Pharm D Year 3 Syllabus

This page gives the complete syllabus for Year 3 of the Pharm D course, exactly as prescribed by the Pharmacy Council of India (PCI) in the Pharm.D. Regulations 2008. Every subject of the year is listed below with its full syllabus: scope and objectives and the detailed syllabus and lecture wise schedule for theory subjects, and the full list of experiments for practical subjects.

Subjects in this year

Code	Subject	Type
3.1	Pharmacology-II	Theory and Practical
3.2	Pharmaceutical Analysis	Theory and Practical
3.3	Pharmacotherapeutics-II	Theory and Practical
3.4	Pharmaceutical Jurisprudence	Theory
3.5	Medicinal Chemistry	Theory and Practical
3.6	Pharmaceutical Formulations	Theory and Practical

3.1 Pharmacology-II (Theory)

Scope of the Subject: This subject will provide an opportunity for the student to learn about the drug with regard to classification, pharmacodynamic and pharmacokinetic aspects, adverse effects, uses, dose, route of administration, precautions, contraindications and interaction with other drugs. In this subject, drugs acting on autacoids, respiratory system, GIT, immune system and hormones, and pharmacology of autocoids and hormones will be concentrated. In addition, pharmacology of chemotherapeutic agents, vitamines, essential minerals and principles of toxicology are also taught. In addition to theoretical knowledge, the basic practical knowledge relevant to therapeutics will be imparted.

Objectives of the Subject: Upon completion of the subject student shall be able to:

a. understand the pharmacological aspects of drugs falling under the above mentioned chapters, b. carry out the animal experiments confidently, c. appreciate the importance of pharmacology subject as a basis of therapeutics, and d. correlate and apply the knowledge therapeutically.

Detailed Syllabus and Lecture Wise Schedule

Title of the topic

Pharmacology of Drugs acting on Blood and blood forming agents

a) Anticoagulants b) Thrombolytics and antiplatelet agents c) Haemopoietics and plasma expanders

Pharmacology of drugs acting on Renal System

a) Diuretics b) Antidiuretics

Chemotherapy

a) Introduction b) Sulfonamides and cotrimoxazole c) Penicillins and Cephalosporins d) Tetracyclins and Chloramphenicol e) Macrolides, Aminoglycosides, Polyene & Polypeptide antibiotics f) Quinolines and Fluroquinolines g) Antifungal antibiotics h) Antiviral agents i) Chemotherapy of tuberculosis and leprosy j) Chemotherapy of Malaria k) Chemotherapy of protozoal infections (amoebiasis, Giardiasis) l) Pharmacology of Anthelmintic drugs m) Chemotherapy of cancer (Neoplasms)

Immunopharmacology

Pharmacology of immunosuppressants and stimulants

Principles of Animal toxicology

Acute, sub acute and chronic toxicity

The dynamic cell: The structures and functions of the components of the cell

a) Cell and macromolecules: Cellular classification, subcellular organelles, macromolecules, large macromolecular assemblies b) Chromosome structure: Pro and eukaryotic chromosome structures, chromatin structure, genome complexity, the flow of genetic information. c) DNA replication: General, bacterial and eukaryotic DNA replication. d) The cell cycle: Restriction point, cell cycle regulators and modifiers. e) Cell signaling: Communication between cells and their environment, ionchannels, signal transduction pathways (MAP kinase, P38 kinase, JNK, Ras and PI3-kinase pathways, biosensors.

The Gene: Genome structure and function:

a) Gene structure: Organization and elucidation of genetic code. b) Gene expression: Expression systems (pro and eukaryotic), genetic elements that control gene expression (nucleosomes, histones, acetylation, HDACS, DNA binding protein families. c) Transcription and Transcription factors: Basic principles of transcription in pro and eukaryotes. Transcription factors that regulate transcription in pro and eukaryotes.

RNA processing: rRNA, tRNA and mRNA processing.

