Sesame oil, extracted from Sesamum indicum seeds, has been widely used in the pharmaceutical industry due to its stability, bioavailability-enhancing properties, and compatibility with lipophilic drugs. It serves as an essential excipient and solvent in various drug formulations, including injectables, oral medications, and topical preparations. The pharmaceutical industry requires a highly refined version of sesame oil, free from impurities, toxins, and oxidation byproducts, to meet international regulatory standards.
Sesame (Sesamum indicum L.) is one of the oldest oilseed crops cultivated by humans, belonging to the Pedaliaceae family. Alongside rapeseed, soybeans, and peanuts, it is recognized as one of China’s primary oil crops. The origins of sesame trace back to ancient archaeological sites in present-day Pakistan, highlighting its long history as a cultivated plant. Today, it is widely grown in countries such as India, China, and Malaysia, with evidence suggesting that sesame has been used in Chinese diets for over 5,000 years.
Globally, leading sesame producers include India, Sudan, Myanmar, China, and Tanzania. In recent years, Africa’s sesame production has surged, with Tanzania surpassing India as the world’s top sesame producer. According to data from the Food and Agriculture Organization (FAO), global sesame production reached approximately 5.9 million tons in 2017, with Tanzania contributing 806,000 tons and China producing 733,000 tons.
The nutritional significance of sesame seeds gained official recognition in 2002 when they were added to the list of approved medicinal and food ingredients by China’s former Ministry of Health.
Sesame oil, extracted from Sesamum indicum seeds, has been widely used in the pharmaceutical industry due to its stability, bioavailability-enhancing properties, and compatibility with lipophilic drugs. It serves as an essential excipient and solvent in various drug formulations, including injectables, oral medications, and topical preparations. The pharmaceutical industry requires a highly refined version of sesame oil, free from impurities, toxins, and oxidation byproducts, to meet international regulatory standards.
This article explores the production process of pharmaceutical-grade sesame oil, its diverse applications in medicine, and the stringent quality measures that ensure its safety and effectiveness.
Pharma-Grade Sesame Oil: Extraction and Refinement
The production of pharmaceutical-grade sesame oil follows a rigorous process to ensure purity, stability, and compliance with pharmacopeial standards. The process begins with the selection of high-quality sesame seeds, which undergo multiple cleaning stages to remove dust, stones, and other contaminants. The cleaned seeds are then processed using one of the following extraction methods:
- Cold Pressing: This mechanical extraction method preserves the oil’s natural antioxidants and maintains its stability. However, the yield is lower compared to solvent extraction.
- Solvent Extraction: In this method, organic solvents such as hexane are used to extract oil from sesame seeds. The solvent is later removed through distillation, leaving behind refined sesame oil with a higher yield.
After extraction, the crude sesame oil undergoes a multi-step refining process to remove impurities, including:
- Degumming: Eliminates phospholipids and other hydratable impurities.
- Neutralization: Removes free fatty acids to improve stability.
- Bleaching: Reduces color pigments and removes potential oxidation products.
- Deodorization: Eliminates unwanted odors and volatile compounds, ensuring a neutral-smelling oil suitable for pharmaceutical applications.
The final refined product adheres to strict pharmacopeial standards, such as those set by the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopeia (USP). These standards specify acceptable peroxide levels, acid values, and moisture content to ensure long-term stability.
Key Pharmaceutical Applications and Dosage Forms
Sesame oil’s unique properties make it an ideal choice for multiple pharmaceutical applications. Some of its most common uses include:
- Injectable Formulations
Sesame oil is widely used as a vehicle in intramuscular and subcutaneous injections, particularly for oil-based depot formulations. These formulations provide a sustained release of active pharmaceutical ingredients (APIs) into the bloodstream over an extended period.
- Examples:
- Testosterone undecanoate injections: Used in hormone replacement therapy, where sesame oil acts as a solvent to facilitate slow drug absorption.
- Vitamin D injections: The lipophilic nature of vitamin D makes sesame oil an ideal carrier.
Sesame oil’s role in injectables is primarily due to its high solubility for lipophilic drugs, excellent biocompatibility, and resistance to oxidation.
