ORGANIC
CHEMISTRY
General
principles
A brief
review of classification &
sources of organic
compounds, sp3, sp2 ,sp hybridization, sigma & pi- bonds, bond
lengths, bond angles & bond energies along with their significance in
reactions should be carried out. An overview of bond polarization, hydrogen
bonds, inductive effects, resonance, and hyperconjugation be taken. Concept of
homolytic & heterolytic bond fission, acidity & basicity with different
theories should be covered briefly. Ease of formation & order of
stabilities of electron deficient & electron rich species along with the
reasons for the same should be covered. Relationships between energy content,
stability, reactivity & their importance in chemical reactions should be
covered. Calculations for determining empirical & molecular formula should
be covered.
Different
classes of compounds
The following classes of compounds
should be taught in detail with respect to their IUPAC / systematic
nomenclature, industrial [wherever applicable] & laboratory methods of
preparations, physical properties & chemical reactions with emphasis on
reaction mechanisms [arrow based] & stereochemistry [wherever applicable].
Ø Alkanes
[including cyclic compounds]
Ø Alkenes
[including cyclic compounds]
Ø Alkynes [only
open-chain compounds]
Ø Aliphatic
hydroxyl compounds
Ø Alkyl halides
Ø Aldehydes &
Ketones
Ø Carboxylic acids
Ø All functional
derivatives of carboxylic acids.
Protection
& deprotection of groups
Introduction to protection &
deprotection of functional groups. Two examples each for amino, hydroxyl, &
carbonyl groups. The significance of these in syntheses should be explained.
Aromaticity
& chemistry of aromatic compounds
Concept of aromaticity, Huckel's rule
& its use in determining the aromatic/non-aromatic character of a compound.
A brief coverage of structure of benzene. Detailed coverage of electrophilic
& nucleophilic aromatic substitution reactions. Reactivity &
orientation in these reactions. Reactivity & orientation in mono- &
disubstituted benzenes. Benzyne mechanism.
Different
aromatic classes of compounds
The following classes of compounds with
respect to their IUPAC / systematic nomenclature, industrial [wherever
applicable] & laboratory methods of preparations,
physical properties & chemical
reactions with emphasis on reaction mechanisms [arrow based] &
stereochemistry [wherever applicable].
Ø Aromatic
hydrocarbons.
Ø Phenolic
compounds.
Ø Aromatic &
aliphatic amines.
Ø Diazonium salts.
Ø Aromatic nitro-
compounds, aryl halides, & ethers.
Polycyclic
aromatic hydrocarbons
Syntheses & reactions with
mechanisms of bi & tricyclic fused carbocyclic rings like naphthalene,
anthracene, & phenanthrene.
Carbonyl
Chemistry
Carbonyl chemistry involving group
conversions & their reaction mechanisms along with stereochemistry wherever
applicable.
1. Wolf-Kishner
reduction & Huang-Minlong modification.
2. Reduction of
arylsulfonyl hydrazine/hydrazones to alkanes.
3. Bamford Steven
reaction.
4. DCC Oxidation of
alcohol.
5. Michael addition
/ 1,4-addition / conjugate addition.
6. Mannich
condensation / reaction.
7. Robinson
annulation.
8. Stobbe
condensation.
9. Darzen's
glycidic ester synthesis.
10. Beckmann
rearrangement.
11. Baeyer Villiger
rearrangement.
12. Curtius, Wolff,
& Lossen rearrangements.
13. Willgerodt
rearrangement.
14. Pinacol-pinacolone
rearrangement.
15. Methylene transfer reactions. Use of
diazomethane & sulphur ylides in the same.
16. Mono- & dialkylations
in 1,3-dicarbonyl compounds.
17. Formation &
use of enol ethers, enol acetates & enamines as protective groups & in
regiospecific alkylations.
Heterocyclic
Chemistry
IUPAC Nomenclature of heterocyclic rings
[3-10 membered] containing O, S, & N atoms. Nomenclature of above rings
containing mono-, di-, & multiple [same or different] heteroatoms should
also be covered. Nomenclature of 2 & 3 fused rings containing mono-, di-,
& multiple heteroatoms [same or different] should also be covered. Syntheses
& reactions of three to six- membered rings in detail. Syntheses of five
& six-membered rings containing mono- or any di- heteroatoms [O, S, &
N]. Syntheses of quinoline, isoquinoline, benzoxazole, benzothiazole, &
benzimidazole, benzotriazole, and benzothiazole.
Bridged
rings
Bridged ring systems & their
nomenclature.C8, C9, C11 bridged bicyclic alkanes. Chemistry of hexamine,
morphan, biperiden, amantadine, diazabicyclo[2.2.2] octane
Kinetic
& thermodynamic control
Kinetic & thermodynamic control of sulfonation,
enolate anion formation & alkylation of enamine reactions.
Stereochemistry
Stereochemistry. Chirality &
asymmetry [introduction of the same to S, P, & N]. Definition &
classification [different types of isomerisms]. Enantiomers, diastereomers.
Enantiomerism & diastereomerism. Meso compounds & their optical
activity. Stereochemistry in acyclic compounds. Newman projection formulae
& their significance. Conformational analysis of n- butane. Absolute &
relative configuration. Assigning R & S configuration based on Cahn Ingold
& Prelog system. Racemic mixture- its definition & resolution.
Definitions of terms stereoselective, stereospecific, Enantiomeric excess &
diastereomeric excess. Stereochemistry in cyclic systems. Conformations of
cyclohexane. Cis-trans relationship in cyclohexane. Prediction of stability of
different conformations of 1, 2- 1,3- & 1,4- disubstituted cyclohexanes.
Effect of multiple substitutions on the stability of cyclohexane conformations.
Chair conformations of cis-, & trans-decalins, perhydrophenanthrenes, &
a tetracyclic steroidal nucleus. An introduction to atropisomerism.
Carbohydrates
Carbohydrates. Definition &
classification. D & L nomenclature in sugars. Different ways of drawing /
representing a sugar molecule [including cyclic Structure], interconversion of
these representations. Anomers & epimers. Mutarotation. Reactions of
glucose. Chain extension & chain reduction of a sugar.
Amino
acids & proteins
Amino acids & proteins. Definition
& classification. D & L Amino acids, natural, essential, & non-
essential amino acids. Denaturation, Strecker, Gabriel phthalimide methods for
the preparation of amino acids. Peptide bond & its formation. Two
protective groups each, for -NH2 & -COOH functionalities during protein
synthesis. Sequencing of a protein by chemical & enzymatic methods.
Pericyclic
reactions
Pericyclic reactions. Concept of HOMO
& LUMO. Drawing of HOMO & LUMO of 1, 3-butadiene, allylic cation,
radical & anion, & 1, 3, 5-hexatriene, Diel's-Alder & retro Diel's
Alder reaction.
PHARMACEUTICAL ANALYSIS
Importance
of quality control in pharmacy
Acid-base
titrations
Definitions of acids & bases
according to Arrhenius & Lewis theory. Definitions of normality, molarity,
molality, & equivalent weight. Primary & secondary standards with
examples & differences between them. Standardization of strong acids &
bases using primary & secondary standards. Preparation of standard
solutions of & calculations of equivalent weights of oxalic acid, potassium
acid phthalate, calcium chloride dihydrate, & sodium carbonate. Calculation
of factors involved in standardization of sodium hydroxide, hydrochloric acid,
& oxalic acid. Direct, back & differential titrations. Application of
direct & back titrations to preparations like boric acid & borax in a
mixture, ammoniated mercury, milk of magnesia, & zinc oxide ointment.
Law of mass action, acid-base
equilibria, pH scale, pH & hydronium ion concentrations in aqueous systems,
calculations of pH for weak acids & weak bases. Use & applications of
pH meter. Hydrolysis of salts. Strengths of acids & bases, dissociation
constant.
Theory of acid-base indicators.
Neutralization [titration] curves.
Definition, different types of buffers
[chemical & biological], & their composition. Buffer capacity, buffered
isotonic solutions. Calculations involving preparation of various buffer
capacity solutions. Biological & pharmaceutical applications of buffers.
