In an EMA draft guideline, current data were not thought to indicate that the presence of cellulose acetate phthalate (CAP) or hydroxypropyl methylcellulose acetate phthalate (HPMCP) as excipients in human medicines constitutes a risk to human health. For dibutyl phthalate (DBP), diethyl phthalate (DEP) and polyvinyl acetate phthalate (PVAP), permitted daily exposures (PDEs) of 0.01, 4 and 2 mg/kg bw/day, respectively, were proposed. These were based on reproductive and developmental effects seen in studies on laboratory animals.

Meanwhile, in EMA’s draft reflection paper on methyl- and propylparaben as pharmaceutical excipients, a PDE of 5 mg/kg bw/day was recommended for propylparaben (based on reproductive organ effects in female rats treated orally). This value applies to individuals older than 2 years; for younger children, it was considered that further data are needed to evaluate potential health risks. Current intakes of methylparaben as a pharmaceutical excipient were not considered to be a health concern for humans of any age.

Both draft reports are open for public consultation until October 2013.

European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP).

Guideline on the use of phthalates as excipients in human medicinal products. Draft. EMA/CHMP/SWP/362974/2012. 25 April 2013.

Reflection paper on the use of methyl- and propylparaben as excipients in human medicinal products for oral use. Draft. EMA/CHMP/SWP/272921/2012. 25 April 2013.


The above item was taken from the June 2013 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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