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WO2016012898A1 - Composition pharmaceutique orale de lurasidone - Google Patents

Composition pharmaceutique orale de lurasidone Download PDF

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Publication number
WO2016012898A1
WO2016012898A1 PCT/IB2015/055249 IB2015055249W WO2016012898A1 WO 2016012898 A1 WO2016012898 A1 WO 2016012898A1 IB 2015055249 W IB2015055249 W IB 2015055249W WO 2016012898 A1 WO2016012898 A1 WO 2016012898A1
Authority
WO
WIPO (PCT)
Prior art keywords
composition
lurasidone
pharmaceutical composition
oral pharmaceutical
water
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/IB2015/055249
Other languages
English (en)
Inventor
Makrand Krishnakumar Avachat
Suchet Shireesh KULKARNI
Tushar Shriram SAWAI
Bipin Raychand GANDHI
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.)
Lupin Ltd
Original Assignee
Lupin 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 Lupin Ltd filed Critical Lupin Ltd
Publication of WO2016012898A1 publication Critical patent/WO2016012898A1/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
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; 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
    • A61K9/2027—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 an oral pharmaceutical composition of lurasidone or pharmaceutically acceptable salts thereof.
  • the invention relates to an oral pharmaceutical composition of lurasidone or pharmaceutically acceptable salts thereof; one or more water- soluble pharmaceutical excipients and a single disintegrating agent wherein the composition is free of starch.
  • the oral pharmaceutical composition of lurasidone or pharmaceutically acceptable salts of the invention exhibits an invariant level of dissolution even when the content of lurasidone or pharmaceutically acceptable salts thereof is varied.
  • Lurasidone is an atypical antipsychotic which belongs to the chemical class of benzisothiazol derivatives and its chemical name is (3a/?,4S,7i?,7aS)-2- ⁇ (li?,2i?)-2-[4-(l ,2-benzisothiazol-3- yl)piperazin-lylmethyl]cyclohexylmethyl ⁇ hexahydro-4,7-methano-2H-isoindole-l ,3-dione.
  • Lurasidone hydrochloride is developed by Dainippon Sumitomo Pharma under the trade name Latuda ® .
  • Latuda ® tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride.
  • Latuda ® tablet contains inactive ingredients which include mannitol, pregelatinized starch, croscarmellose sodium, hypromellose, magnesium stearate, Opadry® and carnauba wax, yellow ferric oxide and FD&C Blue No. 2 Aluminum Lake. US patent No.
  • 7,727,553 discloses a pharmaceutical preparation for oral administration particularly granules, comprising combination of first and second disintegrating agents, a water-soluble excipient and a polymer binder. It also mentions that such granules can rapidly release the active ingredient and can show equivalent dissolution profile even though content of active ingredient are varied in the range of 5 mg to 20 mg or in the range of 5 mg to 40 mg. It further discloses that in order to secure the bioequivalence when a pharmaceutical preparation having different amounts is administered at the same dose, there was issued "Guideline for Bioequivalence testing of Oral Solid Dosage Forms with Different Content" (Notification No. 64 of the Evaluation and Licensing Division, PMSD dated Feb.
  • US patent No. 8,729,085 discloses a composition comprising lurasidone, pregelatinized starch, a water-soluble excipient and water-soluble polymer binder which shows a rapid dissolution and has an equivalent dissolution profile even though contents of the active ingredient therein are varied in the wide range. It further discloses that the preparation which comprises pregelatinized starch can provide an equivalent dissolution profile with higher contents of lurasidone.
  • WO 2012/156981 discloses a pharmaceutical composition comprising lurasidone or salts thereof and one or more water-insoluble pharmaceutical excipients, wherein the composition is free of water-soluble excipients. It further discloses that none of the prior art discloses or teaches or suggests how to develop stable formulations of lurasidone without using water- soluble excipients which can also exhibit rapid or modified disintegration as well as equivalent dissolution profile over wide dose range.
  • Lurasidone has solubility of less than several pg/ml in water and thus can impose a challenge to make a pharmaceutical composition having an equivalent in-vitro dissolution profile over a wide range of lurasidone content.
  • compositions of lurasidone using water- soluble excipients with combination of first and second disintegrating agents discloses pharmaceutical compositions of lurasidone using water- soluble excipients with combination of first and second disintegrating agents.
  • Another prior art teaches the use of only water-insoluble excipients in pharmaceutical compositions of lurasidone.
  • Another prior art essentially involves the use of pregelatinised starch for the pharmaceutical compositions of lurasidone.
