Course

Unit 1

Historical perspective of drug delivery. Sustained Release (SR) and Controlled Release (CR) formulations: Introduction & basic concepts, advantages/ disadvantages, factors influencing, physicochemical & biological approaches for SR/CR formulation. Mechanism of drug delivery from SR/CR formulation. Polymers: introduction, definition, classification, properties and application in dosage forms. Factors of drug, biomaterial/excipient and delivery system on controlled release.

Personalized Medicine: introduction, definition, pharmacogenetics, categories of patients for personalized medicines: customized drug delivery systems, bioelectronic medicines, 3D printing of pharmaceuticals, telepharmacy with respect to emerging technologies.

Unit 2

Rate Controlled Drug Delivery Systems: Principles & fundamentals, types, with emphasis on developments. Principles & fundamentals, parametric analysis of system components on controlled release from implants.

Rate preprogrammed drug delivery systems, classification, and

principles

Activation modulated drug delivery systems; mechanically activated, pH activated, feedback regulated drug delivery systems. Developments in enzyme activated, and osmotic activated drug

delivery systems.

Unit 3

Gastro-Retentive Drug Delivery Systems: With emphasis on fundamental principles and latest developments, advantages and disadvantages, modulation of GI transit time, approaches to extend GI transit.

Buccal Drug Delivery Systems: Principle of muco-adhesion, advantages and disadvantages, mechanism of drug permeation, with emphasis on methods of formulation and its evaluations.

Analysis of biopharmaceutical considerations for controlled release

by peroral route.

Unit 4

Ocular Drug Delivery Systems: With an emphasis on barriers of drug permeation and methods to overcome barriers.

Analysis of rationale behind design of novel drug delivery systems

for ocular drug delivery.

Unit 5

Transdermal Drug Delivery Systems: Structure of skin and barriers, penetration enhancers, transdermal drug delivery systems, with emphasis on methods to overcome barriers, formulation and evaluation.

Analysis of rationale behind design of novel drug delivery systems

for short and long-term transdermal drug delivery.

ASSIGNMENTS

1. Rationalize the need for ocular drug delivery based on clinical and technological unmet
2. Selection of polymers for delivery of biological molecules for vaccination using microneedle technology through transdermal route.
3. Less invasive drug delivery to the eye with the help of advanced biomaterials and delivery

system towards design of implants: parametric analysis.

4. Design and optimization strategies to improve the programmability and reproducibility of controlled release technologies for any one of the emerging areas of bioengineering, biomedical engineering, tissue engineering and regenerative medicine applications: A case
5. Field trip from institute to industry to learn the latest process trend in any one of API, generic, or advanced pharma companies for two weeks and develop a report.
6. Field trip to rural and urban sides to identify the unmet needs for latest drug delivery technologies in chronic diseases like diabetes, cardiovascular, and neurological
7. Clinic on advanced drug delivery technologies (Drafting by analyzing the technologies).
8. Concept discussions on personalizing therapy: Gastro-retention as a strategic approach for controlled drug delivery and its challenges and opportunities.
9. Buccal and sublingual drug delivery: the opportunity to bypass the first pass
10. Ocular drug delivery from cul-de-sac to deliver to the posterior
11. Microneedle technology from controlled delivery to vaccination from the context of drug delivery across barriers.

This course on Drug Delivery Systems (DDS) is aimed to impart required knowledge, skill set and attitide for the design and development of new medicines and pharmaceutical products, which is going to make a major stake in novel drug delivery systems, complex pharmaceuticals, and combination product-based medical devices. This course is designed to systematically introduce students to the area of delivery of drug and biological products by imparting the required knowledge, skill-set and attitude through pharmaceutical engineering for technology development. Foster them with the right attitude to identify emerging challenges and develop solutions based on the principles of drug delivery to meet unmet clinical needs. Students are also trained to do the critical review, analysis, and reporting of the research and development activities. This is to ensure the fair practice of pharmaceutics in generic formulations, as well as advanced and novel delivery systems in different settings of the industry in companies, research, clinical, and academics to provide professional input for efficient practice of medicines.