Protein synthesis: Mechanisms of protein synthesis, initiation in eukaryotes, translation control and posttranslation events

Altered gene functions: Mutations, deletions, amplifications, LOH, traslocations, trinucleotide repeats and other genetic abnormalities.

Oncogenes and tumor suppressor genes.

The gene sequencing, mapping and cloning of human disease genes.

Introduction to gene therapy and targeting.

Recombinant DNA technology: principles. Processes (gene transfer technology) and applications

3.1 Pharmacology-II (Practical)

List of Experiments:

Study of laboratory animals and their handling (a. Frogs, b. Mice, c. Rats, d. Guinea pigs, e. Rabbits).
Study of physiological salt solutions used in experimental pharmacology.
Study of laboratory appliances used in experimental pharmacology.
Study of use of anesthetics in laboratory animals.
To record the dose response curve of Ach using isolated ileum/rectus abdominis muscle preparation.
To carry out bioassay of Ach using isolated ileum/rectus abdominis muscle preparation by interpolation method.
To carry out bioassay of Ach using isolated ileum/rectus abdominis muscle preparation by three point method.
To record the dose response curve of Histamine using isolated guineapig ileum preparation.
Study of agonistic and antagonistic effects of drugs using isolated guineapig ileum preparation.
To carry out bioassay of Histamine using isolated guineapig ileum preparation by interpolation method.
To carry out bioassay of Histamine using guineapig ileum preparation by three point method.
To study the routes of administration of drugs in animals (Rats, Mice, Rabbits).
Study of theory, principle, procedure involved and interpretation of given results for the following experiments: a) Analgesic property of drug using analgesiometer. b) Antiinflammatory effect of drugs using ratpaw edema method. c) Anticonvulsant activity of drugs using maximal electroshock and pentylene tetrazole methods. d) Antidepressant activity of drugs using pole climbing apparatus and pentobarbitone induced sleeping time methods. e) Locomotor activity evaluation of drugs using actophotometer and rotorod. f) Cardiotonic activity of drugs using isolated frog heart and mammalian heart preparations.

Practicals: Title of the Experiment:

Study of agonistic and antagonistic effects of drugs using Guineapig ileum preparation.**
To study the effects of drugs on intestinal motility using frog's esophagus model*
To study the effects of drugs using rat uterus preparation.**
To study the anticonvulsant property of drugs (any one model).*
To study antihistaminic property of drug using histamine induced anaphylactic reaction in guinea pigs.
To study the apomorphineinduced compulsive behaviour (stereotypy) in mice.*
To study the muscle relaxant property of diazepam in mice using rotarod apparatus.*
To study the antiinflammatory property of indomethacin against carrageenaninduced paw oedema.**
To study the anxiolytic effect of diazepam in mice using mirroredchamber apparatus.**
To demonstrate the effect of various drugs on the blood pressure and respiration of anaesthetized dog.
To study the effect of anthelmintics on earthworms.
To study the taming effect of chlorpromazine.*
To study the effects of drugs on vas deferense of the male rat.**
To study the effect of drugs on pesticide toxicity using rats as model.
To study the effect of drugs on heavy metal toxicity.

** indicate major experiment & * indicate minor experiment

3.2 Pharmaceutical Analysis (Theory)

Quality Assurance:

a. Introduction, sources of quality variation, control of quality variation. b. Concept of statistical quality control. c. Validation methods - quality of equipment, validation of equipment and validation of analytical instruments and calibration. d. GLP, ISO 9000. e. Total quality management, quality review and documentation. f. ICH - international conference for harmonization - guidelines. g. Regulatory control.

