KM Kundnani College's Moodle Portal

Module 1

: Data Integrity Definitions and Principles

Module 2

: Documentation : Good Documentation Practices

Module 3

: Data governance and Risk Management : Laboratories,Manufacturing, QA

Module 4

: GAMP and Electronic Data Management

Module 5

: Regulatory Expectations :WHO/FDA/MHRA/EU/PICS/Health Canada

Module 6

: EU/FDA Inspection Case Studies : With Focus on theHuman Element

Module 7

: Good Practices in Data Management and Quality RiskManagement

Module 8

: Role Play and Assessment.

The course deals with the various physical and physicochemical properties, andprinciples

involved in dosage forms/formulations. Theory and practical components of the subject help

the student to get a better insight into various areas of formulation research and development,

and stability studies of pharmaceutical dosage forms.

Scope: The main purpose of the subject is to understand what drugs do to the living organisms and how their effects can be applied to therapeutics. The subject covers the information about the drugs like, mechanism of action, physiological and biochemical effects (pharmacodynamics) as well as absorption, distribution, metabolism and excretion (pharmacokinetics) along with the adverse effects, clinical uses, interactions, doses, contraindications and routes of administration of different classes of drugs. 

Objectives: Upon completion of this course the student should be able to

 1. Understand the pharmacological actions of different categories of drugs 

2. Explain the mechanism of drug action at organ system/sub cellular/ macromolecular levels.

 3. Apply the basic pharmacological knowledge in the prevention and treatment of various diseases.

The course deals with

1. Source, Composition, General methods of Extraction, Evaluation, chemical tests, therapeutic uses of drugs containing phytoconstituents like steroids, triterpenoids, anthraquinone, flavanoids and alkaloidal glycoproteins.

2. Biosynthesis of alkaloids from different Amino acids

3. Regulatory requirements for manufacture of ASU

4. Excipients from natural sources

5. Herbal drug formulation and challenges.

6. Pharmacodynamic and Pharmackinetic formulations

7. Spectroscopic techniques to characterize natural molecules.

Course Objectives

1. To make the learner understand the concept of nutraceuticals and dietary supplements along with the classification with respect to health benefits, chemical nature and mechanism of action.

2. To expose the learner to the health benefits of various classes of phytochemicals along with their salient chemical features, pharmacokinetics, doses and marketed preparations.

3. To introduce to the learner the formulation challenges of nutraceuticals and health supplements and the importance of the safety and stability of nutraceutical formulations.

4. To make the learner aware of the regulatory aspects of nutraceuticals in India and major countries

Course Outcomes

Upon completion of the course student will be able to –

1. Explain concept of nutraceuticals and dietary supplements, classify these based on chemical nature, health benefits and mechanism of action.

2. Discuss the chemistry of phytochemicals, their health benefits, pharmacokinetics, interactions with food and recommended doses along with the marketed preparations.

3. Explain the challenges in formulating nutraceuticals.

4. Understand the significance of safety and stability studies of nutraceuticals.

5. Describe the labeling and regulatory aspects for manufacture and sale of nutraceutical products.

PIC by Dr Meena Kanyalkar

Unit 2: i) Acid, base and buffer ii) Major and minor electrolytes, iii) Dental products

Unit 5: Radiopharmaceuticals

The Course will make students understand 

a. Extraction of Phytoconstituents, Plant Tissue culture

b. Utility of Natural Products

c. Complete Pharmacognosy & Phytochemistry of drugs containing Volatile oils, Resins and Tannins.

d. Excipients of Natural origin-Colourants, sweeteners, binders & diluents.

Final Year CBCS Pharmacognosy III (Theory) 

1.       To introduce the learner to the chemistry, sources, cultivation and collection of crude drugs containing phytoconstituents like steroidal, triterpenoidal, anthraquinone, flavonoid glycosides and alkaloids. 

2.       To introduce the learner to the biosynthesis of alkaloids obtained from different amino acids 

3.       To introduce the learner to glycoproteins with the representative examples and their utility in diagnosis or therapeutics. 

4.       To make the learner aware of regulatory requirements for manufacture and sale of Ayurvedic, Siddha and Unani (ASU) Medicines and Phytopharmaceuticals, monographs of herbal drugs 

5.       To make the learner understand formulation aspects and challenges of Herbal formulations, standardization and interactions of drugs of natural origin 

6.       To apply the spectroscopic techniques in characterization of phytoconstituents of both aliphatic and aromatic nature

Final year Pharmacology III MMS