How Is Tacrolimus API Powder Made and What Is It Used For?

What Is Tacrolimus Used For?

Tacrolimus Chemical Structure
Tacrolimus Chemical Structure

Tacrolimus, also known as FK506, with the cas number 109581-93-3, is a medication commonly used to prevent organ transplant rejection and treat certain autoimmune disorders.

There are more than 3 customers who sent inquiries on vegan tacrolimus API powder, which of course we don’t have.

This is like you are looking for vegan vitamin d3 powders.

While 99% of the VD3 bulk powder is of animal origin, and there is no supplier for vegan vd3, at least no such suppliers in China.

First, check how it is produced in our factory, and then you will understand that there is no such vegan tacrolimus.

As the immunosuppressant, tacrolimus suppresses the immune system to prevent the body from attacking and rejecting transplanted organs or tissues.

Some of the main uses of tacrolimus for humans include:

#1. Organ transplantation:

Tacrolimus is commonly used as part of a multi-drug regimen to prevent organ transplant rejection. It is typically used by combining other immunosuppressive medications to reduce the risk of rejection and improve the success of the transplant.

#2. Autoimmune disorders:

Tacrolimus is effective in the treatment of certain autoimmune disorders, such as atopic dermatitis (eczema) and psoriasis. It works by suppressing the immune system to reduce inflammation and skin irritation.

#3. Other uses:

Tacrolimus has also been studied to treat other conditions, such as Crohn’s disease, ulcerative colitis, and multiple sclerosis.

However, its use in these conditions is still being evaluated and more research is needed to determine its effectiveness.

It is important to note that tacrolimus can have serious side effects and should be used cautiously.

It can cause serious infections, kidney problems, and high blood pressure, among other complications.

It is also not recommended for use in pregnant women or nursing mothers due to the risk of harm to the fetus or infant.

Besides its wide usage for humans, tacrolimus is also compounded into many types of formulations in veterinary clinics.

To be continued…

Production Process

Tacrolimus powder is manufactured commercially through fermentation, extraction, and purification.

The production procedure is as below:

#1. Inoculation.

Streptomyces was inoculated in a slant medium and incubated at 26°C for 15 days

#2. Fermentation.

The mature slant was selected for injection in a seed medium and incubated for 50 h at 26°C at 300 rpm on a shaker.

A 2% inoculum was added to the fermentation medium and placed in a fermentation tank.

The fermentation tank was placed at 26°C for fermentation.

Methanol and sodium chloride solution was added again when the fermentation proceeded to 30 hours and again when the fermentation proceeded to 50 hours.

The amount of methanol to be added was 0.01% of the volume of the fermentation broth, while the amount of sodium chloride solution to be added was 0.05 % of the volume of the fermentation broth.

The concentration of the sodium chloride solution was 1.0mol/L and the NaCl solution would not be replenished until the fermentation was carried out for 80H.

During the whole fermentation process, the tank pressure was kept at 0.0.1MPa, the aeration was 0.5 VVM, and the initial concentration of dissolved oxygen in the tank was 100 %.

At the same time, the dissolved oxygen concentration in the fermenter was maintained above 25% by changing the rotational speed during the fermentation.

In the end, the fermentation broth was collected by releasing the tank after 90 hours of fermentation.

#3. Extraction and Separation

The collected fermentation broth is separated and extracted to obtain tacrolimus.

Tacrolimus within the fermentation broth can be separated and extracted by recrystallization.

Although there are more details to be filled in on the manufacturing process, we just listed the simple procedure for your ref.


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