Chromatography:

Introduction, history, classification, separation techniques, choice of methods. The following techniques be discussed with relevant examples of pharmaceutical products involving principles and techniques of separation of drugs from excipients.

a. Column Chromatography: Adsorption column chromatography, Operational technique, frontal analysis and elution analysis. Factors affecting column efficiency, applications and partition chromatography. b. TLC: Introduction, principle, techniques, Rf value and applications. c. PC: Introduction, principle, types of paper chromatography, preparation techniques, development techniques, applications. d. Ionexchange chromatography: Introduction, principles, types of ion exchange synthetic resins, physical properties, factors affecting ion exchange, methodology and applications. e. HPLC: Introduction, theory, instrumentation, and applications. f. HPTLC: Introduction, theory, instrumentation, and applications. g. Gas Chromatography: Introduction, theory, instrumentation - carrier gases, types of columns, stationary phases in GLC & GSC. Detectors - Flame ionization detectors, electron capture detector, thermal conductivity detector. Typical gas chromatogram, derivatisation techniques, programmed temperature gas chromatography, applications. h. Electrophoresis: Principles of separation, equipment for paper and gel electrophoresis, and application. i. Gel filtration and affinity chromatography: Introduction, technique, applications.

Electrometric Methods: Theoretical aspects, instrumentation, interpretation of data/spectra and analytical applications be discussed on the following topics.

a. Potentiometry: Electrical potential, electrochemical cell, reference electrodes, indicator electrodes, measurement of potential and pH, construction and working of electrodes, Potentiometric titrations, methods of detecting end point, Karl Fischer titration. b. Conductometry: Introduction, conductivity cell, conductometric titrations and applications. c. Polarography: Instrumentation, DME, residual current, diffusion current and limiting current, polarographic wave, Ilkovic's equation, Effect of oxygen on polarographic wave, Polarographic maxima and suppressors and applications. d. Amperometric Titrations: Introduction, types of electrodes used, reference and indicator electrode, instrumentation, titration procedure, advantages and disadvantages of Amperometry over potentiometry. Pharma applications.

Spectroscopy: Theoretical aspects, instrumentation, elements of interpretation of data/spectra and application of analytical techniques be discussed on:

a. Absorption Spectroscopy:

Theory of electronic, atomic and molecular spectra. Fundamental laws of photometry, Beer-Lambert's Law, application and its deviation, limitation of Beer law, application of the law to single and multiple component analysis, measurement of equilibrium constant and rate constant by spectroscopy. Spectra of isolated chromophores, auxochromes, bathochromic shift, hypsochromic shift, hyperchromic and hypochromic effect, effect of solvent on absorption spectra, molecular structure and infrared spectra.

Instrumentation - Photometer, U.V.-Visible spectrophotometer - sources of U.V.-Visible radiations, collimating systems, monochromators, samples cells and following detectors - Photocell, Barrier layer cell, Phototube, Diode array, applications of U.V.-Visible spectroscopy in pharmacy and spectrophotometric titrations.

Infrared Spectroscopy: Vibrational transitions, frequency - structure correlations, Infrared absorption bands, Instrumentation - IR spectrometer - sources of IR, Collimating systems, monochromators, sample cells, sample handling in IR spectroscopy and detectors - Thermocouple, Golay Cells, Thermistor, Bolometer, Pyroelectric detector, Applications of IR in pharmacy.
Fluorimetric Analysis: Theory, luminescence, factors affecting fluorescence, quenching. Instrumentation, Applications, fluorescent indicators, study of pharmaceutically important compounds estimated by fluorimetry.

b. Flame Photometry: Theory, nebulisation, flame and flame temperature, interferences, flame spectrometric techniques and instrumentation and pharmaceutical applications. c. Atomic Absorption Spectrometry: Introduction, Theory, types of electrodes, instrumentation and applications. d. Atomic Emission Spectroscopy: Spectroscopic sources, atomic emission spectrometers, photographic and photoelectric detection. e. NMR & ESR (introduction only): Introduction, theoretical aspects and applications. f. Mass Spectroscopy: (Introduction only) - Fragmentation, types of ions produced mass spectrum and applications. g. Polarimetry: (Introduction only) - Introduction to optical rotatory dispersion, circular dichroism, polarimeter. h. X-RAY Diffraction: (Introduction only) - Theory, reciprocal lattice concept, diffraction patterns and applications. i. Thermal Analysis: Introduction, instrumentation, applications, and DSC and DTA.

