Pharmaceutics II

Classification, excipients, granulation, compression defects, coating techniques, and capsule formulation.

• Classification and formulation of tablets
• Tablet excipients (diluents, binders, disintegrants, lubricants, glidants)
• Granulation techniques (wet, dry, direct compression)
• Tablet compression machines and tooling
• Tablet compression defects (capping, lamination, sticking, picking, mottling, chipping)
• Tablet coating processes (sugar coating, film coating, enteric coating)
• Evaluation of tablets (hardness, friability, disintegration, dissolution, weight variation)
• Hard gelatin capsules (composition, shell manufacturing, sizes 000 to 5, filling)
• Soft gelatin capsules (composition, plasticizers, rotary die process)
• Quality control and stability of capsules

Formulation and physical stability of emulsions, suspensions, ointments, creams, pastes, and gels.

• Suspensions: flocculated vs deflocculated systems, sedimentation volume
• Suspending agents and formulation of pharmaceutical suspensions
• Emulsions: theories of emulsification, identification tests (dye, dilution, conductivity)
• Emulsifying agents (natural, synthetic, semi-synthetic, HLB value)
• Physical instabilities in emulsions (creaming, cracking, phase inversion, coalescence)
• Semisolid dosage forms: classification and properties of ointment bases
• Formulation and evaluation of ointments, creams, pastes, and gels

Primary, secondary and tertiary packaging materials, glass, plastics, metals, closures, blister/strip packs.

• Functions and classification of packaging (primary, secondary, tertiary)
• Glass containers: types of glass (Type I, II, III, NP) and hydrolytic resistance test
• Plastic containers: polymers (polyethylene, polypropylene, PVC, PET), advantages and hazards
• Metals (aluminum, tin) and collapsible tubes
• Rubber closures: composition, coring, compatibility testing
• Blister packaging, strip packaging, and child-resistant closures
• Quality control tests for packaging materials

Components, propellants, valves, MDIs, DPIs, and nebulizers for pulmonary delivery.

• Definition, advantages, and limitations of aerosol drug delivery
• Propellants: liquefied gases (CFCs, HFAs) and compressed gases
• Aerosol containers and valve assembly (metered dose valves, actuators)
• Formulation of pharmaceutical aerosols (solutions, suspensions, emulsions)
• Metered Dose Inhalers (MDIs), Dry Powder Inhalers (DPIs), and Nebulizers
• Quality control and evaluation of aerosols (leak test, flame extension, discharge rate)

Small & large volume parenterals, vehicles, cleanrooms, pyrogen testing, and sterility testing.

• Definition, routes of parenteral administration, advantages and disadvantages
• Small Volume Parenterals (SVP) vs Large Volume Parenterals (LVP / IV fluids)
• Aqueous vehicles (WFI, Sterile WFI, Bacteriostatic WFI) and non-aqueous vehicles
• Cleanroom classification, HEPA filtration, laminar airflow benches, aseptic processing
• Formulation additives: antioxidants, antimicrobial preservatives, buffers, tonicity adjusters
• Sterility testing methods (membrane filtration and direct inoculation)
• Pyrogen testing: Rabbit pyrogen test and Bacterial Endotoxin Test (LAL test)
• Particulate inspection and container closure integrity

Vaccines, toxoids, sera, immunoglobulins, storage standards, and cold chain maintenance.

• Classification of biologicals: live attenuated, inactivated vaccines, toxoids, antisera
• Manufacturing principles and storage of immunological products
• National immunization cold chain requirements in Nepal (2°C to 8°C)
• Vaccine Vial Monitor (VVM) stages and usability guidelines
• Adverse events following immunization (AEFI) awareness

Prescriptions, Latin terminology, pediatric dose calculations, and pharmaceutical incompatibilities.

• Parts of a medical prescription and legal dispensing responsibilities
• Official Latin terms, pharmaceutical abbreviations, and directions
• Posology and pediatric dose calculations (Young's rule, Dilling's rule, Clark's rule, Fried's rule)
• Physical incompatibilities (liquefaction, immiscibility, insolubility) and remedies
• Chemical incompatibilities (precipitation, gas evolution, oxidation) and remedies
• Therapeutic incompatibilities (drug interactions, contraindications, synergistic toxicity)
• Labelling requirements and patient cautionary advisories

Types, suppository bases, displacement value, fusion moulding, and quality evaluation.

• Types of suppositories (rectal suppositories, vaginal pessaries, urethral bougies)
• Ideal suppository bases: fatty bases (theobroma oil/cocoa butter), hydrophilic bases (PEG, glycerogelatin)
• Polymorphism of theobroma oil (alpha, beta, gamma forms)
• Displacement value: concept, practical calculation, and significance
• Manufacturing by fusion moulding and lubrication of moulds
• Quality evaluation: breaking test, melting range, liquefaction time

Eye drops, eye lotions, eye ointments, tonicity calculation, buffers, and preservation.

• Physiological factors and essential requirements of ophthalmic products (sterility, tonicity, clarity)
• Isotonicity calculation: sodium chloride equivalent and freezing point depression methods
• Ophthalmic preservatives (benzalkonium chloride, chlorobutanol, thiomersal)
• Viscosity increasing agents (HPMC, methylcellulose, polyvinyl alcohol)
• Formulation and filling of sterile eye drops and eye ointments
• Packaging and in-use stability of multi-dose ophthalmic containers

QA vs QC, WHO-GMP guidelines, SOPs, validation, and stability testing.

• Definitions and functional differences between QA and QC
• Core principles of Good Manufacturing Practice (GMP / WHO-GMP)
• Documentation, Standard Operating Procedures (SOPs), and Batch Manufacturing Records (BMR)
• In-process quality control (IPQC) for solid and liquid manufacturing
• Validation: process validation, equipment qualification (DQ, IQ, OQ, PQ)
• ICH stability testing: climatic zones, real-time vs accelerated stability testing

Sutures, ligatures, wound dressings, bandages, catheters, IV sets, and syringes.

• Surgical sutures and ligatures: absorbable (catgut, synthetic polyglycolic acid) vs non-absorbable (silk, nylon)
• Primary wound dressings, absorbent cotton wool, surgical gauze, bandages
• Plaster of Paris and adhesive surgical tapes
• Cannulas, urinary catheters, IV administration sets, and hypodermic syringes
• Sterilization methods and regulatory quality standards for surgical appliances