SUPER REFINED® OLEIC ACID NF
 

SUPER REFINING technology was developed by Croda to improve the quality of naturally occurring oils.  SUPER REFINING involves proprietary flash chromatography that reduces polar impurities normally present in lipids.  When applied to Oleic Acid NF the resulting SUPER REFINED OLEIC ACID NF is a nearly colorless product with a low Peroxide Value

Oleic acid is a naturally occurring fatty acid commonly found in vegetable and animal fats.  The raw material source for SUPER REFINED OLEIC ACID NF is exclusively non-animal in origin. This is designed to help meet the needs of our customers and to increase regulatory acceptance of final formulations. 

Oleic acid is an 18 carbon fatty acid with one double bond at the omega 9 (w-9) position also referred to as C18:1n-9 and (Z)-9-Octadecenoic acid.  The empirical formula is C18H34O2 the structure is illustrated below.
 


Oleic acid does not exist alone in nature.  Included in oleic acid products are other naturally occurring fatty acids such as stearic and palmitic which are saturated.  In addition unsaturated fatty acids such as linoleic are also present.  SUPER REFINED OLEIC ACID NF contains 80 to 88% Oleic Acid with the other related fatty acids comprising the remaining balance.

 

PRODUCT FEATURES

  • Plant derived material, a Non-animal product.

  • High Oleic Acid content, minimum 80%

  • Low Peroxide Value

  • Colorless

  • Lot to lot uniformity imparted by the Super Refining process
     

PHARMACEUTICAL AND HEALTHCARE USES

  • Emulsifying and solublizing agent1

  • Defoamer2

  • Absorption enhancer in topical, transdermal and oral dosages3,4,5,6,7,8,9

  • Component of Self Emulsifying Drug Delivery Systems (SEDDS)10

  • Nasal and pulmonary MDI (Meter Dose Inhalers)11

  • Oral and Parenteral Diagnostic vehicle12,13

  • Raw material for the production of other pharmaceutical ingredients


PHYSICAL DATA

 

Solubility Profile, 2.5% w/w @25°C
·         Mineral Oil: ST* (* Soluble clear when warm)
·         Isopropanol: SC
·         Propylene Glycol: SC
·         Water: I

 

Solubility of Active Pharmaceutical Ingredients (API), 3% w/w
·         Bacitracin: I
·         Diphenhydramine HCl: I
·         Lidocaine: SC
·         Ibuprofen: SC
   
Hildebrand Solubility Parameter (HSP) = 8.99
   
Required HLB = 15.97  

SC=Soluble Clear, ST=Soluble Translucent, P=Partially Soluble, D=Dispersible, I=Insoluble


TYPICAL ANALYSIS OF SUPER REFINED OLEIC ACID NF
 

Appearance Clear Liquid
Color (APHA) 60 Max.
Peroxide Value mEq/kg) 5.0 Max.

 

 

REGULATORY STATUS 

  • NF Monograph Compliant
     

  • PhEur (EP) Monograph Compliant
     

  • FDA Inactive Ingredient Guide (inhalation and nasal aerosols, tablets, and transdermal preparations)
     

  • Listed in 21 CFR 172 Food Additives Permitted for Direct Addition to Food for Human Consumption
     

  • TSCA Listed
     

COMMERCIAL INFORMATION

SUPER REFINED OLEIC ACID NF contains 200 ppm BHT, a food approved antioxidant.  The material is packaged in lined tight-head steel drums with a nitrogen headspace to protect the product from oxidation.  The product is commercially available in 35 and 400 pound containers.

Samples may be obtained by contacting our Sample Department at (732) 417-0800, by email at marketing@crodausa.com, through our website www.crodausa.com, or your Croda Sales Representative.

 

REFERENCES
 

  1. United States Pharmacopoeia, The United States Pharmacopoeia Convention, Rockville, MD
     
  1. Food Chemical Codex, National Academy Press, Washington, DC
     
  1. Aarti Naik, Louk Pechtol, Russell 0. Potts, Richard H. Guy, “Mechanism of oleic acid-induced skin penetration enhancement in vivo in humans” Journal of Controlled Release 37 (1995) 299-306
     
  2. Philip G. Green, Richard H. Guy, Jonathan Hadgraft, “In vitro and in vivo enhancement of skin permeation with oleic and lauric acids”, International Journal of Pharmaceutics, 48 (1988) 103-111
     
  1. Fumiyoshi Yamashita, Yasuo Koyama; Megumi Kitano; Yoshinobu Takakura; Mitsuru Hashida “Analysis of in vivo skin penetration enhancement by oleic acid based on a two-layer diffusion model with polar and nonpolar routes in the stratum corneum”, International Journal of Pharmaceutics 117 (1995) 173-179
     
  1. M.A, Yamane, A.C. Williams, B.W. Barry, “Effects of terpenes and oleic acid as skin penetration enhancers towards 5-fluorouracil as assessed with time; permeation, partitioning and differential scanning calorimetry”, International Journal of Pharrnaceutice 116 (1995) 237-251
     
  1. Yacov Meshulam, Tamar Kadar, Ada Wengier, Shlomit Dachir, and Aharon Levy, “Transdermal Penetration of Physostigmine: Effects of Oleic Acid Enhancer”,Drug Development Research 28:510-515 (1993)
     
  2. Green, Guy, Hadgraft, “In vitro and In vivo enhancement of skin permeation with oleic and lauric acids”, Int'l J. of Pharmaceutics, 48(1988)103-111
     
  1. Tae-Wan Kim, Boem-Jin Lee, “Enhanced Bioavailabilty of Aceclofenac Using Solid Dispersion:Bioequivalence Test of Capsule and Tablet with Different Does in Human Volunteers”, Proceedings of Controlled Release Society 29th Annual Meeting
     
  1. MacGregor, Embleton, Lacy, Perry, Solomon, Seager, Pouton, “Influence of lipolysis on drug absorption from the gastro-intestinal tract”, Adv. Drug Delivery Reviews 25 (1997) 33-46
     
  1. Handbook of Pharmaceutical Excipients, Second Edition, 1994, American Pharmaceutical Association and the Royal Press, Royal Pharmaceutical Society of Great Britain.
     
  1. N. Thorsgaard Pedersen, “Fat Digestion Test”, Digestion 37:  suppl. 1, pp. 25-34 (1987)
     
  1. Bonte, Graham, Moore, “Experimental Myocardial Imaging with 131I-Labeled Oleic Acid”, Radiology 108: 195-196, July 1973

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