3.2 Pharmaceutical Analysis (Practical)

List of Experiments:

Separation and identification of Amino Acids by Paper Chromatography.
Separation and identification of Sulpha drugs by TLC technique.
Effect of pH and solvent on the UV spectrum of given compound.
Comparison of the UV spectrum of a compound with that of its derivatives.
Determination of dissociation constant of indicators using UV-Visible spectroscopy.
Conductometric titration of mixture of acids with a strong base.
Potentiometric titration of a acid with a strong base.
Estimation of drugs by Fluorimetric technique.
Study of quenching effect in fluorimetry.
Colourimetric estimation of Supha drugs using BMR reagent.
Simultaneous estimation of two drugs present in given formulation.
Assay of Salicylic Acid by colourimetry.
Determination of Chlorides and Sulphates in Calcium gluconate by Nepheloturbidimetric Method.
Determination of Na/K by Flame Photometry.
Determination of pKa using pH meter.
Determination of specific rotation.
Comparison of the IR spectrum of a compound with that of its derivatives.
Demonstration of HPLC.
Demonstration of HPTLC.
Demonstration of GC-MS.
Demonstration of DSC.
Interpretation of NMR spectra of any one compound.

3.3 Pharmacotherapeutics-II (Theory)

Scope of the Subject: This course is designed to impart knowledge and skills necessary for contribution to quality use of medicines. Chapters dealt cover briefly pathophysiology and mostly therapeutics of various diseases. This will enable the student to understand the pathophysiology of common diseases and their management.

Objectives of the Subject: Upon completion of the subject student shall be able to -

a. know the pathophysiology of selected disease states and the rationale for drug therapy b. know the therapeutic approach to management of these diseases; c. know the controversies in drug therapy; d. know the importance of preparation of individualised therapeutic plans based on diagnosis; and e. appreciate the needs to identify the patientspecific parameters relevant in initiating drug therapy, and monitoring therapy (including alternatives, timecourse of clinical and laboratory indices of therapeutic response and adverse effects).

Detailed Syllabus and Lecture Wise Schedule

Etiopathogenesis and pharmacotherapy of diseases associated with following systems / diseases - Title of the topic

Infectious disease: Guidelines for the rational use of antibiotics and surgical Prophylaxis, Tuberculosis, Meningitis, Respiratory tract infections, Gastroenteritis, Endocarditis, Septicemia, Urinary tract infections, Protozoal infection - Malaria, HIV & Opportunistic infections, Fungal infections, Viral infections, Gonarrhoea and Syphillis
Musculoskeletal disorders: Rheumatoid arthritis, Osteoarthritis, Gout, Spondylitis, Systemic lupus erythematosus.
Renal system: Acute Renal Failure, Chronic Renal Failure, Renal Dialysis, Drug induced renal disorders
Oncology: Basic principles of Cancer therapy, General introduction to cancer chemotherapeutic agents, Chemotherapy of breast cancer, leukemia. Management of chemotherapy nausea and emesis
Dermatology: Psoriasis, Scabies, Eczema, Impetigo

3.3 Pharmacotherapeutics-II (Practical)

Practicals : Hospital postings in various departments designed to complement the lectures by providing practical clinical discussion; attending ward rounds; follow up the progress and changes made in drug therapy in allotted patients; case presentation upon discharge.

Students are required to maintain a record of cases presented and the same should be submitted at the end of the course for evaluation.

The student shall be trained to understand the principle and practice involved in selection of drug therapy including clinical discussion.

A minimum of 20 cases should be presented and recorded covering most common diseases.

Assignments : Students are required to submit written assignments on the topics given to them. Topics allotted should cover recent developments in drug therapy of various diseases. A minimum of THREE assignments [1500 - 2000 words] should be submitted for evaluation.

Format of the assignment : 1. Minimum & Maximum number of pages. 2. Reference(s) shall be included at the end. 3. Assignment can be a combined presentation at the end of the academic year. 4. It shall be computer draft copy. 5. Name and signature of the student. 6. Time allocated for presentation may be 8+2 Min.

