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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Associated Conditions

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

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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
Entrocel	Solution	18 mg/1mL	Oral	Mallinckrodt	2009-06-01	2012-10-31
Goniotaire	Solution	25 mg/1mL	Ophthalmic	Altaire Pharmaceuticals Inc.	2002-01-18	Not applicable
Mc Methylcellulose Solution 1%	Solution	1 g / 100 mL	Rectal	E Z Em, Inc.	1982-12-31	2009-08-04

Over the Counter Products

Name	Dosage	Strength	Route	Labeller	Marketing Start	Marketing End
Alcon Tears 0.5%	Solution	0.5 %	Ophthalmic	Alcon, Inc.	1969-12-31	Not applicable
Alcon Tears 1%	Solution	1 %	Ophthalmic	Alcon, Inc.	1970-12-31	Not applicable
Alcon Tears Lubricant Eye Drops	Solution / drops	5 mg/1mL	Ophthalmic	ALCON LABORATORIES, INC.	2022-03-01	Not applicable
AQUA TEAR EYE DROPS	Solution / drops	3 mg/1ml	Ophthalmic	บริษัท แม็กซิมอินเตอร์คอร์ปอร์เรชั่น จำกัด จำกัด	2019-09-04	Not applicable
Artelac Lubricant Eye Drops	Solution	0.32 %	Ophthalmic	Bausch & Lomb Inc	2005-03-25	2008-07-28
Aurovisc	Solution	20 mg/1mL	Ophthalmic	Aurolab	2022-09-26	Not applicable
Aurovisc Lubricant HYPROMELLOSE 2208 (15000 MPA.S) Gel/Drops	Solution, gel forming / drops	20 mg/1mL	Ophthalmic	Aurolab	2022-09-26	Not applicable
Aurovisc Lubricant HYPROMELLOSE 2208 (15000 MPA.S) Solution/Drops	Solution / drops	20 mg/1mL	Ophthalmic	Aurolab	2022-09-26	Not applicable
Corneo Hypromellose	Solution	0.3 %	Ophthalmic	Orimed Pharma Corporation	2015-09-16	Not applicable
EYE GLO MOIST EYE DROPS	Solution / drops	0.1 %w/v	Ophthalmic	Duopharma Marketing Sdn. Bhd.	2020-09-08	2021-12-12

Mixture Products

Name	Ingredients	Dosage	Route	Labeller	Marketing Start	Marketing End
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
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
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
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
Artificial Tears	Hypromellose (0.3 %) + Dextran (0.1 %)	Solution	Ophthalmic	Alcon, Inc.	2005-03-16	2009-02-24
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
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
Artificial Tears	Hypromellose (0.2 % w/v) + Glycerin (0.2 % w/v)	Solution	Ophthalmic	TEVA Canada Limited	2011-04-19	Not applicable
Artificial Tears	Hypromellose (3 mg/1mL) + Dextran 70 (1 mg/1mL) + Glycerin (2 mg/1mL)	Solution / drops	Ophthalmic	AvPAK	2023-01-05	Not applicable
Biomedic Artificial Tears	Hypromellose (0.2 g/100mL) + Glycerin (0.2 g/100mL)	Liquid	Ophthalmic	Kc Pharmaceuticals, Inc.	2019-04-30	Not applicable

Unapproved/Other Products

Name	Ingredients	Dosage	Route	Labeller	Marketing Start	Marketing End
Entrocel	Hypromellose (18 mg/1mL)	Solution	Oral	Mallinckrodt	2009-06-01	2012-10-31
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
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
Goniosoft	Hypromellose (25 mg/1mL)	Liquid	Ophthalmic	OCuSOFT, INC.	1989-10-02	2022-01-31
Goniotaire	Hypromellose 2906 (4000 mPa.S) (25 mg/1mL)	Solution	Ophthalmic	Altaire Pharmaceuticals Inc.	2002-01-18	Not applicable
Vista Gonio Eye Lubricant	Hypromellose 2208 (100 mPa.S) (25 mg/15mL)	Solution	Ophthalmic	Red Wedding LLC	2023-07-01	Not applicable

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
RxNav: 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

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insights and accelerate drug research.

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Details1. Epithelial cell adhesion molecule

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

Hypromellose

Identification

Pharmacology

Interactions

Products

Categories

Chemical Identifiers

References

Clinical Trials

Pharmacoeconomics

Properties

Spectra

Targets

References