How To Compound Mirtazapine Tablets?

mirtazapine 85650-52-8 chemical structure
Mirtazapine Anhydrous Cas 85650-52-8

Mirtazapine API Powder is a white crystalline powder used as the active ingredient of many brands of antidepressants.

It is a noradrenergic-specific 5-hydroxytryptaminergic antidepressant, approved in many countries for the treatment of depression.

It is sedative and well tolerated with almost no anticholinergic effect, meanwhile, it does not affect the cardiovascular system.

Mirtazapine is not only used in anti-depression medicines for humans but it is also used for meds of pets.

As the leading Mirtazapine API Supplier In China, we share two compounding processes for mirtazapine tablets, one for humans, and one for pets.

For human meds, mirtazapine is indicated for depression and is effective for symptoms such as lack of pleasure, psychomotor depression, sleep deprivation, and weight loss.

It can also be used for other symptoms such as loss of interest, suicidal ideation, and mood swings, and is effective one to two weeks after administration.

In pet medicine, mirtazapine is used to improve appetite in dogs cats, and other pets and to treat dysfunctions that are complicated by the loss of appetite and nausea, such as gastrointestinal disease, liver and kidney disease, and other conditions where the loss of appetite and nausea coexist.

With the explosion of the pet economy, much attention has been paid to pet diseases.

Common pet diseases such as appetite disorders and anorexia are often secondary to many chronic diseases and aggravate disease-induced catabolism.

Dogs and cats exhibit varying degrees of anorexia when they have acute and chronic diseases when they have painful surgical procedures, or when they have dental dysfunction or chronic kidney failure.

In addition, older pets usually also show unexplained reduced appetite and weight loss.

If dogs and cats have a reduced appetite and their favorite foods do not work to entice them to eat, medication is needed to increase appetite, and even further medical treatment is needed to provide adequate nutrition.

This is where mirtazapine steps in.

Normally there are no suitable dosages of mirtazapine for pets, vets will just use mirtazapine tabs for humans to treat diseases in pets.

If we can just compound mirtazapine tabs for cats and dogs, then it will save us a lot of trouble with feeding the meds as we can flavor the tabs so your pets will love them.

1. Compounding Process Of Mirtazapine Tablets For Patients:

Contents In Each tablet as are Below:

15 to 45mg mirtazapine

40~180mg lactose

70~200mg starch

8~25mg hydroxypropyl cellulose

0.75~3mg magnesium stearate and 0.75~3mg micronized silica gel

Said coating layer is 2.0%~3.0% of the weight of the tablet core

The particle size range of said mirtazapine is 3.0~96.0μm.

Now we get the materials weighed ready by one of the ratios mentioned above, which is proved to be one of the top choices:

Mirtazapine 30g (Active ingredient)

Lactose 180g (Diluent)

Starch 70g (Disintegrant)

10% hydroxypropyl cellulose aqueous solution 120ml (Diluent)

Magnesium stearate 1.5g (Flow aid)

Micronized silica gel 0.75g (Flow aid)

As you can see the contents in each tab are a range, not a fixed number, we just give you an example of our optimal choice.

First, we sieve lactose and starch through 80 mesh as we need very fine excipients to get them well mixed with mirtazapine.

Then we micronize mirtazapine into micronized powders (particle size determination: Dav=18.453, D10=7.291μm, D50=17.195μm, D90=35.184μm), and mix it with lactose and starch in equal increments.

Then we add 10% hydroxypropyl cellulose aqueous solution to make soft material.

24 mesh sieve is used for granulation: the granules are dried at 60±5℃ for 1.5 hours.

The granules are granulated by a 20-mesh sieve; the prescribed amount of magnesium stearate and micronized silica gel are added to the granules after granulation and mixed well, and the tablets are pressed.

Then the tablets will be coated with conventional coating equipment and gastric-soluble Obadiah.

Then we get the final product: mirtazapine tablets for patients.

To conclude the general production process: Micronize mirtazapine to the specified requirements, weigh the needed amount of mirtazapine mixed with lactose and starch, then add 8-10% aqueous hydroxypropyl cellulose solution to make soft material, then do the granulation, and air drying, then make granules even, add the prescribed amount of magnesium stearate and micronized silica gel, mix them, do the tableting to get the tablet core; coat the tablet, and that is it.

2. How To Compound Mirtazapine Tablets For Pets?

2.1 Weighing

Raw materials needed to be weighed:

Mirtazapine 20g (Active ingredient)

Anhydrous lactose 500g (Diluent)

Microcrystalline Cellulose 350g (Diluent)

Sodium carboxymethyl starch 36.92g (Disintegrant)

β-cyclodextrin 30g (Binder)

Micronized silica gel 3g (Flow aid)

Citric acid 15g (Flavor)

Hydrolyzed chicken liver powder 45g (Flavor)

sucralose 0.08g (Flavor)

Please note: mirtazapine passes through an 80-mesh sieve, other raw materials need to pass a 30-mesh sieve.

Then we start the compounding process:

2.2 Mixing

2.2.1 Mix mirtazapine, β-cyclodextrin (binder), and sodium carboxymethyl starch (disintegrant) well and set aside;

2.2.2 Pre-mix citric acid, sucralose, and a small amount of hydrolyzed chicken liver powder, then add the remaining amount of hydrolyzed chicken liver powder and mix well.

2.2.3 Add a small amount of lactose (diluent) to the material prepared in steps 2.2.1 and 2.2.2 and mix, then add the remaining amount of lactose (diluent), microcrystalline cellulose, and micronized silica gel (flow aid) to it and mix well.

2.3 Tablet pressing:

Adjust the tablet weight to 140mg/tablet and pressure to 20N for tablet pressing, and finally, we get the tablets for our pets.

We know there are more details to be mentioned for the whole process, but we already tried our best to give all the details in our knowledge for the production process.

Any pharmacists or pharmacy owners are welcome to discuss any issues you may have by leaving a comment, and you are welcome to comment or contact us directly by email: sales@octagonchem.com.

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