There are different types of studies in the dietary ingredients industry. The ones that tend to receive the most excitement are human efficacy trials, followed by those that illuminate mechanisms of action. And of course, the enthusiasm for these study results is well-deserved.
 
However, a type of study that does not tend to engender much reaction is the pharmacokinetic (PK) study. This type of study discerns how the body reacts to a certain substance through examination of the active’s absorption, bioavailability, metabolism, and excretion.

What’s the Value of a Pharmacokinetic Study?

The primary purpose of PK studies is to understand the movement of an active ingredient in the human body after it is administered. These studies provide valuable data on the bioavailability of the ingredient, which is crucial for determining the optimal dosage and ensuring the desired therapeutic effects.
 
When mapping out the research journey that will substantiate the ingredient, a PK study should be conducted during the early stage of the ingredient development to evaluate dose-response relationship as well as relationships among dosage regimens, active concentrations, and potential adverse effects.
 
Early in the research phase, PK studies can contribute to the process of formulation development and delivery methods by identifying the most efficient ways to enhance absorption and bioavailability, among other goals. PK studies help in fine-tuning or confirming the effective dosage and understanding potential metabolic interactions. PK studies play a crucial role in building the foundation for future substantiating claims and ensuring consistent product performance, thereby supporting marketing efforts.
 
PK studies significantly bolster an ingredient’s scientific portfolio by providing comprehensive data on the crucial characteristics of an active such as its concentration in plasma, presence or absence of first pass metabolism, the time taken to eliminate the active from the body, and most importantly its bioavailability.
 
This data enhances credibility and supports supplement claims with robust scientific evidence. For instance, understanding the bioavailability of an ingredient can differentiate a product in the market, highlighting superior absorption rates compared to competitors. Furthermore, PK studies can identify the optimal dosage range, ensuring efficacy while minimizing the daily dosage required, thus enhancing the overall compliance of the ingredient, especially when taken long term.

How a Pharmacokinetic Study Works

In general, a pharmacokinetic study involves several critical steps:
 
1. Study design and setup: The study begins with designing a protocol that outlines the objectives, methodology, and parameters to be measured. Participants are selected based on inclusion criteria relevant to the ingredient under study.
 
2. Dosing and sampling: Pharmacokinetic studies are performed on healthy participants who receive a specific dose of the ingredient, and biological samples (usually blood, but in few instances other biological metrics such as urine, or saliva) are collected at multiple time points to measure the concentration of the active.
 
3. Data analysis: The collected samples are analyzed using sophisticated and validated techniques such as liquid chromatography-mass spectrometry (LC-MS). The resulting data is used to generate pharmacokinetic profiles, including parameters like Cmax (maximum concentration), Tmax (time to reach Cmax), T1/2 (half life — time required to eliminate by half its concentration) and AUC (area under the concentration-time curve).
 
4. Interpretation and reporting: The data is interpreted to understand the absorption, distribution, metabolism, and excretion of the ingredient. These findings are compiled into a detailed report that highlights the key pharmacokinetic characteristics based on which bioavailability/bioequivalence of the ingredient is determined.
 
Case Study 1: Nutriventia’s TurmXTRA 60N
 
TurmXTRA 60N provides 150 mg curcuminoids in 250 mg single capsules. TurmXTRA 60N is a proprietary water-dispersible turmeric extract designed for enhanced bioavailability, confirmed with three different PK studies to assess when compared against standard turmeric extracts. The studies revealed that TurmXTRA 60N exhibited a significantly higher Cmax and AUC compared to standard turmeric extracts, indicating superior absorption and sustained presence in the bloodstream. These findings highlight TurmXTRA 60N’s potential for providing prolonged effects with just a single daily dose.
 
Case Study 2: Nutriventia’s Melotime
 
Melotime is a patent-pending and proprietary extended-release granular melatonin ingredient that helps mimic the body’s natural sleep pattern and supports quality sleep. It was formulated for improved bioavailability which was evaluated in a PK study to determine its pharmacokinetic profile. The study demonstrated that Melotime had a faster Tmax as compared to a conventional melatonin ingredient, suggesting quicker onset of action.

Value of a Pharmacokinetic Study for Brand Customers

For brand customers, PK studies offer several benefits:
 
Scientific validation: PK studies provide concrete evidence of an ingredient’s absorption and bioavailability, enhancing the credibility of health claims.
Product differentiation: Brands can leverage PK data to differentiate their products in a competitive market, highlighting superior pharmacokinetic properties.
Consumer trust: Transparent communication of PK study results helps build consumer trust by showcasing the scientific rigor behind the product.
 
Whether it’s long-term systemic support for gains and improvements as will be evidenced by tests administered by one’s physician, or shorter-term results such as attaining a full night’s sleep, human efficacy studies cannot be successful without first identifying dose and manner of absorption. PK studies set the course for the ingredient’s ultimate success in the marketplace.
 

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About the Author: Rajat Shah is Co-Founder of Nutriventia. She uses her diverse leadership experience and rich technical expertise to lead the Nutriventia brand for Inventia Healthcare Limited. She holds a master’s in computer science and Engineering and an MBA in Marketing and Strategy. She has continued to advance her knowledge in pharmacology and medicine from Harvard Medical School. At the age of 22, she designed and commercialized a profiling solution for researchers which was extensively used by universities in the U.S.