Atorvastatin Tablets Are Not Enteric-Coated
Atorvastatin tablets are film-coated, not enteric-coated, and this distinction is clinically important because enteric coatings delay drug absorption by 3-4 hours. 1
How to Identify Your Atorvastatin Formulation
Visual Identification from FDA Labeling
- Atorvastatin calcium tablets are described as "white to off-white, oval, biconvex film-coated tablets" with specific engravings (e.g., "APO" on one side, dose identifier on the other). 1
- The FDA label explicitly states these are film-coated, not enteric-coated formulations. 1
Key Differences Between Film-Coated and Enteric-Coated Tablets
Absorption characteristics:
- Film-coated atorvastatin is rapidly absorbed in the stomach and upper intestine, with peak plasma levels reached within 1-4 hours after ingestion. 2, 3
- Enteric-coated formulations (used for aspirin, pancreatic enzymes) are designed to resist gastric acid and dissolve only at pH >5.5 in the duodenum, delaying peak levels by 3-4 hours. 4
Physical appearance:
- Enteric-coated tablets typically have a glossy, smooth coating that protects against moisture and gastric acid, often appearing more uniform and shiny than standard film coatings. 5, 6
- Film-coated tablets like atorvastatin have a thinner coating primarily for aesthetic purposes, taste masking, and ease of swallowing—not for acid resistance. 1
Clinical Implications of Atorvastatin's Film Coating
Dosing Flexibility
- Atorvastatin can be taken at any time of day, with or without food, because the film coating does not require specific pH conditions for dissolution. 1
- Food decreases the absorption rate (lower peak concentration, longer time to peak) but does not significantly affect clinical efficacy. 2
No Need for Gastric Protection
- Unlike enteric-coated aspirin (which requires 3-4 hours to reach therapeutic levels), atorvastatin achieves therapeutic plasma concentrations within 1-4 hours regardless of gastric pH. 4, 2
- The film coating provides no protection against gastric acid, nor is such protection necessary for atorvastatin's mechanism of action. 1, 3
Common Pitfalls to Avoid
- Do not confuse film-coated with enteric-coated: Film coatings are cosmetic and functional (ease of swallowing), while enteric coatings are pharmaceutical barriers designed to delay drug release until the small intestine. 5, 6
- Do not assume all coated tablets are enteric-coated: Most statins, including atorvastatin, use simple film coatings that dissolve immediately upon contact with gastric fluid. 1, 2
- Do not crush or chew atorvastatin tablets: While the film coating is not enteric, crushing may alter absorption kinetics and is not recommended per FDA labeling. 1