Modern Pharmaceutics (M Pharm, Pharmaceutics)
Teacher
Dr Amulyaratna Behera
Category
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Course Name : Modern Pharmaceutics
CODE(Credit) : CUTM1583(4-0-0)
Course Objectives
To impart advanced knowledge and skills required to learn various aspects and concepts at pharmaceutical industries
Learning Outcomes
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Upon completion of the course, student shall be able to understand
- The elements of preformulation studies.
- The Active Pharmaceutical Ingredients and Generic drug Product development.
- Industrial Management and GMP Considerations.
- Optimization Techniques & Pilot Plant Scale Up Techniques.
- Stability Testing, sterilization process & packaging of dosage forms.
Course Syllabus
Module I.
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.
Module II.
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.
Module III.
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.
Module IV.
Compression and compaction: Physics of tablet compression, compression, consolidation, effect of friction, distribution of forces, compaction profiles. Solubility.
Module V.
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.
Session Plan
Session 1
Drug excipient interaction,methods, kinetics of stability, Stability testing. Theories of dispersion and pharmaceutical Dispersion (Emulsion and Suspension, SMEDDS)
https://www.youtube.com/watch?v=mRJvss9bMVc
Session 2
Preparation and stability Large and small volume parental –physiological and formulation consideration, Manufacturing and evaluation.
Session 3
Concept and parameters of optimization, Optimization techniques in pharmaceutical formulation and processing.
Session 4
Statistical design, Response surface method, Contour designs, Factorial designs and application in formulation
Session 5
Introduction to Pharmaceutical Validation, Scope & merits of Validation.
Session 7
ICH & WHO guidelines for calibration and validation of equipments
Session 10
Manufacturing Process Model, URS, DQ, IQ, OQ & P.Q. of facilities.
Session 12
Objectives and policies of current good manufacturing practices
Session 13
Layout of buildings, services, equipment and their maintenance
Session 16
Inventory management and control, production and planning control
Session 17
Sales forecasting, budget and cost control, industrial and personal relationship
Session 35
Case Studies
Case Studies
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