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Soft Gelatin tablets usually packed in HDPE container, but now a days Blister packs are preferred due to cost effectiveness. Blister packs are of materials comprises of PVC based films and Aluminum foil as lidding material.

Plastic materials are not 100% barrier towards water vapor. Some permeation is always there with respect to permeability properties of film material and also the available area for permeation and the thickness of film.

Gelatin is a highly hygroscopic material and absorbs moisture rapidly. If the blister film get thinned down due to stretching at the time of thermoforming, it will not provide required barrier for moisture, and thus moisture ingression takes place, which is the subsequently absorbed by the soft gelatin shell.

As more moisture absorbed by the gelatin, it softens and start melting. The drug formulation ( usually a liquid) leaks out. That is why pharma companies recommend stoaring of the blister packs in cool and dry atmosphere, as the %RH and temperature directly affects the moisture permeation through blister film.

Samir Bagalkote

Pune.

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14y ago

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