3.4 Pharmaceutical Jurisprudence (Theory)

Scope of the Subject: This course exposes the student to several important legislations related to the profession of pharmacy in India. The Drugs and Cosmetics Act, along with its amendments are the core of this course. Other acts, which are covered, include the Pharmacy Act, dangerous drugs, medicinal and toilet preparation Act etc. Besides this the new drug policy, professional ethics, DPCO, patent and design Act will be discussed.

Objectives of the Subject: Upon completion of the subject student shall be able to (Know, do, and appreciate) -

a. practice the Professional ethics; b. understand the various concepts of the pharmaceutical legislation in India; c. know the various parameters in the Drug and Cosmetic Act and rules; d. know the Drug policy, DPCO, Patent and design act; e. understand the labeling requirements and packaging guidelines for drugs and cosmetics; f. be able to understand the concepts of Dangerous Drugs Act, Pharmacy Act and Excise duties Act; and g. other laws as prescribed by the Pharmacy Council of India from time to time including International Laws.

Detailed Syllabus and Lecture Wise Schedule

Title of the topic

Pharmaceutical Legislations - A brief review.
Principle and Significance of professional ethics. Critical study of the code of pharmaceutical ethics drafted by PCI.
Drugs and Cosmetics Act, 1940, and its rules 1945. Objectives, Legal definition, Study of Schedule's with reference to Schedule B, C&C1, D, E1, F&F1, F2, F3, FF, G, H, J, K, M, N, P, R, V, W, X, Y. Sales, Import, labeling and packaging of Drugs And Cosmetics Provisions Relating to Indigenous Systems. Constitution and Functions of DTAB, DCC, CDL. Qualification and duties - Govt. analyst and Drugs Inspector.
Pharmacy Act - 1948. Objectives Legal Definitions, General Study, Constitution and Functions of State & Central Council, Registration & Procedure, ER.
Medicinal and Toilet Preparation Act - 1955. Objectives, Legal Definitions, Licensing, Bonded and Non Bonded Laboratory, Ware Housing, Manufacture of Ayurvedic, Homeopathic, Patent & Proprietory Preparations.
Narcotic Drugs and Psychotropic substances Act - 1985 and Rules. Objectives, Legal Definitions, General Study, Constitution and Functions of narcotic & Psychotropic Consultative Committee, National Fund for Controlling the Drug Abuse, Prohibition, Control and regulations, Schedules to the Act.
Study of Salient Features of Drugs and magic remedies Act and its rules.
Study of essential Commodities Act Relevant to drugs price control Order.
Drug Price control Order & National Drug Policy (Current).
Prevention Of Cruelty to animals Act - 1960.
Patents & design Act - 1970.
Brief study of prescription and Nonprescription Products.

Assignments: Format of the assignment 1. Minimum & Maximum number of pages 2. It shall be a computer draft copy 3. Reference(s) shall be included at the end. 4. Name and signature of the student 5. Assignment can be a combined presentation at the end of the academic year. 6. Time allocated for presentation may be 8+2 Min

Case studies relating to 1. Drugs and Cosmetics Act and rules along with its amendments, Dangerous Drugs Act, Medicinal and Toilet preparation Act, New Drug Policy, Professional Ethics, Drugs (Price control) Order, Patent and Design Act. 2. Various prescription and nonprescription products. 3. Medical and surgical accessories. 4. Diagnostic aids and appliances available in the market.

3.5 Medicinal Chemistry (Theory)

Modern concept of rational drug design: A brief introduction to Quantitative Structure Activity Relationaship (QSAR), prodrug, combinatorial chemistry and computer aided drug design (CADD) and concept of antisense molecules.

A study of the development of the following classes of drugs including SAR, mechanism of action, synthesis of important compounds, chemical nomenclature, brand names of important marketed products and their side effects.

