Storage dosage forms

Physical, chemical, and biological properties Dosage form, storage conditions, stability... 

Product/Established Name Generic/Proprietary Name Dosage Form Storage Conditions Sterility... 

With liquid and semi-solid dosage forms, the rate and the extent of desorption are influenced by the solvent system of the preparation, pH, and temperature conditions during processing and storage. If a severe problem exists, it will usually manifest itself via an outward sign, such as container collapse, product discoloration, or precipitation [14]. 

Primary container-closure system-related data will need to cover storage, transportation, and use. The choice of materials of construction, their description, and the ability of the container-closure system to protect from moisture and/or light will need to be considered. The compatibility of the container-closure and its contents will need to consider sorption, leaching, and safety. The performance of the container-closure system will also need to be considered in terms of dose delivery from any associated device that is to be supplied as part of the product. Container-closure components will require adequate specifications covering description, identification, critical dimensional tolerances, and test methodology (including pharma-copeial and noncompendial methods). More data are likely to be required for liquid or semi-liquid products than for solid dosage forms. In the latter, product stability data and container-closure system specifications may suffice. 

During the process of manufacture an unavoidable criterion is the loss of active ingredients. Therefore, all Official Standards for pharmaceutical chemicals and dosage forms should accomodate such losses caused due to loss in manufacture, unavoidable decomposition and storage under normal conditions for a stipulated period. 

It has become an usual practice to include a definite overage in certain dosage forms so as to compensate the noticeable losses caused either due to manufacturing or storage (anticipated decomposition), in order that the finished product may comply with the prescribed official standards after the stipulated duration of storage. 

An ideal bioadhesive should be nontoxic, nonabsorbable, and nonirritating to the mucus membrane, form a strong noncovalent bond with the mucin-epithelial cell surfaces, allow easy incorporation of drug and should not offer hindrance to drug release, and should not decompose on storage or during the shelf-life of the dosage form. Some of the other desirable characteristics of the polymer have been discussed under bioadhesion. 

Assignment of Climatic Zones and Recommended Storage Conditions Stability Testing Parameters for Different Dosage Forms... 

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