Course

Unit 1

Targeted Drug Delivery Systems: (8hrs) History, concepts, molecular aspects of events, and biological process involved in drug targeting.

Tumor targeting and brain-specific delivery.

Challenges and opportunities for controlled release nanomedicines (CRNMs).

Unit 2

Targeting Methods: (10hrs) Introduction, preparation, and evaluation. Nanoparticles & Liposomes: Types, preparation and evaluation.

Monoclonal antibodies, preparation and application.

Preparation and application of niosomes, aquasomes, phytosomes, and electrosomes. Microcapsules / Microspheres: types, preparation and evaluation.

Unit 3

Protein and Peptide Delivery: (4hrs) Barriers for protein delivery.

Formulation and evaluation of delivery systems of proteins and other macromolecules.

Unit 4

Vaccine delivery systems: (4hrs)Vaccines, uptake of antigens, Single-shot vaccines,

Mucosal and transdermal delivery of vaccines.

Unit 5

Pulmonary Drug Delivery Systems(10hrs): Aerosols, propellents, containers types, preparation and evaluation.

Intranasal route delivery systems; Types, preparation and evaluation.

Unit 6

Nucleic acid-based therapeutic delivery system: (9hrs) Gene therapy, introduction (ex-vivo & in-vivo gene therapy).

Potential target diseases for gene therapy (inherited disorder and cancer). Gene expression systems (viral and nonviral gene transfer). Liposomal gene delivery systems.

Biodistribution and pharmacokinetics. knowledge of therapeutic antisense molecules and aptamers as drugs of the future.

Molecular Pharmaceutics (Nanotechnology & Targetted DDS) (NTDS) provides adequate background for translational medicine, particularly in nanomedicine which is mainly helping in improving drug efficacy while reducing toxicity by nanotechnology and targeted drug delivery. This course provides the required knowledge, skill set, and attitude for students to develop new nanomedicines or microscale delivery systems through pharmaceutical engineering and technology development. There is a prerequisite of attending the drug delivery system course offered as part of the 1^st semester M Pharm Pharmaceutics program. In this course, the aspects of miniaturization, nanoscale behavior of delivery systems and selection of the biomaterials for developing nanosystems, the behavior of drugs in solid and liquid states at nanodimensions, and targeting ligands are systematically taught.

By attending this course, the expected learning outcomes are, that they could be able to solve pharmaceutical drug delivery problems at the nano/microscale. Apply the principle behind the development and analysis of novel nanocarrier systems for passive and active targeting. Apply DOE, bioengineering, pharmaceutical engineering, biomedical engineering, and tissue engineering principles to advance nano/microcarrier systems. Analyze the requirements of the development of molecular pharmaceutical approaches toward precision medicine applications. Analyze the challenges related to pharmaceutics, biopharmaceutics, pharmacokinetics, and pharmacodynamics in nanoparticle delivery and solve it to develop new medicines. Create solutions for tertiary care problems based on nano-microscale drug delivery systems based on molecular pharmaceutics principles.

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

KNOWLEDGE:

(K1) Categorise the various approaches for the development of targetable macromolecular, nano, and microscale novel drug delivery systems.

(K2) Correlate the various drug delivery principles to the requirement of targetable macromolecular, nano, and microscale novel drug delivery systems wherever necessary. (K3) Articulate the criteria for the selection of drugs and excipients/ biomaterials for the development of the delivering system.

(K4) Organise the formulation and evaluation requirements of nano drug delivery systems through selected examples.

(K5) Assess the unique physico-chemical and biological behavior of nano/ microscale novel drug delivery systems.

(K6) Solve unmet clinical/technological needs based on molecular pharmaceutics principles in the areas of nanotechnology, biomaterials, bioengineering, biomedical engineering, tissue engineering, regenerative medicine, and precision medicine.

SKILL:

(S1) Validate new phenomena for active and passive targeting.

(S2) Test the principles against challenges in overcoming the barrier for drug delivery. (S3) Identify an appropriate route of delivery to deliver the cargo mainly to the site of action.

(S4) Solve technological limitations of a given route of drug delivery.

(S5) Adapt principles of personalized medicines based on nanotechnology, drug delivery to develop delivery systems for a target group.

(S6) Solve the drug delivery requirement of a given nano/microscale drug delivery system.

