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WO2007033515A1 - Formulation orale contenant de la moxifloxacine et son procédé de préparation - Google Patents

Formulation orale contenant de la moxifloxacine et son procédé de préparation Download PDF

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Publication number
WO2007033515A1
WO2007033515A1 PCT/CN2005/001504 CN2005001504W WO2007033515A1 WO 2007033515 A1 WO2007033515 A1 WO 2007033515A1 CN 2005001504 W CN2005001504 W CN 2005001504W WO 2007033515 A1 WO2007033515 A1 WO 2007033515A1
Authority
WO
WIPO (PCT)
Prior art keywords
moxifloxacin
pharmaceutical preparation
weight
film
forming material
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.)
Ceased
Application number
PCT/CN2005/001504
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English (en)
Chinese (zh)
Inventor
Xue Qi Fu
Bang Ai Zhao
Bing Qi Zhang
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.)
Shenzhen Tys R & D Co Ltd
Original Assignee
Shenzhen Tys R & D Co 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 Shenzhen Tys R & D Co Ltd filed Critical Shenzhen Tys R & D Co Ltd
Priority to PCT/CN2005/001504 priority Critical patent/WO2007033515A1/fr
Publication of WO2007033515A1 publication Critical patent/WO2007033515A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61K31/4709—Non-condensed quinolines and containing further heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents

Definitions

  • the present invention relates to a pharmaceutical preparation and a preparation method thereof, and in particular, the present invention relates to a moxifloxacin
  • Moxifloxacin is a new generation of fluoroquinolone antibiotics.
  • moxifloxacin hydrochloride has been approved for upper and lower respiratory tract infections caused by sensitive microorganisms, such as acute exacerbation of chronic bronchitis, community acquired pneumonia, acute bacterial sinusitis and Treatment of uncomplicated skin and soft tissue infections.
  • Moxifloxacin hydrochloride tablets were first registered in Mexico in February 1999 and first in Germany in September 1999. Infusions were first marketed in the United States and Germany in December 2001. Currently, the products are already in Germany, Spain, Italy, Sweden. Listed in Switzerland, the United States, Canada, Australia, Argentina, Brazil, South Korea, Malaysia and other countries.
  • the pharmaceutical preparation of the invention is preferably in the form of a tablet, which may optionally be coated, for the coating, Coating agents commonly used in the pharmaceutical field, such as various hydroxypropyl methylcellulose (HPMC) and/or polyethylene glycol, may also be used, and the coating may also contain conventional pigments such as titanium dioxide or iron oxide red. .
  • HPMC hydroxypropyl methylcellulose
  • the coating material specifically mentioned in Examples 1, 4, 5, and 6 was HPMC.
  • the coatings referred to refer to the coating of the tablet of the tablet, and it is not mentioned that the film-forming material is used to prepare the intermediate particles or to coat the particles.
  • the comparative patent formulation is the uncoated core formulation of Example 4 in the Chinese patent (Patent No. 99813124. 5, Publication No. CN1325306A), but in the publication, ** is sodium carboxymethylcellulose, Translated from croscarmellose soldium, see the second page of the original patent specification, and in fact the translation is incorrect, correctly translated as croscarmellose sodium (disintegrant).
  • the hardness is measured by Mansanto hardness tester.
  • the friability, disintegration degree and dissolution rate are determined according to the Chinese Pharmacopoeia 2000 version.
  • the dissolution method is determined according to the first method in the Chinese Pharmacopoeia 2000 edition two appendix XC.
  • the dissolution medium is 0.1 M hydrochloric acid solution, the rotation speed is 100 rpm, and the measurement is performed.
  • the dissolution value was 45 minutes.
  • the object of the present invention is to solve the problem that moxifloxacin produces red impurities during the preparation process, especially during tableting, and provides a stable oral pharmaceutical preparation of moxifloxacin, especially a tablet, and a preparation method of the same
  • the prepared tablets have good hardness and dissolution properties.
  • the present invention adopts the following technical solutions:
  • the present invention discloses an oral pharmaceutical preparation of moxifloxacin containing moxifloxacin or a salt thereof and/or a hydrate thereof, the pharmaceutical preparation further comprising at least one intermediate granule for preparing a preparation or powder or granule package a film forming material of the garment, the film forming material comprising:
  • the polyacrylic resin is also often referred to as a poly(meth)acrylic resin.
  • the moxifloxacin oral pharmaceutical preparation is preferably present in the form of a tablet, or may be an oral preparation such as a granule dosage form.
  • the tablet of the tablet may optionally be coated.
  • a coating formulation commonly used in the pharmaceutical field may be used, such as various hydroxypropyl methylcellulose. Based on (HPMC) and/or polyethylene glycol, the coating may also contain conventional pigments such as titanium dioxide or iron oxide red.
  • the moxifloxacin or a salt thereof and/or a hydrate thereof thereof means moxifloxacin hydrochloride.
  • the pharmaceutical formulation also contains a pharmaceutically acceptable amount of a pharmaceutically acceptable excipient.
  • excipients include starch, dextrin, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, croscarmellose sodium, micronized silica gel, magnesium stearate, lactose. Among them, lactose is not essential in the present invention.
  • the pharmaceutical preparation contains '
  • the pharmaceutical preparation contains
  • the weight percentage is 0. 2 ⁇ 10. 0% of the film forming material polyethylene glycol;
  • microcrystalline cellulose 5 to 30% by weight of microcrystalline cellulose
  • the film-forming material is 0. 5 ⁇ 10 ⁇
  • the film-forming material is 0. 5 ⁇ 10. /.
  • a part of the film-forming material is mixed with moxifloxacin or a salt thereof and/or a hydrate thereof and a pharmaceutically acceptable excipient, and the remaining part of the film-forming material is formulated into a weight percentage of 0.5 to 10% of an aqueous solution or a water-dispersed solution or dilute ethanol. a solution, prepared as a binder and mixed with the above mixture; or
  • the granule is prepared by using a soft material made of water or dilute ethanol; or The film-forming material is formulated into a 0.5% by weight aqueous solution or a water-dispersed solution or a dilute ethanol solution, a powder of moxifloxacin or a salt thereof and/or a hydrate thereof and a pharmaceutically acceptable excipient or The granules are coated.
  • the method further comprises the step of drying the finished granules or coated granules, adding magnesium stearate, mixing and then tableting to form a tablet.
  • the moxifloxacin or a salt thereof and/or a hydrate thereof thereof means moxifloxacin hydrochloride.
  • the pharmaceutically acceptable excipients include starch, dextrin, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, croscarmellose sodium, micronized silica gel, magnesium stearate, lactose. Among them, lactose is not essential in the present invention.
  • the oral pharmaceutical preparations of moxifloxacin of the present invention can be granulated and tableted. It maintains stable properties, does not cause discoloration after contact with iron container or stainless steel punch, die or friction, bright, good hardness, and rapid drug dissolution; and can ensure quality after long-term storage, such as tablet core placed at room temperature The quality remained unchanged for two years, the hardness did not change significantly, the color remained yellow, and the dissolution rate remained above 90%.
  • the method for obtaining a stable moxifloxacin or a salt thereof and/or a hydrate tablet thereof according to the present invention is granulated by a film-forming material granule or coating granulation.
  • the film-forming material used may be hydroxypropylmethylcellulose (HPMC), hydroxyethylmethylcellulose, methylcellulose, hydroxypropylcellulose, hydroxyethylcellulose, sodium carboxymethylcellulose, poly (Meth) Acrylic Resins (stomach-soluble or gastric-dispersed), polyethylene glycol, polyvinylpyrrolidone-vinyl acetate copolymer (eg Kollidon® VA64 or Plasdone® S-630), polyvinyl alcohol- A mixture of one or more of a polyethylene glycol graft copolymer (such as Kollicoat® IR), Carbopol, gelatin, and poloxamer. 0% ⁇ 0%. 2%. 0%.
  • HPMC hydroxypropylmethylcellulose
  • the film-forming material is used as a binder, and the concentration of the film is 0. 5 ⁇ 10. 0%;
  • the remaining part of the film-forming material is mixed with the main drug and other auxiliary materials, and the ratio of the film-forming material used for formulating the solution to the total amount of the film-forming material used is not particularly limited, and only needs to satisfy the solution used as the binder and
