Title of the Course Assignments (Pharmaceutical Analysis)
Marks 50
Number of Hours per week 2
Total Hours 30
Class T. Y. B.Pharm.
Semester VI
Sr.No Topic
1. There will be several problem solving sessions where there will be discussions on
methodology and approaches to solve problems including discussions on how to gather
information from internet and literature. The problems will be given to the students as home
60
assignments where students can go through the literature and come out with solutions and
present it in the class. There shall be many assignments. No assignment shall be of more than
10 marks. The student shall submit the assignment in A4 size paper either hand written or
typed and pinned together. Marks will be awarded by the teacher and at the end of the
semester teacher will submit the marks along with the assignment copies of all the students
to the office.
Laboratory
Books Recommended: As recommended by the teacher
Title of the Course Pharmaceutical & Medicinal Chemistry Laboratory - I
Marks 50
Number of Hours per week 4
Total Hours 60
Class T.Y. B.Pharm.
Semester VI
Sr.No. Topic Hrs.
Functional group transformation: Minimum one exercise to be given for each of the preceding
types of transformations, if possible leading to synthesis of drugs or drug intermediates
1 Esterification (synthesis of acetyl salicylic acid) 8
2 Hydrolysis 4
3 Amide formation (acetylation, benzoylation), 8
4 Diazotization and coupling 4
5 Bromination 4
6 Nitration and Sulfonation in aromatic rings 8
7 Simple oxidation and reduction reactions 8
8 Synthesis of Heterocycles (e.g. Hydantoin, Benzimidazole ) 8
9 Aliphatic substitution reactions 4
10 Clasien / aldol condensation 4
Title of the course Pharmaceutics Laboratory - III
Marks 50
Number of hours per week 4
Total hours 60
Class T.Y. B.Pharm
Semester VI
Sr.No. Experiment
1 At least one representative example of each formulation type included in theory of
Pharmaceutics IV and V(Preparation and evaluation, with stress on official formulations)
61
Books Recommended
Sr.No. Title Author/Editor Edition Publisher
1 Vogel’s A Text book of
Practical Organic Chemistry
A. Vogel 3rd,
1962
Longman group limited,
London
2 Advanced Practical Organic
Chemistry
J. Leonard, trvor
P. Toube, B.
Lygo, G.
Proctor
2nd ,
1990
Stanley Thornes
3 Practical Organic Synthesis:
A Student's Guide
Reinhart Keese,
Martin P.
Brändle
Title of the Course Pharmaceutical Analysis Laboratory-II
Marks 50
Number of Hours per week 4
Total Hours 60
Class T.Y. B.Pharm.
Semester VI
Sr.No Experiment Hrs.
1 Atomic absorption spectroscopy (Alkali earth metal determinations) ** 4
2 Absorption spectroscopy (UV, Visible); ** 8
3 Fluorescence spectroscopy (Quinine salt), Quenching phenomenon. ** 4
4 Chromatography (PC, CC, TLC) application to reaction monitoring, purity
assessment of drugs, separation of the mixtures.
12
5 Medicaments in formulations**: Liquid oral, tablet, injectable, aerosol, capsule,
ointment, eye drops, suppositories, lozenges, etc. (one each);
16
6 Multi component analysis for drugs in combination**. eg: Using simultaneous
equation method, using iso absorption point method, Using solvent extraction
method, Using colorimetric and UV methods.
8
7 Refractometry**
Caibration of Abbe’s Refractometer, Estimation of refractive index of natural oils
and laboratory solvents , determination of the percentage of glycerin in the unknown
by calibration curve.
4
8 Polarimetry **
Instrument information, Optical rotation of dextrose solution, determination of
specific optical rotation of ethambutol,
4
**Applications may also include the compounds to which the techniques are applicable.
62
Title of the Course Pharmacognosy Laboratory-I
Marks 50
Number of Hours per Week 4
Total Hours 60
Class T.Y. B. Pharm.
Semester VI
Sr.No. Experiment
1 Study of simple and compound microscope, magnification, micrometry, and microscopical
drawing using camera lucida, Projection microscope. etc.
