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Role and Function of Excipient in Drug Formulation

excipient

In the pharmaceutical world, excipients play a very important role in the manufacture of effective and safe drugs. As a crucial yet often forgotten component, excipients are key to the success of modern drug formulations. Let's delve deeper into what excipients are, their ideal properties, and their diverse functions and uses in the pharmaceutical industry.

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What are Excipients?

The word excipient comes from the Latin excipere which means besides. So, basically, an excipient is anything other than the active pharmaceutical ingredient (API) used in drug manufacturing. Although considered inactive, excipients actually have various important functions that affect the quality, safety, and effectiveness of the drug.

In general, excipients are derived from nature, such as corn, wheat, sugar, and minerals. Nowadays, many newer and more complex excipients have been developed. The nature of excipients, which are inert or do not react chemically with other ingredients, characterizes drug formulations.

Ideal Properties in Excipients

Besides inert and harmless properties, there are several other properties that are ideal for excipients in drug formulations.

1. Stable and Reproducible

Excipients must have good stability and be able to be produced consistently with the same quality. This stability is important so that the excipients do not undergo chemical or physical changes during storage and use.

2. No Unintended Interactions with Drugs

Excipients should not react or interact with the active substance in the drug so as not to alter the effectiveness or safety of the drug. This property ensures that the excipient serves only as a carrier or complement without interfering with the performance of the drug.

3. Pharmacologically inert

Excipients should be pharmacologically inert, meaning they have no pharmacological or therapeutic effect. This is important to ensure that only the active substance provides the therapeutic effect, while excipients only support the formulation and delivery of the drug.

4. Desired Functionality

Excipients should have a desired function in the drug formulation, such as fillers, wrappers, crushers, lubricants, or preservatives. These functionalities help in the production process and drug stability.

5. Cost-effective

Excipients should be economical and not add significantly to the cost of drug production. Cost-effectiveness is important to keep drug prices affordable for consumers.

By ensuring that excipients meet these criteria, drug manufacturers can produce safe, effective and high-quality products.

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Excipient Functions and Uses

  • Fillers: Many drugs require additional volume to make them easier to take. Lactose is often used as a filler in tablets and capsules due to its inert and soluble nature.
  • Binder: During the tableting process, the active ingredients and excipients need to be mixed into one solid mass. Cornstarch and cellulose serve as binders that help these ingredients come together.
  • Disintegrant: In order for the active substance to be absorbed by the body quickly, the tablet must disintegrate after consumption. Cornstarch is often used as a disintegrant to ensure the tablet breaks apart and releases the active substance in the digestive tract.
  • Lubricant: To prevent the drug substance from sticking to equipment during the production process, excipients such as cellulose are used as lubricants.
  • Preservative: Excipients can also serve as preservatives to prevent the growth of microorganisms and extend the shelf life of the product.

Excipient Usage Example

Lactose

Aside from being a filler, lactose also helps in the tableting process, providing the right texture and ensuring the tablet has enough strength to be consumed without breaking prematurely.

Cornstarch

Cornstarch not only functions as a crusher, but also as a filler and binder, making it a versatile excipient in tablet formulations.

Cellulose

Cellulose, especially in microcrystalline form (microcrystalline cellulose), is a very popular excipient due to its ability to improve the physical stability of tablets and its compatibility with various active substances.

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Proper excipient selection is essential to ensure the drug functions properly and safely. Excipients must be compatible with the active substance and other ingredients in the formulation, not interfere with the stability or effectiveness of the drug, and not cause adverse reactions in patients. 

This is where our products, such as lactose, cornstarch and cellulose, come into play. With guaranteed quality and ideal properties that support drug formulation, our products provide a reliable solution for pharmaceutical industry players looking for high-quality additives to ensure their drugs are safe and effective. Get more detailed information here, or contact WhatsApp PRB Care

 

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