Through this Guidance you are able to understand the basics requirements of Table scoring, agencies recommendations and data to be generated on split tablets.
3. INTRODUCTION
This document provides guidance for NDAs and ANDAs having tablets that have been
scored.
It provides:
Guidelines to follow, data to provide, and criteria to meet and detail in an application to
support approval of a scored tablet.
Nomenclature and labeling for approved scored tablets
This guidance does not address specific finished product release testing, where additional requirements may apply to scored tablets.
4. BACKGROUND
What? Score - a debossed line running across the planar surface of the tablet.
Why? It facilitates the breaking of tablet into fractions when less than a full tablets is
required for a dose. (In the same manner as the listed drug)
RLDVS Generic
If RLD is scored, then Generic should be scored.
If RLD is not scored, then Generic should not be scored.
If scoring configuration is patented, then it should be discussed with OGD.
5. BACKGROUND
Scoring of tablets facilitates the splitting of tablet into fractions when less than a full
tablet is desired for a dose. (For adjusting the dose in the same manner as the RLD)
Although there are no standards or regulatory requirements that specifically address
scoring of tablets, Agency recognizes the need for consistency scoring between a generic
product and its RLD.
Agency concluded that tablet splitting have safety issues in some cases. Concerns with
splitting of tablet include variations in the tablet content, weight, dissolution or
disintegration. In addition, there may be stability issues with splitting tablets.
How much drug is present in split tablet and available for absorption
6. DISCUSSION
As an outgrowth of these discussion,Agency is providing recommendations for applicant
content regarding the scientific basis for functional scoring on solid oral dosage form
products to ensure the quality of both NDA andANDA scored tablet products.
Guidelines and Criteria
Nomenclature and Product labeling
7. GUIDELINES AND CRITERIA
Split tablet dose should not be below the
minimum therapeutic dose indicated on
the approved labeling.
Safe to handle and should not pose
unintended drug exposure.
Modified release products for which the
control of drug release can be
compromised by tablet splitting should
not have a scoring feature.
The split tablet, when stored in
pharmacy dispensing containers (no
seal/no desiccant), should demonstrate
adequate stability for a period of 90 days
at 25±2º C, /60±5 RH
Meet all finished products specifications
(Mechanical and Non mechanical)
Scoring configuration of generic drug
products should be the same as the RLD.
An evaluation of tablet splitability
should be done during post approval
changes at Level -2 and Level -3.
Below are the guidelines and criteria by which a scored tablet characteristics are evaluated as part of review process are
8. CRITERIA
For Immediate Release SolidOral Dosage Forms:
Uniformity of
Dosage Unit -
USP General Chapter
<905>
Here one split portion of a whole tablet is considered as a unit dose and should meet the
uniformity of dosage unit requirements.
Testing forWeight Variation: It is allowed for split tablet portion intended to have 25mg or more of
a drug substance that comprises 25 percent or more (by weight) of the split portion. Otherwise, the
test of Content Uniformity should be used.
Tablet Splitability
(Mechanical and
Non-mechanical)
The tablets splitability to be tested at both ends of proposed hardness range.
1. Loss of mass: 15 tablets to be tested to ensure the loss of mass less than 3.0% between the
individual segments when compared to the whole tablet.
2.Split tablets portions should meet USP Friability requirements.
Dissolution Dissolution data on split tablet portions should meet finished product release requirements.
9. CRITERIA
Parameter
Modified Release Solid Oral Dosage
Forms (Using MatrixTechnology)
Modified Release Solid Oral Dosage Forms
(Using Compressed Film Coated
Components)
UOD,Tablet splitability.
All criteria mentioned for Immediate release
dosage should be met.
All criteria mentioned for Immediate release
dosage should be met.
Dissolution
a) Dissolution should be demonstrated at
both ends of the hardness range.
b) Dissolution on whole versus split tablet
portions should meet the similarity factor (f2)
criteria.
(a+b) and
c) Dissolution profile on pre-compressed beads
versus post-compressed whole and split tablet
portions should meet similarity factor (f2) criteria
to ascertain the integrity of beads during
compression.
For Modified Release Solid Oral Dosage Forms:
10. NOMENCLATURE AND PRODUCT
LABELING
The New products meeting the above criteria can be labeled as “functional scoring”. And it
should be appear in Dosage form and strength, How supplied sections of label.
For current marketed products, manufactures have the option to perform an assessment
and provide data for evaluation.
11. REFERENCES
FDA Guidance for IndustryTablet Scoring: Nomenclature, Labeling, and Data for
Evaluation – March 2013
MAPP on scoring configuration of Generic drug products (5223.2), November 1, 1995.
