| B Pharmacy 7th Semester Syllabus Pdf |
Instrumental Methods of Analysis Syllabus
Theory (PT- 711)
Unit 1
• UV Visible Spectroscopy
Auxochromes, Chromophores, Beer and Lambert’s law, Electronic transitions, Spectral Shifts, Derivations and Deviations, and Solvent effect on absorption spectra.
Instrumentation- Sample cells, Sources of the radiation, Wavelength selectors, Detectors- Silicon Photodiode, Photovoltaic cell, Phototube, and Photomultiplier tube.
Applications- Single-component, Spectrophotometric titration, and multi-component analysis.
• Fluorimetry
Definitions and Theory, Doublet and triplet electronic states, Concepts of singlet, Factors affecting fluorescence, Internal and External conversation, Quenching, and Instrumentation and application.
Unit 2
• IR Spectroscopy
Introduction and Theory, Factors affecting vibration, Fundamental modes of vibrations in polyatomic molecules, and handling of the sample.
Instrumentation Technique– Selectors of wavelength, Sources of radiation, Detectors- Golay cell, Thermistor, Thermocouple, Pyroelectric detector, Bolometer, and their applications.
• Flame Photometry– Principles and Theory, Interference, Instrumentation and application.
• Atomic Absorption Spectroscopy– Principles and Theory, Interference, Instrumentation and application.
• Nepheloturbidometry – Theory and Principles, Instrumentation, and Application.
Unit 3
Introduction to Chromatography
• Adsorption and partition column chromatography– Advantages, Disadvantages, Applications, and Methodology.
• Thin Layer Chromatography– Principles, Introduction, Advantages, Disadvantages, Applications, Methodology, and Rf Values.
• Paper Chromatography– Introduction, Advantages, Disadvantages, Applications, Development Techniques, and Methodology.
• Electrophoresis– Introduction, Techniques of paper, gel, capillary electrophoresis, applications, and Factors affecting electrophoretic mobility.
Unit 4
• Gas Chromatography– Theory, Instrumentation, Introduction, Advantages, Disadvantages, Applications, Temperature programming, and Instrumentation.
• HPLC (High-Performance Liquid Chromatography)– Theory, Introduction, Instrumentation, Advantages, Disadvantages, and their Application.
Unit 5
• Ion Exchange Chromatography– Introduction, Classification, Methodology, Applications, mechanism of ion exchange, properties, Ion exchange resins, and factors affecting ion exchange.
• Gel Chromatography– Theory, Introduction, Instrumentation and Application.
• Affinity Chromatography– Theory, Introduction, Instrumentation, and their Application.
Practical (PT- 791)
I. Assay of Paracetamol by the UV-spectrophotometry methods.
II. Determination of the Absorption Maxima and the effect of the solvent on the absorption of Maxima of the organic compounds.
III. Estimation of the dextrose by the colorimetric.
IV. Simultaneous estimation of Ibuprofen and paracetamol by UV Spectroscopy.
V. Estimation of the sulfanilamide by colorimetry.
VI. Estimation of the Quinine Sulphate by fluorimetry.
VII. Study of the quenching of fluorescence.
VIII. Determination of potassium by flame photometry.
IX. Determination of chlorides and sulfates by the nephelo turbidimetry.
X. Separation of the amino acids by paper chromatography.
XI. Separation of the sugars by thin layer chromatography.
XII. Determination of sodium by flame photometry.
XIII. Separation of the plant’s pigments by column chromatography.
XIV. Demonstration of the experiment on Gas chromatography.
XV. Demonstration of the experiment on HPLC.
Industrial Pharmacy-II Syllabus
Theory (PT- 716A)
Unit 1
• Pilot Plant Scale Techniques
General considerations include the significance of the personnel requirements, Raw materials, Space requirements, Pilot plant scale-up consideration for liquids orals, solids, semi-solids, related documentation, SUPAC guidelines, and Introduction to platform technology.
