CRODAMOL CAP

Synthetic Lipid Esters

Crodamol Chemistry

Synthetic lipid esters in the CRODAMOL range are a diverse group of functional excipients. The esters are formed from a variety of acids and alcohols with at least one component containing a fatty chain. This long chain has an enormous effect on the nature of the ester and ultimately the ester’s performance as a pharmaceutical excipient. In general, CRODAMOLS with short chains, branched chains or double bonds have lower viscosities.

An ester in the CRODAMOL range has the general structure:
 

Crodamol Functionality in Pharmaceutical Dosage Forms

Due to the wide range of physical and chemical properties CRODAMOLS are used in topical t, oral o and parenteral p dosages. These characteristics allow the CRODAMOLS to perform a variety of functions in the delivery of an Active Pharmaceutical Ingredient (API).

• Viscosity Modification – CRODAMOLS can increase or decrease the viscosity of the

  formulation depending on the structure of the CRODAMOL, its concentration and

  the viscosity of the preparation.  This can be illustrated in the following example.

  Adding CRODAMOL EO (Ethyl Oleate NF) to triglyceride oils will reduce the

  viscosity of the system.  Adding CRODAMOL SS (Cetyl Esters Wax NF) to the

  same triglyceride oil will increase the viscosity of the formulation.

   

• Solubilizer of Active Pharmaceutical Ingredients (API) – With a broad chemical diversity, CRODAMOLS can solubilize various lipophilic components. A useful tool to predict solubility of an API is through the use of the Hildebrand Solubility Parameter (HSP). Generally substances within 2 to 3 Hildebrand Solubility Parameter units can be considered chemically similar and therefore, are soluble or miscible. Included in Table 1 are the HSP for a number of our CRODAMOLS.
   

• Absorption Enhancer – Due to the multiple modes of action some of the CRODAMOLS influence percutaneous absorption. Absorption maybe enhanced due to drug solubility in the lipid, allowing penetration through the lipid barrier of the skin. Equally important is the skin hydrating nature of the CRODAMOLS, which allows the API to pass through the dermal layer.
   

• Vehicle – CRODAMOLS are anhydrous and can function as effective lipophilic vehicles for oral, parenteral or topical use. Esters effectively carry the API to the site where drug delivery is intended to occur. In combination with other excipients CRODAMOLS provide functional characteristics required for the dosage. Many of the CRODAMOLS impart a dry elegant feel to the skin that is more desirable than the “greasy” feel of mineral oil.
   

• Skin Spreading Adjustor – It may be desirable to adjust the skin “spreading” properties of topical dosages. CRODAMOLS can be used either to promote surface area coverage or to limit mobility of the system. Spreading characteristic on human skin is not necessarily correlated to viscosity of the system and therefore, must be considered independently. This relationship, called Spreading Factor, can be seen in Table 1.
   

• Emollient Properties – Liquid CRODAMOLS are oily by nature. When applied to the skin a thin lipid film is deposited on the surface. The film replaces the skin’s lipids and limits water permeability resulting in soft, smooth and supple skin.
   

• Water Repellent – Topical formulations containing CRODAMOLS resist wash off due to the water-repellent nature of the esters. This is useful in both human and animal health when it is necessary to overcome environmental influence after dosing. CRODAMOLS are beneficial for dosages such as protectives and sunscreens that are intended for long duration of action.
   

CRODAMOL Products for Pharmaceutical Dosage Forms

CRODAMOL EO P
(Ethyl Oleate NF)
Liquid at 25^oC
Refractive Index 1.4500
Specific Gravity (at 25^oC) 0.870

• An excellent solvent used in intra-muscular injections and topical dosage.¹

• Viscosity modifier, which reduces viscosity of the total formulations and is effective with triglyceride oils.

