MedPath

Hypromellose

Generic Name
Hypromellose
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
Drug Type
Small Molecule
CAS Number
9004-65-3
Unique Ingredient Identifier
3NXW29V3WO

Overview

Hypromellose, or hydroxypropyl methylcellulose (HPMC) , 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 . 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 . Hypromellose is also found in eye drops as a lubricant .

Indication

Used as an ophthalmic protectant and lubricant, in artificial tears, and as a diagnostic aid (contact lens procedures; gonioscopy).

Associated Conditions

  • Dry Eyes
  • Ocular Discomfort
  • Ocular Irritation

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/07/03
Not Applicable
Not yet recruiting
Center for Sight Las Vegas
2025/03/20
Phase 4
Recruiting
2025/01/08
Phase 4
Recruiting
2024/04/23
Phase 1
Not yet recruiting
2024/01/24
Phase 4
Completed
Chang Gung Memorial Hospital
2024/01/23
Phase 4
Completed
Scripps Poway Eyecare and Optometry
2024/01/03
Phase 2
Completed
2023/01/30
Phase 4
Completed
2022/10/26
Phase 4
Completed
Tauber Eye Center
2021/04/30
Not Applicable
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

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
Hypromellose Eye Drops
国药准字H20103788
化学药品
眼用制剂
5/9/2022
Hypromellose Eye Drops
国药准字H20067905
化学药品
滴眼剂
3/25/2020
Hypromellose Eye Drops
国药准字H20053470
化学药品
眼用制剂
4/30/2020
Hypromellose Eye Drops
国药准字H20073657
化学药品
眼用制剂
5/16/2023
Hypromellose Eye Drops
国药准字H20045427
化学药品
眼用制剂(滴眼液)
8/12/2020
Hypromellose Eye Drops
国药准字H20093895
化学药品
眼用制剂
11/4/2020
Hypromellose Eye Drops
国药准字H20066274
化学药品
眼用制剂
5/31/2021
Hypromellose Eye Drops
国药准字H20074116
化学药品
眼用制剂
1/9/2023
Hypromellose Eye Drops
国药准字H20064221
化学药品
眼用制剂
8/26/2021
Hypromellose Eye Drops
国药准字H20043417
化学药品
滴眼剂
8/13/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
LOSTEAR EYE DROPS 0.3% W/V
N/A
N/A
N/A
7/6/2016
GENTEAL EYE GEL
N/A
alcon hong kong ltd
N/A
N/A
2/16/2004

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
MediHerb Gotu Kola Complex (Export Only)
389071
Medicine
A
5/25/2022

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