Unit 2
• Technology Development and Transfer
WHO guidelines for Technology Transfer (TT)- Technology transfer protocol, Terminology, Quality risk management, Transfer from R and D production (Cleaning, Process, and Packaging), Granularity of Technology Transfer process (API, finished products, excipients, and packaging materials), Documentation, Premises and equipment, Quality control.
Qualifications and validation, Analytical method transfer, Commercialisation of practical aspects and problems (case study), Approved regulatory bodies and agencies, Technology Transfer agencies in India- APCTD, TIFAC, NRDC, BCIL, TBSE, SIDBI, Technology Transfer related documentation- confidential agreement, MoUs, licensing, and legal issues.
Unit 3
• Regulatory Affairs
Introduction, Regulatory authorities, Historical overview of Regulatory affairs, Role of the Regulatory Affairs department, Responsibilities of Regulatory affairs professional.
• Regulatory requirements for the drug’s approval
Drug Development Teams, Pharmacology, Non-clinical Drug Development, Drug Metabolism and Toxicology, General Consideration of IND (Investigational New Drug) Applications, Investigators Brochure (IB).
New Drugs Application (NDA), Clinical Research or BE studies, Clinical Research Protocol, Data Presentation for FDA submission, Biostatistics in Pharmaceutical Product Development, and Management of Clinical Studies.
Unit 4
• Quality Management Systems
Quality management and certifications, Concepts of Quality, Total Quality Management (TQM), Quality by Design, Six Sigma concepts, Out of specifications, Change control, Introduction to ISO 9000 series of quality system standards, NABL, GLP, and ISO 14000.
Unit 5
• Indian Regulatory Requirements
Central Drug Standard Control Organisation, and State Licencing Authority- Organisation, Responsibility, Certifications Pharmaceutical Products, Regulatory requirements, and Approval procedure for the New Drugs.
Novel Drug Delivery System Syllabus
Theory (PT- 716B)
Unit 1
• Controlled drug delivery systems
Introduction, terminology, advantages, disadvantages of the controlled drugs delivery systems, Approaches to design controlled release formulations based on the diffusion, selection of the drugs candidates, and ion exchange principles, physiological and biological properties of the drugs relevant to the controlled release of the formulation.
• Polymers used in the formulation of Drug Delivery Systems
Definitions, Classification, Properties of the polymers, Advantages, and Disadvantages, and polymers applications in the formulation of the DDS (drug delivery systems).
Unit 2
• Microencapsulation– Definitions, advantages, disadvantages, microspheres or microcapsules, methods of microencapsulation, microparticles, and applications.
• Mucosal Drug Delivery System
Introduction, Definitions, Principles of bioadhesion or mucoadhesion, Concepts, Advantages, Disadvantages, Transmucosal permeability, Formulations consideration of the buccal delivery systems.
• Implantable Drug Delivery System
Introductions, Advantages, Disadvantages, Concepts of the implants and the osmotic pump.
Unit 3
• Transdermal Drug Delivery System
Introduction, Permeation through the skins, Factors affecting the permeation, Formulations approach, Permeation enhancers, and Basic component of the TDDS.
• Gastroretentive Drug Delivery System
Introduction, Advantages, Disadvantages, Approaches for GRDDS, Floating, high-density systems, Inflatable and gastro adhesive system, and its applications.
• Nasopulmonary of the drug delivery systems (DDS)
Introduction to the Nasopulmonary drug delivery systems, Formulations of the Inhalers (Dry powdered and meter doses), and Nasal sprays in drug delivery systems.
Unit 4
• Targeted drug delivery
Concepts and approaches of the targeted drugs delivery systems, Advantages, and Disadvantages, Introduction to the liposomes, niosomes, Monoclonal antibodies, nanoparticles, and targeted drugs delivery systems applications.
Unit 5
• Ocular Drug Delivery Systems
Introduction, Intraocular barriers and methods to overcome- a preliminary study, Ocular formulations, and Ocuserts.
• Intrauterine Drug Delivery Systems
Introduction, Advantages, Disadvantages, Development of intrauterine devices, and their applications.