ATTITUDE:

(A1) Investigate the unmet clinical/ technological needs of targeted drug delivery in a tertiary care setting.

(A2) Discuss the rationale behind the development of a novel targeted drug delivery system. (A3) Articulate the principles of various chemical, physical, and biological phenomena to advance targetted drug delivery.

(A4) Learn sustainably the fundamental discoveries in biology, chemistry, physics, engineering, and medicine and apply in targeted drug delivery.

(A5) Participate in team discussions effectively.

(A6) Develop problem-solving skills.

REFERENCES

1. Y Chien, Novel Drug Delivery Systems, 2nd edition, revised and expanded, Marcel Dekker, Inc., NewYork, 1992.
2. Nikolaos Peppas, Hydrogels in Medicine and Pharmacy, Fundamentals, Ist edition, CRC Press, 2019.
3. P. Sharma, K. Kaladhar, Nanomedicine- Translational Research, Status and Future Challenges, Ist Edn., Elsevier, 2024.
4. Mathiowitz, Encyclopedia of controlled delivery, 1^st Edn (2Vol. Set), Wiley Interscience Publication, John Wiley and Sons, Inc, New York! Chichester/Weinheim, 1999.
5. P.Vyas and R.K.Khar, Controlled Drug Delivery – concepts and advances, Ist Edn, Vallabh Prakashan, New Delhi, 2002.
6. K. Jain, Controlled and Novel Drug Delivery, Ist Edn., CBS Publishers & Distributors, New Delhi, First edition1997 (reprint in 2001).
7. Donbrow, Microcapsules and Nanoparticles in Medicine and Pharmacy, Ist Edn., CRC Press, 2020.

8. S. Kwon, M. M. de Villiers, P. Aramwit, Nanotechnology in Drug Delivery, Ist Edn., Springer, NewYork, 2009.
9. L. Wise, R. S. Langer, Medical Applications of Controlled Release, Ist Edn., CRC Press, 2019.
10. Li, B. R. Jasti, Design of Controlled Release Drug Delivery Systems, Ist Edn., McGraw-Hill Education, 2005.
11. T. Azar, Modeling and Control of Drug Delivery Systems, Ist Edn. Elsevier, 2021.
12. M. Grumezescu, Drug Targeting and Stimuli Sensitive Drug Delivery Systems, Ist Edn. Elsevier, 2018.
13. K. Tekade, Basic Fundamentals of Drug Delivery, Ist Edn., 2018.

14. S. Milane, M. M. Amiji, Systemic Drug Delivery Strategies, Delivery Strategies and Engineering Technologies in Cancer Immunotherapy, Volume 2, Elsevier Science, 2022.
15. J. Sefton, M. V. Sefton, N. Peppas, Advances in Chemical Engineering, Molecular and Cellular Foundations of Biomaterials, Ist Edn. Elsevier Science, 2004.

16. M. Ottenbrite, S. W. Kim, Polymeric Drugs and Drug Delivery Systems, Ist Edn., CRC Press, 2019.

JOURNALS

1. ACS Molecular Pharmaceutics (ACS)
2. Journal of controlled release (Elsevier)
3. Biomaterials (Elsevier)
4. Advanced Drug Delivery Reviews (Elsevier).
5. Indian Journal of Pharmaceutical Sciences (IPA)
6. Indian drugs (IDMA).

ASSIGNMENTS

• Selection of Hydrogels for protein and peptide delivery, types, preparation, and
• Comment on new nanoparticulate carriers such as cubosomes, biomimetic niosomal nanoparticles (BNNs), and Shape anisotropic lipid nanoparticles (SALNs) and their potential from delivery and targeting perspectives.
• Discuss molecular aspects of active and passive targeting: Challenges and
• Comment on design development and optimization of nanoparticulate single-shot vaccines (protein and gene-based) concerning COVID-19.
• Discuss classic examples of drug delivery at molecular, nano, and microscale for the treatment of cancer and diabetes.
• Monoclonal antibodies for drug therapy and drug
• Nanoparticles nanospheres: A drug delivery perspective.
• Advanced nano/microparticulate systems and fabrication
• Regulatory requirements for nanomedicine: challenges and
• Overcoming challenges of protein and peptide delivery using advanced
• Requirements of nanoparticulate vaccines; role of
• Pulmonary route as a substitute for the systemic route of a delivery; case study of asthma, diabetes, and pulmonary infections.