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AKTU Sterile Dosage Form and Novel Drug Delivery System (Theory) (BP805T) Syllabus PDF – B.Pharm 8th Semester
Sterile Dosage Form and Novel Drug Delivery System (Theory) BP805T
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Official AKTU syllabus of Sterile Dosage Form and Novel Drug Delivery System (Theory) (BP805T) for B.Pharm 8th Semester – 3 credits, L-T-P 3-0-0. Read the unit-wise course content, course outcomes, evaluation pattern and recommended books online, or download the PDF.
Syllabus — Sterile Dosage Form and Novel Drug Delivery System (Theory)
Download PDFBP805T · 3 credits · L-T-P 3-0-0
Course Objectives
- Understand the scientific and technological foundations of advanced and novel drug delivery systems, including their classification, design rationale, materials, and formulation development challenges.
- Examine the role of polymers, lipids, and excipients in formulating biodegradable, targeted, and controlled-release drug delivery systems.
- Study specialized drug delivery routes such as oral, mucosal, transdermal, ocular, parenteral and drug carriers including and their impact on therapeutic efficacy.
- Apply principles of Quality by Design (QbD), preclinical evaluation, and regulatory science to assess NDDS development and clinical translation.
- Explore the emerging field of precision medicine, including its genetic, molecular, and technological underpinnings relevant to pharmacy.
Course Outcomes
| CO | Upon successful completion of this course, the students will be able to: |
| No. | |
| 1 | Classify and explain the different types of NDDS and describe their need in overcoming limitations of conventional drug delivery. |
| 2 | Identify appropriate pharmaceutical ingredients for designing site-specific or controlled-release delivery systems. |
| 3 | Design oral, mucosal, parenteral, and transdermal NDDS, and evaluate their mechanisms and formulation parameters. |
| 4 | Apply QbD principles and preclinical evaluation tools to assess NDDS quality and safety. |
| 5 | Demonstrate an understanding of the scope, principles, and challenges of precision medicine in modern pharmacotherapy. |
Course Content
| Unit | Topics | No. of |
|---|---|---|
| I | Fundamentals, Polymers & Materials for NDDS 1. Limitations of conventional dosage forms (e.g., solubility, permeability, toxicity, first-pass metabolism) 2. Classification of NDDS: Controlled Release, Targeted, Stimuli- Responsive (Smart), Chronotherapeutic, Transdermal and Mucosal, Implantable and Injectable Depot Systems, Vesicular, Polymeric, Ocular, Pulmonary, and Nasal Drug Delivery Systems 3. Biodegradable and biocompatible polymers: PLA, PLGA, PCL, chitosan, gelatin 4. Lipids and surfactants: lecithin, phospholipids, Span/Tween, SLNs 5. Inorganic systems: silica, gold nanoparticles, iron oxide, MOFs 6. Excipients in NDDS: GRAS substances, IIG database, regulatory constraints | 12 hours |
| II | Oral and Mucosal Delivery Systems 1. Gastro-retentive systems: floating, bioadhesive, expandable systems 2. Colon-targeted systems: pH-triggered, microbially-triggered, time-dependent systems 3. Buccal, nasal, and pulmonary carriers: films, sprays, DPIs, liposomes 4. IVIVC and biorelevant dissolution testing. | 6 hours |
| III | Transdermal NDDS 1. Introduction to Transdermal drug delivery: Need, advantages disadvantages, basic structure and components. Formulation aspects including permeation enhancers. 2. Long-acting systems: in-situ gels, microspheres, implants, ocular inserts 3. Transdermal and microneedle technologies: iontophoresis, sonophoresis, micro needles Aseptic manufacturing, scale-up challenges, and process analytical tools (PAT) | 6 hours |
| IV | Evaluation, Quality, and Translation 1. Preformulation and QbD: QTPP, CQAs, CPPs 2. Characterization methods: particle size, zeta potential, SEM/TEM, in-vitro release, permeability assays (PAMPA, Caco-2) 3. Non-clinical evaluation: PK/PD modeling, biodistribution, toxicology 4. Regulatory pathways: 505(b)(2), complex generics, ICH Q8 Q10, EMA pathways 5. Case studies: Liposomal Amphotericin B for Fungal Infections, mRNA-Lipid Nanoparticle Vaccines (e.g., COVID-19 Vaccines), Depot Antipsychotic Injections (e.g., Risperidone Microspheres), | 6 hours |
Transdermal Patch for Hormone Replacement Therapy, Ocular Inserts for Glaucoma Management, Oral Colon-Targeted Delivery for Inflammatory Bowel Disease, Inhalable Insulin for Diabetes Mellitus, Dendrimers for Targeted Cancer Therapy, Chronotherapeutic Drug Delivery in Hypertension.
- Nanosystems and precision medicine
- Liposomes, niosomes, transferosomes, polymeric nanoparticles, solid-lipid nanoparticles, dendrimers.
- - size-fits-
| V | a. Sterile Dosage Forms (Parenteral & Ophthalmic) Introduction & classification: SVP vs LVP; routes; Advantages/limitations. Water for Injection (WFI): Types, preparation, storage/distribution; pharmacopoeial requirements. Formulation components: Vehicles, buffers, co-solvents, surfactants antioxidants, preservatives, chelators; isotonicity & osmolality. Manufacturing: Aseptic vs terminal sterilization; filtration lyophilization principles; environmental controls. Containers & closures: Glass/Plastic systems; elastomers; selection factors; evaluation & container closure integrity. Form fill Seal and Blow Fill Seal Technology Ophthalmics: Solutions/suspensions/ointments/gels/inserts physiological factors (pH, tonicity, viscosity); residence-time enhancers preservative-free systems (e.g., BFS). Quality control & compliance: Sterility tests, LAL/endotoxin particulate matter, clarity, extractable volume; labelling & documentation overview of cGMP/cleanrooms and environmenta monitoring. | 14 hours s ; |
Recommended References
- Aulton, M. E. and Taylor, K. Manufacture of Medicines. Elsevier.
- Banga, A. K. Transdermal and Intradermal Delivery of Therapeutic Agents. CRC Press.
- Dash, A. K. and Cudworth, G. C. Therapeutic Proteins and Peptides: Formulation, Processing and Delivery Systems. CRC Press.
- Jain, N. K. Drug Delivery Systems. CBS Publishers & Distributors.
- Kreuter, J. Colloidal Drug Delivery Systems. CRC Press.
- Martin, A., Sinko, P. J. and Singh, Y. Pharmaceutical Sciences. Lippincott Williams & Wilkins.
- Torchilin, V. P. Nanoparticulates as Drug Carriers. Imperial College Press.
- Remington. The Science and Practice of Pharmacy. Pharmaceutical Press.
| Course Code* | Course Title* | Course Type |
| BP806T AEC1 | Pharmaceutical Packaging | Elective |
| BP806T AEC2 | Supply Chain Management | |
| BP806T AEC3 | Industrial Safety and Waste Management | |
| BP806T AEC4 | Traditional Healing Practices of India | |
| BP806T AEC5 | Futuristic Pharma through AR/VR: Pharma 4.0 | |
| BP806T AEC6 | Herbal Cosmetics for Industry Perspective | |
| Credit | Hours Per Week (L-T-P) | Max. Hours. |
| L | T | P |
| 2 | -- | 30 |
| Maximum Marks | SE | ESE |
| 50 | 20 | 30 |
* One course shall be selected from the list The syllabi for elective subjects are given in the APPENDIX
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