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Semester VIII · PCI syllabus 2026
Sterile Dosage Forms and Novel Drug Delivery System
BP805T
3 credits
Theory
Coming soon
Unit 1: 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
Unit 2: 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
Unit 3: 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)
Unit 4: 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), 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
- 6. Nanosystems and precision medicine a) Liposomes, niosomes, transferosomes, polymeric nanoparticles, solid-lipid nanoparticles, dendrimers. b) Precision medicine: definition and scope, evolution from” one- size-fits-all” to personalized approaches
Unit 5: 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 sterilisation; filtration; lyophilisation 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/endotoxins, particulate matter, clarity, extractable volume; labelling & documentation; overview of cGMP/cleanrooms and environmental monitoring
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