TW201422224A - Oral composition containing dapoxetine free base - Google Patents

Oral composition containing dapoxetine free base Download PDF

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TW201422224A
TW201422224A TW102133202A TW102133202A TW201422224A TW 201422224 A TW201422224 A TW 201422224A TW 102133202 A TW102133202 A TW 102133202A TW 102133202 A TW102133202 A TW 102133202A TW 201422224 A TW201422224 A TW 201422224A
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dapoxetine
free base
film
product
pharmaceutical product
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TW102133202A
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Chinese (zh)
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Hong-Ryeol Jeon
Bong-Sang Lee
Su-Jun Park
Bong-Geun Cha
Jun-Ki Kim
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Ctc Bio Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/138Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives

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  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
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  • Pharmacology & Pharmacy (AREA)
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  • Organic Chemistry (AREA)
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  • General Chemical & Material Sciences (AREA)
  • Reproductive Health (AREA)
  • Chemical Kinetics & Catalysis (AREA)
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  • Medicinal Preparation (AREA)
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Abstract

The present invention provides a pharmaceutical product that can be orally administered by disintegrating or dissolving in the oral cavity, containing dapoxetine or a pharmaceutically acceptable salt thereof as an active agent, characterized in that the active agent is dapoxetine free base, particularly in the form of films.

Description

含有達泊西汀游離鹼的口腔用組成物 Oral composition containing dapoxetine free base

本發明關於一種口腔用藥物產品,尤其是膜狀形式的口腔用藥物產品,該藥物產品提供快速藥效、改善味道並可在口腔中崩散或溶解。 The present invention relates to an oral pharmaceutical product, particularly a pharmaceutical product in the form of a film which provides rapid efficacy, improves taste and can be broken or dissolved in the oral cavity.

達泊西汀(dapoxetine)及其藥學上可接受的鹽用來治療或改善早洩(premature ejaculation)極為有用(見,美國專利第7,718,705號)。 Dapoxetine and its pharmaceutically acceptable salts are extremely useful for treating or improving premature ejaculation (see, U.S. Patent No. 7,718,705).

例如,早已可在市面上購得的PriligyTM(Janssen Korea公司)便是含有達泊西汀氯鹽(dapoxetine chloride)作為活性成分的錠劑的藥物產品。依據此錠劑的藥劑使用說明書所述,必須佐以至少一整杯水整顆吞服此錠劑以避免嚐到苦味。 For example, already available in the market Priligy TM (Janssen Korea Corporation) is a pharmaceutical product containing Dapoxetine chloride (dapoxetine chloride) as an active ingredient of the lozenges. According to the instructions for use of the tablet, the tablet must be swallowed with at least one full cup of water to avoid bitter taste.

因此,本發明目的是提供一種藥物產品,該藥物產品能展現與習知產品相等的功效兼具較低苦味,並能藉由在 口腔(嘴)中崩散或溶解而用藥。 Accordingly, it is an object of the present invention to provide a pharmaceutical product which exhibits the same efficacy as a conventional product and which has a lower bitter taste and can be The medicine is disintegrated or dissolved in the mouth (mouth).

本發明欲研發一種在口腔中崩散或溶解且含有達泊西汀或藥學上可接受之達泊西汀鹽作為活性成分的產品,相較於習知產品(例如,錠劑或膠囊),該產品能增快該藥物的作用起始時間(onset time)。然而,如市售已知產品的藥物使用說明書所指出般,由於達泊西汀氯鹽的苦味所致,導致實質上很難研發出達泊西汀氯鹽的口腔崩散或溶解產品。 The present invention is intended to develop a product which disintegrates or dissolves in the oral cavity and contains dapoxetine or a pharmaceutically acceptable dapoxetine salt as an active ingredient, compared to conventional products (for example, tablets or capsules). This product can increase the onset time of the drug. However, as indicated by the drug use instructions for commercially available products, it is substantially difficult to develop an orally disintegrating or dissolving product of dapoxetine chloride salt due to the bitter taste of dapoxetine chloride salt.

為了解決此苦味問題,本發明力圖從數種達泊西汀鹽類及達泊西汀游離鹼中研發出達泊西汀的改良劑型,且驚喜地發現,即使是當藉由在口腔中崩散或溶解而經由口腔用藥時,游離鹼形式的達泊西汀展現出改善的味道並能有效治療早洩。 In order to solve this bitterness problem, the present invention seeks to develop an improved dosage form of dapoxetine from several dapoxetine salts and dapoxetine free base, and surprisingly found that even when collapsed in the oral cavity When administered orally or dissolved, the free base form of dapoxetine exhibits an improved taste and is effective in treating premature ejaculation.

