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
This method entails the application of successive layers of a solution and/or suspension containing drug substances and binders onto starter seeds, which can consist of inert materials or crystals of granules of the same drug. In this method, drug particles and other components are either dissolved or suspended in the application medium. The droplets strike … Read more
Equipment must be located, designed, constructed, adapted, and maintained to suit the operations to be carried out. The layout and design of equipment must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build-up of dust or dirt, and, in general, any adverse effect on the … Read more
GENERAL: SIFTING, MIXING ANG GRANULATION: COMPRESSION (TABLETS): COATING (TABLETS): FILLING OF HARD GELATIN CAPSULES: Empty Capsule shells shall be regarded as drug component and treated accordingly. They shall be stored under conditions which shall ensure their safety from the effects of excessive heat and moisture. PRINTING (TABLETS AND CAPSULES): PACKING OPERATION: Before packaging operations are … Read more
Granulation is required to improve the flow of powder mixtures and mechanical properties of Tablet. Granulation is the act or process in which primary powder particles are made to adhere to form larger, multiparticle entities called granules. It is the process of collecting particles together by creating bonds between them. Bonds are formed by compression … Read more
Unit Operations: The manufacture of Tablets is a complex multi-stage process under which the starting materials change their physical characteristics a number of times before the final dosage form is produced. Numerous unit operations are involved in making Tablets including sifting, mixing, granulation, drying, sizing, blending, lubrication, compression and coating. DISPENSING OF RAW MATERIALS (API … Read more
