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Updated: Jul 16, 2026
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Self-Nanoemulsification of Healthy Oils to Enhance the Solubility of Lipophilic Drugs
Published on: July 27, 2022
Enhanced Bioavailability of a Novel Oil-Based Lutein Formulation: A Randomized, Double-Blind, Single-Dose,
Rambabu Maddela1, Srinivasa Rao Kotagiri1, Abhijeet Morde2
1AnaCipher Clinical Research Organization, Ramanthapur, Hyderabad, Telangana, India.
Advances in Therapy
|July 14, 2026
Summary
A new oil suspension of lutein (LUT) significantly enhanced systemic bioavailability compared to a reference formulation (REF). This improved lutein absorption highlights the importance of formulation in carotenoid delivery.
Area of Science:
- Nutrition Science
- Pharmacokinetics
- Carotenoid Research
Background:
- Lutein, a xanthophyll carotenoid, is vital for ocular health.
- Systemic bioavailability of lutein varies significantly based on formulation.
- This study compares a novel lutein oil suspension (LUT) with a reference formulation (REF).
Purpose of the Study:
- To compare the bioavailability and pharmacokinetic profile of a new lutein oil suspension (LUT) against a reference lutein formulation (REF).
- To assess lutein absorption following a single oral dose under fed conditions in healthy adults.
Main Methods:
- Randomized, double-blind, single-dose, parallel-group study in 80 healthy adult males.
- Administration of 25 mg lutein as LUT or REF under standardized high-fat fed conditions.
- Serial blood sampling up to 72 hours post-dose; serum lutein quantified via HPLC; pharmacokinetic parameters analyzed using non-compartmental analysis.
Main Results:
- The LUT formulation showed significantly higher serum lutein concentrations from 8 to 72 hours post-dose compared to REF.
- LUT achieved approximately 32% higher Cmax and significantly greater total systemic bioavailability (AUCs increased by 35-78%).
- LUT demonstrated consistently over 2-fold higher serum lutein levels from baseline across all post-dose time points; both formulations were well tolerated.
Conclusions:
- The novel lutein oil suspension (LUT) formulation significantly enhances systemic lutein bioavailability compared to the reference formulation.
- Formulation design critically influences lutein bioavailability, underscoring the need for optimized delivery systems.
- Further clinical studies are recommended to explore the efficacy implications of this enhanced lutein absorption.
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