Non-aqueous
titrations
Acid-base definitions according to
Lowry-Bronsted, Lewis & Arrhenius concept. Factors affecting strengths of
acids & bases. Intrinsic structure & surrounding environment.
Protophilic, protogenic, amphiprotic & aprotic solvents. Acid-base
equilibria in non- aqueous media. Titrants & indicators used for the assay
of acidic & basic substances. Preparation of perchloric
o o
oacid, formation of
onium ion. Assay
of 1 2
3 amines &
amine hydrochlorides using
perchloric acid & the reactions
involved in it. Standardization of sodium ethoxide solution. Assay of phenols
& phenobarbitone. General applications of non-aqueous titrations
Oxidation-reduction
titrations
Definition of oxidation, reduction,
oxidizing & reducing agent. Equivalent weight, the concept of half
reactions. Systematic balancing of half reactions with respect to:
1. Oxalic
acid-KMnO4,
2. FeSO4-ceric
nitrate, &
3. I2-sodium
thiosulphate solution titrations.
Calculation of equivalent weight of
oxalic acid, KMnO4, FeSO4, permanganate & I2 from half- reactions.
Calculation of factors for titrations mentioned in a, b & c.
1. Redox
titrations:
2. KMnO4 as a self
indicator, it's preparation, standardization, & use in the assay of ferrous
gluconate tablets, H2O2, & NaNO2 solution.
3. Iodimetric &
iodometric titrations. Definitions & difference between iodimetry &
iodometry. Preparation, standardization of iodine solution. Assay of ascorbic
acid & sulphur ointment by iodimetry. Assay of copper sulphate & ferric
chloride by iodometry.
4. Bromometric
titrations.
5. Iodate
titrations. Definition. Preparation, standardization & use of KIO3 in the
assay of ascorbic acid & KI.
6. Cerimetric
titrations. Preparation, standardization & use of ceric solutions in the
assay of paracetamol tablets. Its advantages over permanganate solutions.
7. Bromine
titrations. Preparation, standardization & use of bromine solution in the
assay of phenol & isoniazid tablets.
8. Potassium
dichromate titrations. Preparation, standardization & use of potassium
dichromate solution in the assay of ferrous ammonium sulphate.
Precipitation
titrations
The principle of solubility product
& sparingly soluble salts.
Titrants & indicators used in
Mohr's, Volhard's, & Fajan's methods. Preparation & standardization of
silver nitrate & ammonium thiocyanate solutions. Assay of sodium chloride
by Mohr's method, use of nitrobenzene in the assay of halides, ammonium
chloride, & thiourea by Volhard's method. Calculation of factors in
argentometric titrations. Titration curve method. General applications of
precipitation titrations.
Complexometric
titrations
Difference between double salts &
co-ordinate compounds. Definitions of coordination number of metal ions,
ligands- uni-, bi-, & multidentate. Complexing, chelating, &
sequestering agents with respective examples. Structure of complexes of
platinum with ammonia. Ethylenediamine tetraacetate [EDTA] as a multidentate
ligand in complexometry. Coordinate compounds of EDTA with bi-, tri-, &
tetravalent metal ions. Stability of complexes & factors affecting it, use
of buffers in EDTA titrations. Selective analysis of ions based on pH
adjustments, use of masking & demasking agents, pM or metal ion indicators.
Standardization of EDTA solution, titration curves, and examples of assays
carried out by direct & back titrations & by replacement of one complex
by the other. Applications of complexometry in the assays of calcium gluconate,
milk of magnesia, zinc undecenoate ointment, & aluminium hydroxide gel.
Assay of NaF by indirect titration.
Gravimetry
Principles of gravimetry. Factors
affecting precipitation, formation, & properties of the precipitate.
Colloidal state. Impurities in the precipitate, conditions of precipitation.
Precipitation from homogenous solutions, washing, drying, & ignition of the
precipitate.
Experimental techniques of drying &
ignition. Applications of gravimetry in pharmacy.
Extraction
techniques
Liquid-liquid extraction, separation of
mixtures by extraction. Distribution law. Successive & multiple extraction
[Craig method], continuous counter- current extraction. Effect of temperature
& pH on extraction. Inert solute, associate ion pair formation, emulsion
problem in extractions. Applications in pharmacy.
Potentiometry
Theory, ion-selective electrodes,
measurement of potential, red-ox titration curve, pH measurement, the relation
of pH to potential. Applications in pharmacy.
Miscellaneous
methods of analysis
Diazotization titrations. Kjeldahl
nitrogen estimation. Karl Fisher titrations. Liquid gelenicals. Oxygen flask
Determination of alcohol content in liquid gelenicals. Oxygen flask combustion
method.
Calibration
Calibration of instruments.
General
principles of spectroscopy
Wave-particle duality, wave properties, particulate properties.
Line & band
spectrum.
Electromagnetic spectrum. Absorption
& emission spectroscopy. Understanding of terms such as absorbance,
transmittance, absorptivities, molar absorptivity, E 1cm 1%,
λmax, the effect of solvent & pH on
λmax.
Ultraviolet-visible
Spectrometry
Different electronic transitions.
Auxochromes & their effects, auxochromic, bathochromic & hypsochromic
shifts [red & blue shifts]. Beer-Lambert law, its derivation, deviations in
Beer's law. Single & double beam spectrophotometers covering sources of
radiations, different monochromators, detectors such as barrier cell, photocell,
photomultiplier tube. Photodiode array detector. Applications of this technique
in qualitative & quantitative estimations giving emphasis on
problem-solving. Fieser-Woodward rules for calculations of theoretical λmax
values.
Spectrofluorimetry
Principle, definitions & types of
luminescence. Mechanism of fluorescence & phosphorescence. Singlet &
triplet states & intersystem crossing. Fluorescence yield & factors
affecting it. Quenching of fluorescence & fluorescence quenchers. Structure
& fluorescence. A brief discussion of instrumentation. Applications of
fluorimetry in pharmacy.
Flame
photometry & atomic absorption spectrometry
Principle & instrumentation with
emphasis on working & importance of different
components. Temperature, flame
absorption & emission profiles. Interferences & their avoidance.
Quantitative estimations & applications.
Infrared
spectrometry
Infrared region in EM spectrum. The
principle, different stretching & bending vibrations. Components [&
their working] of a dispersive instrument. Fourier transform [FT] technique, FT
instruments & their comparison with dispersive instruments. Sample handling
techniques. Functional group & fingerprint regions in the spectrum.
Functional groups identification & their use in the characterization of
compounds. Problems based on the identification of functional groups from
spectra of unknown compounds.
Proton
nuclear magnetic resonance spectrometry
The principle involved in the technique.
Knowledge about fundamental terms involved such as quantized absorption, flipping
of nucleus, spin number, magnetic moment, magnetogyric ratio, relaxation, etc.
Equations relating these terms to the frequency of radiation & magnetic
field [without derivation of the equations]. Types of relaxation processes. Low
& high-resolution instruments. A brief discussion on the low-resolution
instrumentation [60 MHz]. Quantitative knowledge of the relationship between
MHz & magnetic field. An introduction to superconductivity magnets.
Solvents & reference standards used. Setting up of NMR scale. Sample
preparation. Shielding & deshielding of a proton & its effect on
chemical shifts. Discussion on & importance of equivalent & non
equivalent protons [number of signals], chemical shifts [position of signal]
& their calculation from the spectrum, chemical shifts of different H's,
splitting [multiplicity] of a signal, coupling constants [J values] ,
integration [area under the signal]. Importance of these terms in
identification [or confirmation] of different functional groups. Significance &
contribution of J value in stereochemistry. Prediction [expected theoretical
values] of chemical shifts & multiplicities for all protons from simple
structures containing up to 12-15 carbons. An introduction to FT-technique
& its significance in 13C-NMR spectrometry.
Mass
spectrometry
Principle. Low & high-resolution
instruments. Components & importance of each in brief. Different types of
mass spectrometric techniques. Brief knowledge of Chemical Ionization mass
spectrometry. Calculations of hydrogen deficiency index [HDI] or unsaturation
index [UI]. Base or parent peak, molecular ion, M + 1, M + 2 peaks.
