Mannitol is an excipient used in pharmaceutical products. It is used as a sweetening agent, tablet and capsule diluent, tonicity agent, bulking agent, and as an excipient in chewable tablets. Pharmaceutical products are inert in nature, which means that they do not react with the active pharmaceutical agents of the drug. Mannitol is the same; it’s an inert material that is derived from sugar cane. 

In this article, we shall go into detail about what Mannitol Sugar is, its applications, and why it is used in the pharma industry.

What is Mannitol?

Mannitol is a type of sugar alcohol that is used as a sweetener in medicines. It is poorly absorbed by the intestines as it is a low-calorie sweetener. Mannitol sugar is a naturally occurring alcohol that is extracted from fruits and vegetables. It is widely used as an osmotic diuretic and elevates blood plasma osmolality, resulting in enhanced flow of water from tissues into interstitial fluid and plasma. 

Types of Mannitol provided by MB Sugars:

Why is mannitol sugar used in the pharma industry?

1. It is an inert carrier

No oxidation, primary amine reactions, or acid-base reactions are facilitated by mannitol.

2. Mannitol sugar is highly soluble

Since mannitol is so highly wettable, it can speed up the process of breakdown and help the drug release. Additionally, it can make poorly soluble APIs more soluble.

3. It is non-hygroscopic

It provides better chemical/physical stability; protection of hydrolyzable/moisture-sensitive actives; and greater protection against moisture in formulations.

4. It can be used as a crystal

It is widely used as a crystal in solid dispersion due to its stability in solution form.

5. It is used as a stabilizer

It stabilizes a variety of pharmaceutical preparations like liquid formations, and protects proteins from denaturation/degradation upon lyophilization, spray drying, and reconstitution. 

Applications of Mannitol in the pharma industry

Granulation

This technique is employed in the pharma industry to manufacture oral solid dosage forms. These are converted into small particles of powdered ingredients, including active pharmaceutical ingredients, to ensure uniform distribution of ingredients throughout the resulting mixture. 

The success of wet granulation depends on the selection of optimum excipients. Here, Mannitol sugar is used as an excipient as it is a good disintegrant and lubricant. It also possesses physicochemical properties like lower hygroscopicity, chemical inertness, and good tableting behavior on compression. It also imparts good taste and mouthfeel, making it useful in chewable, sublingual, and orodispersible tablet formulations.

Freeze drying

This technique is also known as lyophilization. It ensures long-term stability, perfect cake appearance, short reconstitution time, and maintenance of biological activities upon reconstitution. This objective is achieved by the addition of mannitol under the right conditions. 

Mannitol is used as a bulking agent in lyophilization as it promotes efficient freeze-drying and enhances the appearance of the end products. It also ensures echogenicity. During freeze drying, mannitol provides an amorphous matrix, which allows water to escape from the sample and prevents the collapse of the sample. The proteins remain undisrupted during the process, and channels form for water sublimation when mannitol is used. 

Maillard reaction

This reaction leads to changes in food color, organoleptic properties, protein digestibility, and protein functionality. Further, it affects the quality of food and reduces its shelf life, which indeed affects human health. In this case, mannitol is used as an inhibitor that inhibits the Maillard reaction.

Mannitol is chemically inert and does not accompany the Millard reaction. It is a polyol, which is a non-reducing sugar and results in a lighter-colored crust. It does not react with proteins to form a hapten-carrier conjugate and elicit an immune response. Thus, it is used as a bulking agent in food products to enhance stability and in drugs to avoid reactions with API.

Final Word

Mannitol has greater pharmaceutical applications as it is an inert pharmaceutical ingredient. It stabilizes a wide range of pharmaceutical products. The benefits of mannitol include- enhancement of protein therapeutic stability, vaccine stability, and carrier in lyophilized and spray dried formulations.  

M.B. Sugars, a leading pharma-grade sugar and mannitol supplier in India, provides mannitol in the form of mannitol tablets. These tables are designated as Mannitab with varied particle sizes of 100μ, 180μ, 25μ, 50μ, and 150μ. Every mannitol sugar is used in various pharma applications, which are mentioned above. 

To get in touch with MB Sugars, you can contact us at +91-2554-251885.