Hypromellose
Identification
- Summary
Hypromellose is an ingredient used in a wide variety of medications, and is not an approved medication.
- Brand Names
- Bion Tears, Clear Eyes Complete, Genteal, Genteal Tears, Genteal Tears Mild, Gonak, Goniovisc, Isopto Alkaline, Nature's Tears, Systane, Tears Lubricant, Tears Naturale, Tears Renewed
- Generic Name
- Hypromellose
- DrugBank Accession Number
- DB11075
- Background
Hypromellose, or hydroxypropyl methylcellulose (HPMC) 8, is a semisynthetic, inert, and viscoelastic polymer that forms a colloid solution when dissolved in water. It acts as a thickening agent, coating polymer, bioadhesive, solubility enhancer in solid dispersions, and binder in the process of granulation and in modified release formulations 2. It is a commonly used as a delivery component in oral pharmaceutical products that provides the release of a drug in a controlled fashion, effectively increasing the duration of release of a drug to prolong its therapeutic effects 1. Hypromellose is also found in eye drops as a lubricant 3.
- Type
- Small Molecule
- Groups
- Approved
- Synonyms
- Cellulose hydroxypropyl methyl ether
- Cellulose, 2-hydroxypropyl methyl ether
- Hipromelosa
- Hydroxypropyl methylcellulose 2208
- Hydroxypropyl methylcellulose 2910
- Hydroxypropyl methylcellulose 4000
- Hydroxypropyl methylcelluloses
- Hydroxypropylmethylcellulose
- Hypromellose
- Hypromelloses
Pharmacology
- Indication
Used as an ophthalmic protectant and lubricant, in artificial tears, and as a diagnostic aid (contact lens procedures; gonioscopy).4
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- Contraindications & Blackbox Warnings
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- Pharmacodynamics
Hypromellose is the most commonly used in hydrophilic matrix fabrication. It allows for controlled release of drug substances, increasing duration of therapeutic effects 3. The physical characteristics of this drug resemble natural tears, providing lubrication to the ocular surface and maintaining corneal hydration in dry eye syndromes 7.
Hypromellose is considered an inert substance as it has no direct pharmacological activity. The viscosity promoting properties of hypromellose prolong the retention time and improve adhesion of synthetic tears to the cornea and conjunctiva. As a result, the tear film breakdown time is prolonged and/or the tear film stability is enhanced. A stable tear film protects the cornea from dryness and epithelial cells 6.
Hypromellose is a methyl and hydroxypropyl mixed ether of cellulose. It is utilized as artificial tears to prevent conjunctival and corneal damage due to impaired lacrimal secretions. It is also used as a visco-elastic promoting agent by maintaining a deep, viscous chamber and allowing for easier manipulation, helping the vitreous surface to be pushed back, thus preventing the formation of a postoperative flat chamber 5.
- Mechanism of action
Promotes corneal wetting by the stabilization and thickening the precorneal tear film and prolonging the tear film breakdown time, which is usually shortened in dry eye conditions. Hypromellose also acts to lubricate and protect the eye 6.
The surface active properties of the vehicles found in artificial tears solutions act to stabilize the tear film and increase tear viscosity to prevent delay tear evaporation and delay tear drainage 4.
In the intact eye, the corneal surface is moistened primarily by the mucin that is produced in the conjunctiva. Mucin is adsorbed on the corneal surface and forms a hydrophilic surface. This creates a moisture barrier. In the typical dry eye, and particularly in case of mucin deficiency, the application of artificial tear fluid is highly recommended. Both its surface activity and its adsorptive capacity make hypromellose optimal for this use. Hypromellose has a physical-chemical action and leads to, in an aqueous solution, a reduced surface tension as well as an increased level of viscosity. Hypromellose adheres well to the cornea and conjunctiva and provides ample moisture. Irritation symptoms caused by blinking, which occur in the case of tear fluid deficiency, are therefore decreased and symptoms of epithelial desiccation are also alleviated 6.
Target Actions Organism UEpithelial cell adhesion molecule Not Available Humans - Absorption
Not systemically absorbed 6.
- Volume of distribution
Not Available
- Protein binding
Not Available
- Metabolism
- Not Available
- Route of elimination
Not Available
- Half-life
Not Available
- Clearance
Not Available
- Adverse Effects
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- Toxicity
LD 50 (Rat): > 5 g/kg MSDS.
