The Orange Book lists the following as Patents: The active substances or compounds are claimed in patents. Patents on drug products, including formulation-composition patents. Utilize patents for a certain authorized use or indication of the product. The Bolar amendment to the Drug Price Competition and Patent Term Restoration Act permits a pharmaceutical manufacturer (sponsor) to … Read more
A pharmacopoeia constitutes a legally enforceable compilation of standards and quality criteria for medications utilized within a specific country or region. The term “Pharmacopoeia” was first used as a specific title in a publication from Basel, Switzerland, in 1561 by Dr. A. Foes, although it did not gain widespread usage until the early 17th century. … Read more
A specification is characterized as a compilation of tests, references to analytical methods, and relevant acceptance criteria, which consist of numerical limits, ranges, or other standards for the tests outlined. It delineates the criteria that a drug substance or drug product must meet to be deemed acceptable for its intended application. The term “conformance to … Read more
Tablet compression machines are designed with consideration for the types of dies and punches that will be utilized on them. The arrangement of dies and punches on a compression machine is referred to as tooling, which is primarily classified into B and D categories. The B tooling dies and punches can further be specified as … Read more
PAN COATING OVERVIEW Functions of the parts Inlet & Outlet System of a Pan Coater Inlet of the Pan Outlet of the Pan FLUID BED COATING (WURSTER COATING) FBC is a technique for coating pellets, spheres, particles or granules using a spray of solution inside a column. The spray nozzle is installed in the base … Read more
Most coating processes typically utilize one of the general coating systems, such as the standard coating pan, perforated coating pan, and fluidized bed coater. A notable advancement in the efficacy of standard coating pan systems has been marked by the introduction of the Pelligrini pan, immersion sword, and immersion tube systems, where coating solutions are … Read more
Following are the critical parameters in Coating operation Gun Geometry and Calibration Gun geometry and Calibration refers to the position of spray guns which includes ‘Gun Calibration’, ‘Gun to bed distance’, ‘Gun to gun distance’, ‘Gun to side of pan’, ‘choked guns’ and ‘anti bearing technology’. Gun to bed distance: Gun to Bed Height: Gun … Read more
Cryopelletization is a technique in which droplets of a liquid formulation are transformed into solid spherical particles or pellets through the use of liquid nitrogen as the fixing medium. This technology, originally developed for the lyophilization of viscous bacterial suspensions, is capable of producing drug-loaded pellets in liquid nitrogen at -1600C. The process allows for … Read more
Melt Spheronization is a technique in which a drug substance along with excipients is transformed into a molten or semi-molten state, and then shaped using suitable equipment to create solid spheres or pellets. Initially, the drug substance is mixed with the relevant pharmaceutical excipients, including polymers and waxes, and then extruded at a specific pharmaceutical … Read more
Spray drying and Spray Congealing, also referred to as the globulation process, entail the atomization of hot melts, solutions, or suspensions to produce spherical particles or pellets. In both processes, the droplet size is maintained at a small scale to enhance the evaporation or congealing rate, resulting in the production of pellets that are typically … Read more