Pharmacy Practice Syllabus
Theory (PT- 718)
Unit 1
• Hospital and its Organization
Definitions and classification of the hospital- Primary, Secondary, and Tertiary hospital, Classification based on the clinical and non-clinical basis, Organisation structure of a hospital, the medical staff involved in the hospital, and their functions.
• Hospital Pharmacy and its Organization
Definitions and functions of hospital pharmacy, Structure of organizations, Location, Layout and staff requirements, Responsibilities, and functions of hospital Pharmacists.
• Adverse Drug Reactions
Classifications- Excessive Pharmacology effects, Secondary Pharmacological effects, Allergic drug interactions, Idiosyncrasies, Genetically determined toxicity, Toxicity following the sudden withdrawal of drugs.
Drug interaction includes beneficial interactions, adverse reactions, pharmacokinetics drug interactions, and Methods of detecting drug interactions, Spontaneous case reports and record linkage studies, Adverse drug reactions reporting with management.
• Community Pharmacy
Structure and Organisations of retail and wholesale drugs store, Types and design, Legal requirements for establishment and maintenance of the drug store, Dispensing of the proprietary products, Maintenance records of retail and wholesale drug store.
Unit 2
• Drug distribution system in a hospital
Dispensing of drugs to inpatients, Types of drug distribution systems, Charging policy and labeling, Dispensing of drugs to ambulatory patients, and Dispensing of controlled drugs.
• Hospital formulary
Definitions, Introduction, Contents of the hospital formulary, Difference of hospital formulary and Drugs lists, Preparation and revisions, Addition and Deletion of the drugs from hospital formulary.
• Therapeutic drug monitoring
Need for the therapeutic drugs monitoring, Factors to be considered during the therapeutic drug monitoring system, Indian scenario for the therapeutic drugs monitoring.
• Medication adherence
Causes of medication non-adherence, Pharmacists’ role in medication adherence, and Monitoring of the patient’s medication adherence.
• Patient medication history interview
Needs for the patient’s medications history interview, and medications interview forms.
• Community Pharmacy management
Community pharmacy includes Materials, financial, staff, and infrastructure requirements.
Unit 3
• Pharmacy and therapeutic committee
These functions, organization, and policies of the pharmacy and therapeutics committee include drugs into the formulary, Inpatient and Outpatient prescription, Automatic stop orders, and emergency drugs list preparation.
• Information services
Drugs and Poison information centers, Sources of the drugs information, Computerized services, Storage, and Retrieval of information.
• Counseling
Definitions of patient counseling, Steps include patient counseling and special cases that require pharmacists.
• Education and training program in the hospital Pharmacy
Hospital Pharmacist’s role in education with training programs, Internal training programs, and External training programs, Services to nursing homes, hospitals, or clinics, Code of ethics in the community hospital pharmacy, Pharmacists’ role in interdepartmental communications, and community health education.
• Prescribed medication order and communication skills
Prescribed medication orders may be interpreted and legal requirements, Communication skills; Communication with the prescribers and patients.
Unit 4
• Preparation and implementation
Budget preparation and implementation
• Clinical Pharmacy
Introduction to the Clinical pharmacy, with concepts of the clinical pharmacy, Responsibilities, and functions of the Clinical Pharmacists, Drug therapy monitoring- Medications chart review, Pharmacist intervention, Clinical review, Ward round participation, Medications history, and Pharmaceutical Care.
Drugs Dosing patterns and drug therapy based on Pharmacokinetics and disease patterns.
• Over the Counter (OTC) Sales
Introduction and sale of OTC (Over the Counter), Rational use of the common over-the-counter medications.
Unit 5
• Drug Store Management and Inventory Control
The organization of the drugs store, Types of the materials stocked and storage conditions, Purchase and inventory control- principles, purchase procedures, order, procurement, and stocking, Economic order quantity, Reorder quantity level, Methods used for the analysis of the expenditure of the drugs.
• Investigational use of drugs
Principles, description, classification, control, identification, advisory committee, and role of the hospital pharmacists.
• Interpretation of clinical laboratory tests
Blood chemistry, urinalysis, and hematology.