White Paper: Refined Sesame Oil IV-1
SIO演示
ADM-SIO, is a global manufacturer of injectable-grade pharmaceutical oils – used as API’s or excipients for oil-soluble drugs. We offer an大量高纯化油, 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, includingrefined soybeanandolive oils目前主要用作肠胃外营养的大容量乳液。ADM-SIO还带来了美国药典（USP）和欧洲药典（EP）植物油的全部投资组合，包括向日葵和菜籽油，可以用作软凝胶和胶囊中的赋形剂，以及注入级纯化的芝麻油油响应不同的配方需求，例如受控释放。此外，ADM-SIO还提供CGMP生产能力的合同制造能力和FDA审核的实验室。
简介Sesame oil(4,5)
芝麻(胡麻属indicum l .)一直在增长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.
将芝麻油用作药物配方中的赋形剂
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.
软凝胶和胶囊配方：
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).
可注射的配方（油基仓库和其他长效肌内（2））：
植物油可以溶解非常亲脂性药物，并通过肌肉注射给药，该仓库在2-4周内为持续药物提供了持续的药物，因为油在肌肉内组织中扩散。芝麻油通常用于这种应用（1）。氟哌啶醇decanoate是长期作用，不溶于水的抗酸酯酯前药的氟哌啶醇，这是一种治疗精神病的药物，可在芝麻油中溶解并进行肌内施用。峰值血浆浓度发生在注射后6天，然后下降，半衰期约为3周，因此需要每月的个性化维持剂量（1）。睾丸激素enanthate是睾丸激素的前药，用于治疗激素缺乏症，在芝麻油中溶解，大约每2周进行一次肌内施用（1）。
芝麻油IV-1净化的SIO技术
所使用的精炼过程是一个高级纯化过程，旨在净化和提供高质量的产品。该过程使生产具有低水平的杂质和反式脂肪酸的油，同时保持最终产物的出色稳定性。根据GMP要求进行批次生产（5600kg）。过程的最后一步是在0.45μm上的细过滤步骤。最终产品的鼓填充在分类的ISO 8洁净室中进行，在防止氧化的条件下完全有资格（使用惰性气体氮）。由于其纯度和质量较高，除了遵守GMP要求之外，芝麻油IV-1可用于所有肠胃外应用。
芝麻油IV-1特征
我们精致的芝麻油IV-1是一种高度精制的油，符合欧洲药典<0433>和USP/NF专着规格。除专着规格外，其他参数，例如保证污染物级别，例如：
- 剩余溶剂：符合ICH Q3C和EP 5.4要求
- 金属催化剂或金属试剂的残留物：符合EMEA/CHMP/4446/2000和EP 5.20要求
- Absence of TSE/BSE risk
- 没有霉菌毒素和遗传毒性杂质
- Due to our advanced refining process, color of the product is slightly yellow and very clear
- Heavy metals : NMT 10ppm
- 细菌内毒素：NMT 1.25 EU/ml
根据ICH条件实施的稳定性研究数据已经建立了36个月的保质期，并且可以通过控制整个过程中的氧化状态来保证氮气下的最终包装。
SIO GMP标准：
siO精制芝麻油1iv– is manufactured according to the Joint IPEC-PQG Good Manufacturing Practices Guide for pharmaceutical excipients (3). Good Manufacturing Practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorization and licensing for manufacture and sale of excipients, API (Active Pharmaceutical Ingredients) and pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public. The quality of excipients is critical to assure the safety, quality and efficacy of medicines. Excipients have a wide range of applications and are essential components of the drug product formulation. Characteristics that excipients impart to formulated drug products include cosmetic appearance, stability and delivery of the active ingredient. Therefore, applying appropriate GMP principles to excipients is essential. IPEC-PQG Guide makes an essential contribution to the wider understanding and attainment of GMP’s appropriate for the excipient supply industry. Industrials of the Pharmaceutical sector can be assured that excipients manufactured according to this Guide will meet internationally accepted GMP principles. The manufacture of certain excipients for specialist applications presents additional challenges that are outside of the scope of this Guide. Examples include excipients for parenteral use. To meet those challenges SIO has implemented specific procedures to guarantee that products are pyrogen free and the absence of mycotoxins and genotoxic impurities. We also truly believe that merging GMP principles for pharmaceutical excipient manufacturing into the ISO 9001 quality management system enhances not only quality management but also an organization’s operational procedures.
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References:
- 口服和可注射配方中的溶解赋形剂，Robert G. Strickley1,2 2003年11月5日
- 针对成年人的油基仓库和其他长效肌内抗精神病药注射的指南
- ipec_pqg_gmp_guide_2006（1）
- 帕塔克（N.（2014）。芝麻中的增值：生物活性成分的观点，可增强效用和利用能力。药学评论，8（16），147–155。http：//doi.org/10.4103/0973-7847.134249
- Anilakumar, K., Pal, A., Khanum, F., Bawa, A. (2010). Nutritional, Medicinal and Industrial Uses of Sesame (Sesamum indicum L.) Seeds – An Overview. Agriculturae Conspectus Scientifi cus, 75(4), 159 168. Preuzeto s http://hrcak.srce.hr/66001