Hypromellose is considered low toxicity to non-toxic 8.
Adverse events may include blurred vision and contact dermatitis 4. Hypersensitivity and intolerance reactions may occur (for example, eye burning, pain, increased lacrimation, a sensation of foreign body, conjunctival hyperemia, eyelid swelling, pruritus). The stickiness sensation of the eyelids, the decreased sense of smell, photosensitivity 6.
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.Not Available
- Food Interactions
- No interactions found.
Products
- Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.
- Product Ingredients
Ingredient UNII CAS InChI Key Hypromellose 2208 (100 mPa.S) B1QE5P712K Not Available Not applicable Hypromellose 2208 (15000 mPa.S) Z78RG6M2N2 Not Available Not applicable Hypromellose 2906 (4000 mPa.S) 5EYA69XGAT Not Available Not applicable Hypromellose 2906 (50 mPa.S) 612E703ZUQ Not Available Not applicable Hypromellose 2910 (15 mPa.S) 36SFW2JZ0W Not Available Not applicable Hypromellose 2910 (15000 mPa.S) 288VBX44JC Not Available Not applicable Hypromellose 2910 (3 mPa.S) 0VUT3PMY82 Not Available Not applicable Hypromellose 2910 (4000 mPa.S) RN3152OP35 Not Available Not applicable Hypromellose 2910 (50 mPa.S) 1IVH67816N Not Available Not applicable - International/Other Brands
- Hymelose / Hyprosol / Ikleen / Intavis / Irimist / Melose / Melose Drop / Methocel / Naifa / Optichlor / Takflur
- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Entrocel Solution 18 mg/1mL Oral Mallinckrodt 2009-06-01 2012-10-31 US Goniotaire Solution 25 mg/1mL Ophthalmic Altaire Pharmaceuticals Inc. 2002-01-18 Not applicable US Mc Methylcellulose Solution 1% Solution 1 g / 100 mL Rectal E Z Em, Inc. 1982-12-31 2009-08-04 Canada - Over the Counter Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Alcon Tears 0.5% Solution 0.5 % Ophthalmic Alcon, Inc. 1969-12-31 Not applicable Canada Alcon Tears 1% Solution 1 % Ophthalmic Alcon, Inc. 1970-12-31 Not applicable Canada Alcon Tears Lubricant Eye Drops Solution / drops 5 mg/1mL Ophthalmic ALCON LABORATORIES, INC. 2022-03-01 Not applicable US AQUA TEAR EYE DROPS Solution / drops 3 mg/1ml Ophthalmic บริษัท แม็กซิมอินเตอร์คอร์ปอร์เรชั่น จำกัด จำกัด 2019-09-04 Not applicable Thailand Artelac Lubricant Eye Drops Solution 0.32 % Ophthalmic Bausch & Lomb Inc 2005-03-25 2008-07-28 Canada Aurovisc Solution 20 mg/1mL Ophthalmic Aurolab 2022-09-26 Not applicable US Aurovisc Lubricant HYPROMELLOSE 2208 (15000 MPA.S) Gel/Drops Solution, gel forming / drops 20 mg/1mL Ophthalmic Aurolab 2022-09-26 Not applicable US Aurovisc Lubricant HYPROMELLOSE 2208 (15000 MPA.S) Solution/Drops Solution / drops 20 mg/1mL Ophthalmic Aurolab 2022-09-26 Not applicable US Corneo Hypromellose Solution 0.3 % Ophthalmic Orimed Pharma Corporation 2015-09-16 Not applicable Canada EYE GLO MOIST EYE DROPS Solution / drops 0.1 %w/v Ophthalmic Duopharma Marketing Sdn. Bhd. 2020-09-08 2021-12-12 Malaysia - Mixture Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Advanced Eye Relief/ Redness Maximum Relief Hypromellose (5 mg/1mL) + Naphazoline hydrochloride (0.3 mg/1mL) Solution / drops Ophthalmic Bausch & Lomb Incorporated 2010-09-02 Not applicable US Advanced Eye Relief/ Redness Maximum Relief Hypromellose (5 mg/1mL) + Naphazoline hydrochloride (0.3 mg/1mL) Solution / drops Ophthalmic Preferreed Pharmaceuticals Inc. 2010-09-02 Not applicable