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Propylene Glycol

Propylene glycol is a common ingredient used in various medical and pharmaceutical applications. This article explores the use of propylene glycol in clinical trials for different conditions, including dry eye disease, constipation, and as a vehicle for drug delivery. We’ll examine its effectiveness, safety profile, and potential benefits across multiple studies.

Table of Contents

What is Propylene Glycol?

Propylene glycol is a colorless, odorless liquid that is widely used in medical and pharmaceutical applications. It’s often used as an inactive ingredient or excipient in various medications and treatments. This means it helps deliver the active ingredients in a drug but doesn’t have a direct therapeutic effect itself[1].

Medical Uses

Propylene glycol has several important uses in medicine:

  • Vehicle for drug delivery: It’s often used to help dissolve or carry other medications, making them easier for the body to absorb[1].
  • Preservative: It can help extend the shelf life of certain medications[2].
  • Moisturizer: In some formulations, it acts as a humectant, which means it helps retain moisture[2].

Eye Health Applications

Propylene glycol is commonly used in eye drops and artificial tears for treating dry eye conditions:

  • Artificial tears: It’s an ingredient in some over-the-counter eye drops, such as Systane® Balance, which contains 0.3% propylene glycol. These drops help lubricate the eye and relieve symptoms of dry eye disease[2][3].
  • Tear film stability: Propylene glycol can help improve the stability of the tear film, which is the layer of moisture that covers and protects the eye’s surface[4].

Cancer Treatment

In cancer treatment, propylene glycol has been used as part of drug formulations:

  • Melphalan formulations: Traditional formulations of melphalan, a chemotherapy drug used in multiple myeloma and lymphoma treatment, contained propylene glycol. However, newer formulations are being developed without it to potentially reduce side effects[5][6].

Skin Conditions

Propylene glycol is used in some topical treatments for skin conditions:

  • Arsenical keratosis: A study investigated the use of propylene glycol (40%) in combination with other ingredients for treating palmar arsenical keratosis, a skin condition caused by chronic arsenic exposure[7].

Safety and Side Effects

Propylene glycol is generally considered safe when used as directed in approved medical products. However, like any substance, it can cause side effects in some people:

  • Skin irritation: When used in topical products, it may cause mild skin irritation in some individuals[7].
  • Eye irritation: In eye drops, it may cause temporary stinging or burning in some users[2].
  • Allergic reactions: Rarely, some people may be allergic to propylene glycol[1].

It’s important to note that researchers are continually studying propylene glycol and developing new formulations to improve its effectiveness and reduce potential side effects[5][6].

Condition Use of Propylene Glycol Key Findings
Dry Eye Disease Component in artificial tears Compared with other formulations for tear film stability and symptom relief
Post-operative Constipation Ingredient in laxative formulation Evaluated against docusate sodium for preventing constipation after knee surgery
Multiple Myeloma Vehicle for melphalan delivery Propylene glycol-free formulation studied for pharmacokinetics and safety
Dental Procedures Vehicle for antibiotic delivery in LSTR Compared with hyaluronic acid as a vehicle for antibiotics in tooth treatment
Arsenical Palmar Keratosis Component in topical treatment Combined with neem extract and salicylic acid for treating arsenic-induced skin condition

FAQ

  • What is propylene glycol used for in clinical trials? Propylene glycol is used in various ways in clinical trials, including as a vehicle for drug delivery, an ingredient in artificial tears for dry eye treatment, and as a component in laxative formulations for constipation relief.
  • Is propylene glycol safe for use in eye drops? Yes, propylene glycol is generally considered safe for use in eye drops. It is commonly used in artificial tear formulations to help lubricate and moisturize the eye surface in dry eye disease treatments.
  • How does propylene glycol compare to other ingredients in dry eye treatments? In some studies, propylene glycol-containing eye drops were compared to other formulations. For example, one trial compared a new formulation containing glycerin to a product with propylene glycol. The effectiveness can vary depending on the specific formulation and other ingredients used.
  • Can propylene glycol help with constipation? Yes, propylene glycol has been studied as a component in laxative formulations. In one trial, it was compared to docusate sodium for preventing post-operative constipation in patients undergoing knee replacement surgery.
  • Are there any side effects associated with propylene glycol use? While propylene glycol is generally considered safe, some studies monitor for potential side effects. In clinical trials, researchers often assess tolerability and any adverse events related to its use. However, specific side effects were not detailed in the provided trial information.

Ongoing Clinical Trials on Propylene Glycol

  • Testing two moisturizing creams with urea, propylene glycol, and propylene glycol alone for preventing flare-ups in patients with atopic dermatitis

    Recruiting

    1 1 1
    Investigated drugs:
    Norway Sweden

  • Testing HPV Vaccine to Prevent Return of Precancerous Lesions in Patients Treated for High-Grade Abnormal Cell Changes Caused by HPV

    Not yet recruiting

    1 1 1
    Investigated drugs:
    France

  • Study of Mirvetuximab Soravtansine and Bevacizumab for Maintenance in Adults with Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Czechia France Germany Greece +5

  • Study Comparing Propylene Glycol and Urea Creams for Treating Dry Feet in People with Diabetes

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden

  • Study on the Safety and Effectiveness of Melatonin and Ocrelizumab for Patients with Primary Progressive Multiple Sclerosis

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on the Effect of a New Moisturiser with Glycerol and Urea on Skin Barrier in Adults with Atopic Dermatitis

    Not recruiting

    1 1 1
    Investigated drugs:
    Germany

Glossary

  • Propylene Glycol: A colorless, odorless liquid used as a solvent, humectant, and preservative in various pharmaceutical and medical applications.
  • Dry Eye Disease: A condition where the eyes don't produce enough tears or the tears evaporate too quickly, leading to discomfort and potential vision problems.
  • Tear Film Break-up Time: A measure of tear film stability, used to assess the effectiveness of dry eye treatments.
  • Keratoconjunctivitis Sicca: Another term for dry eye syndrome, characterized by a lack of proper lubrication on the eye's surface.
  • Autologous Stem Cell Transplantation: A procedure where a patient's own stem cells are used to replace diseased or damaged bone marrow.
  • Myeloablative Conditioning: A type of high-dose chemotherapy used to prepare a patient for stem cell transplantation.
  • Pharmacokinetics: The study of how drugs move through the body, including their absorption, distribution, metabolism, and excretion.
  • Lesion Sterilization and Tissue Repair (LSTR): A dental technique using antibiotics to treat infected tooth pulp and promote healing.
  • Arsenical Palmar Keratosis: A skin condition characterized by thickening of the skin on the palms, caused by chronic arsenic exposure.

References

  1. https://clinicaltrials.gov/study/NCT05116306
  2. https://clinicaltrials.gov/study/NCT04111965
  3. https://clinicaltrials.gov/study/NCT05660681
  4. https://clinicaltrials.gov/study/NCT00681265
  5. https://clinicaltrials.gov/study/NCT02669615
  6. https://clinicaltrials.gov/study/NCT01969435
  7. https://clinicaltrials.gov/study/NCT02352987