Content uniformity single dose preparations

Uniformity of content of single-dose preparations or Uniformity of mass of single-dose preparations... 

Uniformity of Mass and Content of Single Dose Preparations. 

If a low-dose dmg (< 1 mg per dose unit) is formulated as tablets or capsules, it can be very difficult to uniformly distribute a trace amount of dmg substance into a single unit dose, especially when direct compression is selected as the manufacturing platform. Major factors controlling the degree of homogeneity of the final blend are the mean particle size and the size distribution of dmg substance. It is often difficult to determine whether these factors are suitable for preparation of a low-dose dmg product.2 Generally, reduction of dmg substance particle size by milling or microni-zation is essential for a low-dose dmg product to meet the USP content uniformity criteria for tablets and capsules.3... 

Since the PG activity is very high and most patients receive a single unit dose, PG preparations should be carefully designed from the viewpoints of the content-uniformity. The usual method to distribute the active ingredient in excipients is as follows. 

For preparations in single-dose containers uniformity of mass (solutions) or uniformity of content)... 

Unless otherwise stated, the uniformity of dosage units specification is not intended to apply to suspensions, emulsions or gels in single-dose containers intended for cutaneous administration. The test for content uniformity is not required for multivitamin and trace-element preparations. 

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