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Pharmaceutics I

Pharmaceutical development, calculations, unit operations, physicochemical principles, and biopharmaceutics.

9 Units140 Total Marks200 Teaching Hours

Units

1

Introduction to Pharmaceutical Development & Dosage Forms

History of pharmacy in Nepal, classification of dosage forms (solid, liquid, semisolid, gaseous).

15 hrs10 marks

Subtopics (6)

  • History of pharmacy profession in Nepal
  • Definition and examples of dosage forms
  • Solid dosage forms (Tablets, Capsules, Powders, Granules, Suppositories, Lozenges)
  • Liquid dosage forms (Solutions, Syrups, Elixirs, Emulsions, Suspensions, Liniments, Injections, Tinctures)
  • Semisolid dosage forms (Ointments, Creams, Paste, Gels)
  • Gaseous dosage forms (Aerosol, Inhalants)
2

Pharmacopoeias and Formularies

Definition of Pharmacopoeias, Formularies (NNF), Compendia, and contents of monographs.

10 hrs7 marks

Subtopics (4)

  • Definition of Pharmacopoeias, Formularies and Compendia
  • Contents of Monograph
  • Official Compendia (BP, EP, IP, USP, JP, BPC)
  • Recognized pharmacopoeias in Nepal
3

Unit Operations

Milling, size separation, mixing, filtration, and drying operations in pharmaceutical industry.

35 hrs30 marks

Subtopics (5)

  • Milling: Hammer mill, Ball mill, Colloidal mill
  • Size Separation: Sieves, standards, Cyclone separator
  • Mixing and Homogenization: Double cone blender, Triple roller mill, Silverson mixer
  • Filtration: Theory, membrane filter, sintered glass filter
  • Drying: Tray dryer, fluidized bed dryer, freeze dryer
4

Heat Process

Heat transfer methods, evaporation principles, and pharmaceutical applications.

7 hrs8 marks

Subtopics (5)

  • Heat and temperature definitions
  • Methods of heat transfer (conduction, convection, radiation)
  • Evaporation and pharmaceutical applications
  • Evaporation pan and evaporating still
  • Factors affecting evaporation
5

Distillation

Types of distillation including simple, steam, azeotropic, vacuum, fractional, and molecular.

8 hrs8 marks

Subtopics (6)

  • Simple distillation
  • Steam distillation
  • Azeotropic distillation
  • Vacuum distillation
  • Fractional distillation
  • Molecular distillation
6

Physicochemical Principles of Pharmaceutics

pH, buffers, rheology, surface phenomena, colloids, and reaction kinetics.

30 hrs30 marks

Subtopics (5)

  • pH, buffers and Isotonic solutions (Sorensen's pH scale, buffer equation, buffer capacity)
  • Rheology: Viscosity, Newtonian and Non-Newtonian fluids, capillary viscometer
  • Surface and Interfacial Tension (Capillary method, Drop method), Contact angle, Surfactants
  • Disperse systems and Colloids
  • Kinetics and stability testing (Zero and first order reactions, ICH guidelines)
7

Monophasic Liquid Dosage Forms

Solubility, formulation and preparation of syrups, elixirs, lotions and liniments.

10 hrs7 marks

Subtopics (4)

  • Definition and advantages/disadvantages
  • Solubility and factors affecting it
  • Formulations of monophasic liquid dosage forms
  • Preparation of Syrups, Elixirs, Lotions and Liniments
8

Introduction to Biopharmaceutics

Drug transport, bioavailability, bioequivalence, plasma concentration curves, and pharmacokinetic terms.

20 hrs20 marks

Subtopics (7)

  • Definition and importance of Biopharmaceutics
  • Mechanism of drug transport across GI barrier
  • Bioavailability and Bioequivalence
  • Absolute and relative bioavailability
  • Plasma concentration time curve (oral, IV bolus, IV infusion)
  • Volume of Distribution, Half-life, Steady state concentration, Clearance
  • Loading dose, Maintenance dose, Elimination rate constant
9

Weight and Measures

Metrology, unit conversion, and calculations (percentage, ratio strength, allegation method).

5 hrs5 marks

Subtopics (5)

  • Classification of weight and measure
  • Unit conversion (system to system, unit to unit)
  • Percentage and ratio strength problems
  • Allegation method
  • Isotonic solution calculations