Self Emulsifying

Tecnologie

SELF EMULSIFYING ANHYDROUS DISPERSION SYSTEM (SeADS)

PCT IT2009/000373 (PATENT ISSUED)

THE MAJOR CHALLENGE IN DEVELOPING A PRODUCT:
ACTIVE INGREDIENTS SOLUBILITY

It often happens that the substances delivered in a product are not very stable in water, for example when live probiotic microorganisms should be delivered in a liquid dosage form, which is notoriously the most difficult in terms of probiotics survival.

OUR SOLUTION IS

A LIQUID OILY DISPERSION OF PROBIOTICS SUITABLE FOR

DELIVERING A GOOD QUANTITY OF LIVE CELLS
(UP TO 1 BLN CFU PER DROP)

CREATING A COMPLETELY ANHYDROUS SYSTEM, WHICH IS SUITABLE FOR THE SURVIVAL OF MICROORGANISMS

CREATING A STABLE AND READY-MADE PRODUCT WITHOUT ADDING FURTHER EXCIPIENTS

DELIVERABLE ACTIVE INGREDIENTS

Lactobacillus rhamnosus

Lactobacillus reuterii

LIVE PROBIOTICS

PHARMACEUTICAL FORM
OILY LIQUID DROPS

THANKS TO THIS PHARMACEUTICAL FORM IT IS POSSIBLE TO:
Disperse and deliver live probiotic cells
Increase their survival in the gastric environment
Easily administer the product also to children
Mix the product with water to improve its palatability

STABILITY TESTS

STABILITY OF PROBIOTICS DELIVERED WITH SeADS

Lactobacillus GG – storage conditions 25°C / 60% RH

LONG TERM STABILITY STUDY DATA

Packaging: Glass vial vith dropper				Storage conditions: 25 °C / 60 % RH Sampling: Initial (0), 2, 3, 6, 12, 18
TEST	REQUIREMENTS	INITIAL	2 MONTHS	3 MONTHS	6 MONTHS	12 MONTHS	18 MONTHS
ORGANOLEPTIC	Yellowish viscous dispersion of lactic acid bacteria in oil	Compliant to requirements	Compliant to requirements	Compliant to requirements	Compliant to requirements	Compliant to requirements	Compliant to requirements
PROBIOTICS	≥ 1 bn UFC/gtt	1,2 bn UFC/gtt	1,2 bn UFC/gtt	1,6 bn UFC/gtt	1,4 bn UFC/gtt	1,5 bn UFC/gtt	1,1 bn UFC/gtt
ACIDITY (% OLEIC ACID)	≥ 5%	0,27	0,23	0,21	0,16	0,25	0,26
PROXIDES (MEQ 0² / KG)	< 10 meq 0² / Kg	< 0,25	< 0,25	< 0,25	< 0,25	< 0,25	< 0,25