Stability testing is a complex process that involves testing pharmaceutical formulations for various parameters. Only pharmaceutical testing laboratories with expertise and experience can successfully carry out all the processes involved in stability testing of a pharmaceutical product. On stability testing revolves the efficacy, safety and quality of a formulation and the commercial success of the product.
At the developmental stage stability testing in undertaken to determine and correctly identify the purity as well as the potency of the ingredients. Stability testing is carried out to ascertain that the formulation will maintain its capability and will not undergo chemical, physical, microbiological or toxicological changes when enclosed in a specific packaging or container. The pharmaceutical formulation must be able to retain the same properties and capabilities throughout its storage and use.
There are a number of factors that can affect the stability of a pharmaceutical formulation and only a recognised pharmaceutical testing laboratory can effectively carry out these important processes which include
- Stability of active ingredients
- Interactions between excipients and active pharmaceutical ingredient (API)
- Manufacturing process to follow
- Dosage and the forms of dose like tablet, liquid, etc.
- Packaging and container requirements
- Heat, light and moisture conditions
- Reaction analysis like oxidation, reduction and more
- Length of time for consistent effectiveness
- Consistency in appearance and shape
- Preservative efficacy
- Proper storage conditions
- Regulatory approval of the formulation
- Labelling requirements
Any chemical reaction that takes place in the pharmaceutical formulation like oxidation will lead to degradation in the product. If the packaging is inappropriate it temperature, freezing, moisture, etc. will affect the formulation. These factors can have a detrimental effect on the formulation and lead to loss of effectiveness of the pharmaceutical. It can also be subject to microbial contamination. Since drug formulation is such an expensive undertaking, without stability testing of pharmaceuticals it becomes counter-productive.
Pharmaceutical formulations are designed and developed to help patients suffering from various diseases. In case there is degradation in the formulation, or ingredients become toxic or there is loss in the potency of the active ingredient then the pharmaceutical will not be effective against the disease it is meant for and could even result in death of the patient. Stability testing comes with immense responsibility so the pharmaceutical industryuses the services of only those pharmaceutical testing laboratories that have been approved and recognised. It is also sometimes a legal requirement to provide analysis data for stability testing parameters before regulators approve of a new pharmaceutical formulation. Stability testing works as an assurance that the product will remain stable and effective in all parameters for as long as the ‘expiry date’ displayed on the label.
Stability testing is a key process for regulatory requirements. Without stability testing the shelf life, ‘expiry date,’ of the recommended dosage cannot be mentioned on the label. Stability testing can be considered a guarantee of its effectiveness against countering the disease it is meant for and so must be carried out in a pharmaceutical testing lab that follows scientific principles.