Pharmaceutical Oils
Did you know all the different applications of oils in pharmaceuticals? I didn't until we have received this overview article from ADM and published it on pharmaexcipients.com. I hope you enjoy this read as much as I did.
Oils have been used by the pharmaceutical industry for decades. From parenteral nutrition to soft gel formulations, oils play a key role in a wide range of pharmaceutical products. With an ever increasing number of new drug candidates with poor aqueous solubility and poor oral bioavailability, oils are very attractive candidates to solve real challenges for the formulators.
Parenteral Nutrition: When pharmaceutical oils are considered as an API
Olive oil?and?soybean oil?are used as API for the manufacture of nutritional lipid emulsions products in parenteral nutrition. They provide a source of calories and essential fatty acids for patients who are not able to feed themselves. For parenteral nutrition oils are considered as API and manufactured under cGMP according to the ICH-Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
Injectable Excipients: From emulsions to depot formulations
The therapeutic roles of lipid emulsions have expanded far beyond the nutrition. Many lipophilic drug solutions are formulated as lipid emulsions, including propofol.?Propofol is an intravenous (IV) sedative-hypnotic agent that can be used for initiation and maintenance of Monitored Anesthesia Care (MAC) sedation. Soybean Oil is used as excipient.
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Another example of the use of injectable grade oil in the pharmaceutical industry is in depot formulations. Depot formulations (IM) are suitable to avoid first-pass metabolism or for drugs with low oral bioavailability. The API’s are dissolved in oils (sesame oil) for extend release (IM injection) and long-term stability. Hormones (testosterone, progesterone) or antipsychotics drugs (Haloperidol or Fluphenazine) are good example of injectable formulations with sesame oil.
Oral and Topical Excipients: For Vitamin D and CBD oils the preferred choice
Most of the API’s in the development pipeline today are poorly water soluble. Simple formulation approaches are not enough to address these issues. Lipid excipients can be used for the formulation. On the last FDA approved lipid formulations, the majority are soft gel capsules, hard shell capsules and oral solutions. Continue reading here
Post for pharmaexcipients.com –?Prepared by ADM
Owner, Pharma Line Inc
11 个月Got connected with one gentleman in KR. Thanks!
Director, Innovation & Product Lifecycle
11 个月If you need any specific information about ADM-SIO oils, please contact philippe rougerie or send an e-mail to [email protected]
Owner, Pharma Line Inc
1 年Hi, I can start immediately, with whom, Shall i contact for Korean market? I found the Korean contact through web-site but no answering...
Contract QP, EU-GMP Consultant, Auditor
2 年Very interesting read, my curiosity is how to find an API supplier which complies with EU-GMP Part II for such non conventional APIs.
Unternehmer
2 年Ich gratuliere zu dem sehr informativen Artikel über die Anwendung von Hilfsstoffen / ?len in wichtigen Arzneimitteln, alles Gute Helga Oeser