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WO2013077533A1 - Comprimés de citrate de sildénafil à croquer dans lesquels l'amertume est masquée, et procédé de fabrication associé - Google Patents

Comprimés de citrate de sildénafil à croquer dans lesquels l'amertume est masquée, et procédé de fabrication associé Download PDF

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Publication number
WO2013077533A1
WO2013077533A1 PCT/KR2012/006856 KR2012006856W WO2013077533A1 WO 2013077533 A1 WO2013077533 A1 WO 2013077533A1 KR 2012006856 W KR2012006856 W KR 2012006856W WO 2013077533 A1 WO2013077533 A1 WO 2013077533A1
Authority
WO
WIPO (PCT)
Prior art keywords
sildenafil citrate
chewable
weight
comparative example
tablet
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/KR2012/006856
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English (en)
Korean (ko)
Inventor
최연웅
민병구
조상민
기도형
이병훈
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.)
Korea United Pharm Inc
Original Assignee
Korea United Pharm Inc
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 Korea United Pharm Inc filed Critical Korea United Pharm Inc
Publication of WO2013077533A1 publication Critical patent/WO2013077533A1/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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • 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

Definitions

  • the present invention relates to a method for preparing chewable tablets of sildenafil citrate which is easy to take as a therapeutic agent for erectile dysfunction and is masked by bitter taste.
  • sildenafil is 1 [[3- (6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl) -4- Sildenafil and its pharmaceutically acceptable salts with ethoxyphenyl] sulfonyl] -4-methylpiperazine are described in European Patent Publication No. 0463756.
  • Sildenafil acts as a selective inhibitor of cyclic guanosine 3'5'-monophosphate phosphodiesterase type 5 (cGMP PDE5) and can be used for the treatment of impotence in Korean Patent No. 10-0262926. Yes is described.
  • cGMP PDE5 cyclic guanosine 3'5'-monophosphate phosphodiesterase type 5
  • it is commercially available as an oral tablet formulated using a form of citrate salt with improved solubility and absorption for oral administration of the substance (Viagra, Pfizer).
  • the citrate salt of sildenafil is easy to administer with water in the form of a film-coated tablet, but it is difficult to formulate it into a liquid, gum, oral disintegrating tablet, and chewed tablet which are convenient to take due to the bitter taste in the oral cavity.
  • Korean Patent Publication No. 10-1999-0017127 discloses a porous tablet using a free base of sildenafil.
  • the formulations do not feel bitter in the oral cavity due to the low solubility of sildenafil free base, but have a limitation of low bioavailability due to the low solubility and absorption of sildenafil free base.
  • Korean Patent No. 10-0435514 describes a method for improving the bitter taste of sildenafil citrate salt using sildenafil lactate.
  • Korean Patent No. 10-0344198 describes a method of formulating by masking the bitter taste of sildenafil citrate salt using a sweetening agent, a copulating agent, a flavoring agent, a masking agent, and the like. However, this method does not completely mask the bitter taste of sildenafil citrate salt.
  • the present invention has the object of developing a formulation that improves compliance with medication by developing a chewable tablet that is completely unmasked when taken by completely masking the bitter taste of sildenafil citrate salt and is easy to administer.
  • a sildenafil citrate chewable tablet in which a bitter taste is masked using an additional cyclic group after the mask is bitter using an ion exchange resin having a carboxyl group.
  • the additive is characterized in that it comprises 10 to 70% by weight of the total weight of the chewable tablet.
  • polyvinylpyrrolidone polyvinylpyrrolidone, copolymers of vinylpyrrolidone and vinyl acetate, hydroxypropylcellulose, hydroxypropylmethylcellulose, gum arabic, xanthan gum, sodium alginate and water dispersibility
  • binders selected from the group consisting of starch is characterized in that it comprises 0.5 to 20% by weight of the total weight of chewable tablets.
  • one or two or more disintegrants selected from the group consisting of crosslinked polyvinylpyrrolidone, crosslinked carboxymethylcellulose, sodium starch glycolate and calcium carboxymethylcellulose It is characterized in that it comprises 0.5 to 30% by weight of the total weight of the chewable tablets.