因此,本發明提供一種含有達泊西汀或藥學上可接受之達泊西汀鹽作為活性成分並藉著在口腔中崩散或溶解而用藥的藥物產品,該藥物產品的特色是該活性成分是達泊西汀游離鹼(dapoxetine free base)。 Accordingly, the present invention provides a pharmaceutical product comprising dapoxetine or a pharmaceutically acceptable dapoxetine salt as an active ingredient and which is administered by disintegrating or dissolving in the oral cavity, the pharmaceutical product being characterized by the active ingredient It is dapoxetine free base.

較佳地,本發明更甚至是特別用於能夠無需吞嚥,而是藉由在嘴中溶解來獲得所欲功效。 Preferably, the invention is even more particularly useful for obtaining the desired effect by dissolving in the mouth without swallowing.

根據本發明可在口腔中崩散或溶解而經由口腔用藥之藥物產品的形式可為薄膜(例如,口腔用崩散薄膜(ODF))、口腔用崩散錠、咀嚼錠、顆粒(較佳為無需配水服用的顆粒)、糖果錠及飴糖。 The pharmaceutical product which can be disintegrated or dissolved in the oral cavity according to the present invention and which is administered orally can be in the form of a film (for example, an oral disintegrating film (ODF)), an oral disintegrating tablet, a chewable tablet, or a granule (preferably No need to use water to take the particles), candy ingots and sugar.

特別是,取代使用達泊西汀鹽而改用達泊西汀游離 鹼所製成的薄膜產品(例如,ODF)表現出更優越的性質,且容易製備。 In particular, instead of using dapoxetine salt, instead of dapoxetine free A film product made of a base (for example, ODF) exhibits superior properties and is easy to prepare.

因此,本發明提供一種含有達泊西汀或藥學上可接受之達泊西汀鹽作為活性成分的薄膜產品,且該薄膜產品的特色在於該活性成分為達泊西汀游離鹼。 Accordingly, the present invention provides a film product comprising dapoxetine or a pharmaceutically acceptable dapoxetine salt as an active ingredient, and the film product is characterized in that the active ingredient is dapoxetine free base.

在本發明中,該薄膜可稱為片、口腔用溶解膜或口腔用崩散膜,並藉由將該薄膜置於嘴中,例如置於舌上或舌下及口腔黏膜中,且隨後薄膜會溶化而施用該薄膜。本發明的薄膜產品有利於不需要水便能用藥。 In the present invention, the film may be referred to as a sheet, a dissolving film for oral cavity or a disintegrating film for oral cavity, and by placing the film in a mouth, for example, on the tongue or under the tongue and in the oral mucosa, and then the film The film is applied by melting. The film product of the present invention is advantageous for use without the need for water.

本發明提供一種含有達泊西汀游離鹼並能藉由在口腔中崩散或溶解而經由口腔用藥的藥物產品,該藥物產品提供快速藥效及改善的味道。 The present invention provides a pharmaceutical product comprising dapoxetine free base which can be administered orally by disintegration or dissolution in the oral cavity, the pharmaceutical product providing rapid efficacy and improved taste.

較佳地,本發明提供一種含有達泊西汀游離鹼且無需吞嚥而是藉由在口腔中崩散或溶解以經由口腔用藥的藥物產品,該藥物產品提供快速藥效及改善的味道。更佳者,本發明之藥物產品為膜狀形式。 Preferably, the present invention provides a pharmaceutical product comprising dapoxetine free base and which is administered via the oral cavity by disintegrating or dissolving in the oral cavity without swallowing, the pharmaceutical product providing rapid efficacy and improved taste. More preferably, the pharmaceutical product of the invention is in the form of a film.

以下將詳細描述本發明的各種較佳實施例以期更佳地瞭解本發明。然而,可採各種方式修飾本發明實施例,且該等實施例不應被解釋為用來限制本發明範圍。本發明實施例僅供所屬技術領域中具有通常技術者更佳地理解本發明之 用。 Various preferred embodiments of the invention are described in detail below in order to provide a better understanding of the invention. However, the present invention may be modified in various ways, and the embodiments should not be construed as limiting the scope of the invention. The embodiments of the present invention are only for better understanding of the present invention by those skilled in the art. use.

