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    Also known as: 89796-99-6, Preservex, Aceclofenaco, Aceclofenacum, Aceclofenac betadex, Chebi:31159
    Molecular Formula
    C16H13Cl2NO4
    Molecular Weight
    354.2  g/mol
    InChI Key
    MNIPYSSQXLZQLJ-UHFFFAOYSA-N
    FDA UNII
    RPK779R03H
    Aceclofenac
    Aceclofenac is an oral non-steroidal anti-inflammatory drug (NSAID) with marked anti-inflammatory and analgesic properties used to treat osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. It is reported to have a higher anti-inflammatory action or at least comparable effects than conventional NSAIDs in double-blind studies. Aceclofenac potently inhibits the cyclo-oxygenase enzyme (COX) that is involved in the synthesis of prostaglandins, which are inflammatory mediators that cause pain, swelling, inflammation, and fever. Aceclofenac belongs to BCS Class II as it possesses poor aqueous solubility. It displays high permeability to penetrate into synovial joints where in patients with osteoarthritis and related conditions, the loss of articular cartilage in the area causes joint pain, tenderness, stiffness, crepitus, and local inflammation. Aceclofenac is also reported to be effective in other painful conditions such as dental and gynaecological conditions. In 1991, aceclofenac was developed as an analog of a commonly prescribed NSAID, [DB00586], via chemical modification in effort to improve the gastrointestinal tolerability of the drug. It is a more commonly prescribed drug in Europe.
    1 2D Structure

    Aceclofenac

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-[2-[2-(2,6-dichloroanilino)phenyl]acetyl]oxyacetic acid
    2.1.2 InChI
    InChI=1S/C16H13Cl2NO4/c17-11-5-3-6-12(18)16(11)19-13-7-2-1-4-10(13)8-15(22)23-9-14(20)21/h1-7,19H,8-9H2,(H,20,21)
    2.1.3 InChI Key
    MNIPYSSQXLZQLJ-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C1=CC=C(C(=C1)CC(=O)OCC(=O)O)NC2=C(C=CC=C2Cl)Cl
    2.2 Other Identifiers
    2.2.1 UNII
    RPK779R03H
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 2-((2,6-dichlorophenyl)amino)phenylacetoxyacetic Acid