Calculations of molecular weight based on M
+1 & M + 2 peaks. Formation of
molecular ion & further fragmentation. Rearrangements in mass spectrometry.
Major modes of fragmentations of hydrocarbons, hydroxyl compounds, halogen
compounds, aldehydes, ketones, carboxylic acids, and amines. Introduction
[only] to recent advances in MS.
Polarography.
Principle & instrumentation.
Ilkovich equation [no derivation] & its importance. Dropping mercury
electrode [DME], saturated calomel electrode. Liquid-liquid junction potential,
polarographic cell. Explanation of origin of the S-shaped C-V curve.
Applications
of this technique. Amperometric
titrations, principles, instrumentation, & applications.
Nephelometry
& Turbidimetry
Principles, Tyndall effect. Duboscq
turbidimeter. Eeel's nephelometer. Applications.
Chromatography.
Principle, rate & plate theory, Van
Deemter equation & the parameters affecting separation/band broadening.
Classification of chromatography, retention factor. A detailed
study of thin layer chromatography
[TLC], preparative TLC, paper chromatography [PC], column chromatography, gas
chromatography [GC / GLC].
Qualitative & quantitative
applications of the above techniques. An introduction to high performance TLC
[HPTLC], comparison of TLC & HPTLC. A brief introduction to high pressure /
performance liquid chromatography [HPLC].
Miscellaneous
An introduction to electrophoresis. An
introduction to lasers & masers.
Statistical treatment to experimental data. Sampling techniques & applications in pharmaceutical industry.
BIOCHEMISTRY
Cell
Revision of ultrastructure of the cell,
functions of various cellular constituents. Applications of biochemical principles
to the pharmacy.
Carbohydrates
Types of carbohydrates, their functions,
digestion, & absorption. Aerobic & anaerobic oxidation with energetics.
Glycogenesis, glycogenolysis, & gluconeogenesis. Hexose monophosphate shunt
[HMP shunt]. Diseases associated with carbohydrate metabolism.
Proteins
Different types of proteins. Their
functions, digestion & absorption. Denaturation & its effect on
biological activity. Renaturation of proteins. Urea formation, urea cycle,
creatinine formation. Transamination & deamination. Proteins as enzymes.
Lipids
Different types of lipids. Their
functions, digestion, absorption & metabolism. (Beta-Oxidation of fatty
acids with energetics. Biosynthesis of cholesterol [from acetate],
adrenocorticoids, androgens, progesterone, estrogens, & bile acids / salts.
Ketone bodies, their formation & biochemical significance. Diseases
associated with lipid metabolism.
Vitamins
Definition. Classification, structures
[except B12] biochemical role, sources, daily requirements, & deficiency
symptoms. Vitamins as co-factors in biochemical reactions.
Biological
oxidations & reductions
Oxidation-reduction systems in the body
their role. Oxidative phosphorylation & Electron transport chain.
Cytochromes & inhibitors of the same.
Enzymes
Classification & their various
roles. Enzyme co-factors. Enzyme kinetics. Michaelis-Menton equation along with
its transformations. Double reciprocal plot. Factors affecting enzyme action.
Enzyme inhibition, competitive & non-competitive, & kinetics.
Nucleic
acids
Different types of nucleic acids [NAs]
& their composition. Purine & pyrimidine bases, sugars, & phosphoric
acid. Nucleosides & nucleotides. Formation of NAs & their backbone.
Different ways of representing DNA & RNA molecules. Physico-chemical properties
of NAs. Their stability in acidic & basic solutions. Isolation,
purification & identification, buoyant density, sedimentation coefficient,
& Svedberg constant of NAs. De-novo biosynthesis of NAs. DNA & the
Watson-Crick model & its features. DNA as
the bearer of genetic information. The
Central dogma of molecular genetics & the processes defined in the same.
Replication of DNA. Different types of RNAs with their special features &
functions. Minor or rare bases. Transcription & translation. Different
post-translational modifications of proteins. Triplet codon & the codon
dictionary. Mutations. An introduction to different types of mutations. Their
nature & repair.
Hereditary
diseases.
Eliptocytosis,
spherocytosis, HNPCC, diabetes insipidus.
PHARMACOLOGY
1.
General Pharmacology
Introduction to Pharmacology-
Definition, scope and source of drugs, dosage forms and routes of drug
administration. Pharmacodynamics-Mechanism of drug action, Receptors,
classification and drug-receptor interactions, combined effects of drugs,
factors modifying drug actions.
Pharmacokinetics-Mechanism and principle
of absorption, distribution, metabolism and excretion of drugs. Principles of
basic and clinical pharmacokinetics. Pharmacogenetics. Adverse drug reactions.
Discovery and development of new
drugs-Preclinical and clinical studies.
2.
Detailed pharmacology including classification, mechanism of action and
therapeutic uses of following classes:
Nerohumoral
transmission in autonomic and central nervous system:
Ø Neurohumoral
transmission (Autonomic and somatic). Neurohumoral transmission in the
Ø C.N.S with
special emphasis on Pharmacology of various neurotransmitters. Nitric oxide:
Biosynthesis of nitric oxide and its physiological role.
Ø Therapeutic use
of nitric oxide and nitric oxide donors. Clinical condition in which nitric
oxide may play a part.
Ø Peptides and
proteins as mediators:
Ø General
Principal of peptide pharmacology Biosynthesis and regulation of peptides
Peptide antagonists. Protein and peptide as drugs.
Pharmacology
of peripheral nervous system
Ø Parasympathomimetics,
Parasympatholytics, Sympathomimetics, Sympatholytics, Ganglionic stimulants and
blockers. Neuromuscular blocking agents and skeletal muscle relaxants
(peripheral).
Ø Local anesthetic
agents. Drugs used in Myasthenia Gravis.
Pharmacology
of central nervous System
Ø General
anesthetics. Alcohols and disulfiram. Sedatives, hypnotics and centrally acting
muscle relaxants, Psychopharmacological agents: Antipsychotics,
antidepressants, antianxiety agents, anti-manics and hallucinogens.
Ø Anti-epileptic
drugs. Anti-parkinsonism drugs. Nootropics.
Ø Narcotic
analgesics, drug addiction, drug abuse, tolerance and dependence.
Pharmacology
of cardiovascular system
Ø Introduction of
hemodynamics and Electrophysiology of heart.
Ø Anti-hypertensive
drugs, Anti-anginal agents, Anti-arrhythmic drugs. Drugs used in congestive
heart failure. Anti-hyperlipidemic drugs. Drugs used in the therapy of shock.
Ø Haematinics,
anticoagulants and haemostatic agents. Fibrinolytics and antiplatelet drugs.
Ø Blood and plasma
volume expanders.
Drugs
acting on urinary system
Diuretics and anti-diuretics.
Drugs
acting on Respiratory system
Anti-asthmatic drugs, Mucolytics and
nasal decongestants, Anti-tussives and expectorants. Respiratory stimulants
Pharmacology
of Endocrine system
Basic concepts in endocrine
pharmacology. Hypothalamic and pituitary hormones. Thyroid hormones and
antithyroid drugs, Parathormone, Calcitonin and vitamin-D. Insulin, oral
hypoglycemic agents and glucagon. ACTH and corticosteroids. Androgens and
anabolic steroids. Estrogens, progesterone and oral contraceptives. Drugs
acting on the uteru.
Chemotherapy
Ø General
principles of chemotherapy. Sulphonamides and co-trimoxazole.
Ø Antibiotics-
Penicillins, cephalosporins, chloramphenicol, Macrolides, quinolones and
fluoroquinolons,. Tetracyclines. Aminoglycosides and miscellaneous antibiotics.
Chemotherapy of tuberculosis, leprosy, fungal diseases, viral diseases, AIDS,
protozoal diseases, worm infections, urinary tract infections and sexually
transmitted diseases. Chemotherapy of malignancy.
Autacoids
and their Antagonists
Histamine, 5-HT and their agonsists and
antagonists. Prostaglandins, thromboxanes and leukotrienes. pentagastrin,
cholecystokinin, angiotensin, bradykinin and substance P.,Analgesic,
anti-pyretic, anti-inflammatory and anti-gout drugs.