<製備含有達泊西汀的ODF產品> <Preparation of ODF products containing dapoxetine>

根據習知方法使用表1中所列的成分和用量製備含有達泊西汀氯鹽或達泊西汀游離鹼的ODF產品。 ODF products containing dapoxetine chloride or dapoxetine free base were prepared according to conventional methods using the ingredients and amounts listed in Table 1.

明確言之,將塑化劑、甜味劑及界面活性劑加入蒸餾水中且接著攪拌至溶解或分散。將達泊西汀游離鹼或達泊西汀氯鹽加入上述溶液中,並使用均質機(Ultra turrax T-25,IKA)以5000rpm的轉速進行均質20分鐘。於所得溶液中加入聚合物並再次攪拌,隨後在該溶液中加入香料。在真空下抽除該薄膜形成溶液中的氣體後,使該溶液冷卻至室溫,隨後在PE膜上塗佈適當厚度的該溶液。接著,於80℃下進行乾燥以製備含有達泊西汀氯鹽或達泊西汀游離鹼的薄膜產品。將所製備的薄膜產品切成數片,使每片含有33.6毫克(mg)的達泊西汀氯鹽或30毫克的達泊西汀游離鹼。 Specifically, the plasticizer, sweetener, and surfactant are added to distilled water and then stirred until dissolved or dispersed. Dapoxetine free base or dapoxetine chloride salt was added to the above solution and homogenized for 20 minutes at 5000 rpm using a homogenizer (Ultra turrax T-25, IKA). The polymer was added to the resulting solution and stirred again, followed by the addition of perfume to the solution. After the gas in the film forming solution was removed under vacuum, the solution was allowed to cool to room temperature, and then a solution of a suitable thickness was applied to the PE film. Next, drying was carried out at 80 ° C to prepare a film product containing dapoxetine chloride or dapoxetine free base. The prepared film product was cut into several pieces so that each tablet contained 33.6 mg (mg) of dapoxetine chloride salt or 30 mg of dapoxetine free base.

實施例1中所製備之含有達泊西汀游離鹼的薄膜產品在薄膜性質及薄膜加工性(processibility)方面表現極優秀。 The film product containing dapoxetine free base prepared in Example 1 was excellent in film properties and film processability.

<製備含有達泊西汀的顆粒產品> <Preparation of granule products containing dapoxetine>

根據習知方法使用表2中所列的成分和用量製備含有達泊西汀氯鹽或達泊西汀游離鹼的顆粒產品。 Granular products containing dapoxetine chloride or dapoxetine free base were prepared according to conventional methods using the ingredients and amounts listed in Table 2.

明確言之,將適量的聚乙烯吡咯啶酮加入蒸餾水中以獲得黏結溶液。利用流體床造粒機將該黏結溶液噴入流動的活性成分與木糖醇之混合物中以獲得顆粒。使所獲得的顆粒與蔗糖粉混合以最終製備出顆粒產品。 Specifically, an appropriate amount of polyvinylpyrrolidone is added to distilled water to obtain a binding solution. The binder solution is sprayed into a mixture of the flowing active ingredient and xylitol using a fluid bed granulator to obtain granules. The obtained granules are mixed with sucrose powder to finally prepare a granulated product.

<製備含有達泊西汀的口腔用崩散錠> <Preparation of an orally disintegrating ingot containing dapoxetine>

根據習知方法使用表3中所列的成分和用量製備含有達泊西汀氯鹽或達泊西汀游離鹼的口腔用崩散錠。 Oral disintegrating tablets containing dapoxetine chloride or dapoxetine free base were prepared according to conventional methods using the ingredients and amounts listed in Table 3.

明確言之,將API、微晶纖維素、無水磷酸氫鈣、 低取代羥丙基纖維素、甘露糖醇及蔗糖素依上述比例混合,並將硬脂酸鎂加入該已混合的粉末中。所得混合物以8千牛頓(kN)至10千牛頓的壓力打製成錠而製備出200毫克的圓形錠劑。 Specifically, API, microcrystalline cellulose, anhydrous calcium hydrogen phosphate, The low-substituted hydroxypropylcellulose, mannitol, and sucralose are mixed in the above ratio, and magnesium stearate is added to the mixed powder. The resulting mixture was molded into an ingot at a pressure of 8 kilonewtons (kN) to 10 kN to prepare a 200 mg round lozenge.

