Abstract:
Stability is one of the key determinant in assessing the quality, safety and efficacy of Active Pharmaceutical Ingredient (API) or Finished Pharmaceutical Product (FPP). Stability issues in a pharmaceutical products could result in physical, chemical changes in the finished products. Such degraded products could lead to treatment inefficiency, development of mild to severe adverse reactions in consumer, monetary loss and regulatory noncompliance. The stability of any API or FPP could be influenced by temperature, humidity, direct sun light, changes in storage conditions, frequency of single unit dispensing from bulk package, and other radiation related factors. Temperature is one of the key physical factors which affects drug stability and potency. For example, storage of insulin at 32˚C and above lose its potency after two weeks and on cold storage retains its potency for more than three weeks.1 Few of the pharmaceutical formulations are advised to store it in amber colour containers to prevent its degradation by direct sun light. It should be observed that the radiation related factors are expected to play a major role in affecting the stability of FPPs. The radiation related factors includes radiation from cellular towers, smart phones, mobiles, Wi-Fi supporting devices, electronic gadgets, particle radiation, acoustic radiation and gravitational radiation may also affect the stability of FPP. The effects of radiation gains much significance specifically in the current digital world, because the digital devices have become a part of our daily routine life. The effect of various radiation factors on the stability of APIs or FPPs is a major area of health concern that has to be given due importance. The current guidelines on stability assessments have not incorporated the effects of these radiations on APIs or FPPs. It is essential to study the effect of radiations on stability of any formulation to ensure it’s safety Read more…
