RSS Newsfeed  Your shopping cart.
home
SEARCH

Search in

Keyword

GMP News
05/10/2011
 

New FDA Requirements regarding Tablet Splitting

  

In August, the CDER published the Guidance for Industry "Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation" which provides new recommendations for authorisation applications (NDAs and ANDAs) of tablets that have been scored.

The FDA considers tablet scoring as an issue when determining whether a generic drug product is the same as the original one, the so-called reference listed drug (RLD). Tablets may be manufactured with one or several scores. The score can be used to facilitate the splitting of the tablet into fractions when less than a full tablet is desired for a dose. For this reason, the Agency emphasizes the need for scoring of tablets to be standardised for both generic products and their RLD.

The FDA considers the growing recommendation of doctors or health insurers that tablets should be split by the patients either to adjust the dose or as a cost-saving measure. In this context, the safety of medicinal products can be questioned for example regarding variations in the tablet content, weight, disintegration, dissolution, and stability issues.

The European Pharmacopeia (EP) already provides appropriate provisions to this topic while the United States Pharmacopeia (USP) only published a Stimuli article in 2009.

The new FDA Guideline will now provide consistent and significant criteria for scored tablets. Here are some examples:

  • The API amount after splitting the tablet should not be below the minimum therapeutic dose
  • Modified release products for which the control of drug release can be compromised by tablet splitting (e.g., exterior film coat) should not have a scoring feature.
  • The split tablet should be stable for a period of 90 days!
  • The split tablet portions should meet the same requirements as for the finished-product
  • Any recommended dissolution test data must be generated on a minimum of 12 individual split tablet portions.

The scored tablets should also be tested by the indicated patient group to ensure patients can split these tablets correctly.

Read the Draft Guideline to find out more about the further requirements.

Author:
Dr Gnter Brendelberger
CONCEPT HEIDELBER (a service provider entrusted by the ECA Foundation)

+++Update:

The information in this article may be outdated. In order to find updated information on this subject (e.g. new developments, training courses) please enter a keyword into the search engine at the top of this page.

You may also use our GMP Guideline Database to search for the current Guidelines.

If you want to receive the latest information about major GMP developments on a regular basis you may want to register for our free GMP Newsletter.
 

 


 

 GMP News by Topics
 Analytical QC
 APIs and Excipients
 Computer Validation
 Counterfeit Medicines
 Good Distribution Practices
 GMP Inspections/Audits
 Pharma Technology
 Quality Assurance
 Sterile / Aseptic / Microbiology
 Validation
 Medical Devices
 Pharmaceutical/Clinical
 Development
 Regulatory Affairs