Cocoa butter

Identification

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Name
Cocoa butter
Accession Number
DB11086
Type
Biotech
Groups
Approved
Description

Cocoa butter is an edible natural fat obtained from the Theobroma cocoa seeds that is predominantly found in dark chocolate 4. It is a rich source of monounsaturated and saturated fatty acids [A33040] that mainly contains approximately 33% Oleic Acid, 25% Palmitic Acid, and 33% Stearic acid 1 but does not contain caffeine or theobromine. Fat cocoa solids, including cocoa butter, have lower phenolic content than non-fat cocoa solids but may contain some polyphenols of different structures of flavonoids with antioxidant properties 6.

Cocoa butter is included in chocolate and other food products, and can also be found in over-the-counter skin products such as lotions, creams, and bars intended to maintain skin softness. While cocoa butter has skin moisturizing properties, it was not shown to reduce the likelihood of developing of striae gravidarum, or stretch marks, in a double-blind, randomized clinical trial of women in the first trimester 2. Still, it is a common active ingredient for prevention of skin dryness in cosmetic and skincare products. Oftentimes cocoa butter is used in over-the-counter pharmaceutical products and suppositories. The lipid-lowering effects of cocoa butter have been studied and investigated, as fatty acid constituents of cocoa butter are known to exhibit lipid-lowering properties. Dyslipidemia is characterized by elevated levels of plasma triglyceride and very-low-density lipoprotein (VLDL) cholesterol due to overproduction of large triglyceride-enriched VLDL cholesterol particles 1. Cocoa butter has shown to reduce VLDL cholesterol levels in animal studies, suggesting its potential use in lipid disorders.

Synonyms
  • Cacao butter
  • Cacao seed oil, fermented
  • Oil, cocoa butter
  • Oil,cocoa butter
  • Theobroma cacao (cocoa) seed butter
  • Theobroma cacao oil
  • Theobroma oil
Over the Counter Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
Dermatitica Synergy for treatment of DermatitisOil3.2 mg/50mLTopicalPhytopia Co., Ltd.2016-04-01Not applicableUs
Stretch Marks Remover Stretch Marks RemoverOil3.2 mg/50mLTopicalPhytopia Co., Ltd.2016-04-01Not applicableUs
Suppo H Sup 1000mgSuppository1 gRectalProduits Aloex Ltee1996-06-271997-09-11Canada
Suppo-H 1000mg/supSuppository1 gRectalSantrel International Inc.1992-12-311999-12-31Canada
Terrasil Fissures FormulaOintment50 g/100gTopicalAidance Skincare & Topical Solutions, LLC2014-06-10Not applicableUs
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
Apz Hemorrhoidal SuppositoriesCocoa butter (85.5 %) + Phenylephrine hydrochloride (0.25 %)SuppositoryRectalApz Pharmaceutical CorporationNot applicableNot applicableCanada
Atopic Healer SynergyCocoa butter (4.9 mg/50mL) + Balsam of Peru (3.6 mg/50mL)OilTopicalPhytopia Co., Ltd.2016-04-01Not applicableUs
Avedana HemorrhoidalCocoa butter (88.5 g/100g) + Phenylephrine hydrochloride (.26 g/100g)SuppositoryRectalUnipack2014-09-18Not applicableUs
AverteaxCocoa butter (2.5 mg/1g) + Zinc oxide (0.15 mg/1g)CreamTopicalCamellix, LLC2014-01-01Not applicableUs
AverteaxCocoa butter (2.5 mg/1g) + Zinc oxide (0.15 mg/1g)OintmentTopicalCamellix, LLC2014-01-01Not applicableUs
Calmol 4Cocoa butter (2052 mg/1) + Zinc oxide (270 mg/1)SuppositoryRectalResical Inc.2006-05-13Not applicableUs
Care One HemorrhoidalCocoa butter (2137.5 mg/1) + Phenylephrine hydrochloride (75 mg/1) + Shark liver oil (6.375 mg/1)SuppositoryRectalAmerican Sales Company2003-12-092015-09-01Us
Careone HemorrhoidalCocoa butter (2211 mg/1) + Phenylephrine hydrochloride (6.5 mg/1)SuppositoryRectalAmerican Sales Company2014-12-21Not applicableUs
CareOne HemorrhoidalCocoa butter (2.135 g/2.5g) + Phenylephrine hydrochloride (.0065 g/2.5g)SuppositoryRectalAmerican Sales Company2013-01-022017-12-28Us
Cocoa Butter, Phenylephrine HydrochlorideCocoa butter (.855 g/1g) + Phenylephrine hydrochloride (.0025 g/1g)SuppositoryRectalCVS Health2011-07-01Not applicableUs
Categories
UNII
512OYT1CRR
CAS number
8002-31-1

Pharmacology

Indication

Indicated for topical use in over-the-counter skin products for the treatment of skin dryness and reduction of striae gravidarum (stretch marks).

