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 |
|---|---|---|---|---|---|
2018/10/09 | Phase 2 | Terminated | |||
2018/10/05 | Not Applicable | UNKNOWN | |||
2018/10/04 | Phase 2 | Completed | |||
2018/10/03 | Phase 1 | Completed | Medherant Ltd | ||
2018/10/02 | Phase 3 | UNKNOWN | |||
2018/10/02 | Phase 2 | Completed | Tianjin XinChen-Techfields Pharma Co., LTD. | ||
2018/08/27 | Phase 1 | Terminated | |||
2018/08/21 | Phase 1 | Completed | Medherant Ltd | ||
2018/08/15 | Phase 4 | Completed | |||
2018/08/09 | Phase 4 | UNKNOWN |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| H.J. Harkins Company, Inc. | 52959-076 | ORAL | 600 mg in 1 1 | 12/8/2011 | |
| NuCare Pharmaceuticals,Inc. | 68071-2939 | ORAL | 400 mg in 1 1 | 4/10/2023 | |
| RPK Pharmaceuticals, Inc. | 53002-3370 | ORAL | 400 mg in 1 1 | 4/18/2019 | |
| Polygen Pharmaceuticals LLC | 52605-122 | ORAL | 600 mg in 1 1 | 10/20/2011 | |
| Aurobindo Pharma Limited | 59651-032 | ORAL | 100 mg in 5 mL | 7/15/2023 | |
| Dispensing Solutions, Inc. | 66336-430 | ORAL | 400 mg in 1 1 | 7/2/2013 | |
| REMEDYREPACK INC. | 70518-0005 | ORAL | 800 mg in 1 1 | 1/3/2024 | |
| NuCare Pharmaceuticals,Inc. | 68071-3552 | ORAL | 800 mg in 1 1 | 12/7/2023 | |
| DISCOUNT DRUG MART | 53943-112 | ORAL | 200 mg in 1 1 | 5/15/2025 | |
| NuCare Pharmaceuticals,Inc. | 68071-3172 | ORAL | 400 mg in 1 1 | 10/12/2023 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Ibuprofen Soft Capsules | 国药准字H20223377 | 化学药品 | 软胶囊剂 | 6/7/2022 | |
| Ibuprofen Dispersible Tablets | 国药准字H20010344 | 化学药品 | 片剂(分散) | 4/15/2020 | |
| Ibuprofen Dispersible Tablets | 国药准字H20100189 | 化学药品 | 片剂(分散) | 4/15/2020 | |
| Ibuprofen Tablets | 国药准字H21021323 | 化学药品 | 片剂 | 5/9/2020 | |
| Ibuprofen Tablets | 国药准字H61021456 | 化学药品 | 片剂(薄膜衣) | 1/15/2021 | |
| Ibuprofen Tablets | 国药准字H44021099 | 化学药品 | 片剂 | 1/13/2020 | |
| Ibuprofen Tablets | 国药准字H21020834 | 化学药品 | 片剂 | 6/4/2020 | |
| Ibuprofen Tablets | 国药准字H21022510 | 化学药品 | 片剂 | 5/9/2020 | |
| Ibuprofen Tablets | 国药准字H22022204 | 化学药品 | 片剂 | 4/25/2020 | |
| Ibuprofen Tablets | 国药准字H34021625 | 化学药品 | 片剂 | 3/31/2020 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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