BP806T AEC2

Supply Chain Management (Theory)

Unit-wise topics with PDF download buttons

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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), Depot Antipsychotic Injections (e.g., Risperidone Microspheres), 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.