AR068745A1 - A COMPOSITION IN THE FORM OF ORAL PHARMACEUTICAL DOSAGE OF HIGH DOSAGE UNIT OF SODIUM MYCOPHENOLATE, METHOD FOR USING SUCH COMPOSITION AND ITS USES - Google Patents

A COMPOSITION IN THE FORM OF ORAL PHARMACEUTICAL DOSAGE OF HIGH DOSAGE UNIT OF SODIUM MYCOPHENOLATE, METHOD FOR USING SUCH COMPOSITION AND ITS USES

Info

Publication number
AR068745A1
AR068745A1 ARP080104384A ARP080104384A AR068745A1 AR 068745 A1 AR068745 A1 AR 068745A1 AR P080104384 A ARP080104384 A AR P080104384A AR P080104384 A ARP080104384 A AR P080104384A AR 068745 A1 AR068745 A1 AR 068745A1
Authority
AR
Argentina
Prior art keywords
composition
diseases
dosage
day
management
Prior art date
Application number
ARP080104384A
Other languages
Spanish (es)
Inventor
Sampath K Devarajan
Sukhjeet Singh
Rajesh Jain
Original Assignee
Panacea Biotec 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=40548981&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR068745(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Panacea Biotec Ltd filed Critical Panacea Biotec Ltd
Publication of AR068745A1 publication Critical patent/AR068745A1/en

Links

Classifications

    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
    • A61K31/343—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A61P31/06—Antibacterial agents for tuberculosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Transplantation (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Pulmonology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

Se establecen composiciones en forma de dosificacion farmacéutica oral de una sola unidad solida de alta dosis que comprenden micofenolato de sodio como agente activo en una cantidad de más de aproximadamente 720 mg a aproximadamente 1500 mg, preferentemente de aproximadamente 800 mg a aproximadamente 1440 mg calculado como ácido micofenolico, y uno o más excipientes farmacéuticamente aceptables. En particular las composiciones con forma de dosificacion están destinadas a la administracion de una vez al día o dos veces al día y proveen el agente activo en una forma de liberacion prolongada que se libera de manera sostenida in vivo durante un período de tiempo prolongado. La invencion también se refiere a un proceso de fabricacion de formulaciones de alta dosis y a métodos profilácticos y/o terapéuticos para usar tales formas de dosificacion. La composicion de la presente solicitud es fácil de formular, segura, eficaz y bien tolerada, y es de utilidad en el manejo, por ejemplo, la profilaxis, mejora y/o tratamiento de enfermedades/trastornos en los que están indicados inmunosupresores, especialmente para el tratamiento o prevencion del rechazo de xenoinjertos o aloinjertos de organos, tejidos o células, por ejemplo, después de un trasplante, o el manejo de enfermedades de mediacion inmunologica (enfermedades autoinmunes).Compositions in the form of a single high dose solid pharmaceutical unit dosage comprising sodium mycophenolate as active agent in an amount of more than about 720 mg to about 1500 mg, preferably about 800 mg to about 1440 mg calculated as Mycophenolic acid, and one or more pharmaceutically acceptable excipients. In particular, the dosage form compositions are intended for administration once a day or twice a day and provide the active agent in a prolonged release form that is released sustainably in vivo for a prolonged period of time. The invention also relates to a manufacturing process of high dose formulations and prophylactic and / or therapeutic methods for using such dosage forms. The composition of the present application is easy to formulate, safe, effective and well tolerated, and is useful in the management, for example, prophylaxis, improvement and / or treatment of diseases / disorders in which immunosuppressants are indicated, especially for the treatment or prevention of rejection of xenografts or allografts of organs, tissues or cells, for example, after a transplant, or the management of immunological mediation diseases (autoimmune diseases).

