Excipient: Difference between revisions
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Revision as of 17:05, 10 February 2025
Excipient is a substance added to a pharmaceutical product to serve specific purposes. These purposes can include improving the manufacturing process, protecting, supporting or enhancing stability, or for bioavailability or patient acceptability. They are also used to assist in product identification and enhance any other attribute of the overall safety and effectiveness of the drug during storage or use.
Types of Excipients
Excipients can be classified into the following categories:
- Diluents: These are fillers used to make the required bulk of a tablet when the drug dosage itself is very small. Examples include lactose, calcium phosphate, and sorbitol.
- Binders: These are substances that are added to tablet formulations to add cohesiveness to the powder mix and provide the necessary bonding to form a compact mass. Examples include acacia, starch paste, and gelatin.
- Disintegrants: These are added to a tablet formulation to facilitate its breaking or disintegration when it comes in contact with water in the GIT. Examples include starch, cellulose, alginate, and certain complex silicates.
- Lubricants: These are substances added in small quantities to tablet and capsule formulations to improve certain processing characteristics. Examples include magnesium stearate, calcium stearate, and stearic acid.
Role of Excipients
Excipients play a crucial role in the manufacturing process, the stability, the effectiveness, and the delivery of the active ingredients of a drug. They can ensure that the drug is delivered to the appropriate part of the body, at the right speed, and in the right amounts. They can also ensure that the drug is stable and effective for the duration of its shelf life.
Safety of Excipients
The safety of excipients is evaluated by the International Pharmaceutical Excipients Council (IPEC) and the Food and Drug Administration (FDA). These organizations have established guidelines for the testing and use of excipients.