  • the present invention provides an oral pharmaceutical composition(s) comprising lurasidone or pharmaceutically acceptable salts thereof; one or more water- soluble pharmaceutical excipients, and a single disintegrating agent, wherein the composition is free of starch.
  • Yet another aspect of invention provides an oral pharmaceutical composition(s) comprising lurasidone or pharmaceutically acceptable salts thereof; one or more water-soluble pharmaceutical excipients and a disintegrating agent consisting essentially of a single disintegrating agent, wherein the composition is free of starch.
  • Yet another aspect of the invention provides an oral pharmaceutical composition(s) comprising lurasidone or pharmaceutically acceptable salts thereof; one or more water- soluble pharmaceutical excipients and a disintegrating agent consisting essentially of a single disintegrating agent, wherein the composition is free of starch and the said composition exhibits an equivalent dissolution even when the content of lurasidone is varied.
  • Yet another aspect of the invention provides an oral pharmaceutical composition(s) comprising lurasidone or pharmaceutically acceptable salts thereof; one or more water- soluble pharmaceutical excipients and a disintegrating agent consisting essentially of a single disintegrating agent, wherein the composition is free of starch and the said composition releases at least 90% within 30 minutes in diluted Mcilvaine buffer of pH 3.8.
  • Yet another aspect of the invention provides an oral pharmaceutical composition(s) comprising lurasidone or pharmaceutically acceptable salts thereof; one or more water- soluble pharmaceutical excipients and a disintegrating agent consisting essentially of a single disintegrating agent, wherein the composition is free of starch and the said composition releases at least 50% within 5 minutes in diluted Mcilvaine buffer of pH 3.8.
  • Yet another aspect of the invention provides an oral pharmaceutical composition(s) is prepared by mixing lurasidone, one or more water-soluble pharmaceutical excipients and a disintegrating agent consisting essentially of a single disintegrating agent, optionally granulating said mixture using a water-soluble binder and further mixing with other pharmaceutically acceptable additives.
  • Fig. 1 shows a comparative dissolution profile of Example 2 (Composition B) with Latuda® 40 mg tablet which contains pregelatinized starch.
  • Fig. 2 shows a comparative dissolution profile of Example 2 (Composition C) with Latuda® 80 mg tablet which contains pregelatinized starch.
  • the present invention provides an oral pharmaceutical composition(s) comprising lurasidone or pharmaceutically acceptable salts thereof; one or more water-soluble pharmaceutical excipients and a single disintegrating agent, wherein the composition is free of starch.
  • Yet another aspect of invention provides an oral pharmaceutical composition(s) comprising lurasidone or pharmaceutically acceptable salts thereof; one or more water-soluble pharmaceutical excipients and a disintegrating agent consisting essentially of a single disintegrating agent, wherein the composition is free of starch.
  • Yet another embodiment of the invention provides an oral pharmaceutical composition(s) comprising lurasidone or pharmaceutically acceptable salts thereof; one or more water- soluble pharmaceutical excipient and a disintegrating agent consisting essentially of a single disintegrating agent, wherein the composition is free of starch and the said composition exhibits an equivalent dissolution even when the content of lurasidone is varied.
  • Yet another embodiment of the invention provides an oral pharmaceutical composition(s) comprising lurasidone or pharmaceutically acceptable salts thereof; one or more water- soluble pharmaceutical excipients and a disintegrating agent consisting essentially of a single disintegrating agent, wherein the composition is free of starch and the said composition releases at least 90% within 30 minutes in diluted Mcilvaine buffer of pH 3.8.
  • Yet another embodiment of the invention provides an oral pharmaceutical composition(s) comprising lurasidone or pharmaceutically acceptable salts thereof; one or more water- soluble pharmaceutical excipients, and a disintegrating agent consisting essentially of a single disintegrating agent, wherein the composition is free of starch, and the said composition releases at least 50% within 5 minutes in diluted Mcilvaine buffer of pH 3.8.
  • Yet another embodiment of the invention provides an oral pharmaceutical composition(s) prepared by mixing lurasidone, one or more water-soluble pharmaceutical excipients and a single disintegrating agent optionally granulating said mixture using a water-soluble binder and further mixing with other pharmaceutically acceptable additives.
  • 'lurasidone' as used herein, includes lurasidone base or it's pharmaceutically acceptable acid addition salts with an organic or inorganic acid.
  • inorganic acid are hydrochloric acid, hydrobromic acid, hydroiodic acid and sulfuric acid.
