US20140322296A1 - Piperaquine microcapsules and compositions containing them - Google Patents

Piperaquine microcapsules and compositions containing them Download PDF

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Publication number
US20140322296A1
US20140322296A1 US14/222,102 US201414222102A US2014322296A1 US 20140322296 A1 US20140322296 A1 US 20140322296A1 US 201414222102 A US201414222102 A US 201414222102A US 2014322296 A1 US2014322296 A1 US 2014322296A1
Authority
US
United States
Prior art keywords
composition
sample
drug
microcapsule
polymeric 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.)
Abandoned
Application number
US14/222,102
Other languages
English (en)
Inventor
Christian Stollberg
Giancarla Bianchi
Flavio Fabiani
Luigi Boltri
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.)
Adare Pharma Solutions Inc
Original Assignee
Aptalis Pharma SRL
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 Aptalis Pharma SRL filed Critical Aptalis Pharma SRL
Priority to US14/222,102 priority Critical patent/US20140322296A1/en
Assigned to APTALIS PHARMA S.R.L reassignment APTALIS PHARMA S.R.L ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BIANCHI, Giancarla, BOLTRI, LUIGI, STOLLBERG, CHRISTIAN, FABIANI, FLAVIO
Publication of US20140322296A1 publication Critical patent/US20140322296A1/en
Assigned to APTALIS PHARMA LTD reassignment APTALIS PHARMA LTD CHANGE OF NAME (SEE DOCUMENT FOR DETAILS). Assignors: APTALIS PHARMA SRL
Assigned to APTALIS PHARMATECH, INC. reassignment APTALIS PHARMATECH, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: APTALIS PHARMA LIMITED
Assigned to ADARE PHARMACEUTICALS, INC. reassignment ADARE PHARMACEUTICALS, INC. CHANGE OF NAME (SEE DOCUMENT FOR DETAILS). Assignors: APTALIS PHARMATECH, INC.
Assigned to ADARE PHARMACEUTICALS S.R.L reassignment ADARE PHARMACEUTICALS S.R.L CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNEE NAME PREVIOUSLY RECORDED AT REEL: 036470 FRAME: 0586. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Assignors: APTALIS PHARMA LIMITED
Abandoned legal-status Critical Current

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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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/009—Sachets, pouches characterised by the material or function of the envelope
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5089—Processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00—Antiparasitic agents
    • A61P33/02—Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis
    • A61P33/06—Antimalarials
    • 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
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Definitions

  • references to bisquinoline drug or piperaquine (PQ) or piperaquine phosphate (PQP) also encompasses a salt, solvate, or prodrug thereof; it is also intended for esters, racemic form, enantiomers, diastereomers, polymorphs, hydrates, or hyper-hydrate thereof.
  • the average coating weight of the microcapsules of the present invention is preferably from about 10% w/w to about 20% w/w.
  • the microcapsules have an average coating weight of preferably about 10% w/w, or about 15% w/w, or about 20% w/w.
  • the amount of residual solvent (cyclohexane) is always below 100 ppm for all preparation of microcapsules prepared.

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (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)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Inorganic Chemistry (AREA)
US14/222,102 2013-03-22 2014-03-21 Piperaquine microcapsules and compositions containing them Abandoned US20140322296A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US14/222,102 US20140322296A1 (en) 2013-03-22 2014-03-21 Piperaquine microcapsules and compositions containing them

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361804448P 2013-03-22 2013-03-22
US14/222,102 US20140322296A1 (en) 2013-03-22 2014-03-21 Piperaquine microcapsules and compositions containing them

Publications (1)

Publication Number Publication Date
US20140322296A1 true US20140322296A1 (en) 2014-10-30

Family

ID=51789429

Family Applications (2)

Application Number Title Priority Date Filing Date
US14/779,215 Active US9668979B2 (en) 2013-03-22 2014-03-21 Piperaquine microcapsules and compositions containing them
US14/222,102 Abandoned US20140322296A1 (en) 2013-03-22 2014-03-21 Piperaquine microcapsules and compositions containing them

Family Applications Before (1)

Application Number Title Priority Date Filing Date
US14/779,215 Active US9668979B2 (en) 2013-03-22 2014-03-21 Piperaquine microcapsules and compositions containing them

Country Status (14)

