Stability product-packaging

Drug Products Packaged in Impermeable Containers For drug products packaged in impermeable containers that provide a permanent barrier, moisture or solvent loss is not a concern and for such products stability studies can be conducted under any controlled or ambient humidity conditions. 

Driscoll, D. F., Ling, P. R., and Bistrian, B. R. (2007), Physical stability of 20% lipid injectable emulsions via simulated syringe infusion effects of glass versus plastic product packaging, J. Parenteral Enteral Nutr., 31(2), 148-153. 

Aqueous-based products packaged in semipermeable containers should be evaluated for potential water loss in addition to physical, chemical, biological, and microbiological stability. This evaluation can be carried out under conditions of low RH, as discussed below. Ultimately, it should be demonstrated that aqueous-based drug products stored in semipermeable containers can withstand low-RH environments (Table 2.5). Other comparable approaches can be developed and reported for nonaqueous, solvent-based products. 

APV (1981) International Association for Pharmaceutical Technology Praxis der Validierung (Validation in Practice), Symposium (1981-1982, Gelsenkirchen) [6] Terminology, sterile, semisolid, and solid dosage forms in development and production, analytical methods and stability evaluation, packaging development and packaging validation transfer, cost-effectiveness... 

The specifications for drug substance, drug product, packaging components, excipients, and so on will be established based on sound technical justification, using a continuously expanding experience base that includes information on process, product, analytical methods, stability of drug substance and produces), packaging components, and so on. 

The International Conference on Harmonization (ICH) has developed guidelines for stability testing of new drug substances and products [12-14], The guideline outlines the core stability data package required for Registration Applications. 

Stability testing A brief description of the stability study and the test methods used to monitor the stability of the drug product packaged in the pro-... 

Vehicles and equipment used to distribute, store or handle pharmaceutical products should be suitable for their use and appropriately equipped to prevent exposure of the products to conditions that could affect their stability and packaging integrity, and prevent contamination of any kind. 

Stability testing A brief description of the stability study and the test methods used to monitor the stability of the drug product packaged in the proposed container/closure system and storage conditions should be submitted. Preliminary tabular data based on representative material may be submitted. Neither detailed stability data nor the stability protocol need to be submitted. 

For sunlight stability, products can be evaluated after exposure in their packages to direct sunlight for various periods of time. Accelerated aging can also be evaluated in instruments such as the Atlas Weatherometer in which products can be subjected to intense radiation at elevated temperatures. 

For solid products the risk of migration is low and therefore interaction studies are not required over and above the normal stability test results. For semi-solid products it is necessary to look particularly at the migration of additives, vapour permeation and the effects of the product on the physical parameters of the pack. For liquid products the migration potential for the specific formulation is required, and the determination of active ingredient content under simulated use, along with extractives data is required for parenteral and ophthalmic products. Moisture permeation is important, particularly for solid products packaged in blister packs. 

For products packaged in containers intended for dispensing by a pharmacy to multiple patients, or intended for repackaging or packaging in unit-of-use containers, samples may be taken from previously opened containers. More than one container should be sampled during the stability study. The sampling protocol should be submitted in the drug application. 

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