Summary

• INVOKAMET tablets are not scored¹ and are formulated with croscarmellose as a disintegrant to prepare the product for immediate-release upon swallowing.^2,3
• The tablets are not enteric-coated, delayed-release, extended-release, or controlled-release. No studies have been conducted by Johnson & Johnson to establish bioequivalence between split and intact INVOKAMETtablets.

FORMULATION CONSIDERATIONS

• INVOKAMET is supplied as immediate-release, capsule-shaped, film-coated tablets for oral administration.³
• INVOKAMET tablets are formulated with croscarmellose as a disintegrant to prepare the product for immediate-release upon swallowing.^2,3 The tablets are not enteric-coated, delayed-release, extended-release, or controlled-release.
• No studies have been conducted by Johnson & Johnson to establish bioequivalence between split and intact INVOKAMET tablets.

ADDITIONAL INFORMATION

Food and Drug Administration Guidance

In March 2013, the food and drug administration (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.⁴  INVOKAMETtablets are not scored¹ and have not been evaluated against these FDA splitability criteria.

Professional Practice Guidelines

While there is no published information regarding splitting INVOKAMET tablets, there are a few professional practice guidelines regarding the practice of splitting tablets.^5-7

LITERATURE SEARCH

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 28 October 2024. No published reports of splitting, cutting, or dividing INVOKAMET tablets were identified.