PHARMACOLOGY – II

Chemotherapy of Infections and Cancer 

Basic Principles of Chemotherapy; Systemic Pharmacological study of Anti-bacterial, Antiviral, Anti-fungal, Anti-protozoal and Anti-helmenthic drugs; Cancer Chemotherapy 

Pharmacology of Autocoids: Local Hormones 

Anti-histamines: Histamine, Serotonim and ergot alkaloids; Vasoactive principles; Eicosanoids; Prostagladins, Thromboxanes, Leukotrines and related compounds. Nitric oxide, Donors and inhibitors. Para Drugs acting on blood and blood forming agents -Coagulants, Anti-coagulants, Haematinics (iron, vitamin-B12, Folic acid) and Thrombolytic Agents. 

Pharmacology of Endocrine System 

Systemic Pharmacological study of Pituitary Hormones, Sex Hormones, Oral Contraceptives, Oxytocics and Uterine relaxants; Pharmacology of thyroid and Anti-thyroid drugs, Insulin, Oral hypoglycemics, Glucagon and Adrenocortico steroids; 

Bioethics and Bioassay Of Some Selective Drugs 

Principles of Bioethics, Bioethics of Animals used in Bioassay studies; Principles of Bioassays; Official Bioassays; Biological assay of anti-haemophilic fraction, Heparin sodium, Chorionic gonadotropin, Corticotropin, Insulin, Oxytocin, Vasopressin and Adrenaline; Biological assay of diptheria anti-toxin, anti-rabies vaccine, tetanus anti-toxin and old tuberculin vaccine; 

Toxicology of Drugs and Clinical Pharmacology 

Principles of Toxicology; Definition of Poison; General principles of treatment of poisoning with special reference to barbutirates, Opium and Organophosphorus toxicity; 

Treatment of Poisoning for the following toxins: Methyl Alcohol, Heavy metals, Paracetamol and Digitalis 

Introduction to Clinical pharmacology and Phases of clinical trials; 

PHYSICAL PHARMACY – II

Solubility and Distribution Phenomena 

Definitions, Expressions, Phase rule, Solvent - Solute interactions - polar solvents and semipolar solvents, Solubility of gases in liquids - effect of pressure and temperature, Salting out, Effect of chemical reactions, Solubility calculations. Solubility of liquids in liquids ideal and real solutions, Complete and partial miscibility, Influence of foreign substances, Three component systems, Dielectric constant and solubility. Solubility of solids in liquids Ideal and non ideal solutions solvation and association in solutions. Solubility of salts in water, Solubility of slightly soluble and week electrolytes, Calculating solubility of weak electrolytes as influenced by pH, Influence of solvents on the solubility of drugs, Combined effect of solvents. Distribution of solutes between immiscible solvents - Effect of ionic dissociation and molecular association on partition & extraction, Solubility and partition coefficients, Preservative action of weak acids in emulsions, Drug action and partition coefficients. 

Chemical Kinetics 

Rates and orders of reactions - Rate, order of reaction, Molecularly, Specific rate constant, Units of basic rate constants, Mathematical treatment of rates. 

Apparent zero order kinetics. First order reactions. Second order reactions. Determination of order of a reaction. Elementary idea complex reactions. Specific and general acid base catalysis. Influence of temperature and other factors on reaction rates - Effect of solvents, Ionic strength, Dielectric constant, Catalysts and light. Decomposition and destabilization of medicinal agents against hydrolysis, Oxidation. Kinetics in the solid state. Accelerated stability analysis. 

Interfacial Phenomena 

Introduction, liquid interphases - Surface and interfacial tensions, Surface free energy, measurement of surface and interfacial tensions, Spreading coefficient. Adsorption at liquid interfaces - Surface active agents, Systems of hydrophilic - Lipophilic classification, Solubilization and detergency. Types of monolayer at liquid surfaces, applications of amphiphiles. Absorption at solid interfaces - Solid/Gas interface - Solid/Liquid interface. Electric properties of interfaces - Electric double layer, N emst and zeta potentials. 

