Guidance for Industry 
Orally Disintegrating Tablets 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
December 2008 
Chemistry 
    
Guidance for Industry 
Orally Disintegrating Tablets 
 
 
Additional copies are available from: 
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Phone: 301-796-3400; Fax: 301-847-8714 
druginfo@fda.hhs.gov 
 http://www.fda.gov/cder/guidance/index.htm 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
December 2008 
Chemistry  
 
   Contains Nonbinding Recommendations 
 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION.............................................................................................................1 
II.  BACKGROUND...............................................................................................................1 
III.  DISCUSSION....................................................................................................................2 
IV.  DISINTEGRATION TESTING......................................................................................3 
   Contains Nonbinding Recommendations 
 
1
Guidance for Industry
Orally Disintegrating Tablets 
 
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic.  It 
does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  
You can use an alternative approach if the approach satisfies the requirements of the applicable statutes 
and regulations.  If you want to discuss an alternative approach, contact the FDA staff responsible for 
implementing this guidance.  If you cannot identify the appropriate FDA staff, call the appropriate 
number listed on the title page of this guidance.  
 
 
 
I.  INTRODUCTION  
 
This guidance provides pharmaceutical manufacturers of new and generic drug products with an 
Agency perspective on the definition of an orally disintegrating tablet (ODT)which is a 
different dosage form than, for example, a chewable tablet or a tablet that should be swallowed 
whole with liquidand also provides recommendations to applicants who would like to 
designate proposed products as ODTs. 
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited.  The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required.  
 
II.  BACKGROUND 
 
In an effort to develop drug products that are more convenient to use and to address potential 
issues of patient compliance for certain product indications and patient populations, 
pharmaceutical manufacturers have developed products that can be ingested simply by placing 
them on the tongue.  The products are designed to disintegrate or dissolve rapidly on contact 
with saliva, thus eliminating the need to chew the tablet, swallow an intact tablet, or take the 
tablet with liquids.  This mode of administration was initially expected to be beneficial to 
pediatric and geriatric patients, to people with conditions related to impaired swallowing, and for 
treatment of patients when compliance may be difficult (e.g., for psychiatric disorders). 
 
 
 
                                                 
1 This guidance was prepared by the Office of Pharmaceutical Science in the Center for Drug Evaluation and 
Research (CDER) at the Food and Drug Administration.  
  1 Contains Nonbinding Recommendations 
 
After the Agency received and reviewed applications for the initial products, the CDER 
Nomenclature Standards Committee developed the following definition for an ODT as a new 
dosage form in 1998:   
A solid dosage form containing medicinal substances which disintegrates 
rapidly, usually within a matter of seconds, when placed upon the 
tongue.2
 
Characteristics that were exhibited by the initial products included low tablet weight, small tablet 
size, highly soluble components, and rapid disintegration.  Such characteristics supported the 
intended uses of these products.   
 
However, as firms started developing additional products using different technology and 
formulations, many of these later products exhibited wide variation in product characteristics 
from the initial products.  Because this shift in product characteristics can affect suitability for 
particular uses, the Agency developed this guidance for industry.  
 
III.  DISCUSSION      
 
As briefly discussed in section II, an ODT has previously been distinguished as a separate dosage 
form because of the specific, intended performance characteristics of such a product, which are 
rapid oral disintegration in saliva with no need for chewing or drinking liquids to ingest these 
products.  These characteristics, which are an aid to patient use and compliance, are the primary 
characteristics that constitute the basis for classifying a product as an ODT.    
 
The recommendations in this guidance are based on the intention of the original definition and 
on Agency experience with new drug applications (NDAs) and abbreviated new drug 
applications (ANDAs) submitted for this dosage form.  To determine what the Agency's 
experience has been, we surveyed applications for products submitted to the Agency, completed 
a literature review, and collected information from laboratory studies that showed that although 
disintegration times ranged from a few seconds to longer than a minute, a large majority of these 
products have in-vitro disintegration times of approximately 30 seconds or less.  These products 
represented different manufacturing technologies, a variety of tablet sizes and weights, and 
various disintegration strategies, thus demonstrating that relatively rapid disintegration is readily 
achievable across a variety of products.   
 
Products labeled as ODTs should match the primary characteristics for this dosage form 
(identified above).  Based on the original product rationale and Agency experience, we 
recommend that, in addition to the original definition, ODTs be considered solid oral 
preparations that disintegrate rapidly in the oral cavity, with an in-vitro disintegration time of 
approximately 30 seconds or less, when based on the United States Pharmacopeia (USP) 
disintegration test method or alternative (see section IV).   
 
                                                 
2 CDER Data Standards Manual. 
  2 Contains Nonbinding Recommendations 
 
Although the value of 30 seconds is given as a desired result, it is not intended to represent an 
arbitrary distinction between an ODT and some other tablet form.  It is instead representative of 
a general time period associated with drug products that have been found to have performance 
characteristics appropriate for a disintegrating tablet meant to be taken without chewing or 
liquids.   
   
We recommend that as a primary consideration when developing this type of product, you use 
the defining characteristics for this dosage form designation (rapid disintegration in saliva 
without the need for chewing or liquids).  Products should be developed to match these 
characteristics, rather than labeling a tablet as an ODT because it would eventually disintegrate 
when placed in the mouth.  For example, tablets that take longer than 30 seconds to disintegrate 
or are dosed with liquids may be more appropriately considered to be chewable or oral tablets.   
 
Additional parameters for consideration during product development are tablet size, tablet 
weight, component solubility, and the effect these factors have on the products intended use.  
While tablet size or weight is not explicitly included in the definition, you should consider the 
effect large tablets have on patient safety and compliance.  We generally recommend that the 
weight of the tablet not exceed 500 mg; however, if a tablet intended for use as an ODT weighs 
more than 500 mg, its ability to perform effectively as an ODT should be justified based on 
product performance.  For such products, the extent of component solubility (e.g., tablet residue, 
need for liquids) can influence the acceptability of the product being labeled as an ODT. 
  
IV.  DISINTEGRATION TESTING 
 
Part of the process of determining if a product is an ODT involves testing a product to see how 
long it takes to disintegrate.  Determination of disintegration time appears to be method 
dependent.  Some methods are more discriminating than others.  To provide both a standard for 
and consistency in disintegration testing, we recommend that applicants use the USP method for 
disintegration testing.3  However, other methods that can be correlated with or are demonstrated 
to provide results equivalent to the USP method also can be used and submitted to determine 
disintegration time. 
                                                 
3 USP 29, <701> Disintegration, pp. 2670-2672. 
  3