Summary

• INVOKANA is supplied as immediate-release, film-coated tablets for oral administration.¹
• INVOKANAtablets formulated with croscarmellose as a disintegrant to provide immediate-release upon swallowing.^2-4
• In phase 3 clinical trials, the INVOKANA study drug was to be swallowed whole with liquid and not divided.

FORMULATION CONSIDERATIONS

• INVOKANA tablets are not scored and are therefore not designed to be split.²
• INVOKANA tablets, for oral use, are formulated with croscarmellose as a disintegrant to provide immediate release upon swallowing. The tablets are not enteric-coated, delayed-release, extended-release, or controlled-release.^{1, 3}
• No studies have been conducted by Janssen to establish bioequivalence between split and intact INVOKANA tablets.

ADDITIONAL INFORMATION

FDA Guidance

• In March 2013, the FDA issued a guidance document regarding the scientific basis for functional scoring on solid oral dosage form products to ensure the quality of split tablet products. Scored tablets that meet certain criteria for splitability described in the FDA guidance can be labeled as having functional scoring.⁵ INVOKANA tablets are not scored and have not been evaluated against these FDA splitability criteria.

Professional Practice Guidelines

• While there is no published information regarding splitting INVOKANA tablets, there are a few professional practice guidelines regarding the practice of splitting tablets.^6-7

LITERATURE SEARCH

A literature search of MEDLINE^® (and/or other resources, including internal/external databases) pertaining to this topic was conducted through October 29, 2022. No published reports pertaining to this topic were identified.