This document discusses various specialty excipients used in topical drug delivery systems, categorizing them into emulsifiers, skin penetration enhancers/solubilizers, and stability enhancers. It provides details on the chemical composition, key features, brand names and manufacturers of excipients such as PEG-8 beeswax and glyceryl dibehenate which are used as emulsifiers and consistency agents/thickeners respectively to stabilize formulations and enhance drug delivery.

1. SPECIALITY EXCIPIENTS FOR TOPICAL
DRUG DELIVERY SYSTEM
Power point presentation prepared by :
- Ms JYOTI GULABANI

2. EMULSIFIERS
• AN EMULSIFIER IS A COMPOUND OR
SUBSTANCE WHICH ACTS AS A STABILIZER FOR
THE EMULSION PREVENTING THE LIQUIDS
FROM SEPARATING .

3. PEG-8 beeswax
 IT IS A POLYETHYLENE GLYCOL DERIVATIVE
OF BEESWAX .
 KEY FEATURES :
 A non-ionic oil-in-water emulsifier for
emulsions containing a high concentration of
oil phase and lipophilic PI. Highly compatable
with a variety of oils and wide pH range
tolerance.
 BRAND NAMES: Apifil®
,Tefose®
1500
 MANUFACTURER: Gattefosse
pharmaceuticals,Alfa chemicals.

4. Mixture of glycerol monostearate EP/NF
(and) PEG-75 stearate NF
 GLYCEROL MONOSTEARATE IS GLYCEROL ESTER OF STEARIC ACID .IT
IS FOUND IN FATTY FOODS
 PEG 8 STEARATE IS A POLYETHYLENE GLYCOL ESTER OF STEARIC
ACID.
 KEY FEATURES:
• A non-ionic oil-in-water emulsifier used for difficult-to-formulate
APIs and formulations using alcohol extracts or essential oils.
• A gelling agent is required when excipient is used at less than 8%
concentration.
 BRAND NAMES: Gelot™
64
 MANUFACTURER: Gattefosse pharmaceuticals.

5. Mixture of cetyl alcohol EP/NF (and)
ethoxylated fatty alcohols (ceteth-20,
steareth-20) EP/NF
 CETYL ALCOHOL IS A FATTY ALCOHOL.THE NAME CETYL DERIVES
FROM WHALE OIL FROM WHICH IT WAS ISOLATED.
 ETHOXYLATED FATTY ALCOHOLS ARE THE MAJOR CLASS OF
SURFACTANTS .ETHYLENE OXIDE IS ADDED TO ALCOHOLS AND
PHENOLS TO TURN IT INTO SURFACTANTS .
 KEY FEATURES:
• A non-ionic oil-in-water emulsifier for use in association with Apifil®
as a co-emulsifier to improve heat stability.
• Associates well with Gelot™ 64 to enhance textural properties.
 BRAND NAMES: Emulcire™
61WL2659
 MANUFACTURER: Gattefosse pharmaceuticals

6. SKIN PENETRATION ENHANCERS
/SOLUBILIZERS
• THESE EXCIPIENTS PROVIDE HIGH
SOLUBILIZING POWER FOR A WIDE RANGE OF
ACTIVE PHARMACEUTICAL INGREDIENTS
.THEIR PHYSIOCHEMICAL PROPERTIES ARE
ASSOCIATED WITH IMPROVED DRUG
PENETRATION AND PERMEATION
ENHANCEMENTS

7. Propylene glycol monocaprylate (type
II) NF
IT IS A MIXTURE OF PROPYLENE GLYCOL
MONOESTERS AND DIESTERS OF FATTY ACIDS
COMPOSED PREDOMINATELY OF CAPRYLIC
ACID .
KEY FEATURES : A water-in-oil surfactant /
solubilizer.
BRAND NAME: Capryol™
90
MANUFACTURER: Gattefosse
pharmaceuticals,Abitec pharmaceuticals.

8. Propylene glycol dicaprylocaprate EP
PROPYLENE GLYCOL DICAPRYLOCAPRATE IS A
MEDIUM CHAIN ESTER .
KEY FEATURES :
• Oily phase for emulsion or ointment with
emollient properties.
• Good solvent for lipophilic active
pharmaceutical ingredients.
 BRAND NAMES: Labrafac™
PG ,CAPTEX 200
MANUFACTURER: Gattefosse
pharmaceuticals,Abitec pharmaceuticals

9. Highly purified diethylene glycol
monoethyl ether EP/NF
• IT IS A PRODUCT OF ETHYLENE OXIDE AND
ETHANOL
KEY FEATURES:
• A high purity solvent and solubilizer for poorly
water soluble active pharmaceutical ingredients.
• Associated with improved drug penetration,
permeation and a drug depot effect
BRAND NAMES: Transcutol®
P ,Apisolve 90.
MANUFACTURER:Advance petrochemicals ,
Gattefosse pharmaceuticals

10. STABILITY ENHANCERS
• STABILITY ENHANCERS CONTROL THE
PRODUCT VISCOSITY AND STABILIZING
PRODUCT CONSISTENCY AT ELEVATED
TEMPERATURES .LIPID THICKENERS MAY BE
USED IN EMULSION SYSTEM TO PREVENT
PHASE SEPARATION .

11. Glyceryl dibehenate EP
Glyceryl behenate NF
• GLYCERYL DIBEHENATE IS A FAT USED IN COSMETICS
.IT IS DIESTER OF GLYCERIN AND BEHENIC ACID
(saturated C-22 fatty acid )
 KEY FEATURES :
• A high melting point glyceride appropriate for use in
oral solid dosage forms as a lipid matrix to modify
(sustain or delay) the release of active ingredients.
• Consistancy agent (thickener) for topical formulations.
BRAND NAMES: Compritol®
888 Pellets ,Kemester®
GDB
MANUFACTURER: Gattefosse pharmaceuticals

12. Hard fat NF
• HARD FAT IS A MIXTURE OF GLYCERIDES OF
SATURATED FATTY ACIDS .
KEY FEATURES:
 Consistancy agent (thickener) for topical
formulations.
BRAND NAMES: Gelucire®
43/01
MANUFACTURER: Gattefosse
pharmaceuticals

13. Propylene glycol
monopalmitostearate EP
• IT IS A MIXTURE OF FATTY ACID GLYCERIDES,
PRIMARILY GLYCERYL ESTERS OF PALMITIC AND
STEARIC ACID .
KEY FEATURES:
• A non-ionic consistency agent/gellifier for
cream and lotion emulsions.
BRAND NAMES: Monosteol™
MANUFACTURER: Gattefosse
pharmaceuticals

14. •THANK YOU