EMA tightens rules on using phthalates in medicine capsules

Published: 9-Dec-2014
Ingredients Regulatory

Because of safety concerns


The European Medicines Agency (EMA) has released guidance on the maximum amount of three phthalates that should be allowed in pharmaceuticals, because of safety concerns. These plasticisers – diethyl phthalate (DEP), polyvinyl acetate phthalate (PVAP), and dibutyl phthalate (DBP) – can be used to make medicine capsules. EMA said that 'adverse reproductive and/or developmental effects have been observed in non-clinical studies conducted with DBP, DEP or PVAP.' And because of a dearth of pharmacokinetic exposure data in humans and rats, 'it can presently not be excluded that the findings made are of clinical relevance'.

As a result, EMA recommends that patients’ daily DEP intake from medicines should not exceed 4mg per kg of body weight (mg/kg/day); PVAP consumption through human medicines should not exceed 2mg/kg/day; and DBP should be reduced to 0.01mg/kg/day.

EMA also said that patients could take in more of these phthalates if they helped deliver medicines to certain seriously ill patients.

The Agency said data currently available for the phthalates cellulose acetate phthalate (CAP) and hydroxypropyl methylcellulose acetate phthalate (HPMCP) suggest that they are safe to use in medicines.

'These recommendations are precautionary measures aiming at reducing the phthalate content of medicines…to ensure safety in all types of patient populations,' EMA added.

  • Companies:
  • EMA European Medicines Agency
See more

You may also like

Regulatory

EMA issues positive opinion on Calliditas' orphan drug

Read more
Calliditas' application for orphan drug designation in the European Union (EU) for setanaxib in Alport syndrome has received a positive opinion from European Medicines Agency

Trending Articles

  1. Overcoming CMC challenges in cell and gene therapy: part II Certara’s Dr Hien Anh Bruno, Associate Director, Chemistry, Manufacturing and Controls (CMC), and Dr Deven Shah, CMC Lead, propose mitigation strategies to address the CMC challenges inherent in producing cell and gene therapy (CGT) drugs
  2. Causes and solutions for dark spots in tablet manufacturing Natoli Engineering examines the causes and solutions for dark spots that can halt production
  3. Overcoming CMC challenges in cell and gene therapy: part I Certara’s Dr Hien Anh Bruno, Associate Director, Chemistry, Manufacturing and Controls (CMC), and Dr Deven Shah, CMC Lead, propose mitigation strategies to address the CMC challenges inherent in producing cell and gene therapy (CGT) drugs
  4. Momentum in the US cannabidiol market gains retailers' attention Walmart and other big-name stores in talks with food and drinks makers in preparation for the day CBD-enriched products are allowed on the shelves

Upcoming event

Cleanroom Conference UK

22–23 May 2024 | Exhibition | Birmingham, UK See all

You may also like

Regulatory

EMA issues positive opinion on Calliditas' orphan drug

Calliditas' application for orphan drug designation in the European Union (EU) for setanaxib in Alport syndrome has received a positive opinion from European Medicines Agency
Distribution

Moderna receives positive opinion from the EMA for Spikevax

Moderna has revealed the European Medicine's Agency (EMA) has provided positive opinion on its COVID-19 vaccine Spikevax's marketing authorisation
Regulatory

EMA celebrates 25 years of regulatory management

The EMA was founded in January 1995
Regulatory

EMA publishes draft guideline on quality requirements for DDCs

The latest document focuses on combinations of medicinal products and medical devices
Regulatory

GMP inspection in Bulgaria and Cyprus now on par with US

A mutual recognition agreement between the EU and the US regulatory bodies aims to encompass all EU member states, now standing at 24 of the 28
Regulatory

Brexit update: UK Inspection Reports and GMP Certificates

The ECA Academy sheds light on the latest Brexit guidance documents released by the European Medicines Agency
Regulatory

Poland and Slovenia join EU-US mutual recognition agreement for inspections

GMP drug plant inspections conducted by health authorities in Poland and Slovenia will now be accepted by the US FDA
Subscribe now