Pharmacology
of drug acting on the gastrointestinal tract
Antacids, anti-secretary and antiulcer
drugs.
Laxatives and antidiarrheal drugs.
Appetite stimulants and suppressants. Digestants and carminatives. Emetics and
anti-emetics.
Chronopharmacology
Definition of rhythm and cycles.
Biological clocks and their significance leading to chronotherapy.
Immnopharmacology
Immunostimulants and immunosuppressants.
Vitamins
& Minerals
Vitamin deficiency diseases and their
management. Role of minerals in health & diseases.
Principles
of toxicology
Definition of poison. General principles
of treatment of Poisoning. Treatment of poisoning due to Heavy metals,
insecticides, opioids and other addict forming drugs. Study of acute, sub acute
and chronic toxicity as per OECD guidelines (guidelines
420,423,425,407,408,451/452; only names and significance, detailed procedures
and minute details are not expected).
CLINICAL PHARMACY AND THERAPEUTICS
a)
General
Principles, preparation, maintenance, analysis of observational records in
clinical Pharmacy.
b)
Clinical
trials, type and phases of clinical trials, placebo, ethical and regulatory
issues including Good clinical practice in clinical trials.
c)
Therapeutic
drug monitoring, adverse drug reaction (ADR), types of ADR, Mechanism of ADR.
Drug interaction, Monitoring and reporting of ADR and its significance.
d)
Drug
information services, Drug interactions.
e)
Drug
interaction in pediatric and geriatric patients, drug treatment during
pregnancy, lactation and menstruation.
f)
Pharmacovigilance,
Therapeutic drug monitoring, Neutraceuticals, essential drugs and rational drug
usage.
g)
Age-related
drug therapy: concept of posology, drug therapy for neonates, pediatrics and
geriatrics. Drugs used in pregnancy and lactation.
h)
Drug
therapy in gastrointestinal, hepatic, renal, cardiovascular and respiratory
Disorders.
i)
Drug
therapy for neurological and psychological disorders.
j)
Drug
therapy in infections of respiratory system, urinary system, infective
meningitis, TB, HIV, malaria and filaria.
k)
Drug
therapy for thyroid and parathyroid disorders, diabetes mellitus, menstrual
cycle disorders, menopause and male sexual dysfunction.
l)
Drug
therapy for malignant disorders like leukemia, lymphoma and solid tumors.
m)
Drug
therapy for rheumatic, eye and skin disorders.
BIOTECHNOLOGY
Plant Cell and Tissue Culture
1. Structure of plant cell, DNA, Genes and chromosomes.
Ø Cell and tissue
culture,
Ø Requirements.
Ø Callus culture,
suspension culture, batch culture.
Ø The concept of
somatic hybridization, somatic embryogenesis.
2. Processes and applications,
Ø Isolation and
immobilization of enzymes and plant cells and application.
Ø Protoplast and
cell fusion.
Ø Germplasm
conservation.
Ø Production of
secondary metabolites by plant tissue culture.
Ø Gene transfer
techniques.
Animal
Cell Culture
Introduction to animal cell culture,
medium used in ATC. Use of FCS, primary culture, secondary culture, cell line.
Cloning: concept and application with technical hurdles. Transgenic animals as
a source of food, organs and tissues, concept of xeno transplant.
Fermentation
Technology and Industrial Microbiology
Ø Fermentation as
a biochemical process, types of fermentation.
Ø Fermenter -
working and construction, accessory components, modification.
Ø Fermentation
monitoring and in situ recovery of products.
Recombinant
DNA Technology
Basic concepts
Ø Introduction.
Ø Role of a
restriction endonuclease, DNA ligase, DNA polymerase, Reverse transcriptase.
Process
and Applications
Ø Constructing
Recombinant DNA molecules.
Ø DNA Clones
sources of DNA for cloning.
Ø DNA vectors, role of expression vectors.
Ø Host cell for recombinant work.
Ø Method for screening and selecting
transformants.
Ø Expression of foreign genes.
Ø Uses of
recombinant DNA.
PCR
and applications.
Human gene therapy concept and
applications.
Drug
delivery systems in gene therapy.
Biotechnology
Derived Products
Sources and upstream processing.
·
Introduction.
·
Escherichia
coli as a source of recombinant, therapeutic protein.
Additional production systems,
·
Yeast.
·
Fungal
production systems. Transgenic animals.
·
Transgenic
plants.
·
Insects
cell-based systems.
Upstream processing.
Downstream processing.
Product analysis,
·
Introduction.
·
Protein-based
contaminant.
·
Removal
of an altered form of the protein of interest from the product stream.
Determination of protein concentration.
Immunological approaches to detection of
contaminant, Endotoxin and other pyrogenic contaminants.
·
Pyrogen
detection.
·
DNA
as a contaminant.
·
Microbial
and viral contaminant.
·
Viral
assays.
·
Miscellaneous
contaminants.
·
Validation
studies.
Production and purification of
recombinant proteins like, Insulin, Growth hormones, somatostatin, interferons,
only examples of recombinant blood products.
HUMAN ANATOMY & PHYSIOLOGY
Cell
physiology
Cell, Cell junctions, transport
mechanisms, homeostasis, ion channels, secondary messengers.
The
Blood
Composition and functions of blood, RBC,
WBC, platelets. Homeostasis, blood groups, mechanism of clotting. Introduction
to disorders of the blood.
Gastrointestinal
tract
Structure of the gastrointestinal tract,
functions of its different parts including those of liver, pancreas and
gallbladder, various gastrointestinal structures and their role in the
digestion and absorption of food.
Respiratory
System
Structure of respiratory organs,
functions of respiration mechanism and regulation of respiration, respiratory
volumes and vital capacity.
Autonomic
nervous system
Physiology and functions of the
autonomic nervous system. Mechanism of neurohumoral transmission in ANS.
Sense
organs
Structure and physiology of eye
(vision), ear (hearing), taste buds, nose (smell) and skin.
Skeletal
System
Structure and function of the skeleton.
Articulation and movement. Disorders of bones and joints.
Central
Nervous system
Functions of different parts of the
brain and spinal cord. Neurohumoral transmission in the central nervous system,
reflex action, electroencephalogram, specialized functions of the brain,
cranial nerves and their functions.
Urinary
System
Various parts Structure and functions of
the kidney and urinary tract. Physiology of urine formation and acid-base
balance. Brief Introduction to disorders of the kidney.
Endocrine
Glands
Basic anatomy and physiology of
pituitary, thyroid, parathyroid, adrenal glands and pancreas. Local hormones. A
brief introduction to disorders of various endocrine glands.
Reproductive System
Structure and functions of male and
female reproductive system. Sex hormones, physiology of menstrual cycle, and
various stages of pregnancy and parturition.
Cardiovascular
system
Anatomy of heart and blood vessels,
physiology of blood circulation, cardiac cycle, conducting system of the heart,
heart sound, electrocardiogram, blood pressure and its regulation.
Lymphatic
system
Composition, formation and circulation
of lymph. Spleen and its functions.
PATHOPHYSIOLOGY
Basic
principles of cell injury and adaptation
Causes, pathogenesis and morphology of
cell injury, apoptosis and necrosis.
Basic
mechanisms of inflammation and repair
Pathogeneses of inflammation. Chemical
mediators in inflammation. Pathogenesis of chronic inflammation. Repair of
wounds in the skin, factors influencing healing of wounds.
Disorders
of fluid, electrolyte and acid-base balance
Disorders
of homeostasis: white blood cells, lymphoid tissues, and red blood cells
related diseases.
Immunopathology
including amyloidosis
1. Host parasite Relationship: - normal microbial
flora of human body, infection vs. disease, Pathogenicity vs. Virulence, Koch
& Rivers Postulates, Reservoir of infection-sources of infection, Portals
of Entry, Portals of exit, vectors of infection, communicability of disease,
recognized symptoms of microbial disease, classification of immunity.
·
External defense mechanism of host: Skin, Mucus membrane, chemical
Secretions, Naturally occurring microbial flora.