Pharmacodynamics

In a rat study, treatment with 10% cocoa butter has been shown to lower liver cholesterol and triglyceride levels without affecting the serum cholesterol levels 1. Supplementation of cocoa butter reduced the level of creatinine in vitro, suggesting that cocoa butter may also beneficial to renal function via antioxidant effects 1.

Mechanism of action

Cocoa butter is comprised of saturated fatty acids that exert a neutral cholesterolemic response in humans 5. Stearic acid is one of the major constituent in cocoa butter that is a non-atherogenic type of dietary saturated fat 4. Although it is a saturated fatty acid known to elevate plasma lipids and lipoproteins, stearic acid from plant sources differs from animal-derived sources of stearic acid 5. Possible explanations for this unique property may include chain length, inefficient absorption, metabolism kinetics, and hepatic desaturation of stearic into oleic acid 5. Apart from its lipid-lowering actions, stearic acid may also mediate actions on hemostasis and thrombosis which still remain inconclusive 4. In vitro, stearic acid was demonstrated to promote platelet aggregation and factor VII coagulant activity; however in vivo preliminary studies mixed results 5.

Cocoa butter may contain flavonoids that elicit antioxidant, anti-platelet, anti-inflammatory effects, as well as possibly increasing HDL, lowering blood pressure, and improving endothelial function 4. They inhibit lipid peroxidation, scavenge reactive oxygen species, and attenuate photochemical overproduction of ROS thus minimize UV-induced photodamage and signs of aging on the skin 3.

Additional Data Available
Adverse Effects

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Additional Data Available
Contraindications

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Additional Data Available
Blackbox Warnings

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Absorption

Cocoa butter displays poor bioavailability and low absorption compared to other oils 1.

Volume of distribution

No pharmacokinetic data available.

Protein binding

No pharmacokinetic data available.

Metabolism

No pharmacokinetic data available.

Route of elimination

No pharmacokinetic data available.

Half life

No pharmacokinetic data available.

Clearance

No pharmacokinetic data available.

Toxicity

No toxicokinetic data available.

Affected organisms
Not Available
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
Not Available
Food Interactions
Not Available

References

General References
  1. Yildirim E, Cinar M, Yalcinkaya I, Ekici H, Atmaca N, Guncum E: Effect of cocoa butter and sunflower oil supplementation on performance, immunoglobulin, and antioxidant vitamin status of rats. Biomed Res Int. 2014;2014:606575. doi: 10.1155/2014/606575. Epub 2014 Jul 16. [PubMed:25136602]
  2. Osman H, Usta IM, Rubeiz N, Abu-Rustum R, Charara I, Nassar AH: Cocoa butter lotion for prevention of striae gravidarum: a double-blind, randomised and placebo-controlled trial. BJOG. 2008 Aug;115(9):1138-42. doi: 10.1111/j.1471-0528.2008.01796.x. [PubMed:18715434]
  3. Scapagnini G, Davinelli S, Di Renzo L, De Lorenzo A, Olarte HH, Micali G, Cicero AF, Gonzalez S: Cocoa bioactive compounds: significance and potential for the maintenance of skin health. Nutrients. 2014 Aug 11;6(8):3202-13. doi: 10.3390/nu6083202. [PubMed:25116848]
  4. Ding EL, Hutfless SM, Ding X, Girotra S: Chocolate and prevention of cardiovascular disease: a systematic review. Nutr Metab (Lond). 2006 Jan 3;3:2. doi: 10.1186/1743-7075-3-2. [PubMed:16390538]
  5. Steinberg FM, Bearden MM, Keen CL: Cocoa and chocolate flavonoids: implications for cardiovascular health. J Am Diet Assoc. 2003 Feb;103(2):215-23. doi: 10.1053/jada.2003.50028. [PubMed:12589329]
  6. Jalil AM, Ismail A: Polyphenols in cocoa and cocoa products: is there a link between antioxidant properties and health? Molecules. 2008 Sep 16;13(9):2190-219. [PubMed:18830150]
External Links
PubChem Substance
347911109
Wikipedia
Cocoa_butter
AHFS Codes
  • 84:08.00 — Antipruritics and Local Anesthetics

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
1RecruitingOtherHigh Blood Pressure (Hypertension) / Hypertension,Essential1
4CompletedTreatmentComplications; Cesarean Section1
Not AvailableCompletedPreventionAnaesthesia therapy / Disorder of Shoulder1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
OilTopical
CreamTopical
OintmentTopical
SuppositoryRectal
GelTopical
Kit
OilTopical3.2 mg/50mL
SuppositoryRectal1 g
OintmentTopical50 g/100g
Prices
Not Available
Patents
Not Available

Properties

State
Not Available
Experimental Properties
Not Available

Taxonomy

Classification
Not classified

Drug created on December 03, 2015 09:51 / Updated on June 26, 2019 06:05