MYVACET™ 9-45 Diacetylmonoglycerides registration number has been activated to "A" status!

With the popularity of the development of rabeprazole sodium enteric-coated tablet project, more and more customers have begun to use the excipient
of "diacetylmonoglycerides".

In view of the fact that this accessory is still very new to most customers, KERRY will lead you to a comprehensive understanding today
.

01

What is diacetylmonoglycerides?

Diacetyl monoglycerides, in the food additives its main category belongs to the acetylated mono- and diglycerides under the emulsifier (Acetic Acid Esters of Mono and Diglycerides), the code is E472a
.

In the pharmaceutical field, only the United States Pharmacopeia currently includes the English name Diacetylated Monoglycerides
.

The United States Pharmacopeia defines diacetyl monoglycerides as:

Diacetylated Monoglycerides is glycerin esterified with edible fat-forming fatty acids and acetic acid.
It may be prepared by the interesterification of edible oils with triacetin in the presence of catalytic agents, followed by molecular distillation, or by the direct acetylation of edible monoglycerides with acetic anhydride without the use of catalyst or molecular distillation.

This product is an edible fat fatty acid and acetic acid glycerides, prepared by esterification and molecular distillation of edible oil and triethyl glyceride in the presence of catalyst; Or prepared by direct acetylation of edible monoglycerides and acetic anhydride without catalyst or molecular distillation
.

By definition, the basic structure of diacetyl monoglycerides is shown below, wherein the structure within the red box differs
due to the different fatty acid content of different oil sources.

KERRY's diacetyl monoglyceride MYVACET™ 9-45 is derived from soybean oil and is a clear liquid with a yellowish to amber color
.
The sliding melting point is 4-12 °C, and the temperature when storing is recommended between
15-25 °C.

02

Diacetylmonoglycerides are used in preparations

Diacetylmonoglycerides often have several effects in preparations:

1.
For use in tablet coating

Diacetyl monoglycerides can be used as coating plasticizers, coating anti-sticking agents, and can also provide a smooth moisture barrier layer
.

Example: Diacetyl monoglycerides are recommended as plasticizers for film coatings, and the recommended amount is 5-15%.

For example, the classic white coating powder formula:

HPMC – 53%

HPC – 10%

Myvacet 9-45 K – 15%

Talc – 2%

Titanium Dioxide – 20%

Example: Diacetyl monoglycerides help water-insoluble film-forming materials form stable dispersions in water, and the recommended amount is 10-15%:

Myvacet 9-45

Cellulose Acetate Phthalate

Povidone

Titanium Dioxide

2.
For use in the capsule shell of hard capsules and soft capsules

Helps improve bioavailability

3.
Used in creams and ointments

Diacetylmonoglycerides provide moisture protection

At present, in addition to rabeprazole sodium enteric-coated tablets, colaveram hydrochloride tablets, sevelamam hydrochloride tablets, sodium valproate enteric-coated tablets, erythromycin enteric-coated tablets and other varieties have used diacetylmonoglycerides
.

As the first raw material manufacturer registered for registration, KERRY diacetyl monoglycerides product "MYVACET™ 9-45" has been activated on the CDE raw and auxiliary package platform with a public status of "A" and registration number F20190000732!

Welcome customer partners in need to consult and apply for samples