·
Internal
defense Mechanism: Inflammation, fever, natural killer Cells, Phagocytic Cells,
Soluble mediators-complement Lymphokines, Interferons.
2. Immune response :
·
Specific
immunity & immune response
·
Humoral
immunity antibody response, mediators of Humoral immunity, basic structure of
antibody, antibody classes & functions, maturation of immune response,
immunologic memory.
·
Antigens:
specificity & Immunogenicity, Natural vs. artificial Antigens, Soluble,
cellular antigens, thymus independent antigen, adjuvant.
·
Hypersensitivity
and its types
Cellular
immunity: Transplantation immunity, Cellular immunity to viruses, Implications
of T-cell response. Acquisition of specific immunity: Natural vs. Passive
acquisition.
Mechanism of
autoimmunity. Classification of autoimmune diseases in man. Transplantation and
allograft reactions, mechanism of rejection of allograft. Acquired Immune
Deficiency Syndrome (AIDS).
Infectious
diseases
Hepatitis - Infective hepatitis.
Sexually transmitted diseases (syphilis,
gonorrhea, HIV). Pneumonia, typhoid, urinary tract infections. Tuberculosis.
Leprosy. Malaria. Dysentery (Bacterial and amoebic).
Neoplastic
diseases
Disturbances of growth of cells. General
biology of tumors, differences between benign and malignant tumors.
Classification of tumors. Historical diagnosis of malignancy. Etiology and
pathogenesis of cancer. Invasions, metastasis, patterns of spread of cancer.
Environmental carcinogenesis.
Pathophysiology
of common diseases
Parkinsonism. Schizophrenia. Depression
and mania
Stroke (ischemic and hemorrhage).
Hypertension. Angina. Myocardial infarction, CCF. Atherosclerosis.
Diabetes mellitus.
Peptic ulcer and inflammatory bowel
disease. Cirrhosis and alcoholic liver diseases. Acute and chronic renal
failure.
Asthma and chronic obstructive airway
diseases.
Laboratory
tests for Liver function tests and kidney function tests
MICROBIOLOGY
Introduction
to Microbiology
Scope and application to pharmacy field.
Whittaker's Five Kingdom concept, historical development - biogenesis Vs.
abiogenesis, Germ theory of fermentation, Germ theory of disease, the
contribution of Leeuwenhoek, Robert Koch, Jenner, Louis Pasteur and Ehrlich.
Microscopy
and staining technique
The principle, ray diagram,
construction, working and applications of light compound, dark field, phase
contrast, Fluorescence & electron microscope. The concept of resolving
power, Magnification power, numerical aperture and angular aperture and working
distance. The principle application of oil immersion microscopy. Theory of
staining, principle and technique of staining procedure - Monochrome, Gram,
acid-fast, negative, capsule, endospore.
Biology
of Microorganisms
Cultural characteristics, pure culture
techniques
Bacteria - Morphology and fine structure
of bacteria, Nutritional requirement and type of culture media, growth and
growth curve of bacteria, physical condition for growth, measurement of
bacterial growth (Counting Methods), Reproduction in bacteria, genetic exchange
- transformation, conjugation, and transduction, development of drug resistance
by recombination and mutation, preservation of bacterial culture. Biochemical
properties (sugar fermentation and IMVIC test). Pathogenesis of Staphylococcus,
Mycobacterium. Salmonella Introductory study of disease-causing rickettsia, the
importance of actinomycetes in antibiotic production.
Fungi
and Viruses
Fungi:- Introduction, general
characteristics, morphology, the industrial and medical significance of
Saccharomyces Cerevisae, Penicillium and Aspergillus, Candida Albicans,
Epidermophyton, and trichophyta.
Viruses: - Introduction, structure and
general properties Bacteriophages - Lytic and Lysogenic cycle, Epidemiological
uses of Bacteriophages, human viruses - Cultivation and Multiplication
virus-host cell interaction, Pathogenesis of HIV and Prions, types of Tumor
viruses.
Aseptic
Technique
The omnipresence of microorganisms, the
importance of asepsis, sources of contamination and methods of prevention,
Principle, construction & working of laminar airflow bench.
Sterilization
& Disinfection
Concept and classification, principle
and methods of sterilization, Mechanisms of cell injury.
Construction working & applications
of moist heat & dry heat sterilizer, gamma radiation sterilizer, filtration
sterilizer. Indicators of sterilization, microbial death, kinetic terms-D
value, z value.
Terminology of chemical antimicrobial
Agents, Chemical classification of different disinfectants, characteristics of
ideal disinfectants, factors affecting the action of disinfectants, evaluation
methods (RW Coeff.), Kelsey Sykes test, Chick Martin test.
Microbial
spoilage
Types of spoilage, factors affecting
spoilage of pharmaceutical products.
Vaccines
& Sera
Manufacturing (seed lot system) and
quality control of bacterial vaccines & Toxoids (Tetanus, TAB, Cholera,
BCG, DPT), Viral vaccine (Polio- Salk Sabin, Rabies, MMR, Hepatitis,
Chickenpox, influenza), Antisera (diphtheria, tetanus), antiviral Antisera
(rabies). Preparation of allergenic extracts & diagnostics.
Microbial
Assay
Importance, general methods of assay of
antibiotics (Cup & plate method, paper disc method, turbidometry, dilution
method), methods for fungicidal & antiviral compounds, assay, microbial
limit tests.
DISPENSING & HOSPITAL PHARMACY
1. Introduction to laboratory equipment, weighing methodology, handling of
prescriptions, labeling instructions for dispensed products.
2. Posological calculations involved in
the calculation of dosage for infants. Enlarging and reducing formula,
displacement value.
3. Preparations of formulations
involving allegation, alcohol dilution, isotonic solution.
4. Study of current patent and
proprietary products, generic products and selected brand products,
indications, contraindications, adverse drug reactions, available dosage forms
and packing of
Ø Antihypertensive
drug
Ø Antiamoebic
drugs
Ø Antihistaminic
drugs
Ø Antiemetic drugs
Ø Antacids and
ulcer healing drugs.
Ø Antidiarrheals
and laxatives Respiratory drugs
Ø Antibiotics
Ø Analgesics and
antipyretic drugs.
Compounding
and dispensing of following prescriptions
Ø Mixtures
Ø Solutions
Ø Emulsions
Ø Lotions
(External preparations)
Ø Liniments
(External preparations)
Ø Powder
Ø Granules
Ø Suppositories
Ø Ointments /
Paste
Ø Cream
Ø Incompatibility:
Prescription based on physical, chemical and therapeutic incompatibility.
Ø Tablets
Ø Inhalations
Reading
and counseling of prescriptions from the clinical practice.
Ø Designing from
mock Pharmacy: Layout and structure of retail Pharmacy, compounding,
dispensing, storing, labeling, pricing, recording and counseling of
prescription.
Ø Procurement of
information for the given drug for drug information services. Preparation of
Hospital Formulary.
PHARMACEUTICS
Pharmacy
Profession & Introduction to Pharmaceuticals
Pharmacy as a career, evaluation of
Pharmacy, earlier period middle to modern ages. Definition, importance of
pharmaceuticals, areas concerned, scope of Pharmaceutics, history and
development of the profession of Pharmacy and Pharmaceutical industry in India.
A brief review of present Indian Pharma. Industry in global perspective.
Introduction
to dosage form
Definition of the drug. New drug and
dosage form. The desirable properties of a dosage form, the need of dosage
form. Ideas about the available type of dosage forms and new drug delivery
system.
Sources
of drug information
Introduction to Pharmacopoeia with
reference to IP, BP, USP and International Pharmacopeia. Study of
structure/features (index) general notice and compartment of monographs of
excipients, drug and drug product. Other sources. Textbooks, journals, internet
(drug information system, online database, patient/ consumer information and
non- print material. Classification of information, primary, secondary and
tertiary. Nomenclature of the drug.
Allopathic
dosage form
Merits/demerits, importance, formulation
development - vehicles/excipients with examples for the dosage form: liquid
dosage form: monophasic liquid dosage form. Aromatic waters, syrup, elixir,
linctus, lotion, liniment, glycerites, solutions, spirits, ENT preparations,
mixtures, paints, mouthwash.
