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///Stability testing and shelf life studies

The manufacturer of dosage forms must assure that the packed product will be stable for it's anticipated shelf life. For this he must accumulate valid data on the drug in it's commercial package. Stability data which include certain parameters (selected) together form the stability profile.

We shall investigate stability of your pharmaceutical product through various stages namely

  1. At pre-formulation stage
  2. at phase-2 clinical studies, the product is usually prepared for commercial use
  3. stability at phase-3 clinical studies, i.e. study of totally ready formulation for final approval
  4. stability studies in final container package along with closure
  5. assigning of an expiration period and date for the product.
Types of stability: to be investigated
  1. Chemical: to check chemical integrity and labeled potency
  2. Physical: to investigate appearance, palatibility, uniformity in content, dissolution and suspendibility
  3. Microbiological: sterility check. Presence of antimicrobial agents, if there any
The following information includes a variety of stability investigations on dosage forms as per FDA & ICH guidelines.
  1. Product storage requirements need to be established
  2. Submission of stability information for new drugs, biologics, new drug application and biological product license application.
  3. Preparation of experimental design, data analysis and documentation needed to meet regulatory requirements.
  4. Assessing the intrinsic photostability characteristics of new drug substances and drug products.
  5. Physical stability in case of tablets such as size, shape, weight, colour under normal handling and storage conditions throughout their shelf-life. In-vitro availability of active ingredient during storage. * Tablet hardness and friability test. * Uniformity of weight, order, texture, drug and moisture content, humidity effects.
  6. Stability study related to hard gelatin capsules, suspension, solution, emulsions, ointments, transdermal patches, metered dose inhalers
  7. Incompatibility studies include physicochemical stability of drug at the pre-formulation stage of development, binary mixture investigations
  8. Prediction of shelf-life of the drug product and temperature effects on product.

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