Overview
Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) derived from propionic acid and it is considered the first of the propionics. The formula of ibuprofen is 2-(4-isobutylphenyl) propionic acid and its initial development was in 1960 while researching for a safer alternative for aspirin. Ibuprofen was finally patented in 1961 and this drug was first launched against rheumatoid arthritis in the UK in 1969 and USA in 1974. It was the first available over-the-counter NSAID. On the available products, ibuprofen is administered as a racemic mixture. Once administered, the R-enantiomer undergoes extensive interconversion to the S-enantiomer in vivo by the activity of the alpha-methylacyl-CoA racemase. In particular, it is generally proposed that the S-enantiomer is capable of eliciting stronger pharmacological activity than the R-enantiomer.
Indication
Ibuprofen is the most commonly used and prescribed NSAID. It is a very common over-the-counter medication widely used as an analgesic, anti-inflammatory and antipyretic. The use of ibuprofen and its enantiomer Dexibuprofen in a racemic mix is common for the management of mild to moderate pain related to dysmenorrhea, headache, migraine, postoperative dental pain, spondylitis, osteoarthritis, rheumatoid arthritis, and soft tissue disorder. Due to its activity against prostaglandin and thromboxane synthesis, ibuprofen has been attributed to alteration of platelet function and prolongation of gestation and labour. As ibuprofen is a widely used medication, the main therapeutic indications are:
Associated Conditions
- Acute Pain
- Ankylosing Spondylitis (AS)
- Common Cold
- Cystic Fibrosis (CF)
- Fever
- Gastric Ulcer
- Gout
- Headache
- Insomnia
- Juvenile Idiopathic Arthritis (JIA)
- Menstrual Distress (Dysmenorrhea)
- Migraine
- Mild pain
- Nasal Congestion
- Osteoarthritis (OA)
- Pain
- Pain, Inflammatory
- Patent Ductus Arteriosus (PDA)
- Pericarditis
- Primary Dysmenorrhoea
- Rheumatoid Arthritis
- Severe Pain
- Sinus pressure
- Mild to moderate pain
- Minor aches and pains
- Moderate Pain
Research Report
A Comprehensive Monograph on Ibuprofen (DB01050): From Molecular Mechanisms to Clinical Application and Synthesis
I. Introduction and Historical Context: The Genesis of a Modern Analgesic
Ibuprofen stands as one of the most widely used pharmaceutical agents in modern medicine, a cornerstone of pain and inflammation management available in both prescription and over-the-counter formulations worldwide. Its journey from a laboratory compound to a household name is a compelling narrative of targeted drug discovery, evolving pharmacological understanding, and the perpetual quest for a balance between efficacy and safety. Classified as a non-steroidal anti-inflammatory drug (NSAID), Ibuprofen functions as a non-narcotic analgesic, an anti-inflammatory agent, and an antipyretic.[1] Chemically, it is the prototypical member of the propionic acid class of NSAIDs, a group of compounds that share a common structural and mechanistic heritage.[1]
A. The Quest for a Safer Aspirin
The development of Ibuprofen was not a product of serendipity but of a deliberate and focused research program initiated in 1953 at the Boots Pure Drug Company Ltd. in Nottingham, UK.[4] The project was led by pharmacologist Dr. Stewart Adams, who was tasked with a clear and challenging objective: to discover a novel therapeutic agent for rheumatoid arthritis (RA) that possessed potent anti-inflammatory properties but was devoid of the significant adverse effects associated with the two main therapies of the era—corticosteroids and aspirin.[4]
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2022/08/02 | Phase 3 | Completed | |||
2022/07/29 | Not Applicable | UNKNOWN | Yuzuncu Yıl University | ||
2022/06/23 | Phase 1 | Completed | |||
2022/06/02 | Not Applicable | Completed | |||
2022/05/13 | Phase 4 | Recruiting | University Hospital, Akershus | ||
2022/05/02 | N/A | Completed | Nuria Llorach-Perucho | ||
2022/04/22 | Phase 1 | UNKNOWN | |||
2022/04/22 | Phase 2 | Recruiting | |||
2022/04/15 | Phase 1 | Completed | |||
2022/04/13 | Phase 4 | Recruiting |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Aurohealth LLC | 58602-893 | ORAL | 125 mg in 1 1 | 7/3/2025 | |
Ascend Laboratories, LLC | 67877-626 | ORAL | 800 mg in 1 1 | 11/24/2021 | |
Northwind Pharmaceuticals, LLC | 51655-851 | ORAL | 800 mg in 1 1 | 1/16/2024 | |
Aphena Pharma Solutions - Tennessee, LLC | 71610-387 | ORAL | 800 mg in 1 1 | 1/22/2020 | |