Crude
extract
Infusion, decoction, maceration,
percolation, tincture and extract. Methods of preparations of dry, soft and
liquid extract.
Allergenic
extract
Types of allergens, preparation of
extract, testing and standardization of extracts.
Biological
products
Absorbable and non-absorbable material
types, sutures and ligatures, processing, manufacturing, sterilization,
packing, QC tests of materials like catgut and nylon.
Pharmaceutical
Plant, location, layout
Plant location and layout of an
industry. Various factors affecting locational aspects of chemical and
pharmaceutical plants. The layout of plant building and importance of flow
sheet, the difference between scientific process and technological process, the
layout of various departments, equipment, and product layout v/s process
layout.
Dosage
Form Necessities and Additives
Antioxidants, preservatives, coloring
agents, flavoring agents and diluting agents, emulsifying agents, suspending
agents, ointment bases, solvents, and others.
Powders
Advantages and limitations as dosage
form, manufacturing procedure and equipment, special care and problems in
manufacturing powders, powders of IP, effervescent granules and salts.
Capsules
Hard gelatin capsules, shell formulation
and manufacturing, capsule sizes, storage, filing, cleaning process general
formulation contents and evaluation. Soft gelatin capsules, shell formulation,
formulation contents, filing, sealing and storage. Microencapsulation,
advantages, encapsulation materials, methods of microencapsulation, I.P. formulations
Tablets
Types, ideal requirement,
classification, granulation methods, general formulation, compression machines,
different types of tooling’s, difficulties in tableting, troubleshooting
aspects, evaluation, sugar coating, compression coating, film coating, problems
in tablet coatings and their troubleshooting aspects. IP formulations.
Parenterals
- product requiring sterile packaging
Definition, types advantages and
limitations, general formulation, vehicles, production procedure, production facilities,
controls, tests, selected IP injections, sterile powders, implants, emulsions,
suspensions.
Suspensions
Formulation of deflocculated and
flocculated suspension, manufacturing procedure, evaluation methods, IP
suspensions.
Emulsions
Types, emulsifying agents, general
formulation, manufacturing procedure, evaluation methods, IP emulsions.
Suppositories
Ideal requirements, bases, manufacturing
procedure, evaluation methods, IP products.
Semisolids
Definitions, bases, general formulation,
manufacturing procedure, evaluation methods, IP products.
Liquids (solutions, syrups, elixirs, spirits,
aromatic water, liquid for external uses)
Definition, types, general formulation,
manufacturing procedure, evaluation methods, IP products.
Pharmaceutical
Aerosols
Definition, propellants, general
formulation, manufacturing and packaging methods, pharmaceutical applications.
Impacts of propellants on the environment.
Ophthalmic
preparations
Requirement, formulation, methods of
preparation, containers, evaluation, IP products.
Preformulations
Consideration of Importance, physical
properties, physical forms, particle size, crystal forms, bulk control,
solubility, wetting, flow cohesiveness, compressibility, organoleptic
properties and its effect on final product consideration of Chemical
properties, hydrolysis, oxidation, recemization, polymerization, isomerization,
decarboxylation, enzymatic decomposition, formulation additives, stabilizers,
suspending and dispersing agents dyes, solid excipients etc. and its effect on
quality of finished product.
Stability
of formulated products
Requirements, drug regulatory aspects,
pharmaceutical products stability, shelf life, overages, containers, closures.
Reaction rate and order, acid-base
catalysis, destabilization and accelerated stability testing.
Prolonged
Action Pharmaceuticals
Benefits, limitations, oral products,
terminology, drug elimination rate, types and construction of implants
products, product evaluation, parenteral products, absorption and evaluation.
Novel
Drug delivery system
Critical fluid technology, transdermal
drug delivery system, controlled drug delivery system, multiple emulsion,
nanoparticles, targeted drug delivery system, aerosols, inhalation & new
products reported etc.
GMP
and Validation
Introduction to GMP, QC and QA. Concept
and need of good manufacturing practice guidelines. Elements of GMP covering
controls of area and processes and product. Regulations related to GMP.
Introduction of the validation process. Types of validation. The brief
methodology of process, equipment and instrument validation.
Packaging
Materials
Role and features of Pharmaceutical
packing materials. Glass, plastic, rubber, metal and paper as pharmaceutical
packaging material. General quality control of pharmaceutical packages.
Primary, secondary and tertiary packaging materials. Child resistant and
pilfer-proof packaging.
Cosmetics
Formulation and preparation of
dentifrices, hair creams, lipsticks, face powders, shaving preparations, skin
creams, shampoos, hair dyes, depilatories, manicure preparations etc.
Pilot
plant scale-up techniques
Need, organization and layout, scale-up
techniques for solid and liquid dosage forms. Technology transfer.
BIOPHARMACEUTICS AND PHARMACOKINETICS
Bio-pharmaceutics
Ø The fate of drug
after drug absorption, various mechanisms for drug absorption, drug
concentration in blood, biological factors in drug absorption, physicochemical
factors, dosage form consideration for gastrointestinal absorption.
Ø Drug Absorption:
Ø Gastrointestinal
absorption-biological considerations.
Ø Gastrointestinal
absorption - physicochemical considerations. Gastrointestinal absorption-role
of the dosage form.
Ø Pharmacokinetics.
Compartmental and non-compartmental pharmacokinetics. Biotransformation, drug
disposition - distribution, drug disposition - elimination. Variability-Body
weight, age, sex and genetic factors. Pharmacokinetic variability- diseases.
Pharmacokinetic variability-drug interactions. Individualization and optimization
of drug dosing regimens.
Bio-availability
& Bio-equivalence
Quality parameters of dosage forms.
Assay methods & its validation.
Physicochemical properties of drugs
& added substances and its effect on preparations and biological
availability of dosage forms. Pharmaceutical properties of dosage forms,
disintegration, dissolution rate. Biological, pharmacological effects of dosage
forms. Factors affecting Bioavailability, Determination of bioavailability.
Significance of bio-equivalence studies.
Statistical analysis of bioequivalence studies. Development, scale up &
post approval changes [SUPAC] & in vitro [dissolution] in vivo [plasma
concentration profile] correlation or IV/IV correlation (IVIVC). Multi stage -
Bioequivalence studies. Therapeutic equivalence. Titration design for clinical
rationales. New Drug Application [NDA].
Bio-
pharmaceutical statistics
Post Marketing Surveillance. Process
Validation.
PHARMACEUTICAL
ENGINEERING
Fluid
flow
Type of flow, Reynold's number,
viscosity, the concept of the boundary layer, basic equation of fluid flow, the
study of valves, flow meters, manometers and measurement of flow and pressure
including mathematical problems.
Heat
transfer
Source of heat, mechanism of heat
transfer, the laws of heat transfer, steam and electricity as heating media,
determination of requirement of the amount of steam/electrical energy, steam
pressure, boiler capacity, mathematical problems on heat transfer, steam traps
and reducing valve, lagging etc.
Evaporation
The basic concept of phase equilibrium,
factors affecting evaporation, evaporators, film evaporators, single effect and
multiple effect evaporators, mathematical problems on evaporation.
Distillation
Raoult's law, phase diagram, volatility:
simple steam and flash distillation, principles of rectification, Mc-Cabe
Thiele method for calculations of a number of theoretical plates, azeotropic
and extractive distillation, mathematical problems on distillation.
Drying
Moisture content and mechanism of
drying, the rate of drying and time of drying calculations, classifications and
types of dryers, dryers used in pharmaceutical industries and special drying
methods like freeze drying and lyophilization, mathematical problems in drying.
Size
reduction and size separation
Definition, objectives of size
reduction, factors affecting size reduction, laws governing in energy and power
requirement of a mill, types of mills including ball mill, hammer mill, fluid
energy mill, micronizer, Quadro co-mil, multi mill etc.
Extraction
Theory of extraction, extraction
methods, equipment for various types of the extractionprocess.
Mixing
Theory of mixing, solid-solid,
solid-liquid and liquid-liquid mixing equipment.
Crystallization
Characteristics of crystals like purity,
size, shape, geometry, habit, forms, size and factors affecting them.