  • the sildenafil citrate which is the active ingredient sildenafil citrate salt, ion exchange resin and cyclodextrin by reacting in a solvent to mask the bitter taste and then tableting immediately after mixing without going through a separate process Provides a method of manufacturing cheongjeong.
  • the chewable tablets of sildenafil citrate salt prepared according to the present invention are expected to be very useful when administered to a patient because of rapid dissolution and bitter taste in terms of masking, and ease of taking.
  • the present invention is characterized by providing a chewable tablet that is easy to take by masking the bitter taste of sildenafil citrate salt, a PDE-5 (phosphodiesterase-5) inhibitor, as an active ingredient.
  • sildenafil citrate salt having a bitter taste is adsorbed to an ion exchange resin having a carboxyl group, the drug is not released in the oral cavity and the drug is released by exchanging the drug with other ions in the digestive tract so that the bitter taste is not felt in the oral cavity. It is possible to take the drug.
  • the inclusion of the sildenafil citrate salt was performed together with the cyclodextrin. As a result, it has been found that the masking of bitterness is more complete and the dissolution rate is improved. In addition, by reducing the amount of ion exchange resin used to improve the fluidity and compressibility was also able to solve the process problems.
  • the sildenafil citrate salt used as an active ingredient in the present invention may contain 25 to 100 mg of sildenafil per tablet.
  • the ion exchange resin contains 10 to 30% by weight, preferably 13 to 20% by weight of the total formulation, and cyclodextrin contains 5 to 40% by weight, preferably 10 to 20% by weight of the total formulation. Good to do.
  • the chewable tablet of the present invention contains a saccharide, a binder, a disintegrant, a flavoring agent, a sweetening agent, a lubricant, and the like, which are commonly used in the art as a pharmaceutically acceptable carrier for preparing the formulation.
  • the sugar is an important ingredient that affects the dissolution and absorption of the active ingredient, as well as sweetness, solubility, and touch in the mouth, and should have a good taste, feel, and water solubility in the oral cavity, and the mouth size should be small enough to be free from foreign substances.
  • Sugars that can be used include lactose, mannitol, sorbitol, xylitol, erythritol, glucose, sucrose, fructose, rebulose, maltodextrin, paratinose and the like.
  • the saccharide preferably contains 10 to 70% by weight, preferably 20 to 50% by weight of the total formulation.
  • the binder is a component necessary to exhibit strength in the chewable tablet of the present invention and is used for the purpose of maintaining the shape of the product during handling and storage of the product.
  • polyvinylpyrrolidone, copolymers of vinylpyrrolidone and vinyl acetate, hydroxypropyl cellulose, hydroxypropylmethylcellulose, gum arabic, xanthan gum, sodium alginate, water-dispersible starch and derivatives may be used.
  • the binder is preferably contained 0.5 to 20% by weight, preferably 1 to 10% by weight of the total formulation.
  • the disintegrant component is a component for quickly disintegrating the chewable tablet of the present invention is an important component in the dissolution, absorption of the active ingredient.
  • cross-linked polyvinylpyrrolidone cross-linked carboxymethyl cellulose, sodium starch glycolate, calcium carboxymethyl cellulose, and the like may be used, and preferably cross-linked carboxymethyl cellulose is used.
  • the disintegrant preferably contains 0.5 to 30% by weight, preferably 2 to 10% by weight of the total formulation.
  • the chewable tablet according to the present invention in addition to the above components in the range that does not impair the effects of the present invention, for example, lubricant components such as magnesium stearate, talc, sodium stearyl fumarate and aspartame, stevioside, sucralose Sweeteners, strawberry flavors, blueberry flavors, orange flavors such as flavoring agents, blue No. 1, yellow No. 4, red No. 2 and other colorants may be further included as a pharmaceutical additive to aid in formulating. .
  • lubricant components such as magnesium stearate, talc, sodium stearyl fumarate and aspartame, stevioside, sucralose Sweeteners, strawberry flavors, blueberry flavors, orange flavors such as flavoring agents, blue No. 1, yellow No. 4, red No. 2 and other colorants may be further included as a pharmaceutical additive to aid in formulating. .
  • a chewable tablet was prepared using the above ingredients. Manufacturing process 1
  • the chewable tablet was manufactured through the tableting step.
