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Drug products frozen

For frozen drug products, the recommended cycle study should include an evaluation of effects caused by accelerated thawing in a microwave or a hot-water bath unless contraindicated in the labeling. [Pg.54]

If the drug product is intended to be stored frozen, the retest period or shelf life should be based on long-term data. If accelerated conditions are not studied, a single batch should be evaluated at an elevated temperature for an appropriate time to address the effects of short-term excursions outside the proposed label storage condition. [Pg.501]

Ikeda [3.36] presented a two stage freezing process for an antibiotic (Panipenem), which reacts with another component of the drug (Betamipron) and has therefore to be separated until its use. The first substance is filled into the vials and frozen. The precooled second substance is filled then into cooled vials and frozen. By this process, the amount of undesirable reaction product could limited to 0.5 % during a 6-months storage at 40 °C. If the two products were frozen simultaneously the amount of reaction product was 1.2%. [Pg.219]

Freeze-drying is an aseptic process whereby water is removed from a frozen product mainly by sublimation, i.e. by the conversion of ice directly into the vapour state without the intermediary of liquid water. It is a batch process, of relatively long duration, and is used frequently for drugs of poor stability. Drugs are reconstituted into solution immediately prior to injection. The process consists of three stages ... [Pg.328]


See other pages where Drug products frozen is mentioned: [Pg.270]    [Pg.377]    [Pg.302]    [Pg.445]    [Pg.445]    [Pg.274]    [Pg.554]    [Pg.187]    [Pg.57]    [Pg.237]    [Pg.143]    [Pg.1611]    [Pg.406]    [Pg.97]    [Pg.798]    [Pg.65]    [Pg.300]    [Pg.515]    [Pg.523]    [Pg.524]    [Pg.242]    [Pg.575]    [Pg.255]    [Pg.285]    [Pg.423]    [Pg.272]    [Pg.315]    [Pg.347]    [Pg.143]    [Pg.33]    [Pg.436]    [Pg.433]    [Pg.434]    [Pg.2161]    [Pg.449]    [Pg.1010]    [Pg.539]    [Pg.3087]    [Pg.851]    [Pg.252]    [Pg.77]    [Pg.154]    [Pg.271]   
See also in sourсe #XX -- [ Pg.13 , Pg.14 ]




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Frozen drug products stability

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