Solubility curves and calculation curves and calculations of heat balance
around S Swanson's Walker crystallizer , supersaturation theory and its
limitations, Nucleation mechanism, crystal growth, study of various types of
crystallizers, tanks, agitated batch, Swanson’s Walker, single vacuums,
circulating magma and crystal crystallizers, cracking of crystals and its
prevention. Numerical problems on yields. Introduction to polymorphism.
Filtration
and Centrifugation
Theory of filtrations, filter aids,
filter media, industrial filters, including filter press, rotary filter, edge
filters, filter leaf and laboratory filtration equipment etc., Factors
affecting filtration, mathematical problems on filtrations, optimum cleaning
cycle in batch filters. Principles of centrifugation, industrial centrifugal
filters and centrifugal sedimentars.
Dehumidification
and humidity control
Basic concept and definition, wet bulb
and adiabatic saturation temperatures, psychometric count and measurement of
humidity, application of humidity measurement in pharmacy, equipment for
humidification and dehumidification operations
Refrigeration
and air conditioning
Principles and applications of
refrigeration and air conditioning.
Material
of constructions
General study of composition, corrosion,
resistance, properties and applications of the materials of construction with
special reference to stainless steel, glass, ferrous metals, cast iron, non
ferrous metals, copper and alloys, aluminum and alloys, lead, tin, silver,
nickel and alloys, chromium and non metals, stone, slate, brick, asbestos,
plastics, rubber, timber, concrete. Corrosion and its prevention with reference
to commonly used material in pharmaceutical plants.
Automated
process control systems
A process variable, temperature,
pressure, flow level and vacuum and their measurement. Elements of automatic
process control and introduction to automatic process control. Elements of
computer-aided manufacturing (CAM).
Industrial
hazards & safety precautions
Mechanical, chemical, electrical, fire,
dust, noise hazards, Industrial dermatitis, accident, records, safety
requirements/equipment etc.
PHYSICAL PHARMACY
Matter,
properties of matter
States of matter, change in the state of
matter, latent heat and vapor pressure, sublimation- critical point, eutectic
mixtures, gases, aerosols- inhalers, relative humidity, liquid complexes,
liquid crystals, glasses state, solid crystalline and amorphous polymorphism.
Micromeritics
and powder rheology
Particle size and distribution, average
particle size number and weight distribution, particle number, methods of
determining particle size and volume, optical microscopy, sieving,
sedimentation, determining surface areas, permeability, adsorption, derived
properties of powders, porosity, packing arrangement densities, bulkiness and
flow properties.
Surface
and interfacial phenomenon
Liquid interface, surface and
interfacial tensions, surface free energy, measurement of surface and interfacial
tension, spreading coefficient, adsorption and liquid interfaces, surface
active agents, HLB classification, solubilization, detergency, absorption at
solid interfaces, solid gas and solid-liquid interfaces, complex films,
electrical properties of interfaces.
Viscosity
and rheology
Newtonian systems, law of flow,
kinematics viscosity, effect of temperature, non- Newtonian systems,
pseudoplastics, dilatant, plastic, thixotropy in formulations, determination of
viscosity and thixotropy by capillary, falling ball, rotational viscometer,
application of theology in pharmacy
Dispersion
systems
Colloidal dispersions: Definition,
types, properties of colloids, protective colloids, application of colloids in
pharmacy.
Suspensions and emulsions: Interfacial
properties of suspended particles settling in suspension, theory of
sedimentation, effect of Brownian movement, sedimentation of flocculated
particles, sedimentation parameters, wetting of particles, significance of electrical
properties in dispersions, controlled flocculation, flocculation in structured
vehicles, rheological considerations, emulsions: types, theories, physical
stability.
Complexation
Classification of complexes, methods of
preparations and analysis, applications.
Buffer
Buffer equations and buffer capacity in
general. Buffers in pharmaceutical systems, preparations and stability,
buffered isotonic solutions. Measurements of tonicity calculations and methods
of adjusting isotonicity.
Solubility
Miscibility-influence of foreign substances
three component systems;
Ø dielectric
constant and solubility, solubility of solids in liquids
Ø ideal and
non-ideal solutions solvation and association in solutions solubility of salts
in water
Ø solubility of
slightly soluble and weak electrolyte
Ø 
calculating solubility of weak
electrolytes as influenced by pH, influence of solvents on the solubility of
drugs
Ø combined effect
of pH and solvents, distribution of solutes between immiscible solvents, effect
of ionic dissociation and molecular association on partition, extraction,
preservatives action of weak acids in emulsions, drug action and distribution
coefficient.
PHARMACOGNOSY
Introductory
Pharmacognosy
Historical development, modern concept
and scope of Pharmacognosy. The significance of Pharmacognosy in various
systems of medicine practiced in India viz: Ayurveda, Unani, Homeopathic and
Siddha.
Classification
of crude drugs
Based on alphabetical, morphological, pharmacological, chemical, taxonomical and chemotaxonomic methods: organized and
unorganized drugs: official and unofficial drugs.
Plants, animals and minerals: marine
products: plant tissue culture.
Factors
influencing quality of crude drugs
Exogenous factors: temperature,
rainfall, daylight, altitude and soil. Endogenous factors: Mutation,
polyploidy, & hybridization in medicinal plants. Production factors
including collection, drying, storage and transport methods.
Study of morphological and histological
characters of crude drugs, Ergastic cell inclusions, anatomical structures of
both monocot and dicot stems, leaves and roots: barks, fruits and seeds.
Techniques
in microscopy
Details of mountants, clearing agents,
chemomicroscopic (microchemical) reagents.
Introduction
to phytoconstituents
Definition, classification, chemical
tests and pharmaceutical importance of: carbohydrates and their derivatives,
fats and proteins, alkaloids, glycosides, flavonoids, steroids, saponins,
tannins, resins, lipids and volatile oils.
Principles
of plant classification
Ø Diagnostic
features and medicinal significance of important plants with special reference
to:
Ø Algae:
Rhodophyceae (Agar, Alginic acid, Diatoms).
Ø Fungi: Ergot,
Yeast and penicillium.
Ø Gymnosperm:
Pinaceae (Turpentine, Colophony), Gnetaceae (Ephedra).
Ø Angiosperm: Apocynaceae, Asteraceae, Lamiaceae, Rubiaceae, Rutaceae, Solanaceae, Scrophulariaceae, Leguminosae,
Papaveraceae, Acanthaceae and Apiaceae.
Ø Pteridophytes:
Male fern.
Pharmaceutical
aids
Biological sources, chemical
constituents, adulterants and uses of: Starches, acacia gum, tragacanth,
sterculia, guar gum, pectin, arachis oil, castor oil, sesame oil, cottonseed
oil, olive oil, cotton, silk, wool, regenerated fibers, asbestos, kaolin,
prepared chalk, kieselguhr.
Animal
products
Biological sources, chemical
constituents, adulterants and uses of: Shellac, cochineal, cantharides,
woolfat, lard, beeswax, honey, musk, lanolin, gelatin.
Plant
products
Introduction to plant bitters,
sweeteners, nutraceuticals, cosmeceuticals and photosensitizing agents.
Toxic
drugs
Study of allergens, hallucinogens,
narcotics.
Enzymes
Biological sources, preparation,
characters, and uses of: diastase, papain bromelain, ficin, yeast, pancreatin,
urokinase, pepsin, trypsin, penicillinase, hyaluronidase and streptokinase.
Natural
pesticides and insecticides
Introduction to herbicides, fungicides,
fumigants and rodenticides tobacco, pyrethrum, & neem.
Adulteration
and evaluation of crude drugs
Different methods of adulteration:
Evaluation of drugs by organoleptic, microscopic, physical, chemical and
biological methods. Deterioration of herbal drugs by insects.
Quantitative
microscopy
Definition and determination of stomatal
index, stomatal number, palisade ratio, vein islet number, vein termination
number, lycopodium spore method. Micrometers and measurement of microscopic
characters.
