Course

This course offers comprehensive training in preformulation, drug analysis, development of sustained and controlled release formulation and evaluation. Students will participate in a series of in vitro lab-based experiments designed to develop practical skills and deepen their understanding of pharmaceutical product development and testing. Students will gain hands-on experience with laboratory techniques and instrumentation relevant to each of these areas. Being the experts in handling drugs, pharmacy professionals are expected to have the right attitude to judiciously handle, document, and report all pharmaceutical activities. This include studies related to the role of the excipients and their properties in formulation development, the role of processing conditions in the design of delivery systems and mechanistic aspects of drug release and analysis of pharmaceutical formulations by various techniques.

Students also learn to apply theoretical knowledge to practical scenarios, enhancing their problem-solving abilities and research skills. This lab course prepares students for careers in the pharmaceutical industry and research institutions, equipping them with the expertise needed for the preformulation, product development and evaluation of drug delivery systems.

COURSE LEARNING OUTCOMES:

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

KNOWLEDGE:

(K1) Illustrate preformulation aspects of drugs and excipients. (K2) Appraise osmotic activation principles in drug delivery.

(K3) Integrate the principles of floating phenomena in drug delivery. (K4) Reflect the dissolution behaviour of different formulations.

(K5) Validate the rate-controlled drug delivery principles for transdermal patches. (K6) Comment on excipient-drug interaction minimization by pre-formulation studies. SKILL:

(S1) Validate a prototype sustained release matrix tablets.

(S2) Assess the preformulation requirements of selected drugs.

(S3) Comment on effect of particle characteristics on formulation development. (S4) Estimate the drug content in given dosage forms.

(S5) Assess the effect of compression force in tablet preparation (S6) Devise osmotically controlled systems and transdermal patches. ATTITUDE:

A1: Follow responsible learning attitude.

A2: Communicate effectively in group discussions

A3: Appreciate emerging trends to improve knowledge A4: Cultivate critical thinking in formulation development

A5: Demonstrate a willingness to collaborate with peers and professionals. A6: Display a proactive approach to problem-solving and finding solutions.

PRACTICALS

1. Quantification of single component formulations/API / biological samples by UV Vis spectrophotometer using different methods like Calibration graph method, Linear Equation Method, Single point Analysis, Absorptivity Value methods
2. Quantification of the single component formulations /API / biological samples by HPLC using different methods like Calibration graph method, Linear Equation Method, and Single point Analysis.
3. Simultaneous estimation of multi-component formulations/API / biological samples by

4. Estimation of riboflavin/quinine sulphate by
5. Estimation of sodium/potassium by flame
6. To perform an In vitro dissolution profile of CR/SR marketed

7 Optimization and formulation of sustained-release matrix tablets.

8. Formulation and evaluation of osmotically controlled drug delivery
9. Formulation of floating/ hydrodynamically balanced drug delivery
10. Formulation and evaluation of Mucoadhesive
11. Formulation and evaluation of transdermal
12. Preformulation studies of selected
13. Study the effect of compressional force on disintegration time of
14. Determine the micromeritic properties of powders and
15. Study the effect of particle size on the dissolution of a
16. Evaluate the influence of binders on the dissolution of
17. Apply drug release kinetic model to determine the release

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. K. Jain, Controlled and Novel Drug Delivery, Ist Edn, CBS Publishers & Distributors, New Delhi, 1997 (reprint in 2001).
3. G Banker, C T. Rhodes, Modern Pharmaceutics 4^th Edn., Marcel Dekker, Taylor and Francis, New York, 2009.

4. H. Becket, J. B. Stenlake. Practical Pharmaceutical Chemistry Vol. I and II, 4^th Edn, The Athlon Press of the University of London. 1998.
5. D. Sethi, Sethi’s HPLC High-Performance Liquid Chromatography: Quantitative Analysis of Pharmaceutical Formulations, Volume 8., 1^st Edn. India: CBS Publishers &Distributors New Delhi, 2015.

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 (Taylor and Francis).
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).