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PowerPoint Presentation: Presentation on – Quality control test of solid dosage form Submitted by – Moriyom Akhter Department of Pharmacy World University of Bangladesh QUALITY CONTROL TESTS FOR SOLID DOSAGE FORM: QUALITY CONTROL TESTS FOR SOLID DOSAGE FORM Solid dosage form: Solid dosage form Oral Solid dosage forms (Tablets and Capsules) are some of the most popular and convenient methods of drug delivery. They can be produced in a non-sterile environment and the process. With the high volume of products produced in this dosage forms, it is important that the unit operations for their production be thoroughly understood. This course focuses on the fundamentals of each processing step (unit operation) required for the manufacture and packaging of tablets and capsules. It will continue with a detailed review all of the major unit operations associated with OSD manufacturing process. This includes: Ingredient Dispensing/Formulation; Blending; Granulation; Drying; Compression/Encapsulation; Coating; Packaging and Miscellaneous Operations. Types of solid dosage form : Tablets, Capsules , Powders, Effervescent, Oral Insufflations Dentifrice Dusting, Lozenges PowerPoint Presentation: The development of a solid dosage form will be dependent upon the specific product and process. However, the formula ranges, physical and chemical specifications of the drug substance and excipients, in-process variables, interaction effects of the dosage form ingredients under normal and stress aging conditions, should be confirmed by limited challenge in pilot-scale and production-size batches. Following specifications must be determined prior to the development of the SDF QC of Raw Materials QC for Manufacturing Procedures and Equipment Granulation/Mix Analysis In-Process Controls QC of FDF QC of packaging & Labelling QC of raw materials for SDF: QC of raw materials for SDF Characterization of the chemical and physical properties of the drug substance that is API & excipients is one of the most important steps in the development of a solid dosage form. Chemical properties especially the identification of impurities are very important & they must be identified in visual inspection with color and odor. Physical characteristics of raw materials must be observed, the quantities and source of materials used and the testing performed. The physical properties of the API and excipients such as solubility, polymorphism, hygroscopicity , particle size, density, etc. must be addressed. They should be able to provide data to demonstrate that dissolution profiles and content uniformity will be satisfactory over a wide range of particle sizes. For example, a manufacturer may establish a specification of 90% of the particles must be less than 300 microns. For validation of this process, one would expect the use of micronized as well as material with particles close to 300 microns in size. In addition to release or dissolution, variation in particle size, particle shape, and/or bulk density can also have an effect on the uniformity of dosage forms, particularly those manufactured by direct compression or direct encapsulation. PowerPoint Presentation: QC test for the raw materials of the capsule The gelatin of the capsule shells should be assayed for various physical properties like bloom strength, viscosity and its loss (by atomic force microscopy). Chemical tests like purity, microbial properties, and limits for heavy metals like arsenic, ash content should be determined. The colorants should also be checked for purity, limits for heavy metals, color properties, dye content, subsidiary dye content and color value. Organoleptic properties: which include color and odor of the API & excipients. Quality Checks during Manufacturing: Quality Checks during Manufacturing For manufacturing of the solid dosage form detailed manufacturing directions, specifying equipment and operating parameters must be specified. The failure to specify the
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