Lake Erie Medical DBA Quality Care Products LLC | 49999-042 | ORAL | 800 mg in 1 1 | 3/20/2019 | |
RPK Pharmaceuticals, Inc. | 53002-3010 | ORAL | 600 mg in 1 1 | 4/18/2019 | |
REMEDYREPACK INC. | 70518-0761 | ORAL | 600 mg in 1 1 | 4/28/2025 | |
Bryant Ranch Prepack | 71335-0690 | ORAL | 400 mg in 1 1 | 3/16/2021 | |
NuCare Pharmaceuticals,Inc. | 68071-2815 | ORAL | 800 mg in 1 1 | 8/19/2022 | |
Prasco Laboratories | 66993-490 | INTRAVENOUS | 10 mg in 1 mL | 10/31/2023 |
EMA Drug Approvals
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No EMA approvals found for this drug. |
HSA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
CHEMISTS’ OWN IBUPROFEN LIQUID CAPSULES 200 mg blister pack | 282022 | Medicine | A | 11/2/2016 | |
MEDIHEALTH MIGRAINE RELIEF ibuprofen lysine 342 mg tablet blister pack | 192599 | Medicine | A | 12/5/2011 | |
MEDREICH IBUPROFEN 200mg tablets blister pack | 160247 | Medicine | A | 3/18/2009 | |
SANDOZ IBUPROFEN PLUS CODEINE film coated tablet blister pack | 211512 | Medicine | A | 6/27/2013 | |
BLACK & GOLD IBUPROFEN 200 mg sugar coated tablet blister pack | 165316 | Medicine | A | 9/16/2009 | |
BUTAFEN ibuprofen 200 mg film-coated tablets blister pack | 155484 | Medicine | A | 9/30/2008 | |
NUROFEN ZAVANCE LIQUID CAPSULES ibuprofen 200mg soft capsule blister pack | 163477 | Medicine | A | 7/17/2009 | |
COMBIGESIC tablet blister pack | 268812 | Medicine | A | 2/3/2016 | |
SPIRO LIFECARE IBUPROFEN ibuprofen 200mg softgel capsule | 315483 | Medicine | A | 3/18/2019 | |
ADMED IBUPROFEN 200 mg film coated tablet blister pack | 407499 | Medicine | A | 4/11/2023 |
Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
PMS-IBUPROFEN | 00839264 | Tablet - Oral | 600 MG | 7/9/2008 | |
ROBAX PLATINUM | glaxosmithkline consumer healthcare ulc | 02247147 | Tablet - Oral | 200 MG | 7/2/2003 |
SUPER STRENGTH MOTRIN IB LIQUID GELS | mcneil consumer healthcare division of johnson & johnson inc | 02317850 | Capsule - Oral | 400 MG | 7/6/2009 |
IBUPROFEN 200 MG | pendopharm division of pharmascience inc | 02291932 | Tablet - Oral | 200 MG | 6/1/2007 |
IBUPROFEN LIQUID FILLED CAPSULES | 02281384 | Capsule - Oral | 200 MG | 11/7/2006 | |
IBUPROFEN TABLETS | 02314754 | Tablet - Oral | 200 MG | 3/5/2010 | |
IBUPROFEN DAYTIME | vita health products inc | 02434466 | Capsule - Oral | 200 MG | N/A |
APO-IBUPROFEN | 00506052 | Tablet - Oral | 400 MG | 12/31/1983 | |
CHILDREN'S MOTRIN CHEWABLE TABLETS | mcneil consumer healthcare division of johnson & johnson inc | 02247343 | Tablet (Chewable) - Oral | 50 MG | 5/14/2003 |
COLD + SINUS DAYTIME COLD + SINUS NIGHTTIME | vita health products inc | 02388030 | Tablet
,
Kit - Oral | 200 MG | 5/23/2014 |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
IBUPROFENO AUROVITAS PHARMA 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Aurovitas Spain, S.A.U. | 86554 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Sin Receta | Commercialized |
IBUPROFENO ZENTIVA KS 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 85948 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
IBUPROFENO PHARMA COMBIX 600 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Combix S.L.U. | 74207 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
IBUPROFENO CODRAMOL 200 MG POLVO ORAL | Farmalider S.A. | 79595 | POLVO ORAL | Sin Receta | Commercialized |
IBUDOL RAPID 400 mg GRANULADO PARA SOLUCION ORAL | 72763 | GRANULADO PARA SOLUCIÓN ORAL | Sin Receta | Commercialized | |
PHARMAFREN 200 MG/30 MG CAPSULAS DURAS | Laboratorios Cinfa S.A. | 83605 | CÁPSULA DURA | Sin Receta | Commercialized |
PARACETAMOL/IBUPROFENO WINADOL 500 MG/200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | Nutra Essential Otc S.L. | 87955 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Sin Receta | Not Commercialized |
NOVIDOL 50 mg/g GEL | Menarini Consumer Healthcare S.A.U. | 67207 | GEL | Sin Receta | Commercialized |
NEOBRUFEN 600 mg GRANULADO EFERVESCENTE | 61610 | GRANULADO EFERVESCENTE | Medicamento Sujeto A Prescripción Médica | Commercialized | |
IBUPROFENO BRIL 600 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Brill Pharma S.L. | 79553 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
Philippines FDA Drug Approvals
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Saudi SFDA Drug Approvals
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Malaysia NPRA Drug Approvals
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UK EMC Drug Information
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