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IN2013DE03085A - - Google Patents

Info

Publication number
IN2013DE03085A
IN2013DE03085A IN3085DE2013A IN2013DE03085A IN 2013DE03085 A IN2013DE03085 A IN 2013DE03085A IN 3085DE2013 A IN3085DE2013 A IN 3085DE2013A IN 2013DE03085 A IN2013DE03085 A IN 2013DE03085A
Authority
IN
India
Prior art keywords
manufacturing
ophthalmic
formulation
present
pharmaceutical
Prior art date
Application number
Inventor
V Shah Mandar
Bahri Deepak
Original Assignee
Sentiss Pharma Private 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 Sentiss Pharma Private Ltd filed Critical Sentiss Pharma Private Ltd
Priority to EP14811969.6A priority Critical patent/EP3057576A1/en
Priority to UAA201603600A priority patent/UA116273C2/en
Priority to US15/028,930 priority patent/US9801813B2/en
Priority to PCT/IB2014/065262 priority patent/WO2015056149A1/en
Priority to IN3085DE2013 priority patent/IN2013DE03085A/en
Priority to CA2924562A priority patent/CA2924562A1/en
Priority to EA201690532A priority patent/EA030535B1/en
Publication of IN2013DE03085A publication Critical patent/IN2013DE03085A/en

Links

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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • 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
    • A61K31/38—Heterocyclic compounds having sulfur as a ring hetero atom
    • A61K31/382—Heterocyclic compounds having sulfur as a ring hetero atom having six-membered rings, e.g. thioxanthenes
    • 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
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • 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
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
    • 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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/38—Cellulose; 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/06—Antiglaucoma agents or miotics

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The present invention relates to a process for manufacturing an ophthalmic formulation of a carbonic anhydrase inhibitor, hydroxyl ethyl cellulose (HEC), and a beta-adrenergic antagonist for use in the treatment of ocular hypertension and glaucoma wherein the ophthalmic pharmaceutical formulation is devoid of benzalkonium chloride or any other preservatives. The present process for manufacturing is simpler, cost effective process to prepare the pharmaceutical ophthalmic formulation in a single tank, without the use of additional tanks that can be sterile filtered.
IN3085DE2013 2013-10-17 2014-10-13 IN2013DE03085A (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
EP14811969.6A EP3057576A1 (en) 2013-10-17 2014-10-13 Preservative-free ophthalmic pharmaceutical formulation
UAA201603600A UA116273C2 (en) 2013-10-17 2014-10-13 Preservative-free ophthalmic pharmaceutical formulation
US15/028,930 US9801813B2 (en) 2013-10-17 2014-10-13 Preservative-free ophthalmic pharmaceutical formulation
PCT/IB2014/065262 WO2015056149A1 (en) 2013-10-17 2014-10-13 Preservative-free ophthalmic pharmaceutical formulation
IN3085DE2013 IN2013DE03085A (en) 2013-10-17 2014-10-13
CA2924562A CA2924562A1 (en) 2013-10-17 2014-10-13 Preservative-free ophthalmic pharmaceutical formulation
EA201690532A EA030535B1 (en) 2013-10-17 2014-10-13 Preservative-free ophthalmic pharmaceutical formulation

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IN3085DE2013 IN2013DE03085A (en) 2013-10-17 2014-10-13

Publications (1)

Publication Number Publication Date
IN2013DE03085A true IN2013DE03085A (en) 2015-04-24

Family

ID=52023563

Family Applications (1)

Application Number Title Priority Date Filing Date
IN3085DE2013 IN2013DE03085A (en) 2013-10-17 2014-10-13

Country Status (7)

Country Link
US (1) US9801813B2 (en)
EP (1) EP3057576A1 (en)
CA (1) CA2924562A1 (en)
EA (1) EA030535B1 (en)
IN (1) IN2013DE03085A (en)
UA (1) UA116273C2 (en)
WO (1) WO2015056149A1 (en)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
UA129631C2 (en) 2020-03-31 2025-06-18 Сентісс Фарма Прайвет Лімітед METHOD FOR STERILIZING A SOLUTION FORMING A THYMOL-CONTAINING GEL BY ASEPTIC FILTRATION
KR20230035517A (en) 2020-04-07 2023-03-14 컴반지오, 인크. Freeze-dried mesenchymal stem cell-derived secretome and uses thereof
WO2022159533A1 (en) * 2021-01-21 2022-07-28 Kowa Company, Ltd. Methods of treating fuchs endothelial corneal dystrophy after descemetorhexis
CN112920138B (en) * 2021-01-27 2023-03-07 成都摩尔生物医药有限公司 Preparation method of timolol impurity
KR102808906B1 (en) 2021-06-18 2025-05-19 대우제약 주식회사 Method for sterile filtration of high viscosity eye drop
EP4309644A1 (en) * 2022-07-22 2024-01-24 Warszawskie Zaklady Farmaceutyczne Polfa S.A. Preservative-free ophthalmic composition comprising an antiglaucoma agent
US20240091268A1 (en) * 2022-09-07 2024-03-21 Combangio, Inc. Preparation and purification methods for mesenchymal stem cell derived secretome
CN116139151B (en) * 2022-12-22 2025-02-11 武汉科福新药有限责任公司 A topical pharmaceutical composition containing timolol and preparation method thereof

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4438123A (en) * 1980-03-04 1984-03-20 Merck & Co., Inc. Ophthalmic compositions of carbonic anhydrase inhibitors for topical application in the treatment of elevated intraocular pressure
US4797413A (en) 1986-05-14 1989-01-10 Merck & Co., Inc. Thieno thiopyran sulfonamide derivatives, pharmaceutical compositions and use
US4731368A (en) 1986-12-08 1988-03-15 Merck & Co., Inc. Thienopyridine sulfonamides and their ophthalmological formulation
US4847289A (en) 1987-06-08 1989-07-11 Merck & Co., Inc. Thiophene sulfonamide antiglaucoma agents
US5153192A (en) 1990-04-09 1992-10-06 Alcon Laboratories, Inc. Thiophene sulfonamides useful as carbonic anhydrase inhibitors
US5378703A (en) 1990-04-09 1995-01-03 Alcon Laboratories, Inc. Sulfonamides useful as carbonic anhydrase inhibitors
IE911192A1 (en) 1990-04-12 1991-10-23 Merck & Co Inc Substituted aromatic sulfonamides as antiglaucoma agents
US6071904A (en) * 1996-12-11 2000-06-06 Alcon Laboratories, Inc. Process for manufacturing ophthalmic suspensions
IT1395044B1 (en) 2009-06-30 2012-09-05 Marzoli Spa AXIAL OPENING OPTION
TW201109325A (en) * 2009-07-30 2011-03-16 Wakamoto Pharma Co Ltd Aqueous composition for eye drops
WO2011067791A2 (en) * 2009-12-03 2011-06-09 Lupin Limited Process for preparing pharmaceutical ophthalmic compositions

Also Published As

Publication number Publication date
US9801813B2 (en) 2017-10-31
EP3057576A1 (en) 2016-08-24
UA116273C2 (en) 2018-02-26
WO2015056149A1 (en) 2015-04-23
EA030535B1 (en) 2018-08-31
CA2924562A1 (en) 2015-04-23
US20160235665A1 (en) 2016-08-18
EA201690532A1 (en) 2016-09-30

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