Overview
Carboxymethylcellulose is a cellulose derivative that consists of the cellulose backbone made up of glucopyranose monomers and their hydroxyl groups bound to carboxymethyl groups. It is added in food products as a viscosity modifier or thickener and emulsifier. It is also one of the most common viscous polymers used in artificial tears, and has shown to be effective in the treatment of aqueous tear-deficient dry eye symptoms and ocular surface staining . The viscous and mucoadhesive properties as well as its anionic charge allow prolonged retention time in the ocular surface . Sodium carboxymethylcellulose is the most commonly used salt.
Indication
Indicated for the symptomatic relief of burning, irritation and discomfort of the eyes due to dryness or exposure to wind or sun.
Associated Conditions
- Dry Eyes
- Ocular Irritation
Research Report
Carboxymethylcellulose: A Comprehensive Monograph on its Physicochemical Properties, Pharmacology, and Multifaceted Applications
1. Introduction and Chemical Profile
1.1. General Description and Classification
Carboxymethylcellulose (CMC), also known by its International Nonproprietary Name (INN) carmellose, is a water-soluble, anionic polymer derived from natural cellulose.[1] Structurally, it is a cellulose ether, specifically a derivative where carboxymethyl groups are attached to the hydroxyl groups of the glucopyranose units that form the cellulose backbone.[3] While classified as a "Small Molecule" in certain databases like DrugBank (ID: DB11059), its chemical nature and functional properties are those of a high-molecular-weight polysaccharide.[3] This distinction is fundamental to understanding its mechanism of action and diverse applications.
CMC is a multifaceted compound with a broad spectrum of uses. In medicine, it is primarily employed as an active pharmaceutical ingredient in two distinct therapeutic areas: as an ocular lubricant in artificial tear formulations to treat dry eye syndrome and as a bulk-forming laxative to manage constipation.[3] Beyond its role as an active ingredient, CMC is a ubiquitous pharmaceutical excipient, serving as a disintegrant, binder, and viscosity modifier in various dosage forms.[7] Its utility extends far beyond medicine into numerous industries, where it is valued as a thickener, stabilizer, and emulsifier in food, cosmetic, and manufacturing applications.[4] The most prevalent form used in these applications is its sodium salt, sodium carboxymethylcellulose, which enhances its solubility and functionality.[3]
1.2. Chemical Structure and Synthesis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2022/03/23 | Phase 4 | Completed | |||
2021/11/04 | Phase 1 | Withdrawn | |||
2019/04/17 | Phase 4 | UNKNOWN | |||
2018/02/01 | Phase 2 | Completed | |||
2017/01/04 | Phase 2 | Withdrawn | |||
2016/05/02 | Phase 4 | Completed | Koffler Vision Group | ||
2015/09/18 | Phase 3 | Completed | |||
2015/09/09 | Phase 4 | Withdrawn | Danbury Eye Physicians & Surgeons, PC | ||
2015/05/27 | Phase 3 | Completed | |||
2015/03/24 | Not Applicable | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Allergan, Inc. | 0023-4515 | OPHTHALMIC | 5 mg in 1 mL | 8/22/2025 | |
Allergan, Inc. | 0023-9537 | OPHTHALMIC | 5 mg in 1 mL | 8/22/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
REFRESH OPTIVE FUSION SENSITIVE | 02450534 | Solution - Ophthalmic | 0.5 % / W/V | 4/26/2016 | |
REFRESH OPTIVE GEL DROPS | 02463652 | Solution - Ophthalmic | 1 % / W/V | 7/28/2017 | |
REFRESH CELLUVISC | 00870153 | Drops - Ophthalmic | 1 % / W/V | 12/31/1991 | |
CLEAR EYES FOR DRY EYES | prestige brands inc | 02286858 | Solution - Ophthalmic | 1.0 % | 3/26/2008 |
REFRESH CONTACTS | 02304015 | Solution - Ophthalmic | 0.5 % / W/V | 3/13/2008 | |
PRESERVATIVE-FREE THERA TEARS LUBRICANT EYE DROPS | medtech products inc | 02242082 | Drops - Ophthalmic | 0.25 % / W/V | 6/1/2002 |
NUTRIGEL CAP 300MG | carmaran ltée | 00658014 | Capsule - Oral | 300 MG | 12/31/1987 |
REFRESH OPTIVE ADVANCED SENSITIVE | 02425815 | Emulsion - Ophthalmic | 0.5 % / W/W | 10/14/2014 | |
SALIVART AER | all star sales and service ltd. | 00894397 | Aerosol - Oral | 1 % | 12/31/1990 |
REFRESH PLUS | 02049260 | Drops - Ophthalmic | 0.5 % / W/V | 1/31/2000 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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