2 Studies on morphological features of leaves, roots and rhizomes, stem, flowers, fruits, seeds,
barks, woods, etc
3 Studies of plant tissues : palisade, epidermis, cork, parenchyma, collenchyma, sclerenchyma,
vascular tissues, secretary organs, spores, etc
4 Studies of stomata (diacytic, paracytic, animocytic , anisocytic, dumb-bell shaped stomata, etc.)
5 Studies of covering and glandular trichomes (minimum of 5 each type).
6 Studies of calcium oxalate crystals (acicular, prism, rosette, sandy, microneedles, crystal sheath,
etc.
7 Studies on starches (maize, wheat, rice, potato, etc.).
8 Determination of stomatal number and stomatal index
9 Determination of palisade ratio.
10 Determination of vein-islet and vein termination number
11 Quantitative microscopy using lycopodium spores.
12 Determination of total ash and acid insoluble ash
13 Determination of alcohol and water soluble extractive values
14 Development of thin layer chromatography for two drugs (alkaloids, volatile oils, glycoside, etc
15 Evaluation of volatile oil/fixed oil by R.I
16 Determination of swelling factor (isabgol seed or husk)
17 Determination of moisture content by (Karlfisher method, LOD, etc.)
Seminar:
Every student will be assigned a supervisor. The student will select a topic in consultation
with the supervisor. The seminar will be submitted in spiral bound form well in advance
of presentation. The seminar will be presented by the student as per the schedule put up.
63
Final Year B. Pharm.
SEMESTER VII
Title of the course Pharmaceutics -VI
Marks 50
Number of hours per week 2
Total hours 30
Class Final Year B. Pharm.
Semester VII
Sr.No. Topic Hrs
1. Sterile Products: Introduction to sterile dosage forms, parenteral preparationstypes,
general requirements,
1
2. Containers and closures(glass, plastic, rubber) for parenterals, evaluation and
selection,
2
3. Routes of parenteral administration, Formulation considerations in the
development of a small volume parenterals including solutions, suspensions,
emulsions, dry powders, water for injection (preparation and testing)
5
4. Manufacture of small volume parenterals in ampoules and vials, Freeze drying
of small volume parenterals
3
5. Sterilization methods and evaluation using biological indicators 1
6. Production facilities, layout of production facilities, Air systems, Filters, HEPA
filters,Class considerations, Environment control,
3
7. Quality control tests of small volume parenterals 3
8. Opthalmics: anatomy and physiology of eye, Factors affecting topical
ophthalmic delivery
1
9. Ophthalmic solutions, suspensions, ointments, gels, advantages and limitations,
Formulation considerations, manufacture and packaging, Quality control of
ophthalmics, preservative efficacy test
4
10. Contact lens solutions and their formulation and evaluation 1
11. Blood products and Plasma substitutes: collection and storage of blood, whole
human blood, and products obtained from it, methods used for these and
packaging employed for them, quality control of blood and its constituents;
Plasma substitutes their properties and quality control
2
12. Glandular products: Extraction and isolation of insulin from of pancreas, insulin
injections;
2
13. Sutures and ligatures 1
Books Recommended: As under Pharmaceutics IV
64
Title of the course Pharmacology - IV
Marks 50
Number of hours per week 2
Total hours 30
Class Final Year B. Pharm.
Semester VII
Sr. No. Topic Hrs.
1 CVS: Drugs used in the treatment of Hypertension Congestive cardiac
failure Arrhythmia Hyperlipidemia Angina Pectoris
6
2 Diuretics 4
3 Pharmacology of bronchial asthma and cough 3
4 Immunomodulators: immunostimulants/suppressants 6
5 Principle of toxicology: Heavy metal poisoning, Pesticides, Poisoning, opium
poisoning
4
6 Use of radioisotopes in medicine 3
7 Development of new drug: (Importance of preclinical and clinical studies, phases
of clinical trial and placebo)
4
Books Recommended
Sr.No. Title of the book Author/Editor Edition/Year Publisher
1-4 All Books under Pharmacology –II and
5 The Pharmacological
Basis of Therapeutics
Goodman and
Gilman,
11th 2006 McGraw –Hill Medical
Publishing
Title of the Course Pharmacognosy - II
Marks 50
Number of Hours per Week 2
Total Hours 30
Class Final Year B.Pharm.
