Crushing the INVOKANA Tablet for Oral or Enteral Feeding Tube Administration

Summary

• Canagliflozin is supplied as film-coated tablets for oral administration.¹ INVOKANA tablets are immediate-release tablets formulated with croscarmellose, which acts as a disintegrant.²
• In phase 3 clinical trials, the INVOKANA study drug was to be swallowed whole.³
• There were no relevant studies identified regarding crushing of INVOKANA tablets for oral or enteral feeding tube administration.

CLINICAL STUDIES

• According to the unpublished protocols for the nine phase 3 clinical efficacy studies described in the CLINICAL STUDIES section of the INVOKANA^® Prescribing Information, the INVOKANA study drug was to be taken orally and swallowed whole.³
• In a definitive food-effect study, co-administration of a single canagliflozin 300 mg tablet with a high-fat meal had no effect on the pharmacokinetics of canagliflozin; therefore, canagliflozin may be taken with or without food.^1,4 In this study, the tablets were swallowed whole.

FORMULATION CONSIDERATIONS

• INVOKANA tablets for oral use are formulated to provide immediate release upon swallowing.⁵ The tablets are not enteric-coated, delayed-release, extended-release, or controlled-release.
• The tablets are formulated with croscarmellose sodium, which serves as a disintegrant.²
• Based on its solubility and intestinal permeability, the drug substance, INVOKANA, is categorized under the Biopharmaceutics Classification System (BCS)⁶ as BCS Class 4: Low Solubility and Low Permeability Drugs.⁷
• No studies have been conducted by Johnson & Johnson to establish bioequivalence between crushed and intact INVOKANA tablets.

Crushing Tablets to Make an Extemporaneous Oral Liquid

• The drug substance canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9.¹ Additionally, canagliflozin tablets contain the excipient, microcrystalline cellulose¹, which is insoluble in aqueous media.
• Initial phase 1 studies were conducted using an oral suspension of canagliflozin (5 mg/mL or 50 mg/mL prepared in 0.5% w/w hypromellose) to facilitate flexibility of a broad range of dosing.^8-10

Crushing Tablets to Administer via an Enteral Feeding Tube

• No published reports were identified describing the safety, efficacy, or pharmacokinetics of canagliflozin tablets when crushed and administered via enteral feeding tube (eg, gastrostomy tube [Gtube], nasogastric tube [NG-tube], nasoduodenal tube [ND-tube], percutaneous endoscopic gastrostomy tube [PEG-tube], and jejunostomy tube [J-tube]).

REVIEW ARTICLES

While there is no published information regarding crushing INVOKANA tablets for oral or enteral administration, there are a number of references that offer general considerations regarding the practice of crushing tablets and/or administration via enteral feeding tubes.^11-15

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 02 September 2026. No published reports were identified for inclusion.