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所在平台: Udemy |
课程主页: https://www.udemy.com/course/gmp-tablet-manufacturing-technology-in-pharma-industry/
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课程名称:GMP:制药片剂制造技术行业认证 课程概述: 本课程专注于制药行业中药物制造的过程,重点介绍片剂的设计与生产。药物制造包括多个单元操作,如粉碎、造粒、涂层、制片等。通过本课程,您可以在自己的时间内完成学习,享有终身访问权限。若您在私人学院支付超过5000印度卢比或15美元的费用,那么您可能会在经济上有所损失。课程将帮助您比较各类课程的描述与所支付的金额。 药物制备需要确保药物成分以适当的方式、适当的时间和速率,且化学完整性受到保护。由于大多数药物成分不具备理想的流动性,因此在制备过程中通常需要与合适的辅料进行预处理,形成流动性良好的颗粒,以便于压片。制剂科学家通过不同的工艺确保片剂的质量,包括湿法造粒、干法造粒和直接压片,这些工艺中涉及多个步骤(单位过程),如称重、粉碎、混合、造粒、干燥、压实、涂层和包装。 课程的主要目标包括: - 制备强韧的片剂,以抵抗在制造、包装、运输和使用过程中遭遇的机械冲击; - 确保片剂在重量和药物含量上具有均匀性; - 保证片剂的生物利用度符合应用要求; - 确保片剂在长时间内保持化学和物理稳定性; - 制造外观优雅、无缺陷的片剂产品。 影响片剂制造过程选择的因素包括: - 活性药物成分(API)的压缩性质; - API在制造过程中的物理和化学稳定性; - 配方成分的粒径; - 必需的处理设备的可用性; - 制造/配方过程的成本; - 制药片剂生产所需的人力。 此外,所有制造人员必须接受当前良好生产规范(CGMPs)和相关标准操作程序(SOPs)的培训。本课程将涵盖制药片剂制造中的多个重要方面,适合药学文凭、药学学士、硕士及研究生、应届毕业生和寻求制药行业职业机会的员工。 欢迎您参加课程!
Drug manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry. The process of drug manufacturing can be broken down into a series of unit operations, such as milling, granulation, coating, tablet pressing, and others. *Complete the course as per your free time as life time access is available.If you are paying more than 5k INR or $15 for private institute/academy then you are in loss.Please compare the course description and amount you are paying for such course.The design and manufacture of pharmaceutical tablets is a complex multi-stage process whereby formulation scientists ensure that the correct amount of drug substance in the right form is delivered at the appropriate time, at the proper rate and in the desired location with its chemical integrity protected to that point. Most drug substances do not possess the required properties which give satisfactory flow from the hopper to the die cavity of tablet presses. As a result, they are subjected to pre-treatment either alone or in combination with suitable excipients to form free-flowing granules that lend themselves to tabletting.A tablet is a pharmaceutical oral dosage form (Oral Solid unit Dosage, or OSD) or solid unit dosage form. Tablets may be defined as the solid unit dosage form of medicament or medicaments with suitable excipients. Tablets are prepared either by molding or by compression. Tablets are commonly manufactured by wet granulation, dry granulation or direct compression. These methods may be considered to consist of a series of steps (unit processes) - weighing, milling, mixing, granulation, drying, compaction, (frequently) coating and packaging.Unit Operations in tablet manufacturing Numerous unit processes are involved in making tablets, including Particle size reduction and sizing, Blending,Granulation, Drying,Compaction, and (frequently) Coating. Various factors associated with these processes can seriously affect content uniformity, bioavailability, or stability.Primary goals of tablet manufacturing processThe primary goals include:To formulate tablets that are strong and hard to withstand mechanical shock encountered during manufacturing, packing, shipping, dispensing and use.To formulate tablets that are uniform in weight and in drug content.To formulate tablets that are bioavailable according to indication requirements.To formulate tablets that are chemically and physically stable over a long period of time.To formulate tablets that have elegant product identity which is free from any tablet defects.Factors that influence the choice of manufacturing process used during tablet formulationIn general, the choice of formulation process employed during tablet manufacture is dependent upon such factors as:Compression properties of the Active Pharmaceutical Ingredient (API)/ drug substance.Physical and chemical stability of the API during the manufacturing process.Particle size of the formulation ingredients.Availability of the necessary processing equipment.Cost of the manufacturing/formulation process.Personnel requirements during manufacture of pharmaceutical tabletsProduction pharmacists/ supervisorsManufacturing chemistAnalytical chemistQuality assurance managerMachine operatorsMechanicsIn addition to the job-specific responsibilities of these personnel, all manufacturing employees must be versed and trained in Current Good Manufacturing Practices (CGMPs) and in the appropriate Standard Operating Procedures (SOPs) governing their area.Area required for manufacture of tabletsRaw material warehouseReceiving quarantineApproved raw material sectionDispensaryProduction roomMixing, Granulation and Drying SectionTablet Punching SectionCoating SectionQuality control sectionPackaging Section.QUALITY CONTROL EQUIPMENTSFriabilatorDisintegration apparatusHardness TesterVernier CaliperIn This Course Students will learn above pharmaceutical aspects/approach for tablet manufacturing in GMP Area.Students-Diploma in pharmacyB. PharmacyM. PharmacyM. Sc StudentsFreshers & Employees Students seeking oportunitirs for Pharma job careerLook for course discription, Look for See you in the class.