Sterile Dosage Forms and Novel Drug Delivery System

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Unit 1 · Fundamentals, Polymers and Materials for NDDS 12 hrs

The limitations of conventional dosage forms — solubility, permeability, toxicity and first-pass metabolism; the classification of novel drug-delivery systems (controlled-release, targeted, stimuli-responsive, chronotherapeutic, transdermal and mucosal, implantable and injectable depot, vesicular, polymeric, ocular, pulmonary and nasal); biodegradable and biocompatible polymers such as PLA, PLGA, PCL, chitosan and gelatin; lipids and surfactants including lecithin, phospholipids, Span/Tween and solid lipid nanoparticles; inorganic systems such as silica, gold nanoparticles, iron oxide and MOFs; and the excipients used in NDDS, GRAS substances, the IIG database and regulatory constraints.

Unit 2 · Oral and Mucosal Delivery Systems 6 hrs

Gastro-retentive systems — floating, bioadhesive and expandable; colon-targeted systems that are pH-triggered, microbially triggered or time-dependent; buccal, nasal and pulmonary carriers including films, sprays, dry-powder inhalers and liposomes; and in vitro–in vivo correlation with biorelevant dissolution testing.

Unit 3 · Transdermal and Long-Acting Systems 6 hrs

An introduction to transdermal drug delivery — the need for it, its advantages and disadvantages, basic structure and components, and formulation aspects including permeation enhancers; long-acting systems such as in-situ gels, microspheres, implants and ocular inserts; and transdermal and microneedle technologies including iontophoresis and sonophoresis.

Unit 4 · Evaluation, Quality and Translation 6 hrs

Preformulation and Quality by Design — QTPP, critical quality attributes and critical process parameters; characterization methods including particle size, zeta potential, SEM/TEM, in-vitro release and permeability assays (PAMPA, Caco-2); non-clinical evaluation through PK/PD modelling, biodistribution and toxicology; regulatory pathways including 505(b)(2), complex generics, ICH Q8–Q10 and the EMA routes; nanosystems and precision medicine; and case studies such as liposomal amphotericin B, mRNA-lipid-nanoparticle vaccines and depot antipsychotic injections.

Unit 5 · Sterile Dosage Forms — Parenteral and Ophthalmic 14 hrs

The introduction and classification of sterile products — small-volume versus large-volume parenterals, routes and their advantages and limitations; Water for Injection — types, preparation, storage and distribution and the pharmacopoeial requirements; formulation components including vehicles, buffers, co-solvents, surfactants, antioxidants, preservatives and chelators, with isotonicity and osmolality; manufacture by aseptic versus terminal sterilisation, filtration and lyophilisation with environmental controls; containers and closures — glass and plastic systems, elastomers, selection factors, evaluation and container–closure integrity, together with Form-Fill-Seal and Blow-Fill-Seal technology; and ophthalmics — solutions, suspensions, ointments, gels and inserts, the physiological factors of pH, tonicity and viscosity, residence-time enhancers and preservative-free systems.