Country Link
US (2) US9668979B2 (ja)
EP (1) EP2976069B1 (ja)
JP (1) JP6345762B2 (ja)
KR (1) KR20150133267A (ja)
CN (1) CN105228597B (ja)
AU (1) AU2014234258B2 (ja)
BR (1) BR112015024359B1 (ja)
CA (1) CA2907628C (ja)
ES (1) ES2809254T3 (ja)
MX (1) MX354453B (ja)
PL (1) PL2976069T3 (ja)
PT (1) PT2976069T (ja)
SG (2) SG10201706609XA (ja)
WO (1) WO2014147242A1 (ja)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10441554B2 (en) 2017-03-10 2019-10-15 Adare Pharmaceuticals, Inc. Oral amphetamine composition

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104814931B (zh) * 2015-04-14 2017-12-26 华南农业大学 一种喹乙醇缓释颗粒及其制备方法和应用
CN114343230B (zh) * 2022-02-10 2023-05-12 湖北中烟工业有限责任公司 一种薄片添加剂、其制备方法及含有该薄片添加剂的烟草薄片

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090092672A1 (en) * 2007-07-02 2009-04-09 Venkatesh Gopi M Orally disintegrating tablet compositions of lamotrigine

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7618651B2 (en) * 2004-06-24 2009-11-17 Idexx Laboratories Pharmaceutical compositions for drug delivery and methods of treating or preventing conditions using same
PL1898901T3 (pl) * 2005-05-18 2017-07-31 Sun Pharmaceutical Industries Limited Stabilne postacie dawkowania spiro i dispiro 1, 2, 4-trioksolanowych związków przeciwmalarycznych
MX2012006240A (es) * 2009-12-02 2012-10-03 Aptalis Pharma Ltd Microcapsulas de fexofenadina y composiciones que contienen las mismas.

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090092672A1 (en) * 2007-07-02 2009-04-09 Venkatesh Gopi M Orally disintegrating tablet compositions of lamotrigine

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10441554B2 (en) 2017-03-10 2019-10-15 Adare Pharmaceuticals, Inc. Oral amphetamine composition
US11160772B2 (en) 2017-03-10 2021-11-02 Adare Pharmaceuticals, Inc. Oral amphetamine composition
US11896562B2 (en) 2017-03-10 2024-02-13 Adare Pharmaceuticals, Inc. Oral amphetamine composition

Also Published As

Publication number Publication date
BR112015024359B1 (pt) 2022-09-13
CN105228597A (zh) 2016-01-06
JP2016514720A (ja) 2016-05-23
WO2014147242A8 (en) 2015-11-05
CA2907628C (en) 2021-11-16
AU2014234258A1 (en) 2015-10-08
ES2809254T3 (es) 2021-03-03
EP2976069A1 (en) 2016-01-27
CA2907628A1 (en) 2014-09-25
BR112015024359A2 (pt) 2017-07-18
EP2976069B1 (en) 2020-05-06
JP6345762B2 (ja) 2018-06-20
PT2976069T (pt) 2020-08-05
MX2015013470A (es) 2016-06-02
KR20150133267A (ko) 2015-11-27
PL2976069T3 (pl) 2020-10-19
SG11201507843TA (en) 2015-10-29
US20160045447A1 (en) 2016-02-18
WO2014147242A1 (en) 2014-09-25
MX354453B (es) 2018-03-05
AU2014234258B2 (en) 2019-02-14
CN105228597B (zh) 2019-03-26
US9668979B2 (en) 2017-06-06
SG10201706609XA (en) 2017-09-28

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AS Assignment

Owner name: APTALIS PHARMA S.R.L, ITALY

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:STOLLBERG, CHRISTIAN;BIANCHI, GIANCARLA;FABIANI, FLAVIO;AND OTHERS;SIGNING DATES FROM 20140512 TO 20140513;REEL/FRAME:033394/0034

AS Assignment

Owner name: APTALIS PHARMA LTD, IRELAND

Free format text: CHANGE OF NAME;ASSIGNOR:APTALIS PHARMA SRL;REEL/FRAME:034184/0161

Effective date: 20141105

AS Assignment

Owner name: APTALIS PHARMATECH, INC., NEW JERSEY

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:APTALIS PHARMA LIMITED;REEL/FRAME:036470/0586

Effective date: 20150401

AS Assignment

Owner name: ADARE PHARMACEUTICALS, INC., NEW JERSEY

Free format text: CHANGE OF NAME;ASSIGNOR:APTALIS PHARMATECH, INC.;REEL/FRAME:041939/0985

Effective date: 20150429

AS Assignment

Owner name: ADARE PHARMACEUTICALS S.R.L, ITALY

Free format text: CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNEE NAME PREVIOUSLY RECORDED AT REEL: 036470 FRAME: 0586. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT;ASSIGNOR:APTALIS PHARMA LIMITED;REEL/FRAME:042747/0301

Effective date: 20150401

STCB Information on status: application discontinuation

Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION