What is the mechanism of action of this treatment?

Excipients, such as sodium lauryl sulfate (SLS), play a crucial role in drug absorption by modifying the drug's solubility and permeability. SLS, a surfactant, can enhance the absorption of drugs by reducing surface tension and increasing the wettability of the drug particles, thereby improving their dissolution rate. This is particularly important for drugs with poor water solubility, as it can significantly impact their bioavailability and therapeutic efficacy. Understanding the role of excipients like SLS is essential for optimizing drug formulations to ensure consistent and effective drug delivery for patients.

What side effects are associated with this type of intervention?

Sodium lauryl sulfate (SLS) is a common excipient studied for its potential to modulate drug absorption. Known side effects of SLS and similar excipients include gastrointestinal disturbances such as diarrhea and nausea, as well as potential irritation to mucosal surfaces. These side effects are generally related to the surfactant properties of SLS, which can disrupt cellular membranes and alter normal physiological functions.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for treatments directly related to the impact of excipients like Sodium Lauryl Sulfate (SLS) on drug absorption. However, it does highlight a study investigating whether SLS affects drug absorption when taken with other drugs. Generally, excipients are known to influence the pharmacokinetics of drugs, but specific FDA approvals for such applications are not detailed in the context.

What other types of research exist?

Promising novel alternatives to Sodium Lauryl Sulfate (SLS) for modulating drug absorption include cyclodextrins, which can enhance solubility and stability of drugs, and lipid-based excipients like medium-chain triglycerides (MCTs) that improve bioavailability. Additionally, polymer-based excipients such as polyvinylpyrrolidone (PVP) and polyethylene glycol (PEG) are being explored for their ability to enhance drug solubility and absorption.

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Excipient Impact on Drug Absorption

Phase < 1

Recruiting

Led By Kathleen M Giacomini, Ph.D.

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and females between the ages of 18-64 years old, inclusive

Be between 18 and 65 years old

Must not have

Subjects with gastrointestinal disease, gastrointestinal disorder, or gastrointestinal surgery

Subjects taking any drugs, especially known OATP2B1 substrates (aliskiren, atenolol, celiprolol, fexofenadine, rosuvastatin and ticlopidine, etc.) except birth control hormonal medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-48 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if adding sodium lauryl sulfate (SLS) to fexofenadine changes how well the drug works. It looks at people taking fexofenadine and checks drug levels in the blood and stool to see if SLS makes a difference. SLS has been shown to help various substances get into the body better.

Who is the study for?

Healthy adults aged 18-64, willing to avoid certain fruit juices and supplements, can join this trial. They must not be extremely obese, allergic to the drug or its components, have low hemoglobin levels, be pregnant/breastfeeding without birth control use, or have liver/kidney/heart diseases.

What is being tested?

The study is testing how a common non-drug ingredient called sodium lauryl sulfate (SLS) affects the absorption of Fexofenadine Hydrochloride. Participants will take the drug with varying amounts of SLS to see if there's any difference in how well their body absorbs it.

What are the potential side effects?

While specific side effects are not listed for this trial scenario since it involves healthy volunteers and a commonly used medication component (SLS), typical reactions might include digestive discomfort or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 64 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had gastrointestinal issues or surgery.

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I am not on medication that affects drug transport in my body, except for birth control.

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My liver, kidney, or heart function is not impaired.

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My BMI is over 35.

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I do not speak English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area under the plasma concentration versus time curve (AUC) of Fexofenadine

Maximum Plasma Concentration (Cmax) of Fexofenadine

Secondary study objectives

Fexofenadine stool amount

Sodium lauryl sulfate plasma concentration

Sodium lauryl sulfate stool amount

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Fexofenadine without SLSExperimental Treatment1 Intervention

Participants will be administered by mouth with a capsule containing 120 mg fexofenadine hydrochloride and 101 mg microcrystalline cellulose

Group II: Fexofenadine and 30 mg SLSExperimental Treatment1 Intervention

Participants will be administered by mouth with a capsule containing 120 mg fexofenadine hydrochloride, 30 mg SLS and 101 mg microcrystalline cellulose

Group III: Fexofenadine and 3 mg SLSExperimental Treatment1 Intervention

Participants will be administered by mouth with a capsule containing 120 mg fexofenadine hydrochloride, 3 mg SLS and 101 mg microcrystalline cellulose

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Excipients, such as sodium lauryl sulfate (SLS), play a crucial role in drug absorption by modifying the drug's solubility and permeability. SLS, a surfactant, can enhance the absorption of drugs by reducing surface tension and increasing the wettability of the drug particles, thereby improving their dissolution rate. This is particularly important for drugs with poor water solubility, as it can significantly impact their bioavailability and therapeutic efficacy. Understanding the role of excipients like SLS is essential for optimizing drug formulations to ensure consistent and effective drug delivery for patients.

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