Biogenetic
pathways
Formation of primary and secondary
metabolites. Study of Calvin cycle, TCA cycle, Shikimic acid pathway,
Embden-Mayerhoff pathway, acetate hypothesis, isoprenoid pathway. Biosynthesis
of carbohydrates, lipids and volatile oils.
Carbohydrates
& lipids
Biological sources, salient
morphological features, chemical constituents, and uses of: Plantago, bael,
chaulmoogra oil, neem oil, shark liver oil, cod liver oil, guggul lipids.
Tannins
Biological sources, morphology, chemical
constituents, chemical test and uses of: Pale catechu, black catechu, nutgalls,
Terminalia belerica, Terminalia chebula, Terminalia arjuna.
Volatile
oils
Biological sources, morphology, chemical
constituents, adulterants and uses of: Black pepper, turpentine, mentha,
coriander, cardamom, cinnamon, cassia, lemon peel, orange peel, lemongrass,
citronella, cumin, caraway, dill, spearmint, clove, anise, star anise, fennel,
nutmeg, eucalyptus, chenopodium, ajowan, sandalwood.
Resinous
drugs
Classification, formation, sources,
chemical constituents, identification test, adulterants and uses of: benzoin,
Peru balsam, tolu balsam, colophony, myrrh, asafoetida, jalap, colocynth,
ginger, turmeric, capsicum, cannabis, podophyllum.
Glycosides
Nature and classification. Biological
sources, morphology, chemical constituents, adulterants and uses of: Digitalis,
strophanthus, squill, thevetia, oleander, cascara, aloe, rhubarb, senna,
quassia, dioscorea, quillaia, glycyrrhiza, ginseng, gentian, wild cherry,
withania, bitter almond. Biosynthesis of cardiac and anthraquinone glycosides.
Alkaloids
Nature, classification, biological
sources, morphology, chemical constituents, adulterants and uses of: Areca nut,
belladonna, hyoscymous, stramonium, duboisea, coca, coffee, tea, cinchona,
opium, ipecac, nux vomica, ergot, rauwolfia, vinca, kurchi, ephedra, colchicum,
vasaca, pilocarpus, aconite, Solanum xanthocarpum. Biosynthesis of tropane,
cinchona and opium alkaloids.
Extraction
and Isolation Techniques
General methods used for the extraction,
isolation and identification of alkaloids, lipids, glycosides, flavonoids,
saponins, volatile oils and resins. Application of column, paper and thin layer
chromatographic techniques, for the isolation of phytopharmaceuticals.
Phytopharmaceuticals
Isolation, identification and estimation
of: caffeine, eugenol, digoxin, piperine, tannic acid, diosgenin, hesperidin,
berberine, calcium sennosides, rutin, glycyrrhizin, menthol, ephedrine,
quinine, andrographolides and guggul lipids.
Quality
control and Standardization of herbal drugs
Quality control of herbal drugs as per
WHO, AYUSH and Pharmacopoeial guidelines-Extractive values, ash values,
chromatographic techniques (TLC, HPTLC and HPLC) for determination of
chromatographic markers. Determination of heavy metals, insecticides,
pesticides and microbial load in herbal preparations.
Herbal
formulations
Principals involved in Ayurveda, Sidha,
Unani, Chinese and Homeopathic systems of medicines. Preparation of Ayurvedic
formulations like aristas, asava, ghutika, tailia, churna, avaleha, ghrita and
bhasmas: Unani formulations like majooms, Safoofs. Determination of alcohol
contents in arishtas & asavas.
Worldwide
trade of crude drugs and volatile oils
Study of drugs having high commercial
value and their regulations pertaining to trade.
Herbal
cosmetics
Importance of herbals as shampoos
(soapnut), conditioners and hair darkeners, (amla, henna, hibiscus, tea), skin
care (aloe, turmeric, lemon peel, vetiver).
Traditional
herbal drugs
Common names, sources, morphology,
active constituents and uses (traditional, folklore), pharmacological and
clinical uses of: punarnava (Boerhaviadiffusa), shankhpushpi (Convolvulus microphylla),
lehsun (Allium sativum), guggul (Commiphora mukul), kalmegh (Andrographis
peniculata), tulsi (Ocimum sanctum), valerian (Valerian officinalis), artemisia
(Artemisia annua), chirata (Swertia chirata), ashoka (Saraca indica).
Plants
based industries and research institutes in India
Knowledge about the herbal products
being manufactured by premier herbal industries and thrust area of the
institutes involved in plant research.
Patents
Indian and International patent laws,
proposed amendments as applicable to herbal/natural products and processes:
Intellectual Property Rights with special reference to phytoconstituents.
Ayurvedic
system of medicine
Theory, basic concept, diagnosis,
various branches of treatment in ayurveda, types of the drug formulation in
Ayurveda and important Ayurvedic drugs and their uses, formulation of asavas,
arishtas, watika, churna, tailas, ghruta, lep.
Homeopathic
system of medicine
Theory, basic concept, diagnosis,
treatment, source of homeopathic medicines and important homeopathic drugs and
their uses
PHARMACEUTICAL MANAGEMENT
Introduction
to management
Types of management. Basic concepts of
management, management process, function and principles. Levels of management,
pharmaceutical management art, science or profession.
Social responsibilities of management,
functions of management.
Planning
and Forecasting
Planning: Nature, process and types of
planning, steps in the planning process, planning premises. Advantages and
limitations of planning. Management by objective, meaning, objective features,
advantages and limitations. Forecasting: meaning, nature, importance,
limitations. Techniques of forecasting.
Organization
Definition, nature, theories, functions,
line and staff organization concepts.
Research
Management
R & D organizations and research categories.
Elements needed for an R & D organization. Technology transfer.
Inventory
Management
Objective and functions of inventory
control. Types of inventories. Requirements of effective inventory control.
Communication
Nature, types of communication, process,
channels and barriers of communication. Limitations of communications.
Importance in pharmaceutical industries.
Marketing
Research
New product selection, product
management, advertising.
Leadership
and motivation
Leadership: meaning, nature, leadership
styles. Theories of leadership. Motivation: meaning, nature, importance.
Theories of motivation.
Human
resource and development (HRD)
Definition,
HRD methods, HRD process, HRD in Indian industry.
GATT
General Agreement on Tariff and Trade
and its impact on the pharmaceutical industry. History of GATT, its impact on
the pharmaceutical industry. Pharmaceutical market in
India.
World
trade organization (WTO) and trade-related intellectual property rights (TRIPS)
Introduction to WTO. Types of intellectual
property rights: industrial property and copyrights Indian Patent Acts, 1970
with the latest amendment. Definition, types of patents.
Standard
institutions and regulatory authorities
Ø Bureau of Indian
Standards (BIS).
Ø International
Organization for Standardization (ISO).
Ø United States of
Food and Drug Administration (USFDA).
Ø Central Drug
Standard Control Organization (CDSCO).
Ø International
Conference on Harmonization (ICH).
Ø World Health
Organization (WHO).
PHARMACEUTICAL JURISPRUDENCE
1. Historical
background Drug legislation in India, Code of Ethics for Pharmacists.
2. The Pharmacy Act
1948 (inclusive of recent amendments).
3. Drugs and
Cosmetics Act 1940, Rules 1945, including New Drug applications.
4. Narcotic Drugs
and Psychotropic Substances Act, and Rules thereunder.
5. Drugs and Magic
Remedies (Objectionable Advertisements) Act 1954.
6. Medicinal and
Toilet Preparations (Excise Duties) Act 1955, Rules 1976.
7. Medical
Termination of Pregnancy Act 1970 and Rules 1975.
8. Prevention of
Cruelty to Animals Act 1960.
9. Drug (Price
Control) Order.
10. Shops and
Establishment Act.
11. Factory Act.
12. Consumer
Protection Act.
13. Indian
Pharmaceutical Industry- An Overview.
14. Industrial
Development and Regulation act 1951.
15. Introduction to
Intellectual Property Rights and Indian Patent Act 1970.
16. An Introduction
to Standard Institutions and Regulatory Authorities such as BIS, ASTM, ISO,
TGA, USFDA, MHRA, ICH, WHO.
17. Minimum Wages
Act 1948.
18. Prevention of
Food Adulteration Act 1954 and Rule
