Cellulose, Microcrystalline

This article explores the use of Cellulose, Microcrystalline in various clinical trials. While not the primary drug being studied, Cellulose, Microcrystalline plays a crucial role as a placebo or excipient in these trials, helping researchers evaluate the effectiveness of other medications across a range of medical conditions.

Table of Contents

What is Cellulose Microcrystalline?

Cellulose microcrystalline is a purified form of cellulose, which is a natural substance found in plant cell walls. It is commonly used as an inactive ingredient or excipient in pharmaceutical products[1]. Cellulose microcrystalline is also known by its abbreviation MCC.

Uses in Clinical Trials

Based on the clinical trial information provided, cellulose microcrystalline is being used in several studies as a placebo or inactive ingredient. It is not the primary drug being tested, but rather serves as a control substance. Some key uses observed in the trials include:

  • As a placebo in a study on treating generalized periodontitis (advanced gum disease)[1]
  • As an inactive ingredient in a trial studying the effects of stress on ethical decision-making[2]
  • As a placebo in research on treating severe influenza[3]
  • As part of a placebo formulation in a study on spinal cord injury and spasticity[4]
  • As a placebo in research on non-alcoholic fatty liver disease (NAFLD)[5]

Administration and Dosage

Cellulose microcrystalline is typically administered orally. The dosage can vary depending on its use in different studies:

  • In some trials, it was used in doses up to 1000 mg per day[1]
  • In other studies, the dosage ranged from 30 mg to 360 mg per day[2][3]
  • The duration of use in these trials ranged from a single day to several weeks or months

It’s important to note that these dosages are specific to research studies and may not reflect typical use in commercial products.

Potential Benefits

As cellulose microcrystalline is primarily used as an inactive ingredient or placebo in these studies, it does not have direct therapeutic benefits. Its main purpose is to serve as a control substance to compare against active treatments. However, in pharmaceutical products, it can have several benefits:

  • It helps in the formation and stability of tablet formulations
  • It can improve the flow properties of powders in manufacturing
  • It may help in controlling the release of active ingredients in some formulations

Safety and Side Effects

Cellulose microcrystalline is generally considered safe for most people when used as directed. It is classified as “Generally Recognized as Safe” (GRAS) by the U.S. Food and Drug Administration[6]. However, as with any substance, some individuals may experience side effects:

  • Digestive discomfort in some people
  • Potential for allergic reactions in rare cases

If you experience any unusual symptoms while taking a product containing cellulose microcrystalline, consult your healthcare provider.

Other Considerations

While cellulose microcrystalline is widely used in pharmaceutical and food products, there are a few things to keep in mind:

  • It is often used as a filler or bulking agent in supplements and medications
  • People with specific dietary restrictions (e.g., those following a vegan diet) may prefer products using cellulose microcrystalline over animal-derived excipients
  • If you have any concerns about cellulose microcrystalline in your medications or supplements, discuss them with your healthcare provider or pharmacist

Remember, cellulose microcrystalline is an inactive ingredient and does not replace active medical treatments. Always follow your healthcare provider’s advice regarding medications and treatments.

Trial Number Medical Condition Role of Cellulose, Microcrystalline Dosage Form
2022-501957-35-00 Generalized periodontitis Excipient Oral powder
2023-508731-31-01 Acute stress response Placebo Oral powder
2024-511226-32-00 Pleurodesis surgery for pneumothorax Placebo Oral powder
2024-513209-30-00 Severe Influenza Placebo Oral powder
2024-514882-20-00 Spasticity in chronic spinal cord injury Placebo Capsule
2024-517593-21-00 Fibrotic non-alcoholic fatty liver disease Placebo Oral powder

Ongoing Clinical Trials on Cellulose, Microcrystalline

  • Study on the Effects of Ketoprofen and Drug Combination in Patients Undergoing Pleurodesis Surgery for Pneumothorax

    Recruiting

    3 1 1
    Investigated diseases:
    France
  • Study on Riluzole for Reducing Spasticity in Patients with Chronic Spinal Cord Injury

    Recruiting

    3 1
    France
  • Study on Valaciclovir for Treating Advanced Gum Disease in Adults

    Recruiting

    3 1 1
    Investigated diseases:
    France
  • Study on the Effects of Dexamethasone and Oseltamivir in Patients with Severe Influenza

    Recruiting

    3 1 1
    Investigated diseases:
    Spain
  • Daridorexant for Insomnia in Patients with Major Depressive Disorder and Moderate to Severe Insomnia

    Not yet recruiting

    3 1 1
    Investigated diseases:
    Spain
  • A study to evaluate the effectiveness of upadacitinib and pirfenidone in reducing symptom severity in patients with Long Covid

    Not yet recruiting

    3 1 1
    Italy
  • Study of hydrocortisone and fludrocortisone in patients with intermediate/high-risk scheduled cardiac surgery to prevent complications

    Not yet recruiting

    3 1 1
    Investigated diseases:
    France
  • Study on the Effect of Vitamin C and Microcrystalline Cellulose on Reducing Complex Regional Pain Syndrome in Patients Undergoing Upper Limb Surgery

    Not yet recruiting

    3 1 1
    Investigated diseases:
    France
  • Study on the Effects of Yohimbine and Hydrocortisone on Stress and Moral Decisions in Military Personnel

    Not recruiting

    3 1 1
    Investigated diseases:
    The Netherlands
  • Study on the Effect of Diltiazem on Angina in Patients with Coronary Microvascular Dysfunction

    Not recruiting

    3 1 1
    The Netherlands

Glossary

  • Excipient: An inactive substance that serves as a vehicle or medium for a drug or other active substance. Excipients are used in medications to bulk up formulations that contain potent active ingredients, to aid in the manufacturing process, or to enhance stability or bioavailability.
  • Placebo: A substance or treatment with no active therapeutic effect, used as a control in clinical trials to test the effectiveness of new drugs or treatments.
  • Clinical Trial: A research study that prospectively assigns human participants to one or more health-related interventions to evaluate the effects on health outcomes.
  • Randomized Controlled Trial (RCT): A type of clinical trial where participants are randomly assigned to either the group receiving the treatment under investigation or to a group receiving standard treatment or a placebo.
  • Double-blind: A study design in which neither the participants nor the researchers know who is receiving the experimental treatment and who is receiving the placebo or standard treatment.
  • Efficacy: The ability of an intervention to produce the desired beneficial effect under ideal circumstances.
  • Safety: The extent to which a medical treatment can be used with minimal risk of harmful effects, especially in comparison to the disease or condition for which it is used.
  • Adverse Event: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
  • Bioavailability: The proportion of a drug or other substance which enters the circulation when introduced into the body and so is able to have an active effect.
  • Pharmacokinetics (PK): The study of how a drug is absorbed, distributed, metabolized, and excreted by the body over time.

References

  1. http://clinicaltrials.eu/trial/study-on-valaciclovir-for-treating-advanced-gum-disease-in-adults/
  2. http://clinicaltrials.eu/trial-id/2023-508731-31-01
  3. http://clinicaltrials.eu/trial/study-on-the-effects-of-dexamethasone-and-oseltamivir-in-patients-with-severe-influenza/
  4. http://clinicaltrials.eu/trial/study-on-riluzole-for-reducing-spasticity-in-patients-with-chronic-spinal-cord-injury/
  5. http://clinicaltrials.eu/trial/study-on-dasatinib-and-quercetin-for-treating-fibrotic-non-alcoholic-fatty-liver-disease-in-patients-with-biopsy-proven-nafld/
  6. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=182.1745