    2. Airtal

    3. Airtal Difucrem

    4. Aital

    5. Beofenac

    6. Biofenac

    7. Bristaflam

    8. Clanza Cr

    9. Falcol

    10. Falcol Difucrem

    11. Gerbin

    12. Gerbin Difucrem

    13. Preservex

    14. Sanein

    2.3.2 Depositor-Supplied Synonyms

    1. 89796-99-6

    2. Preservex

    3. Aceclofenaco

    4. Aceclofenacum

    5. Aceclofenac Betadex

    6. Chebi:31159

    7. 2-[2-[2-(2,6-dichloroanilino)phenyl]acetyl]oxyacetic Acid

    8. Mfcd00864296

    9. Airtal

    10. Rpk779r03h

    11. 2-(2-(2-((2,6-dichlorophenyl)amino)phenyl)acetoxy)acetic Acid

    12. Ncgc00016957-01

    13. Glycolic Acid [o-(2,6-dichloroanilino)phenyl]acetate Ester

    14. 2-(2-(2-(2,6-dichlorophenylamino)phenyl)acetoxy)acetic Acid

    15. Glycolic Acid, (o-(2,6-dichloroanilino)phenyl)acetate (ester)

    16. 2-((2,6-dichlorophenyl)amino)benzeneacetic Acid Carboxymethyl Ester

    17. 2-[(2,6-dichlorophenyl)amino]benzeneacetic Acid Carboxymethyl Ester

    18. Cas-89796-99-6

    19. Dsstox_cid_25522

    20. Dsstox_rid_80928

    21. Dsstox_gsid_45522

    22. 2-[(2',6'-dichlorophenyl)amino]phenylacetoxyacetic Acid

    23. Aceclofenacum [latin]

    24. Aceclofenaco [spanish]

    25. Hifenac

    26. 2-[(2-{2-[(2,6-dichlorophenyl)amino]phenyl}acetyl)oxy]acetic Acid

    27. Benzeneacetic Acid, 2-((2,6-dichlorophenyl)amino)-, Carboxymethyl Ester

    28. Smr000718629

    29. Sr-01000802972

    30. Aceclofenac [inn:ban]

    31. Brn 4884476

    32. Unii-rpk779r03h

    33. Cincofen

    34. [({2-[(2,6-dichlorophenyl)amino]phenyl}acetyl)oxy]acetic Acid

    35. Clanza

    36. Benzeneacetic Acid, 2-[(2,6-dichlorophenyl)amino]-, Carboxymethyl Ester

    37. (2-{2-[(2,6-dichlorophenyl)amino]phenyl}acetoxy)acetic Acid

    38. Aceclofenac (tn)

    39. Prestwick_772

    40. 2-(o-(2,6-dichloranilino)phenylacetoxy)essigsaeure

    41. Pr-82/3

    42. Aceclofenac (jan/inn)

    43. Aceclofenac [mi]

    44. Prestwick0_000175

    45. Prestwick1_000175

    46. Prestwick2_000175

    47. Prestwick3_000175

    48. Aceclofenac [inn]

    49. Aceclofenac [jan]

    50. Aceclofenac [mart.]

    51. Schembl25734

    52. Aceclofenac [who-dd]

    53. Bspbio_000069

    54. Mls001032069

    55. Mls001304028

    56. Mls002154226

    57. Chembl93645

    58. Spbio_001990

    59. Bpbio1_000077

    60. Dtxsid7045522

    61. Aceclofenac, >=98% (hplc)

    62. Aceclofenac [ep Monograph]

    63. Aceclofenac For Peak Identification

    64. Hms1568d11

    65. Hms2090g07

    66. Hms2095d11

    67. Hms2231b03

    68. Hms3371a10

    69. Hms3712d11

    70. Hms3873i03

    71. Bcp11932

    72. Hy-b0634

    73. Zinc3805798

    74. Tox21_110710

    75. Aceclofenac Betadex [who-dd]

    76. Bbl010788

    77. Bdbm50109016

    78. S4835

    79. Stk594349

    80. Akos005516194

    81. Tox21_110710_1

    82. Ab07468

    83. Ac-5282

    84. Aceclofenac 1.0 Mg/ml In Acetonitrile

    85. Ccg-213835

    86. Db06736

    87. Ks-5033

    88. Ncgc00016957-02

    89. Ncgc00016957-03

    90. Ncgc00016957-05

    91. Ba164135

    92. Aceclofenac 100 Microg/ml In Acetonitrile

    93. Ft-0621715

    94. D01545

    95. 796a996

    96. Q481757

    97. 2-(2,6-dichlorophenylamine)phenylacetoxyacetic Acid

    98. Sr-01000802972-2

    99. Sr-01000802972-3

    100. 2-[2-(2,6-dichloroanilino)phenylacetoxy]acetic Acid

    101. Brd-k68538666-001-03-2

    102. Aceclofenac For Peak Identification, European Pharmacopoeia (ep) Reference Standard

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 354.2 g/mol
    Molecular Formula C16H13Cl2NO4
    XLogP34.3
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count7
    Exact Mass353.0221633 g/mol
    Monoisotopic Mass353.0221633 g/mol
    Topological Polar Surface Area75.6 Ų
    Heavy Atom Count23
    Formal Charge0
    Complexity411
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Indication

    Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Aceclofenac is a NSAID that inhibits both isoforms of COX enzyme, a key enzyme involved in the inflammatory cascade. COX-1 enzyme is a constitutive enzyme involved in prostacyclin production and protective functions of gastric mucosa whereas COX-2 is an inducible enzyme involved in the production of inflammatory mediators in response to inflammatory stimuli. Aceclofenac displays more selectivity towards COX-2 (IC50 of 0.77uM) than COX-1 (IC50 of >100uM), which promotes its gastric tolerance compared to other NSAIDs. The primary metabolite, 4'-hydroxyaceclofenac, also minimally inhibits COX-2 with IC50 value of 36uM. Although the mode of action of aceclofenac is thought to mainly arise from the inhibition of synthesis of prostaglandins (PGE2), aceclofenac also inhibits the production of inflammatory cytokines, interleukins (IL-1, IL-6), and tumor necrosis factors (TNF). It is also reported that aceclofenac also affects the cell adhesion molecules from neutrophils. Aceclofenac also targets the synthesis of glycosaminoglycan and mediates chrondroprotective effects.