  • organic acid are acetic acid, oxalic acid, citric acid, malic acid, tartaric acid, maleic acid and fumaric acid.
  • the preferred salt is hydrochloric acid.
  • the term 'lurasidone' may further encompass its pharmaceutically acceptable solvates, hydrates, enantiomers, derivatives, polymorphs and pharmaceutically acceptable pro-drugs thereof.
  • the pharmaceutical composition of present invention comprises about 10 to about 160 mg of lurasidone, preferably about 20 to about 120 mg of lurasidone and more preferably about 40 to about 120 mg of lurasidone.
  • the pharmaceutical composition comprises lurasidone in the range of about 10% to about 50% by weight, preferably in the range of about 20% to about 45% by weight, particularly in the range of about 20% to about 45% by weight on the basis of the total weight of the composition.
  • lurasidone or pharmaceutically acceptable salts may be unmicronised or micronized.
  • Lurasidone used herein may have 90% by volume particles having about 27 ⁇ or less of particle size and preferably 90% by volume particles having about 20 ⁇ or less of particle size. Particle size may be determined by a suitable technique known in the art.
  • One or more water-soluble pharmaceutical excipient is selected from lactose, sucrose, fructo- oligosaccharide, paratinose, glucose, maltose, hydrogenated maltose, maltotetraose, fructose, lactulose, lactitol, honey sugar, sorbitol, mannitol, maltitol, erythritol, xylitol or mixtures thereof.
  • the water-soluble pharmaceutical excipient is mannitol.
  • the water- soluble pharmaceutical excipient is incorporated in the composition in an amount of about 30% to about 65% by weight, preferably about 40% to about 60% by weight on the basis of the total weight of the composition.
  • starch includes but not limited to corn starch, pregelatinized starch or other starch derivatives thereof.
  • free of starch refers to complete absence of starch in the composition.
  • Water-soluble binder includes but not limited to hydroxypropyl cellulose, hydroxypropyl methylcellulose, polyvinylpyrrolidone, polyvinyl alcohol or mixtures thereof. More preferable one includes hydroxypropyl cellulose, hydroxypropyl methylcellulose.
  • the water- soluble binder is incorporated in composition an amount of about 1% to about 10% by weight, preferably about 2% to about 8% by weight on the basis of the total weight of the composition.
  • disintegrant includes but not limited to carmellose, carmellose calcium, carmellose sodium, croscarmellose sodium, cross-linked polyvinylpyrrolidone, sodium starch glycolate, microfine cellulose, low substituted hydroxypropylcellulose, calcium carboxymethyl cellulose, sodium alginate.
  • the disintegrant is used in the composition in an amount of about 2% to about 3 % by weight, preferably about 5% to about 12% by weight on the basis of the total weight of the composition.
  • single disintegrating agent refers to the use of only one disintegrant.
  • the oral pharmaceutical composition can optionally include one or more additives known in the art. These additives include but not limited to fillers, glidants, lubricants and/or wetting agents known in the art.
  • the oral pharmaceutical composition of the present invention can be formulated into granules, tablet, capsule, caplets or mini-tablets.
  • the oral pharmaceutical composition(s) of lurasidone or pharmaceutically acceptable salts thereof may be further coated with a suitable film coating known in the art.
  • the film-coating composition comprises a base material or mixture of base material selected from hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, polyvinyl alcohol.
  • the film-coating composition may further comprise a plasticizer such as polyethylene glycol, propylene glycol, triacetin, triethyl citrate, glycerin, glycerin fatty acid ester, polyethylene glycol or mixtures thereof. If necessary, an additive such as titanium oxide may also be added therein.
  • the oral pharmaceutical composition(s) of lurasidone or pharmaceutically acceptable salts thereof can be prepared by any suitable method known in the art but not limited to direct compression, dry granulation, wet granulation, fluidized bed granulation, spray drying and solution evaporation.
  • the oral pharmaceutical composition(s) of the invention can be prepared by granulating the mixture of lurasidone hydrochloride, one or more water-soluble pharmaceutical excipients, a single disintegrating agent and optionally other pharmaceutical additives by using water soluble binder. Granules thus formed can be compressed in to a tablet dosage form or alternatively can be filled in to capsule dosage form.
  • the oral pharmaceutical composition of lurasidone or pharmaceutically acceptable salts of the invention exhibits an invariant level of dissolution even when the content of lurasidone or pharmaceutically acceptable salts thereof is varied. This invariant dissolution of the composition of the invention is described with the help of similarity factor of dissolution profile.
