WITEPSOL S 55

Witepsol S 55 is primarily used as a base or matrix material in solid dosage forms, such as suppositories or controlled-release tablets.
Witepsol S 55 provides stability, controlled release properties, and compatibility with various active pharmaceutical ingredients.
Witepsol S 55 may be added to enhance the stability of the product.

CAS Number: 91744-42-2
EC Number / REACH Number: In some safety data it is associated with REACH No. 2119485904-26-0000 (mixture record).
Chemical Family: Hydrogenated glycerides (fatty acid esters of glycerol) with additives (emulsifier & beeswax)
INCI Name: Hydrogenated Coconut Glycerides
Chemical Formula: Not fixed (mixture)
Molecular Weight: Not fixed (mixture)

SYNONYMS:
Witepsol S55, Witepsol S-55, Witepsol S, Hydrogenated coconut glycerides (type S), Hard Fat Type S, Suppository Base S, Witepsol Suppository Base S, Witepsol Solid Lipid Base S, Witepsol S, Witepsol S-51, Witepsol S-55, Witepsol S-58, Hydrogenated Coconut Glycerides, Hard Fat Type S, Suppository Base S, Glyceryl Tristearate Type S, Witepsol Suppository Base S, Witepsol Solid Lipid Base S, Witepsol, S 85, Softisan 100, Softisan 133, Softisan 138, Softisan 142, Witepsol 39, Witepsol BD, Witepsol E15, Witepsol E19, Witepsol E35, Witepsol E75, Witepsol E76, Witepsol E85, Witepsol H, Witepsol H 12, Witepsol H 32, Witepsol H 37, Witepsol H 42, Witepsol Q, Witepsol S, Witepsol S 5, Witepsol W-S 55, Witepsol WH 15, Diglycerides, hydrogenated coco monoglycerides, diglycerides and triglycerides, Glycerides, hydrogenated coco monoglycerides, diglycerides and triglycerides, Hydrogenated coco monoglycerides, diglycerides and triglycerides, Monoglycerides, hydrogenated coco monoglycerides, diglycerides and triglycerides, Witepsol E-75, Witepsol H 5, Witepsol H15, Witepsol S 55, Witepsol W 35, Hard Fat

Witepsol S 55 is an inert hard fat used as base for drug release from suppositories progesterone.
Witepsol S 55 is the trade name for a series of hard fats used as a base for suppositories.
Witepsol S 55 is specifically blended to have certain melting properties and consistencies.

Witepsol S 55 indicates a specific formulation or grade within the Witepsol range.
Each grade has slightly different properties, such as different melting points, to meet the specific needs of suppository or other product formulations.

Witepsol S 55 is a pharmaceutical excipient — a specialized hard fat mixture mainly comprised of hydrogenated glycerides with added emulsifiers and wax components, designed primarily as a base for suppositories, ovules, and other solid dosage forms.
Witepsol products are a range of hard fats used as pharmacopeial bases in suppository and ovule formulations.

The S-series (including S 55) contains non-ionic ethoxylated emulsifiers and other additives (e.g., beeswax) to improve wetting, dispersibility, absorption, and general handling characteristics compared to pure glyceride bases.
Witepsol S 55 specifically is formulated to: Witepsol S 55 aids wetting of mucous membranes, especially for rectal and vaginal dosage forms.

Witepsol S 55 enhances dispersibility and thermal behavior, improving drug release performance.
Witepsol S 55 provides stable solid form at room temperature but melt near body temperature.
Because Witepsol S 55 is a mixture of glycerides + additives, exact standardized formula is not defined; the base mixture typically contains mono-, di-, and triglycerides of saturated fatty acids from vegetable (coconut/palm) oils and emulsifier components.

Witepsol S grades are solid fats (Hard fats) obtained by esterifying glycerol with fatty acids which produces materials with a precise melting point, polarity and consistency.
Hard fats are listed in the USP-NF, Ph. Eur and JP, and since they are glycerol esters of edible fats, they are classified as food additives.

Witepsol S grades are special grades containing beeswax and emulsifier, in addition to the hard fat of pharmacopoeias.
They have hydroxyl values of 55–70 and melting points between 30 and 35.5 C.

Witepsol S grades are hard fats (hydrogenated vegetable glycerides) enhanced with specific additives—most notably non-ionic ethoxylated emulsifiers (like macrogol cetostearyl ether), plus waxes or glyceryl ricinoleate—for improved wetting, dispersibility, and absorption in aqueous or muco-adhesive formulations.
Witepsol S 55 is a hard fat contains special additives.

Witepsol S 55 is suitable for manufacturing vaginal and rectal preparations, requiring a more intensive wetting of mucosae, a greater dispersability or an enhanced absorption.
Witepsol S 55 contains an ethoxylated emulsifier which makes it suitable for use in aquaeous or ethanolic/aquaeous active ingredients (emulsion suppositories).