Colloids and Micromeritics 

Dispersed systems, Size and shape of colloidal particles - pharmaceutical application, Types - Lipophilic, Lipophobic and Association colloids, Comparison of properties of colloidal sols; Optical, Kinetic and Electric properties of colloids, Solubilization gels - Structure, Properties and Applications. 

Particle size and size distribution - average particle size, particle size distribution, number and weight distributions, Particle number; Methods for determining particle size - optical microscopy, sieving, Sedimentation, Particle volume measurement, Particle shape and surface area, Methods for determining surface area - Absorption methods, Air permeability methods; Derived properties of powders - Porosity, Packing arrangements, Densities, bulkiness, Flow properties. 

Rheology and Polymers 

Rheology of Pharmaceutical Fluids: Newtonian and Non-Newtonian Systems; 

Newtonian systems - Laws of flow, Kinematic viscosity, Effect of temperature. 

Non newtonian systems - Plastic and Pseudoplastic dilatant flow. 

Thixotropy - Measurement of thixotropy, Thixotropy in formulation. 

Determination of rheologic properties - choice of viscometer, Capillary, falling sphere, Cup and bob, and cone and plate viscometers. Psychorheology. Applications to pharmacy.

Polymers: Definition, Types of Polymers, Water Soluble and Water Insoluble Polymers; Polymers as Thickening Agents; Pharmaceutical Application of Polymers; 

FORENSIC PHARMACY (PHARMACEUTICAL JURISPRUDENCE)

1. Evolution of Pharmaceutical and Drug Legislation in India. 

2. The Pharmacy Act 1948. 

3. Code of Pharmaceutical Ethics. 

4. Consumer protection Act 1986. 

5. Narcotic and Psychotropic substances Act 1985. 

Drugs and Cosmetics Act 1940 and Drugs & Cosmetic Rules 1945 (also amendments). 

 1. Administration of the Act – The controlling and licensing regulation at state level and central level (the organisation, function and duties of state and central drug control authorities). 

 2. Drugs & Cosmetic Act Rules – the provisions related to  

 a. The manufacture of drugs (other than homeopathic) including schedule C, C(1), F, F(1) and X drugs and cosmetics. 

 b. The sale and distribution of drugs (other than homeopathic) including schedule C, C(1), F, F(1) and X drugs and cosmetics. 

Drugs & Cosmetics Act Rules  

1. (i.) The import and export of drugs & cosmetics. 

    (ii) Labelling and packing requirements for all categories of drugs & cosmetics. 

2.  (i.)  List of schedules to the Drugs & Cosmetics Rules. 

     (ii.) Detailed study of schedule M (new), U and Y. 

3.  Medicinal & Toilet preparations (Excise Duties) Act 1955. 

 1. Drugs and magic Remedies (Objectionable Advertisments) Act 1954. 

 2. Prevention of Food Adulteration Act 1954 (salient features) 

 3. The Factories Act 1948 and the Amendment (salient features.). 

IPR’s and Patent Laws  

 1. Intellectual Property Rights – a brief introduction to various IPR’s. 

 2. Indian Patent Act 1970 and the Amendments to the Act (upto date with reference to WTO Agreement) 

 a. Introduction & Objectives 

 b. Inventions and Not inventions according to the Act. 

 c. Procedure of obtaining patent for drugs and pharmaceuticals. 

 3. Drug Price Control Order (Latest). 

 4. Pharmaceutical Policy 2002. 

DOSAGE FORMULATION DESIGN (PHARMACEUTICS – III)

Pre Formulation Studies 

Study of Physical Properties of Drug: Particle size, Shape, pKa, Solubility, Partition Coefficient, Crystallinity, Polymorphism and Hygroscopicity, 

Powder Characteristics: Bulk density, Flow Properties, Solid State stability, Solution stability, and Stability Protocol, Dissolution and Organoleptic property and their effect on formulation. 

Study of Chemical Properties of Drug: Hydrolysis, Oxidation, Polymerization etc., and their influence on formulation and stability of the Products. 