  • a similarity factor fl shown in Scale-Up and Past-Approval Changes for Intermediate Release Products (SUPAC-IR) is used as an indicative for evaluating a similarity of dissolution profiles.
  • the fl value is calculated by the following equation. It was determined that each manufactured preparation had a similar dissolution profile in case that the fl value calculated from dissolution ratio of each preparation by SUPAC-IR was in the range of 50 ⁇ 2 ⁇ 100. Dissolution ratios at five time points such as 5 min, 10 min, 15 min, 20 min and 30 min after starting the test were used for the calculation of/2 value.
  • Ti and Ri are the percent dissolved of active at each point
  • n is the number of points to be compared.
  • Lurasidone hydrochloride tablets were prepared according to Examples 1 and 2 (Composition
  • Test Media Diluted Mcilvaine buffer, pH 3.8.
  • step 4 Dry the granules of step 3 using fluid bed drier so the loss on dry is within 3% by weight.
  • step 5 Lubricate the dried granules of step 4 with Magnesium stearate.
  • step 4 Dry the granules of step 3 using fluid bed drier so the loss on dry is within 3% by weight.
  • step 5 Lubricate the dried granules of step 4 with Magnesium stearate. 6) Compress the lubricated granules of step 5 into tablet using compression machine & film coat the compressed tablet.
  • Table 1 shows percent release of lurasidone hydrochloride of compositions prepared according to Example 1 and Example 2 (Composition A, B & C)
  • Table 2 shows percent release and f2 value of lurasidone hydrochloride of compositions prepared according to Example 2 (B) and Latuda ® (40 mg tablets)
  • Composition B Latuda® (40 mg tablets)
  • Table 3 shows percent release and f2 value of lurasidone hydrochloride of composition prepared according to Example 2 (C) and Latuda ® (80 mg tablets) Table 3
  • composition B and Composition C Each film coated tablets (Composition B and Composition C) comprising 40 and 80 mg lurasidone hydrochloride of Example 2 and Latuda® 80 mg tablets were subjected to above mentioned dissolution test and a similarity of each dissolution profile was evaluated by determining fl value as shown in table 2 and 3.
  • the pharmaceutical composition has similar dissolution profile in comparison to Latuda® tablets.
  • the pharmaceutical compositions of current invention do not contain starch and exhibit invariant dissolution profile across the wide content of lurasidone hydrochloride which is evident by/2 value as mentioned in table 2 and 3.
  • fl value obtained for Example 2 (Composition B and Composition C) showed similar dissolution profile to the Latuda® 40 and 80 mg tablet containing pregelatinized starch.
  • figure 1 and figure 2 which reflect similarity of the dissolution profile of composition of the current invention without relying upon lurasidone hydrochloride content in tablets and such compositions are also free of starch.
  • the pharmaceutical compositions of current invention have similar dissolution profile in comparison to Latuda® tablets.
  • the compositions of current invention do not contain starch and exhibit invariant dissolution profile across the wide content of lurasidone.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne une composition pharmaceutique orale comprenant de la lurasidone ou des sels pharmaceutiquement acceptables de celle-ci ; un ou plusieurs excipients pharmaceutiques hydrosolubles, un agent délitant essentiellement constitué d'un agent délitant unique. La composition est exempte d'amidon. La présente composition pharmaceutique orale de lurasidone ou des sels pharmaceutiquement acceptables de l'invention présentent un taux invariable de dissolution, même lorsque la teneur en lurasidone ou des sels pharmaceutiquement acceptables de celle-ci est amenée à varier.
