{"id":7328,"date":"2025-07-31T13:49:15","date_gmt":"2025-07-31T05:49:15","guid":{"rendered":"https:\/\/www.qualitester.com\/?page_id=7328"},"modified":"2025-07-31T13:52:22","modified_gmt":"2025-07-31T05:52:22","slug":"usp-1217","status":"publish","type":"page","link":"https:\/\/www.qualitester.com\/ru\/standards\/usp-1217\/","title":{"rendered":"USP 1217"},"content":{"rendered":"

\u00a0USP 1217<\/strong><\/h1>\n

The Standard for Tablet Strength Testing<\/strong><\/h2>\n


In pharmaceutical production, tablet integrity<\/strong> is not just about appearance\u2014it directly influences efficacy, stability, and patient experience. USP<\/strong> establishes a comprehensive framework for evaluating tablet mechanical strength, focusing on tablet hardness<\/strong>, breaking force<\/strong>, and structural durability. These metrics guide formulation, inform quality control, and ensure tablets can withstand manufacturing and real-world handling without failure.<\/p>\n

Modern instrumentation\u2014like Cell Instruments\u2019 MPT-02 \u0422\u0435\u0441\u0442\u0435\u0440 \u0442\u0432\u0435\u0440\u0434\u043e\u0441\u0442\u0438 \u0442\u0430\u0431\u043b\u0435\u0442\u043e\u043a<\/strong>\u2014enables manufacturers to perform these tests with precision and repeatability, aligning with USP <1217> while supporting process efficiency and regulatory compliance.<\/p>\n

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Critical Testing Protocols: From Tablet Hardness Test to Friability<\/strong><\/h2>\n

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Tablet Hardness Test and Break Test: Why Breaking Force Matters<\/strong><\/h3>\n

\"USP<\/strong><\/h2>\n

The \u0438\u0441\u043f\u044b\u0442\u0430\u043d\u0438\u0435 \u043d\u0430 \u0442\u0432\u0435\u0440\u0434\u043e\u0441\u0442\u044c \u0442\u0430\u0431\u043b\u0435\u0442\u043e\u043a<\/strong> isn’t simply about measuring surface resistance. In the context of USP <1217>, it refers to the break test<\/strong>\u2014the compressive force needed to fracture a tablet. This force, also called the tablet crushing strength<\/strong>, offers insights into internal bonding, compression uniformity, and formulation performance.<\/p>\n

The MPT-02 \u0422\u0435\u0441\u0442\u0435\u0440 \u0442\u0432\u0435\u0440\u0434\u043e\u0441\u0442\u0438 \u0442\u0430\u0431\u043b\u0435\u0442\u043e\u043a<\/strong><\/a>, with a digital force sensor and constant platen movement, is tailored for such analysis. It records peak force applied to a sample placed between two platens, helping users determine if the tablet meets required strength standards. The test is especially important for chewable, coated, or scored tablets, where breakage can alter drug delivery or dosage accuracy.<\/p>\n

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Friability of Tablet: Mechanical Robustness Beyond Compression\u00a0\u00a0<\/strong><\/h2>\n


While breaking force tests the resistance to direct pressure, friability tests<\/strong> simulate abrasion and surface stress during handling. According to USP <1216>, which complements USP <1217>, tablets are tumbled inside a rotating drum to measure weight loss from chipping or erosion<\/strong>.<\/p>\n

Friability is critical when evaluating fragile formulations or tablets with surface coatings. Excessive friability suggests that a tablet might crumble during packaging, shipping, or administration. A weight loss greater than 1.0%<\/strong> is typically unacceptable.<\/p>\n

For manufacturers aiming to minimize friability issues, it’s crucial to adjust binder concentrations, optimize compression forces, or refine tablet shape. These adjustments should always be verified using a calibrated tablet tester<\/strong> to prevent overcorrection that might hinder disintegration.<\/p>\n

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Flexure Test and Tablet Brittleness Test: Advanced Structural Insight<\/strong><\/h2>\n


Not all tablets fail in the same way. Some exhibit brittle failure<\/strong>, cracking under minimal stress, while others bend or deform. This is where a flexure test<\/strong>\u2014often a \u0438\u0441\u043f\u044b\u0442\u0430\u043d\u0438\u0435 \u043d\u0430 \u0442\u0440\u0435\u0445\u0442\u043e\u0447\u0435\u0447\u043d\u044b\u0439 \u0438\u0437\u0433\u0438\u0431<\/strong>\u2014becomes valuable. It evaluates how tablets behave under bending forces, simulating handling scenarios that compress the tablet on one side while stretching it on the other.<\/p>\n

The tablet brittleness test<\/strong> evaluates fracture behavior across different strain rates. If a formulation is prone to brittle failure, it may crack during automatic feeding or blister packaging. Flexure testing is especially recommended for elongated or capsule-shaped tablets where diametral compression may not provide reliable results.<\/p>\n