Semester VII
Sr.No. Topic Hrs.
1 Carbohydrates – Agar, Alginic acid, Acacia, Aloe vera gel, Bael, Chitin, Dextrans,
Guar gum, Honey, Inulin, Irish moss, Ispaghula, Pectins, Starches, TKP, Tragacanth.
Biosynthesis of carbohydrates in brief
4
2 Acids - Citrus, Tamarind pulp, Garcinia, Amla 1
3 Fatty acids and their esters - Almond oil, Arachis, Castor, Chaulmoogra oil, Coconut
oil, Cotton seed oil, Croton, Linseed, Jajoba, Olive oil, Mustard oil, Neem, Sesame,
Wheatgerm oil, Fish liver oil, Cocoa butter, Kokum butter, Woolfat, Beeswax,
Carnauba wax, lecithin, Spermaceti. Biosynthesis of fatty acids and triglycerides.
4
65
4 Protein sand enzymes - Protein hydrolysate, Gelatin,; Pepsin, Renin, Trypsin,
Chymotrypsin, Thrombin, Papain, Ficin, Bromelain, Pancreatin, Hyaluronidase
2
5 Peptide toxins : Abrin, Botulinum toxin, Ricin, Bee venom, Snake venom, Scorpion
venom
1
6 Alkaloids: Derived from Ornithine: Belladonna*, Coca, Datura, Hyoscyamus,
Stramonium
Derived from Lysine :Black pepper*, Lobelia
Derived from Nicotinic acid: Areca, Tobacco
Derived from Phenylalanine: Ephedra
Derived from tyrosine and tyramine : Colchicum*, Opium*, Ipecac
Derived from tryptophan: Cathatharanthus, Cinchona*, Ergot*, Nuxvomica,
Rauwolfia
Derived from anthranilic acid : Vasaka
Derived from histidine : Pilocarpus
Purine alkaloids : Cocoa , Coffee, Cola, Tea
Terpenoid alkaloid : Aconite
Steroidal alkaloid : Kurchi, Solanum
20
7 Study of fibers (animal, vegetable, mineral, & synthetic) : Cotton, Jute, Flax,
Viscose, Cellulosics, Silk, Wool, Asbestos, Glasswool, Nylon, Terylene, Polythene
3
Books Recommended ; Will be recommended by the teacher
Title of the Course Pharmaceutical & Medicinal Chemistry-V
Marks 50
Number of Hours per week 2
Total Hours 30
Class Final Year B.Pharm.
Semester VII
Sr. No. Topic Hrs.
1 Antidiabetic agents:
a) Insulin
b) Sulfonylureas
c) PPAR-agonists and Misc.
1
2
1
2 Steroids:
a) Nomenclature and 3-D structure of steroids.
b) Biosynthesis and metabolism of steroids.
c) Corticosteroids – Glucocorticoids - systemic topical and inhaled,
Mineralocorticoids.
d) Male sex steroids and other related agents – Androgens and anabolic
steroids, Antiandrogens, androgen biosynthesis inhibitors, Drugs for
erectile dysfunction.
e) Estrogens- steroidal and non-steroidal, antiestrogens, SERMs. Aromatase
inhibitors.
Progestins & its inhibitors.
1
1
3
2
2
1
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3 Thyroid Agents:
a) Thyroid hormone and analogs.
b) Antithyroid agents
1
4 Introduction to eiconosides 1
5 Drugs for calcium homeostasis. 1
6 Vitamins and their involvement in metabolism :
a) Water soluble vitamins
b) Lipid soluble vitamins
c)
2
7 Introduction to pharmaceutical biotechnology: 1
8 Peptide and protein drugs 2
9 Introduction to antisense agents 1
10 Introduction to drug discovery:
a) Drug discovery from natural products.
b) Molecular modeling and drug design-ligand and structure based.
c) Enzymes and receptors in drug design.
Analog design and prodrugs
1
2
2
1
11 Emerging areas in medicinal chemistry. e.g. drugs based on PDEs and other
topics of current interest.
