acid, lactic acid, phosphoric acid, sodium phosphate, sulfuric acid, and the like can also be used.
  • Components of the diluent may include the following but are not limited to ethanol, polyethylene glycols or blends containing one or more polyethylene glycols of different grades, propylene glycol, polyvinylpyrrolidone, or agents to adjust solution osmolarity or other parenterally acceptable sugars, polyols, mannitol solution, sodium chloride, dextrose solution, electrolytes or any suitable adjuvant thereof.
  • compositions of the present invention can be prepared by the following process; Required amount of solvent was taken was taken in a S.S vessel to which drug was added and dissolved. Then required quantity of buffer was added and stirred well to get a uniform solution. Then required quantity of surfactant was added and stirred well. The final volume was made to q.s with the solvent.
  • the prepared bulk solution prepared was filled in to a suitable container and the solvent was removed by rotary evaporation and the solution was filtered and desired quantity was filled in vials. Alternately the prepared bulk solution after filtration can be filled in vials and vaccuum can be applied to remove the solvent. The vials are then stoppered and sealed. Suitable sterilization techniques are used to keep the composition sterile.
  • Example 1 Preparation of TBA solvate form of Cabazitaxel.
  • the primary drying was performed at temperatures above -45°C at a vacuum rarrging from 10-700 millitorrs.
  • the primary drying steps may contain one or more annealing steps,
  • the freeze drying steps shall be performed in inert gas (N2, argon etc) or air.After completion of cycle the vacuum of chamber was released with Nitrogen and vials are sealed.
  • Example 2 Preparation of Cabazitaxel Injection.
  • cabazitaxel was added in required amount of ethanol (80%) followed by buffer i.e., glycine and stirred until it dissolves.
  • Required quantity of polysorbate 80 was added to the above solution and stirred until it dissolves. Final volume was made up with ethanol (20%). Ethanol was removed from the solution by rotary evaporation. The solution was filtered and desired quantity was filled in vials and the vials were stoppered and sealed. The vials were Stored at 25°C (77°F).
  • Example 8 Recrystallization of Cabazitaxel.

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  • Organic Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
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  • General Health & Medical Sciences (AREA)
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Abstract

La présente invention concerne des formes solvatées d'un nouveau type de cabazitaxel et leur préparation. L'invention concerne en outre une forme solvatée d'alcool butylique tertiaire du cabazitaxel, et son procédé de préparation , et des compositions pharmaceutiques constituées de la forme solvatée d'un nouveau type de cabazitaxel.
PCT/IN2014/000049 2013-01-23 2014-01-23 Formes solvatées d'un nouveau type de cabazitaxel et son procédé de préparation WO2014115168A2 (fr)

Applications Claiming Priority (2)

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IN314/CHE/2013 2013-01-23
IN314CH2013 2013-01-23

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WO2014115168A2 true WO2014115168A2 (fr) 2014-07-31
WO2014115168A3 WO2014115168A3 (fr) 2014-12-04

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019204738A1 (fr) * 2018-04-20 2019-10-24 Zhuhai Beihai Biotech Co., Ltd. Formulations et compositions de cabazitaxel
US11510895B2 (en) 2016-01-15 2022-11-29 Zhuhai Beihai Biotech Co., Ltd. Compositions and formulations including cabazitaxel and human serum albumin

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009115655A2 (fr) * 2008-01-17 2009-09-24 Aventis Pharma S.A. Formes cristallines du dimethoxy docetaxel et leurs procedes de preparation
CN102068407A (zh) * 2010-12-27 2011-05-25 江苏奥赛康药业有限公司 一种cabazitaxel注射液及其制备方法
WO2012142117A1 (fr) * 2011-04-12 2012-10-18 Plus Chemicals Sa Formes solides de cabazitaxel et procédés de préparation associés
WO2013024495A1 (fr) * 2011-08-18 2013-02-21 Dr. Reddys Laboratories Limited Formulations pharmaceutiques de cabazitaxel
WO2013134534A2 (fr) * 2012-03-08 2013-09-12 Plus Chemicals S.A. Formes à l'état solide de cabazitaxel et procédés pour les préparer

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009115655A2 (fr) * 2008-01-17 2009-09-24 Aventis Pharma S.A. Formes cristallines du dimethoxy docetaxel et leurs procedes de preparation
CN102068407A (zh) * 2010-12-27 2011-05-25 江苏奥赛康药业有限公司 一种cabazitaxel注射液及其制备方法
WO2012142117A1 (fr) * 2011-04-12 2012-10-18 Plus Chemicals Sa Formes solides de cabazitaxel et procédés de préparation associés
WO2013024495A1 (fr) * 2011-08-18 2013-02-21 Dr. Reddys Laboratories Limited Formulations pharmaceutiques de cabazitaxel
WO2013134534A2 (fr) * 2012-03-08 2013-09-12 Plus Chemicals S.A. Formes à l'état solide de cabazitaxel et procédés pour les préparer

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11510895B2 (en) 2016-01-15 2022-11-29 Zhuhai Beihai Biotech Co., Ltd. Compositions and formulations including cabazitaxel and human serum albumin
WO2019204738A1 (fr) * 2018-04-20 2019-10-24 Zhuhai Beihai Biotech Co., Ltd. Formulations et compositions de cabazitaxel
CN112055588A (zh) * 2018-04-20 2020-12-08 珠海贝海生物技术有限公司 卡巴他赛的制剂和组合物
US11413265B2 (en) 2018-04-20 2022-08-16 Zhuhai Beihai Biotech Co., Ltd. Formulations and compositions of Cabazitaxel
CN112055588B (zh) * 2018-04-20 2023-09-08 珠海贝海生物技术有限公司 卡巴他赛的制剂和组合物
CN117205305A (zh) * 2018-04-20 2023-12-12 珠海贝海生物技术有限公司 卡巴他赛的制剂和组合物
CN117205305B (zh) * 2018-04-20 2024-04-26 珠海贝海生物技术有限公司 卡巴他赛的制剂和组合物

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