USES and APPLICATIONS of WITEPSOL S 55:
Applications of Witepsol S 55: Suppository and pessary manufacturing.
Suppository Base - Witepsol S 55 is primarily used as a suppository base in pharmaceutical preparation.
Melting Characteristics - Witepsol S 55 has a specific melting range, making it suitable for suppositories that need to dissolve at body temperature.

Compatibility - Witepsol S 55 demonstrates good compatibility with a wide range of pharmaceutical active ingredients.
The only problem with Witepsol S 55 is its oxidation when left in contact with air for a long time.
Witepsol S 55 is therefore necessary to use the drugs that contain it in a short time.

Witepsol S 55 is primarily used as a base or matrix material in solid dosage forms, such as suppositories or controlled-release tablets.
Witepsol S 55 provides stability, controlled release properties, and compatibility with various active pharmaceutical ingredients.
The specific applications and formulations of Witepsol S 55 may vary depending on the intended use and formulation requirements.

Saturated triglycerides: Witepsol S 55 is usually derived from animal fats or vegetable oils, these are the main components of Witepsol S 55.
Antioxidants: Witepsol S 55 may be added to enhance the stability of the product.
Industrial production of Witepsol S 55 involves blending and processing the fatty alcohols and fatty acids to achieve the desired composition and properties of the final product.

The exact details of the manufacturing process of Witepsol S 55 may vary depending on the manufacturer's proprietary methods and formulations.
Uses and Applications of Witepsol S 55: Pharmaceutical Uses.
Suppository and Ovule bases: Witepsol S 55 is ideal for rectal / vaginal drug delivery where melting near body temperature is needed.

Emulsion Suppositories: due to ethoxylated emulsifiers (better incorporation of aqueous APIs).
Witepsol S 55 is used general excipient base in tablets, capsules, chewables (in some formulations).
Other Potential Uses of Witepsol S 55: Solid Lipid Nanoparticles (SLN) — lipid core carrier in specialized drug delivery studies.

Witepsol S 55 is used microencapsulation and implants (experimental/advanced formulation).
Pharmaceutical Manufacturing: Only in licensed, GMP-controlled environments.
Processing Conditions: Melt in controlled baths ~2–5 °C above melting point; avoid overheating.

Storage: Cool, dry conditions to prevent oxidation or rancidity.
Compatibility: Witepsol S 55 works with a range of active pharmaceutical ingredients but compatibility testing is required for novel formulations.
Key applications of Witepsol S 55: Pharmaceuticals, Industries, and Pharma.

-Properties and application: 
Witepsol S grades contain special additives.
They are suitable for manufacturing vaginal and rectal preparations, requiring a more intensive wetting of mucosae, a greater dispersability or an enhanced absorption.
They all contain an ethoxylated emulsifier which makes them suitable for use in aquaeous or ethanolic/aquaeous active ingredients (emulsion suppositories).

-Description of the raw materials used in Witepsol S 55's production:
Fatty Alcohols - Fatty alcohols are alcohols derived from natural fats and oils.
They are typically obtained through the hydrolysis or reduction of triglycerides.
The specific types of fatty alcohols used in Witepsol S 55may vary, but they are typically long-chain alcohols, such as cetyl alcohol or stearyl alcohol.

-Fatty Acids use of Witepsol S 55: 
Fatty acids are carboxylic acids derived from natural fats and oils.
They are usually obtained through the hydrolysis or saponification of triglycerides.
The fatty acids used in Witepsol S 55 may include stearic acid, palmitic acid, or other saturated fatty acids.

KEY CHARACTERISTICS & BENEFITS of WITEPSOL S 55:
*Melting Range Close to Body Temp: 
Witepsol S 55 allows rapid melting on application.

*Enhanced Wetting & Dispersibility: 
Due to ethoxylated emulsifiers.

*Good Processability: 
Pastille form facilitates handling and dosing.

*Physiologically Biocompatible: 
Glycerides are generally well tolerated in pharmaceutical use (GRAS components).

FEATURES AND BENEFITS of WITEPSOL S 55:
Witepsol S 55 has a melting point of 33.5–35.05 C and a hydroxyl value of 55–65.
Witepsol S 55 is enhanced wetting of mucous membranes and enhanced dispersibility.

STEP-BY-STEP INDUSTRIAL CHEMICAL SYNTHESIS PROCESS of WITEPSOL S 55:
*Purification of triglycerides: 
The triglycerides are purified from any impurities, such as free fatty acids or other substances.

*Mixing:
The purified triglycerides are mixed in the correct proportions to achieve the desired consistency.

*Addition of additives: 
Antioxidants or other additives may be added to enhance the stability or properties of the product.

*Cooling and solidification: 
The mixture is cooled and solidified into suppository form.

*Quality control: 
A quality check is carried out to verify the physical and chemical properties of the product.

