Understanding Stability of Formulated Products

Stability testing is the statistical approach for analysing the shelf life of the formulated pharmaceutical products for which they can store without undergoing any change in their original composition. Its significance in pharmaceutical industries arises due to the long-term storage issue of the formulated product, which undergoes the release of simultaneous byproducts. Stability testing provides an effective way to keep the formulated pharmaceutical drugs under room temperature in controlled conditions. The proceeding of this given article will discuss all the affecting parameters and methods for the analysis of the pharmaceutical products.  

Stability testing of formulated products: 

Stability testing is the requisite intermediate step for enhancing the shelf life of the formulated products, which increases the development of the pharmaceutical industry. The shelf life of the formulated product can be enhanced by raising the quality of the active component to get the last long expiry of the product. The stability testing methods govern and monitor the quality of the formulated product as a function of time. The stability of the formulated product is tested in the stability chamber. The stability studies of pharmaceutical for the estimation of the shelf life depends upon the following factors:

1. Development of product
2. The evaluation of the expiry of the product
3. The registration of the product globally
4. The change in critical suppliers.

Significance of stability studies of pharmaceuticals: 

The determination of the life of the pharmaceutical drugs becomes necessary as the physical, chemical, and microbial properties may get affected due to the extreme storage and environmental conditions. The pharmaceutical industry always leads to the development of the new product’s life by conducting its stability testing. There is the following factor that realised the significance of stability studies in the pharmaceutical industries: 

1. Determination of Shelf-life: 

The product’s quality determines the life of the formulated pharmaceutical products under the variable condition of temperature, light intensity, and humidity. Stability testing studies estimate the life of the pharmaceutical product without undergoing any degradation. Based on that, the expiry date of the product gets fixed.  

 2. Recommendation for storage condition:

The recommendation of the pharmaceutical product required different storage conditions depending upon the various types of pharmaceutical drugs. According to the stability studies of pharmaceuticals products, every product has its respective storage condition so that it wouldn’t get degraded.  

 3. Elimination of impurities:

The impurities that may affect the product’s shelf life must be analysed under extreme environmental conditions. If the impurities get examined, they will be eliminated straight away from the product.

4. Development of product

To examine the quality and development of the product, stability testing was found to be the best alternative for identifying the efficiency of the formulated product.

5. Ensured quality of product

The quality assurance of the product is an intermediate section of the process of the formulation of the pharmaceutical product. Stability testing studies of pharmaceuticals guarantee the purity of the component present in the drug. Quality assurance is the final step in formulating the final pharmaceutical product. 

6. Selection of packaging material

Depending upon the environmental conditions like humidity, the pharmaceutical product must be exposed to suitable packaging material so that it won’t degrade. The packaging material must be chosen as the ideal material to fit for the consumption of humans.

 7. Approval of legal authorities 

The approval of legal authorities must be required for the perfect stability report of the pharmaceutical products. If the product fails to meet the authorities’ standards, it will get rejected.  

Types of Stability studies of pharmaceuticals:

1. Real-time stability testing:

This testing is performed on the drugs that undergo periodic testing for the conclusive analysis to identify their composition, efficiency, and reaction against the varying conditions. The duration of the testing is the same as recommended shelf life.

2. Studies of Retained sample stability:

These stability studies of pharmaceutical products inspected the drugs periodically and allowed them to get degraded to determine their permissible levels. This test analyses the drug’s physical, chemical, and microbial composition.

 3. Cyclic temperature stress testing:

 This stability testing recorded the changes that occurred in the drug when it was kept for 24 hours as the test is not compulsory because the drug underwent on a case-to-case basis. 

 4. Accelerated stability testing:

This is the preliminary testing of the pharmaceuticals as it inspects and predicts the product’s life. The drug was exposed to the ambient temperature and the occurred changes were recorded.   

Conclusion:

This article concluded with the insight to a brief explanation of the understanding of the stability testing of a pharmaceutical product. In the above-given discussion, a straightforward approach has been made to analyse the types of stability testing methods, i.e., Real-time stability testing, retained sample stability testing, cyclic temperature stress testing, and accelerated stability testing, along with the importance of the stability testing methods. The critical factors on which the stability testing got decided are shelf-life determination, elimination of impurities, the recommendation for storage condition, product development, quality assurance, selection of packaging, and approval of legal authorities.