Suppositories average weight

Change in size of the tablets, capsules, suppositories or pessaries that does not alter their quantitative composition or their average weight. Conditions to be met dissolution profile unchcmged. 

Blank weight Use suppository molds with constant volume, determine the blank weight accurately, check yield and average weight... 

In preparations that are filled into containers intended for the patient, immediately after preparation (e.g. eye drops, creams) the gross yield is expressed in number of completely filled containers. The net yield may be even lower due to loss in incompletely filled containers. After preparation of a series of suppositories in molds, there will always be a number which must be rejected. A gross yield which is only a little lower than the batch size may indicate that the units which should have been rejected have not been. For preparations such as capsules or divided powders, the gross yield (number) is always equal to the theoretical amount. The preparation loss that occurs in these pharmaceutical forms, manifests itself in a lower average weight than the theoretical weight. This does not mean that a low fill weight (and therefore a low dose) would be acceptable. For these forms additional specifications are needed to limit the preparation loss. 

Eor suppositories not more than 2 of the individual masses deviate more than 5 % of the average mass and no suppository may deviate more than 10 % of the average mass. Eor capsules with a content weight less than 300 mg these percentages are respectively 10 and 20 %, for capsules with a content weight equal to or more than 300 mg respectively 7.5 % and 15 %. For other pharmaceutical forms reference is made to the monograph. 

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