What does Uniformity of drug (tablets or Capsule) means? And what can cause make the uniformity of tablet to be Out of approved specification?

09 August 2022 1 5K Report

What does Uniformity of drug (tablet or Capsule) means? And what can cause make the uniformity of tablet to be Out of approved specification?

Muhammad Zohaib Safdar

Uniformity of drug refers to the consistency in the dose and physical characteristics of a drug product, such as tablets or capsules, within a batch and between batches. This is important because variations in dose and physical characteristics can affect the safety and efficacy of the drug, as well as its stability and shelf-life.

There are several factors that can cause the uniformity of a tablet or capsule to be out of the approved specification:

Poor mixing or granulation: If the ingredients of the tablet are not properly mixed or granulated, there can be inconsistencies in the distribution of the active ingredient and excipients, leading to variations in the weight and dose of the tablet.

Inadequate compression: If the compression force applied during tablet manufacturing is not consistent, the tablets may have different weights and thicknesses, leading to variations in the dose.

Improper tooling or die design: If the tooling or die used to manufacture the tablets is not designed properly, there can be variations in the weight and shape of the tablets, leading to variations in the dose and physical appearance.

Poor storage conditions: Exposure to extreme temperatures, moisture, or light can cause changes in the physical appearance and stability of the tablets or capsules, leading to variations in the dose and physical characteristics.

Aging of the ingredients: Over time, the active ingredient and excipients in a tablet or capsule can degrade or change, leading to variations in the dose and physical characteristics.

It is important to ensure the uniformity of drug products in order to maintain their safety and efficacy, and to ensure that the intended dose is consistently delivered. Any deviations from the approved specification should be thoroughly investigated and corrective actions taken to prevent future occurrences.

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