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    Home > Medical News > Latest Medical News > 655 varieties passed the consistency evaluation, and tablets and capsules are still the focus

    655 varieties passed the consistency evaluation, and tablets and capsules are still the focus

    • Last Update: 2022-05-04
    • Source: Internet
    • Author: User
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    【Report of the Pharmaceutical Network Exhibition】 The consistency evaluation of generic drugs was launched in 2016.
    As of July 25, a total of 4,341 specifications (1,848 varieties) of generic drug reference preparations have been released, and a total of 655 varieties have passed or are deemed to have passed the consistency evaluation
    .

    Among the approved varieties, tablets accounted for more than 50%, capsules accounted for more than 12%, and a total of more than 62%
    .

    Tablets and capsules, as two dosage forms in the oral route of administration, are commonly used, convenient, economical and widely applicable ways of administration in clinical practice, and will remain the two dosage forms that pharmaceutical companies focus on in the future
    .


    Common problems in pharmacy for consistency evaluation of tablets and capsules include research on impurities of raw materials, particle size research, crystal form research, excipient research, packaging material research, formulation technology research, quality research and stability research,
    etc.

    Among the above related influencing factors, pharmaceutical excipients have an important impact on the quality of preparations
    .

    In the process of formulation process development and large-scale production, differences in the type, type, particle size, crystal form, crystal habit, etc.
    of excipients may affect the consistency of formulation quality
    .

    There are many types of pharmaceutical excipients involved in tablets and capsules.
    The process and quality control of similar products produced by different companies are different, which makes the composition and functional indicators of pharmaceutical excipients different, which affects the consistency of preparation quality
    .

    In addition, most pharmaceutical excipients are high molecular polymer materials, and their average molecular weight and molecular weight distribution will affect their physical properties and processing performance
    .

    Usually, the same excipients with different specifications have different molecular weights and molecular weight distributions, which will lead to different physical properties, processing properties, and applications in formulations
    .

       As of July 3, a total of 485 varieties of pharmaceutical excipients have been registered and filed.
    Most of the imported excipients are new, complex and high-end excipients.
    The pharmaceutical excipients in China are mainly domestic traditional and bulk excipients
    .

    With the improvement of the quality and cost control of domestic excipients, more and more enterprises choose from imported pharmaceutical excipients and domestic high-quality pharmaceutical excipients
    .

       In terms of product types, capsules, microcrystalline cellulose and derivatives, lactose, corn starch and derivatives, povidone and derivatives, polyethylene glycol, and coating powder accounted for a large proportion, exceeding 50%
    .

    The above varieties are also common excipients for tablets and capsules
    .

       Based on the composition of the main pharmaceutical excipients of tablets and capsules, API pharmacists invite international and domestic pharmaceutical excipient companies to participate in the sharing
    .

    Assist pharmaceutical companies and R&D companies to understand the main products of international and domestic pharmaceutical excipient companies efficiently and at low cost, as well as different applications of the same products! 38 special sessions on pharmaceutical excipients, starting from solving the practical problems of CROs and preparation companies, involving preparation prescriptions for oral, injection, ophthalmology, and skin administration.
    .
    .
    1.
    Participating companies in the capsule dosage form course (part) 2.
    Participating companies and associations in the tablet course (part) (Note: The above companies have plans to participate in the 87th API China Wuhan Exhibition, and we look forward to your visit to the exhibition site for close communication) From March 2020 to now, a total of more than 6,000 people have watched oral drug delivery Courses related to excipients, the course completion rate reached 84.
    87%.
    .
    .
    1.
    List of audience companies (part) AstraZeneca Baiyunshan Chemical Pharmaceutical Factory Bayer Healthcare Co.
    , Ltd.
    Boehringer Ingelheim Chengdu Kanghong Pharmaceutical Group Co.
    , Ltd.
    Dio Group Chengdu Pharmaceutical Co.
    , Ltd.
    Northeast Pharmaceutical Group Co.
    , Ltd.
    Fresenius Kabi Huarui Pharmaceutical Co.
    , Ltd.
    GlaxoSmithKline (China) Investment Co.
    , Ltd.
    Harbin Pharmaceutical Group Hansoh Pharmaceutical North China Pharmaceutical Group Jiangsu HansunJiangsu Hengrui Livzon Group Roche Pharmaceutical Luoxin Pharmaceutical Sichuan Kelun Pharmaceutical Research Institute Tianjin Pharmaceutical Group Yangzijiang Pharmaceutical Group Kailaiying Kanglong Chemical Beijing Luonuoqiangshi Pharmaceutical Technology Research and Development Center Co.
    , Ltd.
    Beijing Sunshine Nuohe Pharmaceutical Research Co.
    , Ltd.
    Military Medical Research Shanghai Hequan Drug R&D Co.
    , Ltd.
    Shanghai Ruizhi Chemical R&D Co.
    , Ltd.
    Shanghai Pharmaceutical Industry Research Institute Sphinx Drug R&D (Tianjin) Co.
    , Ltd.
    , Institute of Materia Medica, Chinese Academy of Medical Sciences, Dalian University of Technology, Fourth Military Medical University, Donghua University, School of Pharmacy, Fudan University Jiangsu University, Xiamen University, Shandong University, Shenyang Pharmaceutical University, Tianyi University, Wuhan University, China Pharmaceutical University, Chinese Academy of Sciences, Shanghai Institute of Materia Medica Great course, stay tuned! Note: Some courses are charged for review, add API Pharmacist online learning platform assistant to get a three-month membership card for free, and you can watch the wonderful courses if you want!
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