ARP080104384A 2007-10-08 2008-10-07 A COMPOSITION IN THE FORM OF ORAL PHARMACEUTICAL DOSAGE OF HIGH DOSAGE UNIT OF SODIUM MYCOPHENOLATE, METHOD FOR USING SUCH COMPOSITION AND ITS USES AR068745A1 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IN2107DE2007 2007-10-08

Publications (1)

Publication Number Publication Date
AR068745A1 true AR068745A1 (en) 2009-12-02

Family

ID=40548981

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP080104384A AR068745A1 (en) 2007-10-08 2008-10-07 A COMPOSITION IN THE FORM OF ORAL PHARMACEUTICAL DOSAGE OF HIGH DOSAGE UNIT OF SODIUM MYCOPHENOLATE, METHOD FOR USING SUCH COMPOSITION AND ITS USES

Country Status (3)

Country Link
AR (1) AR068745A1 (en)
CL (1) CL2008002984A1 (en)
WO (1) WO2009047799A1 (en)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG10201503411QA (en) 2006-08-03 2015-06-29 Nitec Pharma Ag Delayed-release glucocorticoid treatment of rheumatoid disease
EA201270544A1 (en) * 2009-10-13 2012-09-28 Тева Фармасьютикал Индастриз Лтд. COMPOSITIONS WITH EXTENDED DELIVERY
CN102939300A (en) 2010-06-07 2013-02-20 泰立克公司 Preparation of crystalline ezatiostat hydrochloride ansolvate form d
US8759303B2 (en) 2010-06-07 2014-06-24 Telik, Inc. Compositions and methods for treating myelodysplastic syndrome
WO2011156045A2 (en) 2010-06-07 2011-12-15 Telik, Inc. Tablet formulation of ezatiostat
BE1018740A3 (en) * 2010-08-10 2011-07-05 Oystershell Nv COMPOSITION FOR THE TREATMENT OF HUMID EPITHELIAL SURFACES.
CN102793658A (en) * 2012-08-23 2012-11-28 无锡福祈制药有限公司 Matrix-type preparation containing mycophenolic acid or mycophenolic acid salt and coated tablet thereof
WO2014167442A1 (en) 2013-03-26 2014-10-16 Wockhardt Limited Pharmaceutical compositions comprising mycophenolic acid or salts thereof
RU2670447C2 (en) * 2016-11-17 2018-10-23 Общество с ограниченной ответственностью "Изварино Фарма" Peroral solid dosage form with mycophenolic acid or its salt for use as an immunodepressant for treatment or prevention of organ or tissue transplant rejection and method for production thereof
RU2723255C2 (en) * 2018-11-14 2020-06-09 Общество с ограниченной ответственностью "Изварино Фарма" Extrudate with sodium mycophenolate to produce peroral solid dosage form
CN110787206A (en) * 2019-12-23 2020-02-14 卓和药业集团有限公司 Pharmaceutical composition containing meclofenoxate sodium and preparation method thereof
CN114569570B (en) * 2022-03-15 2023-03-24 浙江长典药物技术开发有限公司 Mycophenolate mofetil and preparation method thereof
CN115192597A (en) * 2022-08-08 2022-10-18 青海大学 Pharmaceutical composition for preventing and treating pulmonary hypertension, preparation method and application thereof
CN117442580B (en) * 2023-12-21 2024-04-05 泊诺(天津)创新医药研究有限公司 High-bioavailability sodium mycophenolate enteric-coated tablet and preparation method thereof

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5455045A (en) * 1993-05-13 1995-10-03 Syntex (U.S.A.) Inc. High dose formulations
GB0419355D0 (en) * 2004-08-31 2004-09-29 Novartis Ag Organic compounds
CA2636873A1 (en) * 2006-02-15 2007-08-23 Sanofi-Aventis Azacyclyl-substituted aryldihydroisoquinolinones, process for their preparation and their use as medicaments

Also Published As

Publication number Publication date
CL2008002984A1 (en) 2009-06-05
WO2009047799A1 (en) 2009-04-16

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