Size, Shape, and other Physical Attributes of Generic Tablets and Capsules

Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules as per USFDA Guidelines:

Summary:

Update: June 2015

RLD Size & ShapeANDA Sample (Test Sample)
If the RLD is less than 17 mm in its largest dimensionNo more than 20 percent larger than the RLD in any single dimension (the resulting single dimension of the generic should not exceed 17 mm)  

No more than 40 % larger than the volume of the RLD
If the RLD is equal to or greater than 17 mm in its largest dimensionNo larger than the RLD in any single dimension.   No larger than the volume of the RLD
USFDA recommends that the largest dimension of a tablet or capsule should not exceed 22 mm and that capsules should not exceed a standard 00 size.NA
Additional flexibility may be given for products that are 8 mm or smaller in their largest dimensionNA
RLD capsule is of size 3 or smallerAllow an increase of one capsule size
When the RLD capsule is of size 2 or larger,An increase of one capsule size should only be considered when adequate justification can be provided for the size increase.  

These recommendations would allow an increase of one capsule size when the capsule size is less than capsule size 00.
RLD capsule is of size 3 or smallerIt will allowed an increase of one capsule size
RLD capsule is of size 2 or LargeIncrease of one capsule size should only be allowed when adequate justification can be described for the size increase.

These recommendations would permitted an increase of one capsule size when the capsule size is less than capsule size 00
Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules

In Summary of Size and Shape Guideline :

The Critical Role of Physical Design in Drug Safety

The FDA emphasizes that a pill’s physical characteristics directly affect a patient’s ability to adhere to a treatment plan. If a generic tablet is significantly larger or a different shape than the brand-name version, it can lead to swallowing difficulties (dysphagia) or cause patients to skip doses entirely.

1. Dimensional Limits (Size)

The primary goal is for generic drugs to be as close in size as possible to the Reference Listed Drug (RLD).

  • The 22mm Rule: The FDA recommends that no tablet or capsule exceed 22 mm in its largest dimension.
  • The 20% Threshold: If the RLD is smaller than 17 mm, the generic version should not be more than 20% larger in any single dimension (length, width, or diameter) than the RLD.
  • Volume Limits: The total volume of the generic should not exceed the RLD’s volume by more than 40%.
  • Large RLDs: If the original brand-name drug is already 17 mm or larger, the generic version should be no larger than the brand-name in any dimension.

2. Shape and Swallowability

Shape is not just an aesthetic choice; it influences the esophageal transit time—the time it takes for a pill to reach the stomach.

  • Oval vs. Round: Clinical studies suggest that oval and capsule-shaped tablets move through the esophagus more efficiently than round tablets of the same weight.
  • Cross-Sectional Area: Manufacturers are encouraged to minimize the largest cross-sectional area to prevent the “stuck in the throat” sensation.

3. Surface Texture and Coating

A pill’s “slickness” is vital for safety. The FDA recommends:

  • Film Coatings: Smooth, film-coated tablets are preferred over uncoated ones because they reduce friction and prevent the medication from sticking to the esophageal wall.
  • Weight Factors: While it seems counterintuitive, heavier pills often have a faster transit time than very light, airy capsules of the same size.

4. Exceptions to the Rule

It is important to note that these size and shape guidelines apply specifically to oral solid dosage forms intended to be swallowed whole. They do not apply to:

  • Chewable tablets.
  • Orally disintegrating tablets (ODTs).
  • Sublingual or buccal medications.
  • Troches or medicated gums.

Read More on PharmaScience.in

  1. Tablet Scoring or Splitability study or Breakability Test
  2. Acronym and Abbreviations
  3. Weight loss and Diet Plan
  4. Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
  5. Health Conditions
  6. Quality Assurance
  7. Microbiology
  8. Nitrosamine Impurities in Pharmaceutical Products

Reference:

Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules by USFDA

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