PCT/IB2015/055249 2014-07-25 2015-07-11 Composition pharmaceutique orale de lurasidone Ceased WO2016012898A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN2410MU2014 2014-07-25
IN2410/MUM/2014 2014-07-25

Publications (1)

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WO2016012898A1 true WO2016012898A1 (fr) 2016-01-28

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107362144A (zh) * 2017-08-03 2017-11-21 华侨大学 一种鲁拉西酮脑靶向脂质体注射剂及其制备方法
EP3318279A1 (fr) 2016-11-02 2018-05-09 Sanovel Ilac Sanayi ve Ticaret A.S. Compositions pharmaceutiques orales solides de chlorhydrate de lurasidone
CN108567758A (zh) * 2017-03-08 2018-09-25 湖南洞庭药业股份有限公司 盐酸鲁拉西酮片剂及其制备方法
CN116077451A (zh) * 2023-01-31 2023-05-09 深圳市泛谷药业股份有限公司 一种盐酸鲁拉西酮口崩片及其制备方法

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5532372A (en) 1990-07-06 1996-07-02 Sumitomo Pharmaceuticals Company, Ltd. Imide derivatives, and their production and use
EP1884242A1 (fr) * 2005-05-26 2008-02-06 Dainippon Sumitomo Pharma Co., Ltd. Composition pharmaceutique
US7727553B2 (en) 2000-09-22 2010-06-01 Dainippon Sumitomo Pharma Co., Ltd. Oral preparations with favorable disintegration characteristics
WO2012156981A1 (fr) 2011-05-13 2012-11-22 Cadila Healthcare Limited Compositions pharmaceutiques de lurasidone
CN103006661A (zh) * 2012-12-06 2013-04-03 江苏先声药物研究有限公司 一种含有盐酸鲁拉西酮的制剂及其制备方法
CN103751139A (zh) * 2013-12-31 2014-04-30 北京万全德众医药生物技术有限公司 鲁拉西酮口腔崩解片
WO2014076712A2 (fr) * 2012-11-14 2014-05-22 Hetero Research Foundation Dispersion solide de chlorhydrate de lurasidone
CN104248769A (zh) * 2013-06-25 2014-12-31 石药集团中奇制药技术（石家庄）有限公司 一种鲁拉西酮药物组合物及其制备方法
CN104337790A (zh) * 2014-11-02 2015-02-11 石家庄四药有限公司 盐酸鲁拉西酮口服制剂及其制备方法

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5532372A (en) 1990-07-06 1996-07-02 Sumitomo Pharmaceuticals Company, Ltd. Imide derivatives, and their production and use
US7727553B2 (en) 2000-09-22 2010-06-01 Dainippon Sumitomo Pharma Co., Ltd. Oral preparations with favorable disintegration characteristics
EP1884242A1 (fr) * 2005-05-26 2008-02-06 Dainippon Sumitomo Pharma Co., Ltd. Composition pharmaceutique
US8729085B2 (en) 2005-05-26 2014-05-20 Dainippon Sumitomo Pharma Co., Ltd. Pharmaceutical composition
WO2012156981A1 (fr) 2011-05-13 2012-11-22 Cadila Healthcare Limited Compositions pharmaceutiques de lurasidone
WO2014076712A2 (fr) * 2012-11-14 2014-05-22 Hetero Research Foundation Dispersion solide de chlorhydrate de lurasidone
CN103006661A (zh) * 2012-12-06 2013-04-03 江苏先声药物研究有限公司 一种含有盐酸鲁拉西酮的制剂及其制备方法
CN104248769A (zh) * 2013-06-25 2014-12-31 石药集团中奇制药技术（石家庄）有限公司 一种鲁拉西酮药物组合物及其制备方法
CN103751139A (zh) * 2013-12-31 2014-04-30 北京万全德众医药生物技术有限公司 鲁拉西酮口腔崩解片
CN104337790A (zh) * 2014-11-02 2015-02-11 石家庄四药有限公司 盐酸鲁拉西酮口服制剂及其制备方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
"Guideline for Bioequivalence testing of Oral Solid Dosage Forms with Different Content", NOTIFICATION NO. 64 OF THE EVALUATION AND LICENSING DIVISION, PMSD, 14 February 2000 (2000-02-14)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3318279A1 (fr) 2016-11-02 2018-05-09 Sanovel Ilac Sanayi ve Ticaret A.S. Compositions pharmaceutiques orales solides de chlorhydrate de lurasidone
WO2018083117A1 (fr) 2016-11-02 2018-05-11 Sanovel Ilac Sanayi Ve Ticaret A.S. Compositions pharmaceutiques orales solides de chlorhydrate de lurasidone
CN108567758A (zh) * 2017-03-08 2018-09-25 湖南洞庭药业股份有限公司 盐酸鲁拉西酮片剂及其制备方法
CN107362144A (zh) * 2017-08-03 2017-11-21 华侨大学 一种鲁拉西酮脑靶向脂质体注射剂及其制备方法
CN107362144B (zh) * 2017-08-03 2020-04-17 华侨大学 一种鲁拉西酮脑靶向脂质体注射剂及其制备方法
CN116077451A (zh) * 2023-01-31 2023-05-09 深圳市泛谷药业股份有限公司 一种盐酸鲁拉西酮口崩片及其制备方法

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