Course Content
Preformulation Studies
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Introduction to preformulation, goals and objectives, study of physicochemical characteristics of drug substances.
Physical properties-solubility profile pKa, pH
Partition coefficient,Physical form (crystal & amorphous),polymorphism
Particle size, shape, flow properties
Chemical Properties: Hydrolysis, oxidation, reduction, racemisation,
Polymerization BCS classification of drugs & its significant
Application of preformulation considerations in the development of solid, liquid oral and parenteral dosage forms and its impact on stability of dosage forms.
INTRODUCTION PPT
Tablets,Liquid orals
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Introduction, ideal characteristics of tablets, classification of tablets
Excipients, Formulation of tablets
Granulation methods,
compression and processing problems.
Equipments and tablet tooling
Tablet coating: Types of coating, coating materials,formulation of coating composition
equipment employed and defects in coating
Quality control tests: In process and finished product tests
Formulation and manufacturing consideration of syrups and elixirs suspensions and emulsions;
Filling and packaging; evaluation of liquid orals official in pharmacopoeia
Capsules
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a. Hard gelatin capsules: Introduction, Production of hard gelatin capsule shells. size of capsules
Filling, finishing and special techniques of formulation of hard gelatin capsules
manufacturing defects. In process and final product quality control tests for capsules
Soft gelatin capsules: Nature of shell and capsule content, size of capsules
Importance of base adsorption and minim/gram factors, production,
in process and final product quality control tests
Packing, storage and stability testing of soft gelatin capsules and their applications.
Pellets: Introduction, formulation requirements, pelletization process, equipments for manufacture of pellets
Parenteral Products,Ophthalmic Preparations:
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a. Definition, types, advantages and limitations. Preformulation factors and essential requirements,
vehicles, additives, importance of isotonicity
Production procedure, production facilities and controls,
aseptic processing c. Formulation of injections, sterile powders,
large volume parenterals and lyophilized products.
Containers and closures selection, filling and sealing of ampoules,
vials and infusion fluids. Quality control tests of parenteral products.
Ophthalmic Preparations: Introduction, formulation considerations; formulation of eye drops,
Eye ointments and eye lotions;
methods of preparation; labeling, containers; evaluation of ophthalmic preparations
Cosmetics,Pharmaceutical Aerosols,Packaging Materials Science
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Cosmetics: Formulation and preparation of lipsticks, shampoos, cold cream and vanishing cream,
tooth pastes, hair dyes and sunscreens.
Pharmaceutical Aerosols: Definition, propellants, containers, valves
Types of aerosol systems; formulation and manufacture of aerosols;
Evaluation of aerosols; Quality control and stability studies.
Packaging Materials Science: Materials used for packaging of pharmaceutical products,
Factors influencing choice of containers,
Legal and official requirements for containers,
stability aspects of packaging materials
quality control tests.
Protected: INDUSTRIAL PHARMACY I
Exercise Files
CLASS 5 IP.pdf
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