SIO Highlights New Range of Highly Purified Pharmaceutical Oils and Manufacturing Capabilities at CPhI 2016
“Possessing more than 100 years of experience, SIO has a proud history of meeting the needs of pharmaceutical customers with highly purified products that meet stringent quality requirements and offer the security of a meticulously managed, safe supply chain,” said Ramon Rubio, SIO Sales Director. “We’re pleased to bring our newest and most exciting offerings to CPhI, including a refined injectable sesame oil, Sesame Oil IV-1, and olive oil, Olive Oil IV, as well as showcasing our manufacturing capabilities.”
Refined Sesame Oil for Excipient Applications
With an increasing number of lipophilic drugs under development, the use of vegetable oils as excipients allows formulators to address drug solubilisation challenges. SIO’s refined Sesame Oil IV-1 is highly refined and compliant with European Pharmacopoeia <0433> and USP/NF monograph specifications. The unique refining process incorporates an advanced purification method, designed to remove impurities and provide a high quality product. SIO Sesame oil is commonly used as excipient for poorly water-soluble APIs (Active Pharmaceutical Ingredients) in intramuscular injections or in oral formulations (soft gels).
Refined Olive Oil for Parenteral Preparations
SIO will also be presenting Refined Olive Oil IV, a new product that can be used as an active pharmaceutical ingredient in parenteral nutrition, or as an excipient for human and veterinary applications. Highly purified, Olive Oil IV is manufactured according to c-GMP standards for Active Pharmaceutical Ingredients (API) and in accordance with the European Pharmacopoeia. SIO is the first company in the world to receive a CEP (certificate of suitability) from the European Directorate for the Quality of Medicines & HealthCare for olive oil. It will allow SIO customers to fill their Drug Master Files with all requested regulatory documentation for parenteral nutrition or other pharmaceutical application using Refined Olive Oil IV.
Pharmaceutical customers located around the world, whether small or large, are increasingly seeking economical ways to produce high-quality products that adhere to stringent regulatory standards. Attendees can learn more about SIO’s manufacturing capabilities, offering cGMP production capacity and a controlled quality environment, audited by the FDA. With a broad range of technologies available, SIO also provides expert services including the development of raw material supply chains, process development, management of regulatory requirements, quality control and production. In addition, the company’s research and development teams use modern analytical techniques (LC, GC and NMR) to understand and advise customers as they work together to develop and produce tailor-made products that suit individual requirements. For pharmaceutical grade oils, SIO provides continuous regulatory monitoring in order to comply with product requirements.
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