: Basic knowledge of the design and operation of pharmaceutical units and of the steps of development of dosage forms through to the final product and submission to the Health authorities for Production licence and marketing.
The concept and the importance of particle size and particle shape in drug formulation. Understanding of the mechanism of basic pharmaceutical operations including size reduction, mixing, separation processes, filtration, drying and freeze-drying, its importance in drug formulation and practical application on a laboratory scale. The teaching with lecture presentation is enhanced with practical classes using drugs and excipients of pharmaceutical specifications.
Course Content (Syllabus)
The design and operation of pharmaceutical industry. Development of pharmaceutical dosage forms. Production licence. Basic pharmaceutical operations. Size reduction – Mechanism, material properties, energy considerations, specific cases. Methods and milling equipment. Size distribution of the productand changes during milling. Mechanical separation of particles. Methods, assessment of efficiency. Separation from air with sieving, aerodynamic classification, sedimentation, elutriation. Filtration and factors that affect the filtration rate, mechanisms and filtration means. Mixing of powdered materials – Mechanism of random mixing and interactive mixing. Sampling techniques, size and mixing indices. Factors affecting the mixing process. Types, characteristics and operation of mixers. Drying- Definitions. Measurement of relative humidity. Theory of drying, movement of liquid during drying, mechanism of heat transfer, drying periods, equilibrium moisture and influence of material. Dryers. Freeze drying – Principles of freeze-drying and applications in Pharmacy.
The practical classes involve the processes of Particle size analysis by sieving and air permeability, size reduction, mixing and drying. Computers and appropriate software are used for data processing.