Question 1

What is the Meaning of Enteric-Coated Tablets?

Accepted Answer

Enteric-coated tablets are oral pharmaceutical formulations designed with a specialized polymer barrier that protects the tablet core from the acidic environment of the stomach. This coating remains intact in the highly acidic gastric fluid, preventing the premature release or degradation of the active pharmaceutical ingredient. The tablet's dissolution is strategically delayed until it reaches the more alkaline conditions of the small intestine, ensuring targeted drug delivery to the intended absorption site within the gastrointestinal tract.

Question 2

What is the Context of Enteric-Coated Tablets?

Accepted Answer

Within human physiology, the gastrointestinal tract presents varying pH environments, from the highly acidic stomach to the more neutral to alkaline small intestine. Enteric-coated tablets leverage this physiological gradient, functioning as a precise drug delivery system that navigates these pH changes. This design is crucial for medications that are sensitive to stomach acid, such as certain enzymes or peptides, or for those that could cause gastric irritation if released in the stomach, thereby optimizing their systemic availability and therapeutic effect.

Question 3

What is the Significance of Enteric-Coated Tablets?

Accepted Answer

The clinical importance of enteric-coated tablets is substantial, as they significantly enhance drug efficacy and patient safety by controlling the site of drug release. This controlled release minimizes gastric upset, a common side effect of many medications, and protects acid-labile compounds from degradation, ensuring optimal absorption and bioavailability. For patients, this translates to improved tolerability, better adherence to treatment regimens, and ultimately, more predictable and effective health outcomes, particularly in conditions requiring long-term medication use.

Question 4

What is the Mechanism of Enteric-Coated Tablets?

Accepted Answer

The core mechanism of an enteric coating relies on pH-dependent solubility. The polymer used in the coating is insoluble at the low pH typical of the stomach (pH 1-3) but becomes soluble as the pH increases, specifically within the duodenum and small intestine (pH 5.5-7.5). This transition allows the coating to dissolve only when the tablet has passed through the stomach, releasing the drug into the intestinal lumen where it can be absorbed or exert its local effect without degradation or causing gastric distress.

Question 5

What is the Application of Enteric-Coated Tablets?

Accepted Answer

Enteric-coated tablets are widely applied in clinical practice for various therapeutic agents, including non-steroidal anti-inflammatory drugs like aspirin to mitigate gastric irritation, enzyme supplements such as pancreatic enzymes for digestive support, and certain proton pump inhibitors for acid suppression. This formulation is also valuable for specific hormonal preparations or nutrient supplements that require protection from gastric acid to maintain their integrity or to ensure their release occurs in the optimal absorption window of the small intestine, thereby maximizing their physiological impact.

Question 6

What is the Metric of Enteric-Coated Tablets?

Accepted Answer

The effectiveness of enteric-coated tablets is primarily assessed through in vitro dissolution testing, adhering to pharmacopoeial standards that simulate the pH changes encountered in the gastrointestinal tract. This testing verifies that the tablet remains intact in acidic conditions for a specified period and then rapidly dissolves in neutral or alkaline conditions. In a clinical context, the ultimate metric involves monitoring therapeutic outcomes, assessing drug bioavailability, and evaluating the absence of gastric side effects, confirming the successful delivery and absorption of the active compound in patients.

Question 7

What is the Risk of Enteric-Coated Tablets?

Accepted Answer

Despite their benefits, enteric-coated tablets carry certain risks if their intended mechanism is compromised. Premature dissolution of the coating, often due to improper storage or if the tablet is chewed or crushed, can lead to gastric irritation or degradation of the drug, rendering it ineffective. Conversely, a coating that fails to dissolve adequately in the intestine may result in poor drug absorption, leading to sub-therapeutic levels and treatment failure. Altered gastrointestinal transit times or extreme pH variations in patients can also affect the coating's performance, necessitating careful clinical consideration.

Enteric-Coated Tablets

Meaning

Context

Significance

Mechanism

Application

Metric

Risk

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