• Skin Spreading Adjustor

• Provides a non-greasy feel

• Absorption enhancer²

• Vehicle

• Additional information is available in CRODAMOL EO datasheet PN-59

CRODAMOL GTCC-PN     T O P
(Caprylic Capric Triglyceride conforming toMedium Chain Triglyceride EP)
Liquid at 25oC
Refractive Index 1.4492
Specific Gravity (at 25oC) 0.945.

• One of the most oxidatively stable CRODAMOLS

• Medium Chain Triglycerides are also used as a unique nutritional source of lipids in oral³ and parenteral^4,5 supplementation.

• Solvent

• Vehicle

• Additional information is available in CRODAMOL GTCC-PN datasheet PN-55.

CRODAMOL PMP T
(PPG-2 Myristyl Ether Propionate)
Liquid at 25^oC
Refractive Index 1.4395
Specific Gravity (at 25^oC) 0.880

• Emollient properties with a dry feel make this ester a suitable selection for mineral oil replacement.

• Good spreading properties.

• Excellent Solvent

• Easy to emulsify

• Freeze thaw dynamics of emulsions are improved with this ester due to its branched chain nature.

CRODAMOL CAP T
(Cetearyl Ethylhexanoate and Isopropyl Myristate)
Liquid at 25oC
Refractive Index 1.4455
Specific Gravity (at 25oC) 0.851

• Exhibits good spreading and surface wetting characteristics since it has a branched chain structure.

• Excellent solvent for lipophilic APIs.

SUPER REFINED^® CRODAMOL SCO T
(Stearyl Octanoate (and) Cetyl Octanoate)
Liquid at 25oC
Refractive Index 1.4454
Specific Gravity (at 25oC) 0.853

• This Super Refined ester is highly purified, reducing the possibility of interactions between excipient and a sensitive API.

• Similar to CRODAMOL CAP in function and chemical structure.  This material does not contain Isopropyl Myristate (IPM).

• Exhibits good spreading and surface wetting characteristics since it has a branched chain structure.

• Excellent solvent for lipophilic APIs.

SUPER REFINED^® CRODAMOL IPM T
(Isopropyl Myristate NF)
Liquid at 25oC
Refractive Index 1.4345
Specific Gravity (at 25oC) 0.851

• This Super Refined Ester is a highly purified version of IPM, reducing the possibility of interactions between excipient and a sensitive API.

• Normally used as a solvent.

• Absorption enhancer.

• Viscosity modifier.

• Emollient.

• Self-emulsifying system component. ⁶

CRODAMOL SS T
Cetyl Esters Wax NF
Solid at 25°C
Refractive Index - n.a.
Specific Gravity (at 60oC) 0.852

• Synthetic spermaceti from non-animal origin designed to be monograph compliant.

• This ester is capable of stabilizing an emulsion while increasing the system’s viscosity.

• Viscosity modifier, stiffing agent.

1. Spiegel AJ,, Noseworthy MM. Use of nonaqueous solvents in parenteral products. J Pharm Sci 1963; 52: 917-927.
    

2. Howard JR, Hadgraft J. The clearance of oily vehicles following intramuscular and subcutaneous injections in rabbits. Int J Pharmaceutics 1983; 16: 31-39.
    

3. Ruppin DC, Middletown WRJ. Clinical use of medium-chain triglycerides. Drugs 1980; 20: 216-224.
    

4. Bach A, Guisard D, Metais P, Debry G. Metabolic effects following a short and medium-chain triglycerides load in dogs I: infusion of an emulsion of short and medium-chain triglycerides. Arch Sci Physiol 1972; 26: 121-129.
    

5. Hatton J, et al. Safety and efficacy of a lipid emulsion containing medium-chain triglycerides. Clin Pharm 1990; 9: 366-371.
    

6. Jiminez SMM, Fresno CMJ, Selles Flores E. Proposal and pharmacotechnical study of a modern dermo-pharmaceutical formulation for cold cream. Boll Chim Farm 1996; 135: 364-373.
    

Order a Sample

Return to Featured Items Archive