Antiinfective agents a) Local antiinfective agents b) Preservatives c) Antifungal agents d) Urinary tract antiinfectives e) Antitubercular agents f) Antiviral agents and Anti AIDS agents g) Antiprotozoal agents h) Anthelmentics i) Antiscabies and Antipedicular agents
Sulphonamides and sulphones
Antimalarials
Antibiotics
Antineoplastic agents
Cardiovascular agents a) Antihypertensive agents b) Antianginal agents and vasodilators c) Antiarrhythmic agents d) Antihyperlipidemic agents e) Coagulants and Anticoagulants f) Endocrine
Hypoglycemic agents
Thyroid and Antithyroid agents
Diureties
Diagnostic agents
Steroidal Hormones and Adrenocorticoids

3.5 Medicinal Chemistry (Practical)

Assays of important drugs from the course content.
Preparation of medicinally important compounds or intermediates required for synthesis of drugs.
Monograph analysis of important drugs.
Determination of partition coefficients, dissociation constants and molar refractivity of compounds for QSAR analysis.

3.6 Pharmaceutical Formulations (Theory)

Scope of the Subject: Scope and objectives of the course: Subject deals with the formulation and evaluation of various pharmaceutical dosage forms.

Objectives of the Subject: Upon completion of the subject student shall be able to (Know, do, appreciate) -

a. understand the principle involved in formulation of various pharmaceutical dosage forms; b. prepare various pharmaceutical formulation; c. perform evaluation of pharmaceutical dosage forms; and d. understand and appreciate the concept of bioavailability and bioequivalence, their role in clinical situations.

Detailed Syllabus and Lecture Wise Schedule

Title of the topic

Pharmaceutical dosage form - concept and classification
Tablets: Formulation of different types of tablets, tablet excipients, granulation techniques quality control and evaluation of tablets. Tablet coating, Type of coating, quality control tests for coated tablet.
Capsules; Production and filling of hard gelatin capsules, Raw material for shell, finishing, quality control tests for capsules. Production and filling of soft gelatin capsules, quality control tests for soft gelatin capsules.
Liquid orals: Formulation and evaluation of suspensions, emulsions and solutions. Stability of these preparations
Parenterals Introduction Containers used for Parenterals (including official tests) Formulation of large and small volume Parenterals Sterilization
Ophthalmic preparations (Semi - Solids): Introduction and classification Factors affecting absorption and anatomy of skin Packaging storage and labeling, Ointments Types of Ointment Base Preparation of ointment, Jellies Types of jellies Formulation of jellies Suppositories, Method of preparation, Types Packaging
Definition and concept of Controlled and novel Drug delivery systems with available examples, viz. parentral, trans dermal, buccal, rectal, nasal, implants, ocular

3.6 Pharmaceutical Formulations (Practical)

List of Experiments :

Manufacture of Tablets a. Ordinary compressed tablet - wet granulation b. Tablets prepared by direct compression. c. Soluble tablet. d. Chewable tablet.
Formulation and filling of hard gelatin capsules
Manufacture of parenterals a. Ascorbic acid injection b. Calcium gluconate injection c. Sodium chloride infusion. d. Dextrose and Sodium chloride injection/ infusion.
Evaluation of Pharmaceutical formulations (QC tests) a. Tablets b. Capsules c. Injections
Formulation of two liquid oral preparations and evaluation by assay a. Solution: Paracetamol Syrup b. Antacid suspensions - Aluminum hydroxide gel
Formulation of semisolids and evaluation by assay a. Salicyclic acid and benzoic acid ointment b. Gel formulation Diclofenac gel
Cosmetic preparations a. Lipsticks b. Cold cream and vanishing cream c. Clear liquid shampoo d. Tooth paste and tooth powders.
Tablet coating (demonstration)

Source: Pharmacy Council of India, New Delhi, Pharm.D. Regulations 2008 (published in the Gazette of India, No.19, Part III, Section 4, New Delhi, 10th May, 2008), Appendix-A (see regulation 8), Pharm.D. Syllabus. Syllabus text above is reproduced from the PCI syllabus.