  • main drug and other auxiliary materials are mixed to prepare granules, the mixture is kept at the necessary humidity; all the film-forming materials and main drugs and other auxiliary materials can also be used.
  • the dilute ethanol is usually 30% ⁇ 50% ethanol.
  • Granulation and drying can be carried out by conventional methods. Such as high-speed mixing granulation, or bubbling granulation drying.
  • the discoloration of the edge of the tablet caused by the rubbing of the drug with the metal punch and the die during the tableting process is solved by using the film forming material and the above granulation method.
  • the pharmaceutical preparation of the present invention may further contain an appropriate amount of excipients, which may be selected from the following excipients: starch, dextrin, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, crosslinked carboxymethyl Cellulose sodium, micronized silica gel, magnesium stearate, lactose. It can also be free of lactose.
  • excipients which may be selected from the following excipients: starch, dextrin, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, crosslinked carboxymethyl Cellulose sodium, micronized silica gel, magnesium stearate, lactose. It can also be free of lactose.
  • the raw materials and auxiliary materials (except magnesium stearate and HPMC) of the above components are thoroughly mixed uniformly, and granules are prepared by using 1.0% of HPMC aqueous solution, dried, and then added with magnesium stearate to be mixed and tableted.
  • the punch and die used for tableting are made of stainless steel.
  • the prepared tablet core may be conventionally coated or may be directly packaged in a light-proof sealed package without coating.
  • Pregelatinized starch 34 3mg Carboxymethyl starch sodium 7. 0 nig
  • the prepared tablet core may be coated by a conventional method or may be directly packaged in a light-proof sealed package without coating.
  • the raw materials and auxiliary materials (except magnesium stearate and HPMC) of the above components are thoroughly mixed uniformly, and granules are prepared by using 4.5% of HPMC aqueous solution, dried, and then added with magnesium stearate to be mixed and tableted.
  • the punch and die used for tableting are made of stainless steel.
  • the prepared tablet core may be coated by a conventional method or may be directly coated with a light-proof sealed package without coating.
  • the prepared tablet core may be coated by a conventional method or may be directly packaged in a light-proof sealed package without coating.
  • the above ingredients were mixed with the raw materials (except magnesium stearate, PEG and HPMC), and PEG and HPMC were mixed to prepare an aqueous solution having a concentration of 5.0%.
  • the aqueous solution was used to prepare granules, and after drying, stearic acid was added. Mix the magnesium, compress it, and get it.
  • the punch and die used for tableting are made of stainless steel.
  • the prepared tablet core may be coated by a conventional method or may be directly packaged in a light-proof sealed package without coating.
  • the raw materials and auxiliary materials (except magnesium stearate) of the above components are thoroughly mixed and uniformly mixed, and the powder coating is carried out with the following solution; or the raw materials and the auxiliary materials are thoroughly mixed and dry granulated, and then the following solution is used for granule coating.
  • the weight gain of the original and auxiliary materials was 8%, that is, the granule-coated preparation contained 0.8% of polyethylene glycol 4000 and 7.2% of HPMC (90SH 100).
  • the granule-coated preparation contained 0.8% of polyethylene glycol 4000 and 7.2% of HPMC (90SH 100).
  • the punch and die used for tableting are made of stainless steel.
  • the prepared tablet core may be coated by a conventional method or may be directly packaged in a light-proof sealed package without coating.
  • Example 7 Example 8
  • Example 9 Example 10 Moxifloxacin hydrochloride 218.4 218.4 218.4 218.4 Microcrystalline cellulose 116.6 116.6 116.6 116.6 Pregelatinized starch ' 32.0 32.0 32.0 32.0 Sodium Carboxymethyl Starch 7.0 7.0. 7.0 Croscone Sodium Cellulose 7.0 7.0 7.0 7.0
  • the non-film-forming material components other than magnesium stearate in Table 4 below were thoroughly mixed uniformly, and the powder coating was carried out with the coating liquid component containing the coating liquid component in Table 4 and the amount, and then the hard fat was added.
  • the magnesium acid mixed hook, tablet, and the punch and die used for tableting are made of stainless steel.
  • Utech RD100 is a poly(meth)acrylic resin
  • Kollicoat IR is a polyvinyl alcohol-polyethylene glycol graft copolymer.
  • Example 14 Example 15 Example 16 Case 17 Case 18 Case 19 Moxifloxacin hydrochloride 54.6 54.6 54.6 218.4 436.8 436.8 Microcrystalline cellulose 17.0 7.1 12.8 88.0 136.0 136.0
  • Microcrystalline cellulose 150 6 mg
  • All the raw materials and auxiliary materials except the magnesium stearate are uniformly mixed, and the granules are prepared by using water. After drying, the magnesium stearate is added and mixed, and the tablet is obtained.
  • the punch and die used for tableting are made of stainless steel.
  • the prepared tablets can be directly packaged in a light-tight seal.
  • Example 2 14 14 Yellow yellow 98.1 97.8 Example 3 15 14 Yellow Yellow 97.8 97.5
  • Example 4 14 14 Yellow Yellow 99.0 99.1
  • Example 5 12 12 Yellow Yellow 100.5 99.3
  • Example 6 12 12 Yellow Yellow 99.0 99.3
  • Example ⁇ 13 13 Yellow Yellow 100.5 98.7
  • Example 8 14 Yellow yellow 98.6 99.9
  • Example 9 14 14 Yellow yellow 98.1 98.5
  • Example 10 14 14 Yellow yellow 98.2 97.1
  • Example 11 13 Yellow yellow 99.2 101.5
  • Example 12 14 15 Yellow yellow 98.3 96.1
  • Implementation Example 14 14 14 Yellow Yellow 99.1 102.5
  • Example 15 14 Yellow Yellow 98.2 98.1
  • Example 16 13 13 Yellow Yellow 99.2 99.5
  • Example 17 14 15 Yellow Yellow 97.3 99.1
  • Example 18 13 13 Yellow Yellow 99.5 101.0
  • Example 19 13 13 Yellow Yellow 98.1 101.3
  • Example 20 14 ⁇ Color Yellow 99.5 100.8 Note: 'Har
  • the dissolution rate was determined according to the first method of the Chinese Pharmacopoeia 2000 edition two appendix XC dissolution method, and the dissolution medium 1M hydrochloric acid solution was rotated at 100 rpm to determine the dissolution value for 45 minutes.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne une formulation orale sous forme de comprimé de moxifloxacine ou de ses sels et/ou hydrates, qui comprend au moins un matériau filmogène utilisé pour l'enrobage des particules intermédiaires. Ledit matériau filmogène peut se composer d'un ou de plusieurs hydroxypropyl méthylcellulose, hydroxyéthylméthylcellulose, méthylcellulose, hydroxypropylcellulose, hydroxyéthylcellulose, carboxyméthylcellulose sodique, résines polyacryliques, polyéthylène glycol, copolymère de polyvinylpyrrolidone/vinylacétate, copolymère greffé PVA-PEG, carbopol, gélatine, poloxamère, polyvinylpyrrolidone. La présente invention concerne également la préparation de ladite formulation, qui comprends les étapes suivantes : mélange ou granulation de la moxifloxacine mélangée aux excipients, enrobage de la substance granulaire intermédiaire au moyen du matériau filmogène, puis compression du mélange. La formulation de comprimé selon cette invention possède une durée de conservation prolongée et présente une dissolution rapide.
PCT/CN2005/001504 2005-09-21 2005-09-21 Formulation orale contenant de la moxifloxacine et son procédé de préparation Ceased WO2007033515A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/CN2005/001504 WO2007033515A1 (fr) 2005-09-21 2005-09-21 Formulation orale contenant de la moxifloxacine et son procédé de préparation

