What’s covered?

Different bulking agents are added to pharmaceutical products.

The medicinal products you use for various ailments and conditions have only a fraction of the active ingredients. For example, the commonly used paracetamol tablet provides only 500mg of the active drug while the total weight is higher. Why is this practice followed?

The common prescription drug 'Cialis' used to treat erectile dysfunction in men has only 20mg of active drug. What is contained in the rest of the pill?

Excipients are part of all pills and capsules

The ingredients other than the active drug are called excipients. The word excipient means 'to except'. Different types of excipients are added to the tablets e.g.,

• Bulking agents

• Coating agents

• Emulsifiers

• Flow agents

• Acidifiers

What is a bulking agent?

''Bulking agents are the products that are added to the formulation of drugs, food supplements and other pharmaceuticals to add some weight to the product and hold the tablet together''.

Just like the active ingredient, bulking agents have some nutritional value and should be approved by drug regulatory authorities after clinical trials before use.

How do these bulking agents work?

These agents are added to tablet formulations to increase the size of tablets for easy handling. These agents expand during manufacturing and form a matrix that helps to carry the drug.

These compounds act as fillers and also provide cryoprotection to the active drug by covering its particles during the manufacturing process.

What are some commonly used bulking agents?

The pharmaceutical industry uses several different bulking agents in different products. The choice of a bulking agent depends upon the nature of the active drug. For example, the bulking agent for vitamin supplements (e.g., Vitamin C and Vitamin D supplements and supplements containing amino acids) will be different from the bulking agents used in antibiotics. Anti-caking agents (e.g., magnesium silicate) are also added to the capsules to prevent the formation of lumps.

Lactose continues to be the most commonly used bulking agent. It will not be a good choice if you are lactose intolerant.

Some other commonly used bulking agents are;

• Mannitol

• Sucrose

• Cellulose

• Glycine

• Gelatin

• Trehalose

• stearic acid

• Dextran

• Magnesium stearate

• Dry starch

• Kaolin

• Sorbitol

• Common salt (sodium chloride)

• Rice flour

What should a good bulking agent be like?

A good bulking agent should have the following characteristics.

• These agents should have the potential to convert the product into an amorphous or crystalline state that you can engulf easily.

• It should not result in triggering the immune system or eliciting an immune response.

• It should be able to create a better quality product in terms of ideal reconstitution time, moisture levels and stability.

• It should facilitate freeze drying and other chemical procedures during manufacturing e.g., lyophilization

• It should not decrease the absorption of a drug or dietary supplements from the intestines.

• It should be hydrophilic, have good compression (for compressed tablets), be non-hygroscopic and chemically inert.

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