40 September 2019 Tablets & Capsules
References
1. "SUPAC: Manufacturing Equipment Addendum
Guidance for Industry." December 2014. Available at:
https://www.fda.gov/regulatory-information/search-
f d a - g u i d a n c e - d o c u m e n t s / s u p a c - m a n u f a c t u r i n g -
equipment-addendum.
2. "SUPAC-IR: Immediate-Release Solid Oral Dosage
Forms: Scale-Up and Post-Approval Changes: Chemistry,
Manufacturing and Controls, In Vitro Dissolution Testing,
and In Vivo Bioequivalence Documentation." November
1995. Available at: https://www.fda.gov/regulatory-inform
ation/search-fda-guidance-documents/supac-ir-immediate-
release-solid-oral-dosage-forms-scale-and-post-approval-
changes-chemistry.
3. "Q4B Annex 6: Uniformity of Dosage Units General
Chapter." June 2014. Available at: https://www.fda.gov/
regulatory-information/search-fda-guidance-documents/
q4b-annex-6-uniformity-dosage-units-general-chapter.
Fred A. Rowley is president and chief guest lecturer at Solid
Dosage Training (925 352 5724, bostonmarathonironman@
yahoo.com). Rowley is also a member of Tablets & Capsules'
editorial advisory board.
equivalent yet produce very different results when using
the same processing parameters.
This problem also occurs in bin, cube, and octagonal
blenders, where the blender shapes differ greatly, yet the
blenders are expected to produce equivalent lubrication.
And the differences don't stop at the vessel shape; there is
also no universal approach to baffle configuration or
placement, as shown by the examples in Figure 3.
Conclusion
If R&D was able to obtain both the target and maxi-
mum tablet hardness values and establish a specification
but production cannot achieve those values, something
has changed, and that change may have been to the
blending process. Causes of soft tablets include using a
different blender fill volume (occupancy), a key raw
material with a different bulk density, a different blender
type (though it may be SUPAC-equivalent), a different
lubricant morphology, or all of the above (see Table 2).
These blending-related process differences can have real
impacts on tablet hardness and can be damaging to prod-
uct quality if not addressed. T&C
