Refined Sesame Oil IV-1 – White Paper
Introduction to Sesame oil
Sesame seeds (Sesamum indicum L.) have been grown in tropical regions throughout the world since prehistoric times. It has been one of the first crops processed for oil production. Sesame oil has been used for healing wounds for thousands of years and is mentioned in the Vedas in India as ideally suited for the human species. Nowadays it is used in food, nutraceutical, cosmetic and pharmaceutical industries. The presence of endogenous antioxidant compounds named lignans comprising sesamin and sesamolin contribute to the unique properties of sesame oil, including its noteworthy stability to oxidation. Provide a high quality product. The process enables production of oils with low level of impurities and trans fatty acids, while maintaining the excellent stability of the end product.
Use of Sesame Oil as an excipient in drug formulation
With an increasing number of lipophilic drugs under development, the use of vegetable oils as excipients can be a good mean to address the drug solubilization hurdle. Sesame oil is commonly used as a solvent, oleaginous vehicle for subcutaneous drugs and intramuscular injections.
Soft gels and capsules formulations:
The development of a solubilized oral formulation in a capsule is normally driven by the desire to either increase or make reproducible the oral bioavailability of a poorly, water-soluble molecule compared to a solid oral dosage format.
For example Dronabinol (9-tetrahydrocannabinol), a natural component of the cannabis plant, used in the treatment of nausea or vomiting associated with cancer chemotherapy, is solubilized by sesame oil in soft gelatin capsules. If solubility and/or oral bioavailability is still not sufficient, the next level of complexity is to add a surfactant (1).
Injectable Formulations (Oil-Based Depot and other Long-Acting Intramuscular):
Vegetable oils can solubilize very lipophilic drugs and are administered by intramuscular injection providing a depot for sustained drug delivery over 2–4 weeks as the oil diffuses within the intramuscular tissues. Sesame oil is commonly used for this kind of applications (1). Haloperidol decanoate is the long acting, water-insoluble decanoate ester prodrug form of haloperidol, a drug to treat psychotic disorders, which is solubilized in sesame oil and administered intramuscularly. The peak plasma concentrations occur about 6 days after injection and thereafter decline with a half-life of about 3 weeks, thus requiring monthly individualized maintenance doses (1). Testosterone enanthate, a prodrug of testosterone and used to treat hormone deficiency, is solubilized in sesame oil and is administered intramuscularly approximately every 2 weeks (1).
See the ADM white paper: “Refined Sesame Oil IV-1 – ADM White Paper” here
(click the picture to download the brochure)
Source: ADM brochure “Refined Sesame Oil IV-1 – ADM White Paper”
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ADM Quality & Compliance – From Source to Final Product
With more than a century of experience, dedicated production lines and specialized R&D and regulatory teams, ADM offers its customers innovative global solutions tailored to the specific challenges of the pharmaceutical industry. At ADM, we offer a range of products that meet major relevant pharmaceutical regulations and are manufactured according to appropriate cGMP standards. We make delivering compliance and consistency a reality, giving you an edge to innovate with confidence. We are committed to providing only the purest and highest quality products for your end solutions.
ADM-SIO, is a global manufacturer of injectable-grade pharmaceutical oils – used as API’s or excipients for oil-soluble drugs. We offer an extensive range of highly purified oils, derived from vegetable origins that meet all relevant pharmaceutical regulations and are manufactured according to cGMP standards. The company’s injection-grade purified pharmaceutical oils, including refined soybean and olive oils, are currently primarily used as large volume emulsions for parenteral nutrition. ADM-SIO also brings a full portfolio of U.S. Pharmacopoeia (USP) and European Pharmacopoeia (EP) vegetable oils, including sunflower and rapeseed oil, which can be used as excipients in soft gels and capsules, as well as injection-grade purified sesame oil that responds to different formulation needs, such as controlled release. In addition, ADM-SIO offers contract manufacturing capabilities with cGMP production capacity and labs audited by the FDA.