Tablet testing product stability studies

The evolution and optimisation of a formulation is an experimental stage that will be conducted on small batches of the material. For a drug with a tablet weight of 250 mg, test batches would t)rpically be 0.5-1 kg, providing up to 4000 tablets for analysis, performance testing and initial stability studies. Similar scales will be used in the optimisation of the product s packaging. 

Example 5 Multiple-Factor Stability Study A well-known example introduced by Shao and Chow [19] is used to illustrate the application of shelf life calculations for a multifactor case. A stability study was conducted on a 300-mg tablet of a drug product to establish the shelf life for each of the two types of packages used for this product bottle and blister. The results are shown in Table 24. Each type of package includes five batches. The tablets were tested for potency at 0, 3, 6, 9,12, and 18 months. Determine the shelf life based on these stability data. 

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