    5.2 MeSH Pharmacological Classification

    Anti-Inflammatory Agents, Non-Steroidal

    Anti-inflammatory agents that are non-steroidal in nature. In addition to anti-inflammatory actions, they have analgesic, antipyretic, and platelet-inhibitory actions. They act by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase, which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins. Inhibition of prostaglandin synthesis accounts for their analgesic, antipyretic, and platelet-inhibitory actions; other mechanisms may contribute to their anti-inflammatory effects. (See all compounds classified as Anti-Inflammatory Agents, Non-Steroidal.)

    5.3 ATC Code

    M01AB16

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    M - Musculo-skeletal system

    M01 - Antiinflammatory and antirheumatic products

    M01A - Antiinflammatory and antirheumatic products, non-steroids

    M01AB - Acetic acid derivatives and related substances

    M01AB16 - Aceclofenac

    M - Musculo-skeletal system

    M02 - Topical products for joint and muscular pain

    M02A - Topical products for joint and muscular pain

    M02AA - Antiinflammatory preparations, non-steroids for topical use

    M02AA25 - Aceclofenac

    5.4 Absorption, Distribution and Excretion

    Absorption

    Aceclofenac is rapidly and completely absorbed from the gastrointestinal tract and circulates mainly as unchanged drug following oral administration. Peak plasma concentrations are reached around 1.25 to 3 hours post-ingestion, and the drug penetrates into the synovial fluid where the concentration may reach up to 60% of that in the plasma. There is no accumulation in regular dosing, with similar maximum plasma concentration (Cmax) and time to reach peak plasma concentration (Tmax) after single and multiple doses.

    Route of Elimination

    The main route of elimination is via the urine where the elimination accounts for 70-80% of clearance of the drug. Approximately two thirds of the administered dose is excreted via the urine, mainly as glucuronidated and hydroxylated forms of aceclofenac. About 20% of the dose is excreted into feces.

    Volume of Distribution

    The volume of distribution is approximately 25 L.

    Clearance

    The mean clearance rate is approximately 5 L/h.

    5.5 Metabolism/Metabolites

    4'-hydroxyaceclofenac is the main metabolite detected in plasma however other minor metabolites include diclofenac, 5-hydroxyaceclofenac, 5-hydroxydiclofenac, and 4'-hydroxydiclofenac. It is probable that the metabolism of aceclofenac is mediated by CYP2C9.

    Aceclofenac has known human metabolites that include 4'-hydroxy-aceclofenac, 5-hydroxy-aceclofenac, and diclofenac.

    S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560

    5.6 Biological Half-Life

    The mean plasma elimination half-life is approximately 4 hours.

    5.7 Mechanism of Action

    Through COX-2 inhibition, aceclofenac downregulates the production of various inflammatory mediators including prostaglandin E2 (PGE2), IL-1, and TNF from the arachidonic acid (AA) pathway. Inhibition of IL-6 is thought to be mediated by diclofenac converted from aceclofenac. Suppressed action of inflammatory cytokines decreases the production of reactive oxygen species. Aceclofenac is shown to decreased production of nitrous oxide in human articular chondrocytes. In addition, aceclofenac interferes with neutrophil adhesion to endothelium by decreasing the expression of L-selectin (CD62L), which is a cell adhesion molecule expressed on lymphocytes. Aceclofenac is proposed to stimulate the synthesis of glycosaminoglycan in human osteoarthritic cartilage which may be mediated through its inhibitory action on IL-1 production and activity. The chrondroprotective effects are generated by 4'-hydroxyaceclofenac which suppresses IL-1 mediated production of promatrix metalloproteinase-1 and metalloproteinase-3 and interferes with the release of proteoglycan from chrondrocytes.

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    01-Jan-2021
    27-Aug-2024
    KGS
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