Stability of a pharmaceutical product means how long it can maintain its original form without any visible changes under the influence of various environmental factors like temperature, humidity, light.
What Is Stability Testing?
Stability testing is the statistical analysis of how long a pharmaceutical product can be stored without any change in its original chemical composition.
Pharmaceutical products when stored for long durations tend to undergo changes and release byproducts. Stability testing provides evidence on how certain pharmaceutical drugs can be stored at room temperature and in controlled conditions.
Why you should go for the stability testing of your product?
The physical, chemical and microbial properties of a pharmaceutical product may change under extreme storage conditions. That’s why; the shelf-life of a product has been studied during the stability testing.
The pharmaceutical industry conducts this testing to develop a new product and establish the shelf-life of a product. Here’s why stability study is important for the pharmaceutical industry.
- Shelf-Life Determination: The quality of a pharmaceutical product varies with time under temperature, humidity and light intensity. Stability testing studies; how long a pharmaceutical product can be stored at normal and accelerated conditions without any degradation. This study helps to determine the shelf-life of that product. As per the report of the study, the expiry date of the product is fixed.
- Storage Condition Recommendation: Different products require different storage conditions. In the stability testing lab, storage conditions and changes in the substances are recorded. As per the stability study, the storage condition is recommended for a particular product.
- Elimination of Impurities: In stability testing, each ingredient has been analysed under various environmental factors. So, it becomes easy to identify and eliminate any impurities that may be formed during the shelf life of the product.
- Product Development: Stability testing is a reliable way to study the effectiveness of a new product. This testing helps to assess the physical, chemical, therapeutic stability of a product. As per the study, R&D professionals redesign the existing product and develop a new product.
- Ensures Quality: Quality assurance is an integral part of the pharmaceutical industry. The product is kept under the influence of high stresses and the rate of decomposition is observed. Stability testing assures the purity of ingredients and the quality of the final product. The stability report ensures that the pharmaceutical product is fit for human consumption. This gives the companies the confidence to launch new products in the market. The chances of product recall may decrease.
- Packaging Material Selection: During stability testing, the pharmaceutical product is exposed to humidity and temperature. As per the effect of water activity and temperature on the product, packaging materials are chosen for the product. The ideal container must tolerate the stresses. The packaging should maintain the quality of the product during transportation and storage.
- Legal Approvals: Stability testing of the pharmaceutical products is required for regulatory approvals. If a product fails to meet the quality standards prescribed by ICH and WHO, the product will not get approval for commercialization.
How Do You Perform a Stability Test?
Stability testing tests the drug stability and monitors changes in physical, chemical, and microbial characteristics.
Physical Changes: With the stability test, researchers monitor changes in the physical attributes of the drug when stored for specified durations. Key changes that are monitored include the change in colour, water content level, change in pH, change in viscosity, presence of crystalline substances, and its difference in dissolution and disintegration properties from the day it was packed.
Chemical Changes: The stability protocol for pharmaceutical products, when analyzing chemical evidence, is to look for the presence of residual solvents, related substances, and any degradation by-products along with assay.
Microbial Changes: Stability studies prove that pharmaceutical drugs, when stored for long periods at room temperature and in temperature-controlled conditions, can lead to a change in the microbial level. In microbial stability studies of drugs, researchers look for the presence of pathogenic microorganisms and the effectiveness of added microbial preservatives, and any impact on the efficiency of the drug.
Types of Stability Studies
Based on the nature of the test and the estimated shelf life periods of certain pharmaceutical drugs, various stability testing methods are used to arrive at statistical data points that help manufacturers release safe and tested products to the market for consumption.
The 4 widely practiced forms of stability testing are
Real-Time Stability Testing: This form of stability testing is conducted on drugs for the same duration as the recommended shelf life. In this, regular periodic tests are conducted and conclusive analysis is done for its composition, efficiency, and reaction to various conditions. The trend analysis from this periodic testing is compared with different batches and a linear conclusion is approached.
Retained Sample Stability Studies: This testing procedure is practised for every marketed product that requires stability studies. In this, the stability of the drug is periodically inspected and is allowed a degradation percentage of 2-5. For example, if a pharmaceutical drug has a shelf life of 5 years, the drug is tested in its 3rd, 6th, 12th, 24th, 36th, 48th and 60th month and the changes in its physical, chemical, and microbial composition are noted and compared with the regulated permissible levels.
Cyclic Temperature Stress Testing: This testing procedure is not compulsory and drugs undergo this test on a case to case basis. In this, the minimum and maximum temperature conditions are mimicked in a controlled environment and the drugs are exposed to these conditions for 24 hours and the changes if any are noted.
Normally the drug undergoes 20 cycles of cyclic temperature stress testing before any conclusive analysis on its stability is made.
Accelerated Stability Testing: This is a form of shelf-life testing and is used to gain insights on the predicted shelf life of the drug. In this, the drug is exposed to more than ambient temperatures and the changes are noted. Earlier the drug used to be exposed to extreme conditions and the amount of heat required to cause chemical composition failure was noted. This information was used to extrapolate the shelf life and relative stability of the pharmaceutical product.
For statistical linearity, the drug is exposed to 4 different temperature conditions and the exposure to accelerated conditions after refrigeration is also noted. Now the protocols are simplified and based on target markets and storage conditions, single accelerated condition storage usually at 40 degree celsius and 75% Humidity is used as per ICH.
Guidelines by ICH to Conduct Stability Testing
The scope and ideal behind ICH stability testing guidelines are to understand the shelf life of pharmaceutical drugs after being stored in different levels of temperature, humidity, and light.
Batches: The batches selected for stability testing should be the same as the ones that are reserved for distribution. The batches tested should be the same as the ones used in clinical trials and post packaging. The batches used are to be monitored for a period of 12 months and for those that were not approved for mass consumption in its first evaluation should be monitored for longer intervals.
Packaging: The packaging used for testing pharmaceutical drugs should be the same as the ones used during clinical trials and production.
Test Procedure: The test procedure should entail everything from efficiency, growth of microbial by-products, the formation of degradation products, the formation of crystalline by-products, the viscosity of the chemical, formation of moisture/water, and the effectiveness of the drug.
Storage Conditions: The packaging material and the quality of the substance used while testing the product should be the same as the one submitted to the regulatory bodies in the clinical trials and production phase.
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