Table of Contents
Why stability of drug is important?
Drug stability affects the safety and efficacy of the drug product; degradation impurities may cause a loss of efficacy and generate possible adverse effects. Therefore, achieving the chemical and physical stability of drugs is essential to ensure their quality and safety.
How is drug stability determined?
A product’s stability must be assessed with regard to its formulation; the influence of its pharmaceutical ingredients; the influence of the container and closure; the manufacturing and processing conditions; packaging components; storage conditions; anticipated conditions of shipping, temperature, light, and humidity; …
What factors affect the stability of a drug?
The degradation of drugs and drug metabolites in samples can occur through either reversible or irreversible processes. Common factors that affect this stability include temperature, light, pH, oxidation and enzymatic degradation.
What are the stability and storage condition of drugs?
Storage conditions. Stability of drugs depends on both environmental factors such as temperature, air, light and humidity, and drug-related factors such as the active ingredient itself, the dosage form (tablet, solution, etc.) and the manufacturing process.
What is a stability protocol?
A Stability Protocol is a detailed plan used to generate and analyze stability data in support of the shelf (expiry) life of a Drug Product or retest period of a Drug Substance in a single specified market. It should include time points and conditions employed, and methodology used to generate stability data.
What is stability of a formulation?
Stability is an essential quality attribute for pharmaceutical formulations. Evaluation of drug stability can prevent toxicity and increase safety, efficacy and quality of the final drug product. In this work, various factors affecting stability of both small molecule and biopharmaceutical compounds were investigated.
What is stability study in pharma?
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.
What are the stability zones and stability conditions?
Throughout the world, there are 5 different ICH Stability Zones:
| Climatic Zone | Type of Climate | Long term Stability Testing Recommended Conditions |
|---|---|---|
| Zone I | Temperate | 21°C/45%RH |
| Zone II | Mediterranean/Subtropical | 25°C/60%RH |
| Zone III | Hot, Dry | 30°C/35%RH |
| Zone IVa | Hot Humid/ Tropical | 30°C/65%RH |
What is stability with example?
Stability is the state of being resistant to change and not prone to wild fluctuations in emotion. An example of stability is a calm, stable life where you don’t have wild ups and downs.
What are the 2 types of stability?
Stability is the ability of an aircraft to correct for conditions that act on it, like turbulence or flight control inputs. For aircraft, there are two general types of stability: static and dynamic.
How is the stability of a drug Measured?
• Definition: Drug stability means the ability of the pharmaceutical dosage form to maintain the physical, chemical, therapeutic and microbial properties during the time of storage and usage by the patient. • It is measured by the rate of changes that take place in the pharmaceutical dosage forms.
Are there any real life issues with drug stability?
Real life situations may sometime demonstrate issues with the stability of a drug product. A drug for thyroid issues has proven especially problematic, not only due to its lack of good stability, but also because it can cause major changes in the body’s response with only very small differences in the amount of medication.
Why is stability testing important to the pharmaceutical industry?
Stability testing is an integral part of pharmaceutical product development and is ongoing throughout the entire drug development process. Product integrity and shelf life are based on stability testing. The pharmaceutical industry is challenged by the frequently changing regulatory requirements.
How does the pH of a drug affect its stability?
In addition to temperature, pH is also a factor that affects the stability of a drug prone to hydrolytic decomposition. Drug stability can frequently be improved though the use of buffering agents between pH 5 and pH 6. Oxidation is another destructive process that produces instability in drug products.