Hypromellose + Carbomer

Allopathic
Indications

Approved Indications:

  • Dry Eye Syndrome (Keratoconjunctivitis Sicca):
    For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
  • Post-Surgical Ocular Lubrication:
    As an adjunctive lubricant therapy after ophthalmic surgery (e.g., LASIK, cataract surgery).
  • Contact Lens Discomfort (without preservatives):
    In certain preservative-free formulations, used to relieve eye irritation associated with contact lens wear.
  • Environmental Eye Irritation:
    Relief from eye discomfort caused by dust, air pollution, prolonged screen time, or air conditioning.

Off-Label/Clinically Accepted Uses:

  • Supportive Therapy in Allergic Conjunctivitis:
    To alleviate mechanical irritation and flushing of allergens.
  • Lubrication in Sjögren’s Syndrome:
    Part of symptomatic management in patients with autoimmune-related dry eye.
  • Protection of Corneal Surface in Neuropathic Cornea or Exposure Keratitis:
    Especially when blinking is impaired.
Dosage & Administration

Route of Administration:
Topical – Ophthalmic (Eye drops or gels)

General Adult Dosing:

  • Eye Drops: 1–2 drops into the affected eye(s) up to 4–6 times daily, or as needed.
  • Gel Formulation: Apply 1 drop into each affected eye 1–4 times daily, typically used at bedtime for prolonged effect.

Pediatric Use:

  • Generally considered safe; same dosing applies as for adults unless otherwise directed by a physician.

Geriatric Population:

  • No specific dose adjustment required. Use as per adult dosing unless otherwise contraindicated.

Hepatic/Renal Impairment:

  • Not systemically absorbed in meaningful quantities; no dose adjustment required.

Administration Tips:

  • Wash hands before use.
  • Avoid touching the dropper tip to the eye or any surface.
  • If using other eye medications, separate doses by at least 5–10 minutes, applying Hypromellose + Carbomer last to ensure retention.
Mechanism of Action (MOA)

Hypromellose and carbomer work synergistically as ocular lubricants. Hypromellose is a cellulose-derived polymer that forms a protective, lubricating, and hydrating film over the corneal surface, reducing friction during blinking and enhancing moisture retention. Carbomer (a high molecular weight cross-linked polymer of acrylic acid) further increases viscosity, prolonging the contact time of the formulation on the eye surface. This dual action stabilizes the tear film, reduces evaporation, and soothes ocular surface inflammation or irritation caused by dryness or environmental exposure.

Pharmacokinetics

Since Hypromellose + Carbomer is applied topically and acts locally on the eye surface, it is not significantly systemically absorbed. However, key pharmacokinetic points include:

  • Absorption: Minimal to no systemic absorption through intact ocular tissues.
  • Distribution: Stays localized to ocular surface.
  • Metabolism: Not metabolized by ocular or systemic enzymes.
  • Elimination: Removed via tear turnover and drainage through the nasolacrimal duct.

Onset of Action:
Immediate symptomatic relief within minutes of application.

Duration of Action:
Varies by formulation; gel-based products have longer retention, up to 4–6 hours.

Pregnancy Category & Lactation

Pregnancy:

  • FDA Pregnancy Category: Not formally classified.
  • Considered safe based on low systemic absorption. No teratogenic or embryotoxic effects reported.
  • Use when clearly needed; risk is minimal.

Lactation:

  • Excretion in Breast Milk: Not expected due to minimal systemic absorption.
  • Safe during breastfeeding; no known adverse effects on infants.
Therapeutic Class
  • Primary Class: Ocular Lubricant / Artificial Tears
  • Subclass: Polymer-based Ophthalmic Lubricants
  • Formulation Type: Viscous drops or gel for prolonged ocular retention
Contraindications
  • Known hypersensitivity to hypromellose, carbomer, or any component of the formulation
  • Use with soft contact lenses (only if preservative-containing drops are used) – preservatives may absorb into the lens and cause irritation
Warnings & Precautions
  • Avoid contamination: Do not touch dropper tip to any surface to prevent microbial contamination.
  • Blurred vision: May occur temporarily after application, especially with gel formulations.
  • Contact lenses: Remove lenses before use unless product is labeled as compatible; reinsert 15 minutes post-application.
  • Preservative Sensitivity: Patients with allergies to benzalkonium chloride or similar preservatives should use preservative-free formulations.
  • Ocular infection or injury: Should not be used in the presence of eye infection unless directed by a physician.
Side Effects

Common (usually mild and transient):

  • Temporary blurred vision
  • Mild eye irritation or stinging
  • Eye redness
  • Sticky eyelids or crusting (especially with gels)

Less Common:

  • Allergic reactions (itching, swelling, tearing)
  • Foreign body sensation
  • Excessive tearing (reflex tearing)

Rare but Serious:

  • Hypersensitivity reaction
  • Worsening redness or discharge – may indicate underlying infection
Drug Interactions
  • No significant systemic drug interactions due to negligible absorption.
  • Local interaction with other eye drops:
    • May affect absorption of concurrently administered ophthalmic drugs.
    • Spacing of 5–10 minutes between different eye drops is recommended.
  • Contact lens interactions (preservative-containing drops):
    • Benzalkonium chloride may discolor or damage lenses and irritate eyes.
Recent Updates or Guidelines
  • EMA and FDA have reaffirmed the safety of polymer-based artificial tears in non-preserved and preserved forms for long-term use in dry eye management.
  • Recent shift toward preservative-free unit-dose packaging to reduce risk of preservative-related toxicity in chronic dry eye users.
  • Guidelines for Dry Eye Disease (e.g., TFOS DEWS II) recommend polymer-based artificial tears like hypromellose + carbomer as part of first-line therapy for mild to moderate dry eye.
Storage Conditions
  • Store below 25°C (77°F)
  • Protect from light and moisture
  • Do not freeze.
  • Keep container tightly closed when not in use.
  • Shelf life after opening:
    • Multidose bottles: Usually 28 days unless otherwise specified
    • Single-dose (preservative-free): Discard immediately after use
  • Shake gel formulations gently before use if separation occurs.