Sterile Dosage Forms and Novel Drug Delivery System (Theory)

• Limitations of conventional dosage forms (e.g., solubility, permeability, toxicity, first-pass metabolism)
• 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
• Biodegradable and biocompatible polymers: PLA, PLGA, PCL, chitosan, gelatin
• Lipids and surfactants: lecithin, phospholipids, Span/Tween, SLNs
• Inorganic systems: silica, gold nanoparticles, iron oxide, MOFs
• Excipients in NDDS: GRAS substances, IIG database, regulatory constraints

• Gastro-retentive systems: floating, bioadhesive, expandable systems
• Colon-targeted systems: pH-triggered, microbially-triggered, time-dependent systems
• Buccal, nasal, and pulmonary carriers: films, sprays, DPIs, liposomes
• IVIVC and biorelevant dissolution testing.

• Introduction to Transdermal drug delivery: Need, advantages disadvantages, basic structure and components. Formulation aspects including permeation enhancers.
• Long-acting systems: in-situ gels, microspheres, implants, ocular inserts
• Transdermal and microneedle technologies: iontophoresis, sonophoresis, micro needles Aseptic manufacturing, scale-up challenges, and process analytical tools (PAT)

• Preformulation and QbD: QTPP, CQAs, CPPs
• Characterization methods: particle size, zeta potential, SEM/TEM, in-vitro release, permeability assays (PAMPA, Caco-2)
• Non-clinical evaluation: PK/PD modeling, biodistribution, toxicology
• Regulatory pathways: 505(b)(2), complex generics, ICH Q8 Q10, EMA pathways
• 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.
• Nanosystems and precision medicine a) Liposomes, niosomes, transferosomes, polymeric nanoparticles, solid-lipid nanoparticles, dendrimers. b) - size-fits-

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/endotoxins particulate matter, clarity, extractable volume; labelling & documentation overview of cGMP/cleanrooms and environmenta monitoring.