Sustained Action Pharmaceuticals 

Concept, Benefits, Limitations, Advantages & Disadvantages, Definition of various types of prolonged action pharmaceuticals. 

Sustained Action Oral Products: Theory-Zero order release approximation, First order release approximation, Approaches based on drug modification and dosage form modification, in vitro & in vivo evaluation of the sustained release products. Formulation -Drug complexes, Encapsulated slow release granules, Tabletted slow release granulations and matrix tablets. 

Microencapsulation: Applications, Core and Coat materials, Techniques- Air suspension, Coacervation-Phase separation, Pan Coating, Spray Drying & Spray congealing, Solvent Evaporation,. Polymerisation. 

New Drug Delivery Systems

Importance, Formulation and Applications. 

Transdermal Drug Delivery Systems: Concept, Advantages and disadvantages, Approaches used in developing Transdermal drug delivery systems (4 types), in vitro evaluation of Transdermal drug delivery systems. 

Liposomes: Formulation, Preparation of liposomes-physical dispersion and solvent dispersion, Characterisation of Liposomes, Applications in Pharmacy. 

Occular Drug Delivery Systems: Concept, Advantages and disadvantages, Mucoadhesives, design of Occuserts (Pilo 40 and Pilo 20), Erodable inserts. 

Nanoparticles: A brief introduction to Nanoparticle technology and Nanoparticles as drug carriers in controlled & targeted drug delivery systems. 

Performance Evaluation Methods 

Bioavailability: Definitions, Objectives, Considerations, Assessments, Enhancement Methods, Dissolution Studies for solid dosage forms and methods of interpretation of dissolution data. 

In vitro and In vivo methods of evaluation 

Bioequivalence: Definition, Objectives, Testing Protocols and Procedures, Experimental Design of single dose bioequivalence study and Statistical Interpretation of data. 

Concepts of Process Validation: Definition, Importance, types of validation in Pharmaceutical Operations and Introduction to different process validation methods. Concepts of Good Manufacturing Practices in Production of Pharmaceutical Products 

Quality Control and Assurance 

Introduction, Quality Assurance, Sources of Quality variation, 

Control of Quality variation: Raw Materials Control - Raw Material Quality Assurance Monograph, Active or Therapeutic Materials Control, 

Quality Assurance at startup - Raw Materials Processing, Compounding, Packing materials. Quality Assurance during packing operation - Auditing, Concept of statistical Quality Control and Quality Control Charts. 

Control & Assurance of Manufacturing practices: Personal, Equipment & Buildings. Control of records - Master formula record, Batch production record. 

Control of production procedures - Manufacturing control, Packing Control and Labels control. Stabilization and stability testing protocols for various pharmaceutical products. 

BIOSTATISTICS (PHARMACOSTATISTICS)

Definition and determination of terms Mean, Median, Mode, relation between mean, median, and mode. Standard deviation, histogram, Coefficient of correlation, regression analysis, curve fitting, theory of probability. 

 

Nature and Scope of Statistical methods and their limitations, compilation, classification, tabulation and applications in pharma and life sciences; Graphical representation; Measures of Average Stem and Leaf Plots; Box and Whisker Plots, Co-plots; Introduction to Probability Theory and Distributions (Concepts without Derivations), Binomial, Poisson & Normal Distributions (Only definition and Problems) 

  

Sampling Methods: Simple, Random, stratified, Systematic and Cluster Sampling Procedures; Data Collection, Data Organization and Data Representation; Bar, Pie, 2-D and 3-D Diagrams; Sampling and Non-Sampling Errors; Sampling Distributions; measure of dispertion.

 

Interference Concerning Means: Point Estimation - Interval estimation - Bayesians estimation - Tests of Hypothesis; Common Parametric and Non parametric tests employed in testing of significance in biological/pharmaceutical experiments.   

Tests of significance - T -test, chi-square test, analysis of variance, elements of Anova (one way and two way). Principles of scientific experiments; concept of CRD, RBD and Latin square diagrams.