<製備含有達泊西汀的咀嚼錠> <Preparation of chewable tablets containing dapoxetine>

根據習知方法使用表4中所列的成分和用量製備含有達泊西汀氯鹽或達泊西汀游離鹼的咀嚼錠。 Chewable tablets containing dapoxetine chloride or dapoxetine free base were prepared according to conventional methods using the ingredients and amounts listed in Table 4.

明確言之,將API、單硬脂酸甘油酯、完全糊化澱粉、微晶纖維素、無水檸檬酸、甘露糖醇、阿斯巴甜及薄荷 腦粉末依上述比例混合,並將硬脂酸鎂加入該已混合的粉末中。所得混合物以12kN至15kN的壓力打製成錠而製備出500毫克的圓形錠劑。 Specifically, API, glyceryl monostearate, fully gelatinized starch, microcrystalline cellulose, anhydrous citric acid, mannitol, aspartame and mint The brain powder was mixed in the above ratio, and magnesium stearate was added to the mixed powder. The resulting mixture was molded into an ingot at a pressure of 12 kN to 15 kN to prepare a 500 mg round lozenge.

<苦味測試> <bitter test>

由10位27歲至53歲的成年男性針對實施例1至實施例4及比較例1至比較例4所製備之產品進行味道評估。以1分至5分作為評估等級,5分表示該產品由於無味覺不適之感,故及易入口,1分表示該產品有苦味,故實在難以入口。即,產品味道越好,其分數應越接近5分,表5示出十位男性的總評分。 The taste of the products prepared in Examples 1 to 4 and Comparative Examples 1 to 4 was evaluated by 10 adult males aged 27 to 53 years. A score of 1 to 5 is used as the evaluation grade, and a score of 5 indicates that the product has an unpleasant taste and is easy to enter. One point indicates that the product has a bitter taste, so it is difficult to enter. That is, the better the taste of the product, the closer its score should be to 5 points, and Table 5 shows the total score of ten males.

如表5所示,當使用達泊西汀游離鹼作為活性成分時,出人意料地苦味會降低。 As shown in Table 5, when dapoxetine free base was used as an active ingredient, the bitterness unexpectedly decreased.

<早洩改善的評估> <Evaluation of early ejaculation improvement>

由3位在插入陰道後於兩分鐘內射精的31歲至49歲成年男性進行早洩改善情形的評估。讓每位受試者在進行性行為前約1.5小時使用實施例1或比較例1的薄膜產品,並比較實施例1之產品與比較例1之產品在改善早洩方面的效果(即,比較使用實施例1之產品及比較例1之產品延後射精的持久時間)。 The assessment of premature ejaculation improvement was performed by 3 adult males aged 31 to 49 who ejaculated within two minutes after insertion into the vagina. Each subject was used to use the film product of Example 1 or Comparative Example 1 about 1.5 hours before sexual activity, and the effects of the product of Example 1 and the product of Comparative Example 1 on improving premature ejaculation were compared (ie, comparative use was carried out). The product of Example 1 and the product of Comparative Example 1 were used to delay the ejaculation duration).

結果,實施例1的產品在三位男性身上皆展現出與 比較例1之產品實質相似的早洩改善功效。 As a result, the product of Example 1 exhibited in three males. The product of Comparative Example 1 was substantially similar to the effect of premature ejaculation improvement.

Claims (4)

一種含有達泊西汀或一藥學上可接受之達泊西汀鹽作為一活性成分且藉由在口腔中崩散或溶解而用藥的藥物產品,其中該活性成分是達泊西汀游離鹼(dapoxetine free base)。 A pharmaceutical product comprising dapoxetine or a pharmaceutically acceptable dapoxetine salt as an active ingredient and which is administered by disintegrating or dissolving in the oral cavity, wherein the active ingredient is dapoxetine free base ( Dapoxetine free base). 如請求項1所述之藥物產品,該藥物產品無需吞嚥而是藉由在口腔中溶解以施用藥物。 The pharmaceutical product according to claim 1, which does not need to be swallowed but is administered by dissolving in the oral cavity. 如請求項1所述之藥物產品,該藥物產品的形式為薄膜、口腔崩散錠、咀嚼錠、顆粒、糖果錠或飴糖物。 The pharmaceutical product according to claim 1, which is in the form of a film, an orally disintegrating ingot, a chewable tablet, a granule, a candy ingot or a loquat. 如請求項3所述之藥物產品,該藥物產品的形式為薄膜。 The pharmaceutical product of claim 3, which is in the form of a film.
TW102133202A 2012-09-13 2013-09-13 Oral composition containing dapoxetine free base TW201422224A (en)

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