US Artificial Tears Hypromellose (2 mg/1mL) + Glycerin (2 mg/1mL) + Polyethylene glycol 400 (10 mg/1mL) Liquid Ophthalmic American Sales Company 2010-09-06 Not applicable US Artificial Tears Hypromellose (0.002 mg/1mg) + Glycerin (0.002 mg/1mg) + Polyethylene glycol 400 (0.01 mg/1mg) Solution / drops Ophthalmic Geri-Care Pharmaceuticals, Corp 2018-06-01 Not applicable US Artificial Tears Hypromellose (0.3 %) + Dextran (0.1 %) Solution Ophthalmic Alcon, Inc. 2005-03-16 2009-02-24 Canada Artificial Tears Hypromellose (0.002 mg/1mg) + Glycerin (0.002 mg/1mg) + Polyethylene glycol 400 (0.01 mg/1mg) Solution / drops Ophthalmic Nucare Pharmaceuticals,inc. 2018-06-01 Not applicable US Artificial Tears Hypromellose (0.002 mg/1mg) + Glycerin (0.002 mg/1mg) + Polyethylene glycol 400 (0.01 mg/1mg) Solution / drops Ophthalmic Preferred Pharmaceuticals Inc. 2021-03-11 Not applicable US Artificial Tears Hypromellose (0.2 % w/v) + Glycerin (0.2 % w/v) Solution Ophthalmic TEVA Canada Limited 2011-04-19 Not applicable Canada Artificial Tears Hypromellose (3 mg/1mL) + Dextran 70 (1 mg/1mL) + Glycerin (2 mg/1mL) Solution / drops Ophthalmic AvPAK 2023-01-05 Not applicable US Biomedic Artificial Tears Hypromellose (0.2 g/100mL) + Glycerin (0.2 g/100mL) Liquid Ophthalmic Kc Pharmaceuticals, Inc. 2019-04-30 Not applicable US - Unapproved/Other Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Entrocel Hypromellose (18 mg/1mL) Solution Oral Mallinckrodt 2009-06-01 2012-10-31 US Gonak Hypromellose Hypromellose 2906 (4000 mPa.S) (25 mg/1mL) + Hypromellose 2906 (50 mPa.S) (25 mg/1mL) Solution Ophthalmic Akorn 1997-01-01 Not applicable US Gonak Hypromellose Hypromellose 2906 (4000 mPa.S) (25 mg/1mL) + Hypromellose 2906 (50 mPa.S) (25 mg/1mL) Solution Ophthalmic Akorn 1997-01-01 Not applicable US Goniosoft Hypromellose (25 mg/1mL) Liquid Ophthalmic OCuSOFT, INC. 1989-10-02 2022-01-31 US Goniotaire Hypromellose 2906 (4000 mPa.S) (25 mg/1mL) Solution Ophthalmic Altaire Pharmaceuticals Inc. 2002-01-18 Not applicable US Vista Gonio Eye Lubricant Hypromellose 2208 (100 mPa.S) (25 mg/15mL) Solution Ophthalmic Red Wedding LLC 2023-07-01 Not applicable US
Categories
- ATC Codes
- S01KA02 — Hypromellose
- Drug Categories
- Classification
- Not classified
- Affected organisms
- Not Available
Chemical Identifiers
- UNII
- 3NXW29V3WO
- CAS number
- 9004-65-3
References
- General References
- Li CL, Martini LG, Ford JL, Roberts M: The use of hypromellose in oral drug delivery. J Pharm Pharmacol. 2005 May;57(5):533-46. [Article]
- Al-Tabakha MM: HPMC capsules: current status and future prospects. J Pharm Pharm Sci. 2010;13(3):428-42. [Article]
- BION TEARS [Link]
- Hypromellose [Link]
- MIMS Hypromellose [Link]
- SUMMARY OF PRODUCT CHARACTERISTICS [Link]
- SUMMARY PRODUCT ASSESSMENT [Link]
- Hydroxypropyl methyl cellulose [Link]
- DailyMed: Genteal Mild Eye Drops (hypromellose 0.2%) [Link]
- External Links
- PubChem Substance
- 347911105
- 1363586
- Wikipedia
- Hypromellose
- MSDS
- Download (229 KB)
