Pharmaceutical Technology II

Particle shapes and sizes. Powder micromeritics. Factors affecting the flow properties of powders. Cohesive pharmaceutical powders; experimental methods used for measuring the “cohesiveness” of powder beds; factors affecting the tensile strength of powders.  Determination of particle size distribution (sieve shaker, zeta sizer etc. methods). Instrumentation of tableting and capsule filling machines. Physics of powder and granule compaction/compression. Drying of Solids: Principles and Importance of drying in Pharmacy. Rate of drying. Distribution of moisture in solids beds. Equilibrium moisture content and importance. Types and operational principles of some industrial drying equipment (tray dryer, fluid bed, freeze drying and sublimation etc.). Factors affecting the selection of drying methods and equipment. Granulation and granulation methods. Pharmaceutical dosage forms. Presentation and formulation of single dosage forms, Factors affecting the design of dosage forms, Tablet processing methods – direct compression, wet granulation, dry granulation etc. Formulation of tablets; Selection and roles of various classes of excipients. . Tablet coating; Reasons and Types of coating materials and methods – pan, sugar, film and enteric coatings; requirements for core tablets and coating of granules; fluidized – bed and compression coating. Hard and soft gelatin capsules. Capsule production; capsule filling; equipment and operations. Parenteral product formulation and production, Plant design and aseptic measures. Pyrogen testing. Quality control standards for tablets and capsules (official and non-official evaluation). In-vitro dissolution tests for solid dosage forms. Natural convention: Non-sink methods such as solvometer, hanging pellet, and static disc methods. Forced convention: Non-sink methods such as wruble, beaker, oscillating tube rotating disc, sounder & ellenbogen methods. Forced convention: Sink methods (adsorption, partition, dialysis and column methods, continuous flow through system, computerised automated systems). Tablet and capsule visual defects Liquid and parenteral product fill volumes, leakage tests and extractable volumes determination. Stability of medicinal products. Different aspects of stability – chemical, physical and microbiological. Review of chemical kinetics relevant to drug degradation, rate expression, order of reactions. Methods of stabilization. Solid state degradation. Stability tests (real time and accelerated) – Long-term stability tests, Field tests and Accelerated stability tests. Expiry dating of medicines, including special hospital formulations. Stability of medicines in pharmaceutical practice. Storage of medicines and effects on stability: Storage of medicinal products at temperatures other than those recommended. Shelf life in the pharmacy, home, ward or clinic. Use of the concept of Q₁₀ values in shelf life estimation.