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    Home > Active Ingredient News > Drugs Articles > CDE solicits general requirements for the design and research of functional scoring of generic oral tablets

    CDE solicits general requirements for the design and research of functional scoring of generic oral tablets

    • Last Update: 2019-07-05
    • Source: Internet
    • Author: User
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    In the evening of July 4, CDE, in order to improve the technical standards of generic drug registration application, our center, referring to the relevant technical requirements of regulatory agencies in various countries, combined with the Chinese Pharmacopoeia and the current situation of research and development and production of generic drugs in China, organized the drafting of the general requirements for functional scoring design and research of generic oral tablets, and issued the draft comments In order to improve the technical standards for the registration application of generic drugs, our center, referring to the relevant technical requirements of regulatory agencies in various countries and in combination with the Chinese Pharmacopoeia and the current situation of research and development and production of generic drugs, has organized and drafted the general requirements for the design and research of functional scoring of generic oral tablets, which is intended to provide technology for the research and development, application and post marketing changes of generic oral tablets with functional scoring Technical reference, now open to all sectors of the community for comments If there is any opinion from all walks of life, please feedback by email before August 2, 2019 Contact: Chen sishijing email: chens@cde.org.cn; shij@cde.org.cn Generic requirements for the design and research of functional scoring of oral tablets (separable scoring tablets) refers to the tablets with one or more notches to facilitate dose segmentation The study shows that the existence of the scoring line, its shape and depth, the shape, size, thickness and curvature of the scoring tablet may affect the accuracy of the dosage of the tablet, and then affect the safety and convenience of clinical use of patients In order to improve the technical standards of generic drug registration application, our center has formulated the following technical requirements by referring to the relevant technical requirements of regulatory agencies in various countries and combining with the current situation of research and development and production of generic drugs in China and China: 1 Design of functional scoring of generic oral tablets According to the definition of generic drugs in the announcement of the work plan for the reform of chemical drug registration and classification, i.e APIs and their preparations with the same active ingredients, dosage forms, specifications, indications, routes of administration and dosage as the original drugs The same scoring characteristics can ensure that the patients can use the same way to segment the tablets when using the imitation film preparation as the original drug (reference preparation) Therefore, in order to fully ensure the replaceability in clinical use, the functional scoring of the imitation film preparation should be consistent with the reference preparation If the reference preparation does not have functional scoring design, it is not recommended to design scoring for the imitative production agent 1.1 for the declared imitation film making agent, if the instruction clearly describes the situation that it needs to be used in different doses, such as the description of "can be taken off" or "half piece", if the declared product does not refer to the functional score of the reference preparation design, the score shall be added and relevant research shall be carried out to meet the requirements before approval If it is not specified in the specification, the relevant research can be further improved after the drug is approved for marketing 1.2 for the varieties declared after the release of the technical requirements, the functional scores of the imitation production agent shall be consistent with the reference preparation 1.3 according to the varieties declared in the conformity evaluation, the research requirements are the same as those of the above-mentioned imitation production agent 2、 In vitro study of notches 2.1 basic requirements selection of segmentation method: it is necessary to investigate the manual segmentation method and adopt a mechanical segmentation method, such as slicer, knife, etc., to ensure that the products can meet the requirements under the segmentation conditions of different principles Research samples: representative samples of each stage in the product development process shall be studied Multi specification products should be studied for each specification with functional scoring Overall quality: the quality of the divided part shall meet the quality standard of the whole piece 2.2 requirements for quick release tablets 2.2.1 weight difference or content uniformity: according to the requirements of the fourth part of the Chinese Pharmacopoeia, 2015 edition, if the theoretical dose of the separated part of the tablet is less than 25mg or the proportion of the main drug content is less than 25%, the content uniformity shall be checked In other cases, the uniformity of unit dose can be examined by the difference of slice weight after segmentation During the above detection, it should be noted that during the test, one segment of each film is taken for the test, and other parts are not used 2.2.2 split weight loss: take 15 whole tablets and test them respectively at the upper and lower limit of the proposed hardness range of the whole tablet Compared with 15 whole tablets, the weight loss of the split part (30 and a half pieces in two and 45 and a half pieces in three) should be controlled within 3.0%, and the tablet debris in the process of breaking off should not be involved in the calculation of weight loss 2.2.3 fragility: the fragility of the divided part shall be inspected at the upper and lower limits of the proposed hardness range of the whole tablet, and the results shall meet the requirements of the fragility inspection of the fourth part of Chinese Pharmacopoeia 2015 2.2.4 dissolution: the separated part shall be subject to dissolution test, and the dissolution result shall meet the quality standard of finished product release, and the test sample quantity shall not be less than 12 separated units 2.3 sustained and controlled release tablet 2.3.1 in addition to meeting the relevant requirements of the rapid release preparation, the tablets using skeleton slow release technology shall also be separated from the detection dissolution curve of the whole tablet after segmentation at the upper and lower limit of the proposed hardness range of the whole tablet, and the similar factor (F2) shall meet the requirements 2.3.2 in addition to meeting the relevant requirements of the rapid release preparation, the tablet (i.e the product of pellet pressing) using the post coating tablet pressing technology shall also detect the dissolution curve of the segmented part, and compare the similar factor (F2) with the pellet before pressing and the whole tablet after pressing, which shall meet the requirements In general, the dissolution curve shall be determined in the medium specified in the quality standard, and the amount of test sample shall not be less than 12 divided units 2.4 stability study it is recommended to investigate the stability of the segmented part at 25 ℃± 2 ℃ / 60% RH ± 5% RH for 90 days According to the storage conditions, packaging forms and clinical use of the products, and with reference to the technical guidelines for stability research of chemical drugs (APIs and preparations), reasonable stability inspection conditions and time limit can also be formulated, and if necessary, they can be specified in the instructions 2.5 for the tablets with functional scores in the change study, if the prescription process is changed, because the change of the prescription process may affect the separability of the scores, the above requirements shall be referred to at the same time when the change study is carried out, and the segmentation ability of the chips before and after the change shall be compared as an important data for evaluating the product quality difference before and after the change For the change of adding or deleting the scores, firstly, the rationality and necessity of adding or deleting the scores shall be confirmed in combination with the scoring characteristics of the reference preparation As the addition and deletion of nicks may involve the change of prescription and process, the degree of change shall be evaluated and the corresponding research shall be conducted according to the technical requirements such as technical guidelines for research on production process change of listed chemicals For the case of increasing nicks, it is necessary to investigate the segmentation ability of the nicks If the formulation and process changes are classified as "significant changes" after evaluation, bioequivalence tests need to be considered Main references [1] FDA tablet scoring: nomenclature, labeling, and data for evaluation [2] FDA MAPP 5223.2 scoring configuration of generic drug products [3] FDA anda submissions: reference to receive standards [4] ep subdivision of tables [5] who pharmaceutical development of multisource (generic) pharmaceutical products - point to consider.
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