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Completed Prevention Allergic Conjunctivitis (AC) 1 4 Completed Prevention Chronic Allergic Conjunctivitis 1 4 Completed Treatment Allergic Conjunctivitis (AC) 1 4 Completed Treatment Anterior Uveitis (AU) / Macular Edema, Cystoid 1 4 Completed Treatment Corneal Edema / Intraocular Pressure (IOP) 1 4 Completed Treatment Corneal Epithelium Defect 1 4 Completed Treatment Dry Eye Syndrome (DES) 1 4 Completed Treatment Dry Eyes 1 4 Completed Treatment Glaucoma / Ocular Hypertension 4 4 Completed Treatment Keratoconjunctivitis Due to Adenovirus / Viral Shedding 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Solution Ophthalmic 2 % Solution Ophthalmic 0.5 % Solution Ophthalmic 1 % Solution / drops Ophthalmic 5 mg/1mL Solution / drops; suspension / drops Ophthalmic 3.2 mg/mL Solution Ophthalmic 0.32 % Solution Ophthalmic 20 mg/1mL Solution, gel forming / drops Ophthalmic 20 mg/1mL Solution / drops Ophthalmic 20 mg/1mL Solution / drops; suspension / drops Ophthalmic 1.92 mg/0/6mL Solution Intraocular; Ophthalmic 23 mg Liquid Ophthalmic Solution Ophthalmic 0.3 % Solution Oral 18 mg/1mL Gel Ophthalmic Solution Ophthalmic 5.000 mg Solution / drops Ophthalmic 0.1 %w/v Solution Ophthalmic 3 mg / mL Solution, gel forming / drops Conjunctival 3 mg Gel Ophthalmic 0.3 % Gel Ophthalmic 3 mg/g Liquid Ophthalmic 200 mg/1L Liquid Ophthalmic 300 mg/1L Gel Ophthalmic .003 g/1g Liquid Ophthalmic 25 mg/1mL Solution Ophthalmic 25 mg/1mL Solution / drops Ophthalmic 25 mg/1mL Solution Ophthalmic; Topical 3 mg Liquid Ophthalmic 3 mg/10mL For solution Topical 7 mg/1mL Solution / drops Ophthalmic Solution Ophthalmic 5 mg/1mL Solution / drops Ophthalmic 0.5 % Solution Ophthalmic 3 mg Solution Ophthalmic 5 mg Solution Rectal 1 g / 100 mL Solution Conjunctival; Ophthalmic 20 mg Solution / drops Ophthalmic 4 mg/1mL Kit; solution Intraocular; Irrigation Solution Conjunctival; Ophthalmic 3 mg Solution Ophthalmic 3 mg / g Solution Conjunctival; Ophthalmic 0.02 g Solution / drops Ophthalmic; Topical 3 mg/1mL Liquid Ophthalmic 3.5 mg/1mL Solution / drops Ophthalmic 10 mg / mL Solution / drops; suspension / drops Ophthalmic 0.32 % Solution / drops; suspension / drops Ophthalmic 3 mg/ml Solution / drops Ophthalmic 3 mg/1ml Solution / drops Ophthalmic 0.2 g/100mL Solution Ophthalmic; Topical Gel Ophthalmic 3 mg/1g Solution Conjunctival; Ophthalmic Tablet, delayed release Oral Solution / drops Ophthalmic 17 mg/1mL Solution Ophthalmic 25 mg/15mL Gel Ophthalmic 0.3 g/1mL Solution Ophthalmic Solution / drops Ophthalmic Liquid Ophthalmic 3 mg/1ml Liquid Ophthalmic 5 mg/1ml - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Not Available
- Experimental Properties
Property Value Source water solubility Soluble https://www.sigmaaldrich.com/catalog/product/usp/1330005?lang=en®ion=CA - Predicted Properties
- Not Available
- Predicted ADMET Features
- Not Available
Spectra
- Mass Spec (NIST)
- Not Available
- Spectra
- Not Available
Targets

- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- General Function
- Protein complex binding
- Specific Function
- May act as a physical homophilic interaction molecule between intestinal epithelial cells (IECs) and intraepithelial lymphocytes (IELs) at the mucosal epithelium for providing immunological barrier...
- Gene Name
- EPCAM
- Uniprot ID
- P16422
- Uniprot Name
- Epithelial cell adhesion molecule
- Molecular Weight
- 34932.005 Da
References
- Geerling G, Daniels JT, Dart JK, Cree IA, Khaw PT: Toxicity of natural tear substitutes in a fully defined culture model of human corneal epithelial cells. Invest Ophthalmol Vis Sci. 2001 Apr;42(5):948-56. [Article]
Drug created at December 03, 2015 16:51 / Updated at November 29, 2023 23:14