BP805TSemester 83 creditsTheory
Sterile Dosage Forms and Novel Drug Delivery System
Complete unit-wise syllabus for BP805T as per the PCI B.Pharm NEP 2020 curriculum (Semester 8 — AI Ethics + Clinical + Final Research).
URL:
https://pharmacode.vercel.app/syllabus/semester-8/bp805t-sterile-dosage-forms-and-novel-drug-delivery-system/Unit-wise Syllabus
5 Units1
Parenteral Products9 Hours- Parenteral formulations: large volume parenterals (LVP) — IV fluids, TPN; small volume parenterals (SVP) — injections, lyophilised products; routes (IV, IM, SC, intradermal)
- Water for injection (WFI): standards, production (distillation, membrane technology), storage, quality testing (TOC, conductivity, bacterial endotoxins, microbial limit tests)
- Parenteral formulation: vehicles (water, non-aqueous: oils, propylene glycol); tonicity adjustment; pH adjustment and buffer systems; antioxidants; antimicrobial preservatives; chelating agents
2
Sterile Manufacturing and Quality Control9 Hours- Aseptic manufacturing: EU GMP Annex 1 (2022) requirements; cleanroom classification; aseptic processing simulation (media fills); laminar airflow workstations (LAFW) and isolators; RABS (Restricted Access Barrier System)
- Terminal sterilisation: moist heat (F0 calculation); dry heat depyrogenation (FH value); radiation; filtration sterilisation — 0.22 μm membrane; SAL (10-6) requirements
- Quality control of sterile products: sterility testing (USP <71>); particulate matter testing (visual inspection, HIAC); container closure integrity testing (CCIT); endotoxin testing (LAL)
3
Nanoparticulate Drug Delivery Systems9 Hours- Polymeric nanoparticles: PLGA, PLA, PCL nanoparticles — preparation (nanoprecipitation, emulsion-solvent evaporation), characterisation (DLS, TEM, DSC), drug loading and release
- Dendrimers: structure (core, branching units, surface groups); PAMAM dendrimers; drug loading (encapsulation, surface conjugation); pharmaceutical applications in anticancer drug delivery
- Carbon nanotubes and graphene-based drug delivery: functionalisation, biocompatibility issues, drug loading mechanisms; regulatory challenges for nanomedicine
4
Biopolymers and Smart Drug Delivery9 Hours- Hydrogels: classification (physical/chemical crosslinking, natural/synthetic); stimuli-responsive hydrogels — pH-responsive, thermosensitive (PNIPAM), redox-responsive; applications in sustained release
- Microspheres and microcapsules: PLGA microspheres by double emulsion-solvent evaporation; poly-lactic acid (PLA) microspheres; microencapsulation of hormones, proteins, vaccines
- Albumin nanoparticles, chitosan nanoparticles: preparation, surface modification; mucoadhesive systems; gene delivery vectors (lipoplexes, polyplexes)
5
Regulatory Requirements for Sterile and NDDS Products9 Hours- Regulatory requirements for sterile products: ICH Q2 (analytical), ICH Q3 (impurities), ICH Q6A (specifications), ICH Q8 (pharmaceutical development) as applied to parenteral products
- Regulatory pathway for nanomedicines: FDA guidance for industry on drug products containing nanomaterials; EMA reflection paper on nanomedicines; characterisation requirements; non-clinical safety studies
- CTD sections for sterile and NDDS products: Module 3 structure for sterile injectables; ICH Q8 design space for aseptic process; Module 4 non-clinical safety data requirements for novel delivery systems
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What's coming next on this page
- Reference textbooks and recommended reading list
- Previous year question papers (PYQ)
- Topic-wise short notes and revision summaries
- Suggested external resources and video tutorials
Other subjects in Semester 8
BP801TEthical Considerations and Translational Applications of AI in PharmacyBP802TClinical PharmacotherapeuticsBP803TIndustrial Pharmacy and Facility DesignBP804TPharmaceutical ManagementBP806T AECAEC Elective (Pharma Packaging / Supply Chain / Industrial Safety / Traditional Healing / AR-VR Pharma 4.0 / Herbal Cosmetics)BP807P + BP808PPracticals — Pharmaceutical Marketing Skills + Sterile Dosage Forms + VAC ElectiveBP810RPResearch Project (Final Submission)