- Soft Gelatin Capsules
Pharmaceutical formulations often use sesame oil in soft gelatin capsules, particularly for drugs that require enhanced solubility and bioavailability.
- Examples:
- Cannabinoid-based medications (e.g., Marinol®, Epidiolex®): Sesame oil improves the solubilization and absorption of cannabinoids, ensuring effective therapeutic results.
- Coenzyme Q10 (Ubiquinone) supplements: Used in cardiovascular treatments, sesame oil enhances absorption.
Typical dosage per soft gelatin capsule ranges from 100 mg to 500 mg, depending on the API’s solubility and pharmacokinetics.
- Topical and Transdermal Formulations
Sesame oil is used in dermatological and transdermal drug delivery systems due to its emollient properties and ability to facilitate drug penetration through the skin.
- Examples:
- Anti-inflammatory creams and ointments: Sesame oil acts as a carrier for active ingredients like corticosteroids.
- Transdermal pain relief gels: Used in formulations containing NSAIDs (e.g., diclofenac).
The oil’s ability to enhance percutaneous absorption makes it a valuable excipient in drug delivery systems designed for localized and systemic effects.
Comparison of Sesame Oil with Other Pharmaceutical Oils
While sesame oil is widely used in the pharmaceutical industry, other plant-based oils such as soybean oil, olive oil, and castor oil are also employed. Below is a comparison:
|
Oil Type |
Primary Use |
Advantages |
Limitations |
|
Sesame Oil |
Injectables, capsules, topicals |
High oxidative stability, bioavailability enhancer |
May cause allergic reactions |
|
Soybean Oil |
Parenteral nutrition, emulsions |
Rich in essential fatty acids |
Lower oxidative stability |
|
Olive Oil |
Ophthalmic and oral formulations |
Anti-inflammatory properties |
Expensive, slower absorption |
|
Castor Oil |
Laxatives, ophthalmic solutions |
Strong solubilizing properties |
Can cause GI distress in oral use |
Quality Control and Regulatory Compliance
To ensure safety, stability, and efficacy, manufacturers of pharmaceutical-grade sesame oil follow Good Manufacturing Practices (GMP) and conduct rigorous quality control tests, including:
- Peroxide Value Analysis: Measures oxidative stability.
- Heavy Metal Testing: Ensures compliance with International Council for Harmonisation (ICH) guidelines for elemental impurities.
- Microbial Contamination Testing: Checks for bacterial endotoxins.
Additionally, packaging plays a crucial role in maintaining sesame oil’s stability. Most pharmaceutical companies store and transport the oil under nitrogen-sealed conditions to prevent oxidation and contamination.
Utah Trading LLC A Trusted Supplier of Sesame Oil
As a reputable B2B supplier, Utah Trading LLC is committed to providing top-quality raw materials, including pharmaceutical-grade sesame oil, to businesses in the pharmaceutical sector.
Our focus on ensuring the highest standards of product quality and compliance with international regulations has allowed us to become a trusted partner for manufacturers who require quality excipients for their drug formulations.
At Utah Trading LLC, we work with trusted global manufacturers to source sesame oil that meets strict European Pharmacopoeia (Ph. Eur.) and United States Pharmacopeia (USP) standards. Our refined sesame oil undergoes rigorous quality control measures, including testing for oxidation stability, contaminants, and purity, ensuring that our clients receive only the best.
We also understand the importance of timely delivery and consistent supply in the pharmaceutical industry, and we are committed to meeting the demands of our customers efficiently.
Conclusion
Sesame oil has established itself as a valuable pharmaceutical excipient due to its stability, biocompatibility, and ability to enhance the solubility of lipophilic drugs. Its applications in injectables, oral capsules, and topical formulations underscore its versatility in modern medicine.
Strict adherence to pharmacopeial standards ensures that pharmaceutical-grade sesame oil remains a safe, reliable, and effective component in drug formulations worldwide. As research in lipid-based drug delivery advances, the role of sesame oil in novel pharmaceutical applications is expected to expand further.
