Pharmaceutical Technology Course

Lesson 1 • History and Scope of Pharmacy

Traces pharmacy from ancient remedies to modern biopharmaceuticals, anchoring the discipline's evolution. Provides context for understanding why current standards and practices exist.

Lesson 2 • Regulatory and GMP Frameworks

Introduces Good Manufacturing Practice principles and the regulatory lifecycle from investigational status to market approval. Connects compliance requirements to daily manufacturing decisions.

Lesson 3 • Drug Classification and Nomenclature

Defines chemical, generic, and brand naming conventions alongside therapeutic and pharmacological classification systems. Enables accurate communication across formulation, regulatory, and clinical teams.

Lesson 4 • Pharmaceutical Dosage Form Overview

Surveys solid, liquid, semi-solid, and specialised dosage forms and their clinical rationale. Sets the stage for detailed formulation chapters that follow.

Lesson 1 • Solubility and Dissolution Principles

Explains thermodynamic and kinetic factors controlling drug solubility and in-vitro dissolution. Directly informs excipient selection and formulation strategies in later chapters.

Lesson 2 • Solid-State Properties of Drugs

Examines polymorphism, crystallinity, amorphous forms, and particle size as determinants of bioavailability and processability. Links solid-state science to manufacturing outcomes.

Lesson 3 • Acid-Base Chemistry and pKa

Reviews ionisation equilibria, Henderson-Hasselbalch applications, and buffer capacity relevant to drug formulation. Prepares students to design pH-adjusted liquid and parenteral formulations.

Lesson 4 • Excipient Compatibility and Interactions

Analyses drug-excipient and excipient-excipient interactions using thermal and spectroscopic screening tools. Prevents incompatibility failures during formulation development.

Lesson 1 • Modified Release Pharmacokinetics

Analyses how extended, delayed, and pulsatile release profiles alter PK parameters and therapeutic outcomes. Bridges biopharmaceutic theory to controlled-release formulation design covered next.

Lesson 2 • Biopharmaceutics Classification System

Defines BCS classes based on solubility and permeability and their regulatory implications for biowaiver eligibility. Guides formulation strategy selection from the earliest development stage.

Lesson 3 • Bioavailability and Bioequivalence

Defines absolute and relative bioavailability, AUC, Cmax, and Tmax, and outlines bioequivalence study design. Prepares students to evaluate generic drug submissions and in-vitro/in-vivo correlations.

Lesson 4 • Pharmacokinetic Compartment Models

Introduces one- and two-compartment models, volume of distribution, and clearance concepts with practical calculations. Provides the quantitative framework for interpreting bioavailability data.

Lesson 1 • Powder Characterisation and Flow

Measures bulk density, angle of repose, compressibility index, and particle morphology to predict powder processability. Directly informs granulation and blending decisions in subsequent sections.

Lesson 2 • Capsule and Pellet Technology

Addresses hard and soft gelatin capsule filling, pelletisation by extrusion-spheronisation, and multi-unit dosing advantages. Broadens solid dosage form expertise beyond conventional tablets.

Lesson 3 • Granulation Techniques

Compares wet granulation, dry granulation, and direct compression with process variables and endpoint determination. Equips students to select and optimise granulation methods for diverse APIs.

Lesson 4 • Tablet Formulation and Compression

Covers binder, disintegrant, lubricant, and filler selection alongside compression force and tooling variables. Connects formulation composition to tablet hardness, friability, and dissolution performance.

Lesson 1 • Semi-Solid Formulations

Covers ointment bases, cream formulation, gel polymers, and rheological characterisation for topical and transdermal products. Links semi-solid structure to drug release and skin penetration.

Lesson 2 • Suspension Formulation and Stability

Explains wetting, flocculation, sedimentation, and rheology control using suspending agents and zeta potential. Prepares students to formulate physically stable oral and topical suspensions.

Lesson 3 • Emulsion Science and Technology

Addresses emulsification theory, HLB system, emulsifying agents, and stability evaluation by creaming and coalescence. Connects colloidal science to practical cream and lotion manufacturing.

Lesson 4 • Solutions and Syrups

Covers co-solvent systems, sweetening agents, preservatives, and clarity testing for oral and topical solutions. Establishes liquid formulation fundamentals before tackling dispersed systems.

Lesson 1 • Sterilisation Methods and Validation

Compares moist heat, dry heat, filtration, radiation, and gas sterilisation with validation cycle development. Enables selection of the appropriate method based on product and container attributes.

Lesson 2 • Parenteral Formulation Requirements

Addresses tonicity adjustment, pH control, pyrogen testing, and particulate matter limits for injectable products. Ensures formulation compliance with compendial and regulatory sterile product standards.

Lesson 3 • Sterility Assurance Fundamentals

Defines sterility assurance level, bioburden, and D-value concepts underpinning all sterilisation validation. Establishes the risk-based mindset required for sterile manufacturing decisions.

Lesson 4 • Cleanroom Design and Classification

Covers ISO cleanroom grades, HVAC design, air change rates, and environmental monitoring programmes. Connects facility design to contamination risk reduction in aseptic processing areas.

Lesson 1 • Quality Management System Principles

Defines quality policy, quality manual structure, CAPA systems, and change control within a pharmaceutical QMS. Provides the organisational framework for all quality activities in subsequent sections.

Lesson 2 • Process Validation and Qualification

Covers design qualification, installation qualification, operational qualification, and performance qualification with statistical acceptance criteria. Demonstrates that manufacturing processes consistently produce product meeting specifications.

Lesson 3 • Stability Testing Programmes

Designs ICH Q1-compliant stability protocols including accelerated, intermediate, and long-term conditions with statistical shelf-life estimation. Connects stability data to label claims and storage condition specifications.

Lesson 4 • ICH Quality Guidelines Overview

Summarises ICH Q8 pharmaceutical development, Q9 risk management, Q10 pharmaceutical quality system, and Q11 development of drug substances. Aligns formulation and manufacturing decisions with harmonised global standards.

Lesson 1 • Nanoparticulate Drug Delivery

Covers polymeric nanoparticles, nanosuspensions, and solid lipid nanoparticles with preparation, characterisation, and stability considerations. Addresses how nanoscale engineering improves solubility and cellular uptake.

Lesson 2 • Pulmonary and Nasal Drug Delivery

Covers aerosol physics, metered-dose inhalers, dry powder inhalers, and nasal spray formulation with deposition modelling. Prepares students to formulate and characterise inhalation products for local and systemic action.

Lesson 3 • Transdermal Drug Delivery Systems

Analyzes passive permeation, chemical enhancers, microneedle arrays, and iontophoresis for transdermal product design. Evaluates skin barrier science and in-vitro permeation testing methods.

Lesson 4 • Liposomal and Lipid-Based Systems

Explains liposome composition, preparation methods, PEGylation, and lipid nanoparticle platforms for small molecules and nucleic acids. Connects lipid carrier design to improved circulation time and targeted delivery.