1
Books Recommended: As under Pharmaceutical Medicinal Chemistry –IV
Title of the Course Pharmaceutical Analysis-V
Marks 50
Number of Hours per week 2
Total Hours 30
Class Final Year B.Pharm.
Semester VII
Sr.No Topic Hrs.
1. Raw material analysis (RMA), Quality control of pharmaceutical excipient 5
2. Packaging material testing (PMT): Packaging material testing, permeability of
plastic, testing of foil, bottles, carrions, shipment.
6
3. Thermal analysis: Theory, introduction and applications of thermogravimetric
analysis (TGA), differential thermal analysis, DSC (Differential Scanning
Calorimetry), thermogravimetry – instruments available;
7
4. Atomic emission and atomic absorption spectrophotometry: Theory, introduction
and application;
5
5. Statistics and statistical quality control: Statistics in quality control – definition of
terms, normal distribution, T-test, F-test, linear regression, correlation coefficient,
statistical validation of analytical procedures – application to analysis; Methods of
statistical analysis as applied to sampling and interpretation of results, regression
regression lines – sampling procedures; Statistical quality control charts; Case
studies to be included.
7
Books Recommended: As under Pharmaceutical analysis –IV
67
Title of the course Biopharmaceutics And Pharmacokinetics
Marks 50
Number of hours per week 2
Total hours 30
Class Final Year B. Pharm.
Semester VII
Sr.No. Topic Hrs
1. Introduction: Definition: absorption, distribution, metabolism, excretion,
elimination, first pass effect, enterohepatic cycling, bioavailability,
biopharmaceutics, pharmacokinetics and pharmacodynamics
2
2. Pharmacokinetics parameters: biological half life, volume of distribution,
clearance: renal clearance, nonrenal clearance, additively of clearance, absolute
bioavailability relative bioavailability, bioequivalence, and other parameters
2
3. Concepts of compartment models: Pharmacokinetics of one compartment model,
mathematical treatment to pharmacokinetics upon i.v. bolus dosing, i.v. infusion
and first order extra vascular input; Methods of estimation of pharmacokinetic
parameters and parameters for bioavailability/ bioequivalence – including method
of residuals, excretion rate method, and sigma minus method of estimation of renal
clearance, renal clearance, mean residence time; Wagner Nelson method
8
4. Multicompartment models: Concepts and examples (excluding derivation or
mathematical treatment)
1
5. Plasma concentration and therapeutic response and introduction to
pharmacodynamics;
1
6. Non-linear pharmacokinetics: Non-linearities in absorption distribution,
metabolism and elimination, examples of drug showing nonlinear
pharmacokinetics
2
7. Dosage regimens: Factors affecting dosage regimens, individualization of dosage
regiments, therapeutic window, multiple dose pharmacokinetics, fluctuation,
accumulation index, steady state concept, time to reach steady state, loading dose,
maintenance dose, dose requiring individuation of dosage regimens
2
8. Drug absorption: Different mechanism of drug transport, passive transport and pH
partition theory, facilitated diffusion, active transport, blood and its drug binding
constituents as carriers of drugs in the body; Perfusion limitation and permeability
limitation and permeability limitation in drug transport; Physicochemical and
physiological factors affecting the absorption of drugs
4
9. Distribution: rate of distribution, perfusion limitation and permeability limitation,
extent of distribution , plasma and tissue binding of drugs, drugs with small,
intermediate and high volume of distribution and their relative plasma and tissue
binding
3
10. Elimination: Organ clearance concepts, hepatic clearance, hepatic extraction ratio,
blood flow limitation in hepatic clearance, first pas effect; Clinical application :
Effect of enzyme induction, enzyme inhibition, blood flow and protein binding on
hepatic clearance, bioavailability, steady state plasma concentration and dosage
3
68
regimens, renal clearance and mechanisms of renal excretion, estimation of renal
clearance, factors affecting renal elimination, clinical applications, biliary
clearance, enterohepatic circulation and other miscellaneous modes of drug
elimination
11. In vitro: in vivo Correlation: Official and unofficial methods of estimation of
dissolution / in – vitro release of drugs from dosage forms; In-vitro in-vivo
correlation and its significance.