By attending this course, they could be able to, solve a drug delivery problem by designing and developing a suitable drug delivery system depending upon the route of administration and duration of delivery. Also, analyze the prototype requirements (Comparator (generic) and Innovator drugs) and advance the generation of the delivery system from rate-controlled, activation based, stimuli-sensitive, feed-back regulated to targeted delivery systems. In addition, apply in silico techniques for formulation optimization by DOE, bioengineering, pharmaceutical engineering, biomedical engineering, and tissue engineering principles to advance the delivery systems. They could be able to foresee the development of drug delivery systems towards precision medicine applications Also analyse the challenges related to pharmaceutics, biopharmaceutics, pharmacokinetics, and pharmacodynamics and solve it

during the development of new delivery systems. In tertiary care they could apply the principles of pharmaceutics for required novel drug delivery systems, complex pharmaceuticals, and combination product based medical devices.

COURSE LEARNING OUTCOMES

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

KNOWLEDGE :

(K1) Appraise the principles of drug delivery for drugs and biologicals.

(K2) Identify the critical gap of unmet clinical needs where drug delivery strategy can be beneficial.

(K3) Correlate the physical, chemical, and biological phenomena with drug release mechanism from delivery systems.

(K4) Modify the drug release from the drug delivery system by activation principles. (K5) Devise a rate-controlled drug delivery system superior to sustained release systems using biomaterials such as polymers and lipids.

(K6) Solve unmet clinical/technological needs by applying principles of biomaterials, bioengineering, biomedical engineering, pharmaceutical engineering, tissue engineering, regenerative medicine, and precision medicine.

SKILL:

(S1) Validate new phenomena for developing an advanced drug delivery system.

(S2) Debate challenges between two different routes of drug delivery.

(S3) Defend the route of delivery with respect to the site of action and off-targetting. (S4) Solve technological limitations of a given delivery system concerning route of drug delivery.

(S5) Manage the drug delivery requirement of a given drug delivery system.

(S6) Program the drug delivery systems applying principles of biomaterials and drug delivery.

ATTITUDE:

(A1) Distinguish the gap of unmet clinical needs to technological need.

(A2) Sketch with the team the rationale behind the development of a novel drug delivery system.

(A3) Articulate the principles of various chemical, physical, and biological phenomena to advance a drug delivery system.

(A4) Assess the fundamental discoveries in biology, chemistry, physics, engineering, and medicine with respect to progress in drug delivery.

(A5) Facilitate the team discussions effectively.

(A6) Role-play in problem-solving skills.

REFERENCE BOOKS:

1. Y Chien, Novel Drug Delivery Systems, 2^nd Edn, revised and expanded, Taylor and Francis, Marcel Dekker, Inc., New York, 1992.
2. P. Sharma, K. Kaladhar, Nanomedicine- Translational Research, Status and Future Challenges, (Ist Edn.), Elsevier, 2024.
3. K. Tekade, Drug Delivery Systems, Elsevier Science, 1^st Edn, 2019.
4. L. Wise, Handbook of Pharmaceutical Controlled Release Technology, 1^st Edn, CRC Press, 2000.
5. J. Rathbone, J. Hadgraft, M. S. Roberts, M. E. Lane, Modified-Release Drug Delivery Technology, 2nd Edn, CRC Press, 2008.
6. K. Jain, Controlled and Novel Drug Delivery, Ist Edn, CBS Publishers & Distributors, New Delhi, 1997 (reprint in 2001).
7. P.Vyas and R. K. Khar, Controlled Drug Delivery- concepts and advances, Ist Edn

Vallabh Prakashan, New Delhi, 2002.

8. R. Robinson, V. H. L. Lee., Controlled Drug Delivery – Fundamentals and applications, 2^nd Edn, Taylor and Francis, Marcel Dekker, Inc., New York, 1992.
9. Mathiowitz, Encyclopedia of controlled delivery, 1^st Edn (2Vol. Set) Wiley Interscience Publication, John Wiley and Sons, Inc, New York! Chichester/Weinheim, 1999.
10. M. Hillery, K. Park, Drug Delivery: Fundamentals and Applications, 2^nd Edn, CRC Press, 2016.
11. Wen, K. Park, Oral Controlled Release Formulation Design and Drug Delivery: Theory to Practice, John Wiley & Sons Inc., 2011.
12. V. Ranade, J. B. Cannon, Drug Delivery Systems, 3^rd Edn, Taylor and Francis, 2011.
13. K. Tekade, Drug Delivery Systems, Elsevier Science, 1^st Edn, 2019.
14. A. E. Benson, M. S. Roberts, A. C. Williams, Fundamentals of Drug Delivery, 1^st Edn, Wiley, 2021.

JOURNALS:

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