Product Presentation

New Pharmacopoeia Monographs for Gattefossé Speciality Excipients

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New Pharmacopoeia Monographs for Gattefossé Speciality Excipients

During the past 10 years Gattefossé has driven the creation of 17 European Pharmacopoeia Monographs for its lipidic excipients. This is combined with the development of 15 US Pharmacopoeia - National Formulary Monographs. Gattefossé is undoubtedly one of the most active speciality excipient manufacturers in terms of it's work with the EP, USP-NF and increasingly JP/JPE to increase formulation options in drug development.

 

 

New Pharmacopoeia Monographs for Gattefossé Products

 

 

Gelucire® 44/14 has achieved official USP-NF status with pending Food Additive (FCC) status. Gelucire® 44/14 is a versatile semi-solid lipidic excipient, proven to improve the bioavailability of poorly soluble drugs. It has a high HLB (14) and can be used either alone or as part a self emulsifying formulation (SEDDS/SMEDDS). Adaptable to a variety of formulation techniques (including granules and tablets), Gelucire® 44/14 is accompanied by a comprehensive regulatory, toxicity and handling dossier (including Type IV DMF); is compatible with gelatin and HPMC capsules, and has been used in globally approved pharmaceutical products.

 

 

Capryol™ 90 and Capryol™ PGMC

 

 

A monograph for Capryol™ 90 and Capryol™ PGMC "Propylene glycol monocaprylate" has recently been published in Pharmacopeial forum 33(2) (March-April 2007). Both products are high performance co-surfactants for use in formulations designed to enhance the bioavailability of poorly soluble drugs. They both have low to medium HLB (4 - 5) and can be used in self emulsifying lipidic formulations. Both products have comprehensive regulatory, toxicity and handling dossiers (including Type IV DMF) and are compatible with gelatin and HPMC capsules.

 

 

Lauroglycol™ 90 and Lauroglycol™ FCC

 

 

Lauroglycol™ 90 and Lauroglycol™ FCC also achieved USP-NF status recently. These are co-surfactants for use in formulations to enhance the bioavailability of poorly soluble drugs. They both have low to medium HLB (4 - 5) and can be used in self emulsifying lipidic formulations. Both products have comprehensive regulatory, toxicity and handling dossiers (including Type IV DMF) and are compatible with gelatin and HPMC capsules.

 

 

Labrafac™ PG

 

 

A monograph for Labrafac™ PG "Propylene glycol dicaprylate/dicaprate" will be published in the Pharmacopeial Forum 33(4) (July-August 2007).This low HLB (2) excipient can be used as an oily vehicle in oral formulations including self emulsifying formulations and it is a specialized oily vehicle for topical emulsions. It is accompanied with a regulatory and toxicity dossier and is compatible with gelatin and HPMC capsules.

 

 

Gattefossé Lipidic Excipient Monograph Development 2005 - 2007

 

 

Date

Product Name

Functionality

Monograph title

Status

2007

Capryol™
Capryol™ PGMC 90

Liquid solubility enhancer

Propylene glycol monocaprylate

USP 31-NF 26 Supp 1

2007

Labrafac™ PG

Liquid oily vehicle

Propylene glycol dicaprylate/dicaprate

USP 31-NF 26, suppl 2

2007

Plurol® Diisostearate

Liquid bioavailability enhancer

Triglycerol diisostearate

EP 5.8

2006

Gelucire® 44/14

Semi-solid bioavailability enhancer

Lauroyl polyoxylglycerides

USP 29-NF 24
IIG/EP (prior 2006)

2006

Lauroglycol™ 90
Lauroglycol™ FCC

Liquid bioavailability enhancer

Propylene glycol monolaurate

USP 29-NF 24
IIG/EP (prior 2006)

2005

Labrasol®

Liquid bioavailability enhancer

Caprylocaproyl polyoxylglyceride

USP 28-NF 23, suppl 1
IIG/EP

2005

Labrafil® M 2125 CS

Liquid bioavailability enhancer

Linoleoyl polyoxylglycerides

USP 28-NF 23, suppl 1
IIG/EP

2005

Labrafil® M 1944 CS

Liquid bioavailability enhancer

Oleoyl polyoxylglycerides

USP 28-NF 23, suppl 1
IIG/EP

2005

Gelucire® 50/13

Semi-solid bioavailability enhancer
and sustained release agent

Stearoyl polyoxylglycerides

USP 28-NF 23, suppl 1
IIG/EP

2005

Labrafac® PG

Liquid oily vehicle

Propylene glycol dicaprylate/dicaprate

EP

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