Modern Pharmaceutics

THEORY 1.

a. Preformation Concepts – Drug Excipient interactions - different methods, kinetics of stability, Stability testing. Theories of dispersion and pharmaceutical Dispersion (Emulsion and Suspension, SMEDDS) preparation and stability Large and small volume parental – physiological and formulation consideration, Manufacturing and evaluation.

b. Optimization techniques in Pharmaceutical Formulation:

Concept and parameters of optimization, Optimization techniques in pharmaceutical formulation and processing. Statistical design, Response surface method, Contour designs, Factorial designs and application in formulation Validation : Introduction to Pharmaceutical Validation, Scope & merits of Validation, Validation and calibration of Master plan, ICH & WHO guidelines for calibration and validation of equipments, Validation of specific dosage form, Types of validation. Government regulation, Manufacturing Process Model, URS, DQ, IQ, OQ & P.Q. of facilities.

cGMP & Industrial Management:

Objectives and policies of current good manufacturing practices, layout of buildings, services, equipments and their maintenance Production management: Production organization, , materials management, handling and transportation, inventory management and control, production and planning control, Sales forecasting, budget and cost control, industrial and personal relationship. Concept of Total Quality Management.

Hrs Hrs Hrs Hrs Compression and compaction: Physics of tablet compression, compression, consolidation, effect of friction, distribution of forces, compaction profiles. Solubility.

Study of consolidation parameters; Diffusion parameters, Dissolution parameters and Pharmacokinetic parameters, Heckel plots, Similarity factors – f2 and f1, Higuchi and Peppas plot, Linearity Concept of significance, Standard deviation , Chi square test, students T-test , ANOVA test.

Hrs Hrs