  • the selection of a suitable solvent for the shielding and the bonding liquid is relatively free, whereas in the preparation process 2 1, the solvent which can be used as the bonding liquid at the same time as the shielding of the main components should be selected.
  • the amount is bound to be limited.
  • the inventors prepared a chewable tablet by mixing the shielded main component, ion exchange resin, and beta-cyclodextrin with excipients without tableting. This manufacturing process 3
  • a chewable tablet was prepared by the step of tableting.
  • sildenafil citrate The chewable tablets of sildenafil citrate were prepared according to Preparation 3 using the ingredients and contents shown in Table 1 below.
  • Sildenafil citrate, polyacrylic potassium and beta-cyclodextrin are dispersed in purified water (0.5 g per tablet) using a stirrer and shielded. It is left to stand for 8 hours and then dried at 50 ° C. After drying, the mixture was formed into a No. 20 sieve and mixed with mannitol, hydroxypropyl cellulose, croscarmellose sodium, stevioside, blueberry flavored Lac, and magnesium stearate.
  • the strength at the time of tableting is 7 to 12 KP.
  • Example 1 Sildenafil Citrate 140.45 140.45 Polyacrylic potassium 100.00 140.00 Beta-cyclodextrin 70.00 70.00 Mannitol 247.55 207.55 Hydroxypropyl cellulose 10.00 10.00 Croscarmellose Sodium 48.00 48.00 Stevioside 2.00 2.00 Blueberry Flavored Coton 2.00 2.00 Magnesium stearate 14.00 14.00 Total weight 634.00 634.00
  • a chewable tablet of sildenafil citrate salt was prepared according to Preparation Process 1, using the same ingredients and contents as in Example 1 described in Table 1.
  • Sildenafil citrate, polyacrylic potassium and beta-cyclodextrin are dispersed in purified water (0.5 g per tablet) using a stirrer and shielded. It is left to stand for 8 hours and then dried at 50 ° C.
  • the mixture was formed into a No. 20 sieve, mannitol, half croscarmellose sodium, and blueberry flavored Lacs were mixed, and hydroxypropyl cellulose was dissolved in purified water (0.1 g per tablet) and added.
  • Granules were granulated to 1.5 ⁇ using a granulator, then dried at 50 ° C., sieved to No. 20, and then mixed with stevioside and magnesium stearate and compressed into tablets.
  • the strength at the time of tableting is 7 to 12 KP.
  • a chewable tablet of sildenafil citrate salt was prepared in Preparation Process 2, using the same ingredients and contents as in Example 1, described in Table 1.
  • Sildenafil citrate, polyacrylic potassium and beta-cyclodextrin are dispersed in 80% ethanol (w / w, 0.35 g per tablet) using a stirrer, shielded and hydroxypropylcellulose is added to form a binding solution. After 8 hours, the binding solution is added to the mixture of mannitol, half croscarmellose sodium and blueberry flavored Lac.
  • Granules were granulated to 1.5 ⁇ using a granulator, then dried at 50 ° C., sieved to No. 20, and then mixed with stevioside and magnesium stearate and compressed into tablets. The strength at the time of tableting is 7 to 12 KP.
  • the dissolution test of sildenafil citrate salt was carried out as follows.
  • Dissolution method Method 1 of dissolution test of Korea Pharmacopoeia (Basket method)
  • UV wavelength 290 nm
  • Example 1 and Example 2 prepared by chewing tablet using polyacrylic potassium and beta-cyclodextrin was completely masked bitter taste, the yield was high as 97%, The dissolution rate was also higher than that of the comparative example.
  • the chewable tablets of sildenafil citrate salt prepared according to the present invention are expected to be very useful when administered to a patient because of the quickness of dissolution and bitter taste in terms of masking and ease of taking.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne un procédé de fabrication de comprimés à croquer de citrate de sildénafil - un agent thérapeutique pour le dysfonctionnement érectile ‑, dans lesquels l'amertume du citrate de sildénafil est masquée et qui sont faciles à prendre. L'invention porte en outre sur des comprimés de citrate de sildénafil à croquer dans lesquels l'amertume est masquée grâce à l'utilisation d'une résine échangeuse d'ions possédant un groupe carboxyle. Lesdits comprimés de sel de citrate de sildénafil à croquer fabriqués selon la présente invention sont excellents en termes de rapidité d'élution et de dissimulation de l'amertume, et sont faciles à prendre ; ils peuvent donc se révéler très utiles en étant administrés à des patients.
PCT/KR2012/006856 2011-11-25 2012-08-28 Comprimés de citrate de sildénafil à croquer dans lesquels l'amertume est masquée, et procédé de fabrication associé Ceased WO2013077533A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR10-2011-0124019 2011-11-25
KR1020110124019A KR20130058160A (ko) 2011-11-25 2011-11-25 쓴맛이 차폐된 실데나필 시트레이트의 저작정 및 이의 제조방법