PHYSICAL and CHEMICAL PROPERTIES of WITEPSOL S 55:
CAS Number: 91744-42-2
EC Number / REACH Number: In some safety data it is associated with REACH No. 2119485904-26-0000 (mixture record).
Chemical Family: Hydrogenated glycerides (fatty acid esters of glycerol) with additives (emulsifier & beeswax)
INCI Name: Hydrogenated Coconut Glycerides
Mixture Type: It is a mixture, not a single defined compound — therefore detailed molecular formula is generalized (glyceride base).
Form: Pastilles / pellets
Appearance: White to almost white
Odor: Practically odorless
Taste: Slightly fatty
Material Type: Hard fat (lipophilic excipient)

Density (20 °C): ~0.93 – 0.96 g/cm³
Melting Range: ~33.5 – 35.5 °C
Solidification Point: Close to body temperature
Viscosity (molten): Low to moderate
Polymorphism: Low tendency
Water Solubility: Insoluble
Solubility in Organic Solvents: Soluble in hot non-polar organic solvents
Partition Behavior: Lipophilic

Hygroscopicity: Non-hygroscopic
Particle Form Stability: Good
Color Stability: Good under normal storage conditions
Flash Point: > 200 °C
Vapor Pressure: Negligible
Surface Activity: Moderate (enhanced vs. pure hard fat)
Wetting Ability: Improved compared to non-emulsified hard fats

Chemical Nature: Mixture of hydrogenated glycerides
Chemical Classification: Hard fat with emulsifier
Substance Type: UVCB (mixture)
Main Components:
Mono-, di-, and triglycerides of saturated fatty acids
Ethoxylated non-ionic emulsifiers
Small amount of wax components
Fatty Acid Origin: Vegetable (mainly coconut/palm)

Chemical Formula: Not fixed (mixture)
Molecular Weight: Not fixed (mixture)
Ionic Character: Non-ionic
Hydroxyl Value (OHV): ~50 – 65 mg KOH/g
Saponification Value: ~230 – 245 mg KOH/g
Acid Value: < 0.5 mg KOH/g
Peroxide Value: Low
pH (aqueous dispersion): Neutral to slightly acidic

Chemical Stability: Stable under normal conditions
Thermal Stability: Stable below decomposition temperature
Oxidation Sensitivity: Low (hydrogenated fats)
Hydrolysis: Resistant under neutral conditions
Reactivity: Inert under normal pharmaceutical processing
Compatibility: Compatible with many APIs
Emulsifying Properties: Oil-continuous systems with enhanced dispersion
Biodegradability: Readily biodegradable

Bio-compatibility: High
Physical Form: Pastilles / solid pellets
Color & Odor: White or nearly white, practically odorless
Melting Point: ~33.5 – 35.5 °C (melts near body temperature)
Hydroxyl Value (OHV): ~50 – 65 mg KOH/g (indicator of glyceride distribution)
Density: ~0.93 – 0.96 g/cm³ (for S-series typical)
Flash Point: > 200 °C (non-flammable under normal conditions)
Solubility: Practically insoluble in water
Partition (n-octanol/water): Not determined / not relevant
Physical State: Solid

FIRST AID MEASURES of WITEPSOL S 55:
-Description of first-aid measures
*General advice:
Show this material safety data sheet to the doctor in attendance.
*If inhaled:
After inhalation: 
Fresh air.
*In case of skin contact: 
Take off immediately all contaminated clothing. 
Rinse skin with
water/ shower.
*In case of eye contact:
After eye contact: 
Rinse out with plenty of water. 
Call in ophthalmologist. 
Remove contact lenses.
*If swallowed:
After swallowing: 
Immediately make victim drink water (two glasses at most). 
Consult a physician.
-Indication of any immediate medical attention and special treatment needed.
No data available

ACCIDENTAL RELEASE MEASURES of WITEPSOL S 55:
-Environmental precautions:
Do not let product enter drains.
-Methods and materials for containment and cleaning up:
Cover drains. 
Collect, bind, and pump off spills. 
Observe possible material restrictions. 
Take up dry. 
Dispose of properly. 
Clean up affected area.

FIRE FIGHTING MEASURES of WITEPSOL S 55:
-Extinguishing media:
*Suitable extinguishing media:
Carbon dioxide (CO2) 
Foam 
Dry powder
*Unsuitable extinguishing media:
For this substance/mixture no limitations of extinguishing agents are given.
-Further information:
Prevent fire extinguishing water from contaminating surface water or the ground water system.

EXPOSURE CONTROLS/PERSONAL PROTECTION of WITEPSOL S 55:
-Control parameters:
--Ingredients with workplace control parameters:
-Exposure controls:
--Personal protective equipment:
*Eye/face protection:
Use equipment for eye protection. 
Safety glasses
*Body Protection:
protective clothing
*Respiratory protection:
Recommended Filter type: Filter A 
-Control of environmental exposure:
Do not let product enter drains.

HANDLING and STORAGE of WITEPSOL S 55:
-Conditions for safe storage, including any incompatibilities:
*Storage conditions:
Tightly closed. 
Dry.

STABILITY and REACTIVITY of WITEPSOL S 55:
-Chemical stability:
The product is chemically stable under standard ambient conditions (room temperature).
-Possibility of hazardous reactions:
No data available