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CN2005/001504 WO2007033515A1 (fr) 2005-09-21 2005-09-21 Formulation orale contenant de la moxifloxacine et son procédé de préparation

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102247313A (zh) * 2010-06-11 2011-11-23 北京润德康医药技术有限公司 一种以莫西沙星为活性成分的口服缓释固体制剂
CN110882281A (zh) * 2019-11-30 2020-03-17 江苏艾兰得营养品有限公司 一种益生菌肠溶片剂及其制备方法
US20210186885A1 (en) * 2016-10-19 2021-06-24 Powder Pharma Coating Inc. Powder coating compositions for coating pharmaceutical pellets

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1160052A (zh) * 1995-12-12 1997-09-24 拜尔公司 一种喹啉羧酸盐酸盐的新结晶型体及其制法和药物制剂
CN1271281A (zh) * 1997-09-25 2000-10-25 拜尔公司 控释活性化合物的药物制剂
CN1325306A (zh) * 1998-11-10 2001-12-05 拜尔公司 莫西沙星药物制剂
WO2005020998A1 (fr) * 2003-09-03 2005-03-10 Ranbaxy Laboratories Limited Compositions pharmaceutiques a base de moxifloxacine et leurs procedes de preparation

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1160052A (zh) * 1995-12-12 1997-09-24 拜尔公司 一种喹啉羧酸盐酸盐的新结晶型体及其制法和药物制剂
CN1271281A (zh) * 1997-09-25 2000-10-25 拜尔公司 控释活性化合物的药物制剂
CN1325306A (zh) * 1998-11-10 2001-12-05 拜尔公司 莫西沙星药物制剂
WO2005020998A1 (fr) * 2003-09-03 2005-03-10 Ranbaxy Laboratories Limited Compositions pharmaceutiques a base de moxifloxacine et leurs procedes de preparation

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102247313A (zh) * 2010-06-11 2011-11-23 北京润德康医药技术有限公司 一种以莫西沙星为活性成分的口服缓释固体制剂
US20210186885A1 (en) * 2016-10-19 2021-06-24 Powder Pharma Coating Inc. Powder coating compositions for coating pharmaceutical pellets
CN110882281A (zh) * 2019-11-30 2020-03-17 江苏艾兰得营养品有限公司 一种益生菌肠溶片剂及其制备方法

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