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WO2013077533A1 true WO2013077533A1 (fr) 2013-05-30

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Country Status (2)

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KR (1) KR20130058160A (fr)
WO (1) WO2013077533A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112826802A (zh) * 2021-01-22 2021-05-25 上海普康药业有限公司 一种枸橼酸西地那非咀嚼片及其制备方法
CN113413388A (zh) * 2021-06-30 2021-09-21 上海奥全生物医药科技有限公司 含有枸橼酸西地那非的药物组合物、制备方法及其应用

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107536045A (zh) * 2017-03-04 2018-01-05 江苏省中国科学院植物研究所 一种蓝莓咀嚼片及其加工方法
KR101878599B1 (ko) * 2017-03-28 2018-07-13 전북대학교산학협력단 메틸설포닐메테인과 만니톨의 흡수촉진 및 고미감소를 위한 공침조성물과 이의 제조방법

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20010036527A (ko) * 1999-10-08 2001-05-07 우재영 실데나필 시트레이트의 속효제형
WO2004017976A1 (fr) * 2002-08-21 2004-03-04 Phoqus Pharmaceuticals Limited, Forme psologique orale a gout masque, a dissolution rapide et comprenant du sildenafil
US20070092553A1 (en) * 2005-10-21 2007-04-26 Pfab Lp Compositions and methods of making rapidly dissolving lonically masked formulations
WO2009074995A1 (fr) * 2007-12-10 2009-06-18 Ajanta Pharma Limited Compositions à croquer de citrate de sildénafil au goût masqué
KR20100138768A (ko) * 2009-06-25 2010-12-31 (주)차바이오앤디오스텍 불쾌한 맛을 효과적으로 은폐한 경구용 속용 필름
WO2011030351A2 (fr) * 2009-09-03 2011-03-17 Rubicon Research Private Limited Compositions pharmaceutiques au goût masqué

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20010036527A (ko) * 1999-10-08 2001-05-07 우재영 실데나필 시트레이트의 속효제형
WO2004017976A1 (fr) * 2002-08-21 2004-03-04 Phoqus Pharmaceuticals Limited, Forme psologique orale a gout masque, a dissolution rapide et comprenant du sildenafil
US20070092553A1 (en) * 2005-10-21 2007-04-26 Pfab Lp Compositions and methods of making rapidly dissolving lonically masked formulations
WO2009074995A1 (fr) * 2007-12-10 2009-06-18 Ajanta Pharma Limited Compositions à croquer de citrate de sildénafil au goût masqué
KR20100138768A (ko) * 2009-06-25 2010-12-31 (주)차바이오앤디오스텍 불쾌한 맛을 효과적으로 은폐한 경구용 속용 필름
WO2011030351A2 (fr) * 2009-09-03 2011-03-17 Rubicon Research Private Limited Compositions pharmaceutiques au goût masqué

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112826802A (zh) * 2021-01-22 2021-05-25 上海普康药业有限公司 一种枸橼酸西地那非咀嚼片及其制备方法
CN113413388A (zh) * 2021-06-30 2021-09-21 上海奥全生物医药科技有限公司 含有枸橼酸西地那非的药物组合物、制备方法及其应用
CN113413388B (zh) * 2021-06-30 2022-11-15 上海奥全生物医药科技有限公司 含有枸橼酸西地那非的药物组合物、制备方法及其应用

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