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


DELIVERABLE ACTIVE INGREDIENTS


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

STABILITY OF PROBIOTICS DELIVERED WITH SeADS

Lactobacillus GG – storage conditions 4°C / No humidity

Packaging: Glass vial vith dropper Storage conditions: 4 °C / no humidity
Sampling: Initial (0), 3, 6, 12, 18
TEST REQUIREMENTS INITIAL 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
PROBIOTICS ≥ 1 bn UFC/gtt 1,2 bn UFC/gtt 1,6 bn UFC/gtt 1,5 bn UFC/gtt 1,5 bn UFC/gtt 1,6 bn UFC/gtt

MAIN ADVANTAGES