In various Pharmacopoeia, It was much discussed about tablet and capsule and others, but less discussed the content uniformity of semi solids like ointment and Gels.
For example, Single component gel (Adapalene 1% gel)
I need Content uniformity test rather than Uniformity of weight.
In US Pharmacopoeia, they are given a test for uniformity.
Read below article which is from The United States Pharmacopeial Convention:
Title: Topical and Transdermal Drug Products, Pharmacopeial Forum; Vol. 35(3) [May–June 2009]
Link: http://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/revisions/topical_and_transdermal.pdf
Other articles:
Title: Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products
Link:http://link.springer.com/article/10.1208%2Fs12248-012-9411-0
DOI: 0.1208/s12248-012-9411-0
The content of semisolid dosage forms can be determined by : active ingredient extraction and then using analytical procedure such as HPLC, titration e.t.c (depending on the suitabiltiy of the method and accessibility) to determine the quantities . The choice of method of extraction from the dosage form will depend on the physicochemical properties of the active ingredient to be extracted.
The ointment contains multiple doses in a single tube, the uniformity of drug needs to be established based on its solubilized / dispersed condition in the matrix.
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