Applies to repaglinide: oral tablet.
Which chapter in European Pharmacopeia specify the testing requirement of split tablet.
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Multi ingredient medications may also be listed when applicable. The recommended dose range is 0.5 mg to 4 mg taken with meals. Out of these cookies, the cookies that are categorised as ”Necessary” are stored on your browser as they are as essential for the working of basic functionalities of the website. Could you please provide some guidance around this?As I am only aware of the FDA requirement for split tablet testing, but could not find any reference for Europe / EU.This website uses cookies to improve your experience while you navigate through the website. But opting out of some of these cookies may have an effect on your browsing experience. By clicking "I agree" you consent to the use of cookies for non-essential functions and the related processing of personal data.
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The characteristics of split tablets to be evaluated include: dose, safety, effect of spitting on modified release products, stability, dissolution, weight variation or content uniformity, friability and the ability of the intended patient population to be able to successfully split the tablets.As far as labelling is concerned, the term ‘functional score’ is a term reserved for labelling products that have been demonstrated to meet the recommendations. The scoring configuration of generic drug products should be the same as the reference drug. However, this would not apply to a pharmacy dispensing a prescription for individually identified patients.The new guidance relates to new drug applications (NDAs) and abbreviated drug applications (ANDAs) for scored tablets and is not retrospective.
Side effects requiring immediate medical attention. for children or the elderly.
In this review, authors have compiled information from currently available resources on tablet scoring. As a test procedure, it prescribes determining uniformity of mass, while setting the somewhat wider acceptance criteria of the test of content uniformity, namely 85 – 115 per cent (in this case of the average mass). A risk assessment should be provided to justify the tests and criteria for product with the proposed functional score.
See below for a comprehensive list of adverse effects. These cookies do not store any personal information.Performance cookies are includes cookies that deliver enhanced functionalities of the website, such as caching. (A scoring feature facilitates the practice of tablet splitting. These requirements have been in force since April 2002 and were revised in 2006. There is no need to include the test in the release specification. At least one week should elapse to assess response after each dose adjustment. All written comments should be identified with this document's docket number: Review Article
Thus, the FDA desired consistent scoring between a generic product and its RLD. The US Food and Drugs Administration (FDA) produced their guidance for industry on tablet scoring in March 2013 to ensure that tablet scoring (breakmarks or breaklines) on generic tablets would enable them to be split in the same effective way as their reference listed products (RLD).These breakmarks on tablets were originally developed to allow tablets to be split into two or four equal parts to help the ingestion of large tablets or to allow a reduction in dose, e.g. It is often the elderly who split tablets to ease their taking or reduce the dose and they often do it by hand and not using a tablet splitting device.
)You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))If unable to submit comments online, please mail written comments to: This guidance provides recommendations to sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding what criteria should be met when evaluating and labeling tablets that have been scored. The European Pharmacopeia (EP) For our other types of cookies “Advertising & Targeting”, “Analytics” and “Performance”, these help us analyse and understand how you use this website. Note: Multiple pictures are displayed for those medicines available in different strengths, marketed under different brand names and for medicines manufactured by different pharmaceutical companies. Along with its needed effects, repaglinide (the active ingredient contained in Prandin) may cause some unwanted effects.
As with the FDA guidance, the requirements were not retrospective.As the requirements on subdivision of tablets are listed in the production section of the European Pharmacopoeia general monograph on tablets, it is normally sufficient to perform the test during pharmaceutical development. shape, size and tablet score may affect tablet splitability. Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation .
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