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Course Detail

Course Name Pharmaceutics Practical II
Course Code MPH207P
Program M. Pharm. Pharmaceutics
Semester 2
Credits 6
Campus Kochi

Scope

This course imparts skill set in developing complex drug products, conventional and cosmetic formulations. Students will learn to design drug delivery systems based on theoretical concepts, develop prototypes at the nano/microscale, and conduct comparative studies using in silico and in vitro methods. It also covers the role of physicochemical characteristics of drugs and excipients in formulation development, optimization, evaluation, and stability studies. Students will learn analytical techniques for drug quantification, characterization, and quality control of pharmaceutical products. Students will get hands-on training in in silico methods to optimize pharmaceutical processes.

The course also trains students in formulation of cosmetic products and its evaluation. The course equips students in computing pharmacokinetic parameters using various compartment models. The dissolution behavior of drugs and the release mechanisms are also covered in the subject. The experiments are designed in such a way that the students get an understanding of the concepts of miniaturization of delivery systems and complex pharmaceuticals.

Objectives and Outcomes

COURSE LEARNING OUTCOMES:

Upon successful completion of the course, the student shall be able to get,

KNOWLEDGE

K1 Discuss the principles of drug delivery carriers by controlling the composition/ processing conditions.

K2Describe the methods of preparation and evaluation of various drug carriers constructs like alginate beads, gelatin/albumin microspheres, liposomes, niosomes and spherules.

K3 Apply principles of pharmacokinetic data analysis of drugs administered by various routes.

K4 Plan the dissolution characteristics of dosage forms and protein binding affinity of drugs .

K5Prepare the clinical data collection manual.

K6Design of creams, shampoo and toothpaste by incorporation of herbal/synthetic constituents.

SKILL

S1 Optimize the drug delivery carriers by controlling the composition and processing conditions.

S2Develop various drug carrier constructs like alginate beads, gelatin/albumin microspheres, liposomes and niosomes, spherules.

S3 Determine the dissolution characteristics of marketed formulations

S4 Perform pharmacokinetic data analysis, permeability study, in vitro/ in silico techniques.

S5Design the formulation by Quality by Design (QBD) approach

S6Develop creams, shampoo, toothpaste, incorporation of herbal constituents.

ATTITUDE

A1Appreciate efforts taken meticulous attention to details. A2Embrace the quality control principles of product development. A3Cultivate the ability to think critically..

A4Foster group learning discussions.

A5 Participate effectively in team to achieve goals.

A6 Develop problem-solving ability.

PRACTICALS

S.No.

Experiments

1.

Effect of polymer concentration on formation of aspirin-loaded microspheres.

2.

Study the effect of polymer concentration in drug release of aspirin loaded microspheres.

3.

Effect of cholesterol concentration on formation of drug-loaded niosomes.

4.

Study the effect of cholesterol concentration on formation of niosomes/liposomes.

5.

Study the effect of cholesterol concentration on drug release of drug-loaded niosomes/liposomes.

6.

Stability studies of tablets.

7.

Comparison of dissolution of two marketed products/brands.

8

Protein binding studies of highly protein bound and poorly protein bound drugs.

8.

Analysis of pharmacokinetic data for one compartment model.

9.

Determination of PK parameters of drug from urinary elimination data.

10

Determination of steady state drug concentration after IV infusion.

10.

Determination of absorption rate constant by method of residuals.

11.

Perform in vitro permeability studies by open end tube.

12

Optimization of formulation by DOE.

12.

Apply QbD for the given drug product/process.

13.

ADME determination using Swiss-ADME software.

14.

Develop a clinical data collection manual.

15.

Preparation and evaluation of turmeric herbal cold cream/tomato extract vanishing cream.

16.

Preparation and evaluation of charcoal/fluoride gel tooth paste.

17.

Formulation and evaluation of polyherbal anti-aging face cream of rose and coriander extract.

Text Books / References

REFERENCE BOOKS

  1. Y Chien, Novel Drug Delivery Systems, 2nd Edn, revised and expanded, Taylor and Francis, Marcel Dekker, Inc., New York, 1992.
  2. Shargel, S. Wu-Pong, A. Yu, Applied biopharmaceutics and pharmacokinetics. 7th Edn., Connecticut Appleton Century Crofts, 1985
  3. Swarbrick, J. G. Boylan, Encyclopedia of Pharmaceutical Technology, Vol 13, Ist Edn., Marcel Dekker Inc, Taylor & Francis, New York, 1996.
  4. Donbrow, Microcapsules and Nanoparticles in Medicine and Pharmacy, CRC Press, 2020.
  5. S. Kwon, M. M. de Villiers, P. Aramwit, Nanotechnology in Drug Delivery, Ist Edn., Springer, New York, 2009.
  6. L. Wise, R. S. Langer, Medical Applications of Controlled Release, Ist Edn., CRC Press, 2019.
  7. Li, B. R. Jasti, Design of Controlled Release Drug Delivery Systems, Ist Edn., McGraw-Hill Education, 2005.

Journals:

  1. Journal of Controlled Release (Elsevier).
  2. Advanced Drug Delivery Reviews (Elsevier).
  3. Biomaterials (Elsevier).
  4. Indian Journal of Pharmaceutical Sciences (IPA)
  1. Journal of Biomaterial Applications (SAGE).
  2. Drug Development and Industrial Pharmacy (Marcel&Decker) (Desirable).
  3. Trends in Biomaterials and Artificial Organs India, (SBAOI).
  4. ACS Biomaterial Science and Engineering, (ACS).
  5. Pharmaceutical Research, (Taylor and Francis).
  6. Colloids and surfaces B Biointerfaces, (Elsevier).
  7. Indian drugs (IDMA)

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