2
Books Recommended
Title of the Course Pharmaceutical Biotechnology
Marks 50
Number of Hours per Week 2
Total Hours 30
Class Final Year B. Pharm.
Semester VII
Sr. No Topic Hrs.
1 Defintition of biotechnology, the different aspects of biotechnology,
pharmaceutical biotechnology and its role in producing therapeutics and
diagnostics and in health care
4
2 Therapeutic proteins, Nucleic acids (Antisense RNA technique).Animal and plant
cell culture: Brief introduction to cell culture with respect to the properties of
animal and plant cells, media requirements, typical media used, typical methods
for setting up primary culture, cell strains vs cell lines. Use of plant/animal cell
culture for production of pharmaceuticals. Recombinant DNA technology for
plant cell culture via use of Agrobacterium species.
6
Sr.No. Title Author/Editor Edition Publisher
1 Biopharmaceutics &
Pharmacokinetics-A
Treatise
D.M. Brahmankar,
Sunil B. Jaiswal
1st, 1995 Vallabh Prakashan
2 Biopharmaceutics &Clinical
Pharmacokinetics-An
Introduction
Robert E. Notari 4th, 1971 Marcel Dekker Inc.
3 Clinical Pharmcokinetics-
Concepts & Applications
Malcolm Rowland
Thomas N. Tozer
2nd, 1989 Lea &
Febiger,Philadelphia
4 Biopharmaceutics &Clinical
Pharmacokinetics
Milo Gibaldi 3rd, 1984 Lea & Febiger,
Philadelphia
5 Pharmacy Review Leon Shargel 1990 Wiley Medical
Publication
6 Principles & Applications of
Biopharmaceutics &
Pharmacokinetics
Dr.H.P.Tipnis
Dr.Amrita Bajaj
2004 Career Publication
69
3 Genomics in Clinical Diagnostics: Restriction fragment length polymorphism,
Gel electrophoresis techniques (PAGE, SDS-PAGE and agarose gel
electrophoresis), immunoblotting, Southern blotting, Northern blotting, Western
blotting, PCR and RT PCR, Sanger dideoxy method of sequencing.
3
4 Immunity, methods of immunization, principles of serology, antigen antibody
reactions, generation of immune response, polyvalent antibodies, hypersensitivity
responses. Preparation and characterization of immune sera, and allergenic
extracts. Monovalent antibodies or monoclonal antibodies, hybridoma
technology, humanization of monoclonal antibodies, application of monoclonals
in therapeutics and diagnostics RIA and ELISA diagnostic methods.
6
5 Vaccines: Preparation and standardization of vaccines. Discussion of different
types of vaccines, different approaches for vaccine preparation and their quality
control parameters
4
6 Pharmacogenomics 4
7 Tutorials 3
Books Recommended : Will be recommended by the teacher
Title of the Course Assignments (Medicinal Chemistry)
Marks 50
Number of Hours per week 2
Total Hours 30
Class Final Year B.Pharm.
Semester VIII
Sr. No. Topic
1. There will be several problem solving sessions where there will be discussions on
methodology and approaches to solve problems including discussions on how to gather
information from internet and literature. The problems will be given to the students as
home assignments where students can go through the literature and come out with
solutions and present it in the class. There shall be many assignments. No assignment
shall be of more than 10 marks. The student shall submit the assignment in A4 size paper
either hand written or typed and pinned together. Marks will be awarded by the teacher
and at the end of the semester teacher will submit the marks along with the assignment
copies of all the students to the office.
Title of the Course Assignments (Biopharmaceutics)
Marks 50
Number of Hours per week 2
Total Hours 30
Class Final Year B.Pharm.
Semester II
Sr.No Topic
1. There will be several problem solving sessions where there will be discussions on
methodology and approaches to solve problems including discussions on how to gather
information from internet and literature. The problems will be given to the students as
70
home assignments where students can go through the literature and come out with
solutions and present it in the class. There shall be many assignments. No assignment shall
be of more than 10 marks. The student shall submit the assignment in A4 size paper either
hand written or typed and pinned together. Marks will be awarded by the teacher and at
the end of the semester teacher will submit the marks along with the assignment copies of
all the students to the office.
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