INDUSTRIAL PHARMACY I
Packing, storage and stability testing of soft gelatin capsules and their applications.
INDUSTRIAL PHARMACY I
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Preformulation Studies
Introduction to preformulation, goals and objectives, study of physicochemical characteristics of drug substances.
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Physical properties-solubility profile pKa, pH
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Partition coefficient,Physical form (crystal & amorphous),polymorphism
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Particle size, shape, flow properties
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Chemical Properties: Hydrolysis, oxidation, reduction, racemisation,
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Polymerization BCS classification of drugs & its significant
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Application of preformulation considerations in the development of solid, liquid oral and parenteral dosage forms and its impact on stability of dosage forms.
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INTRODUCTION PPT
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Tablets,Liquid orals
Introduction, ideal characteristics of tablets, classification of tablets
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Excipients, Formulation of tablets
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Granulation methods,
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compression and processing problems.
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Equipments and tablet tooling
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Tablet coating: Types of coating, coating materials,formulation of coating composition
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equipment employed and defects in coating
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Quality control tests: In process and finished product tests
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Formulation and manufacturing consideration of syrups and elixirs suspensions and emulsions;
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Filling and packaging; evaluation of liquid orals official in pharmacopoeia
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Capsules
a. Hard gelatin capsules: Introduction, Production of hard gelatin capsule shells. size of capsules
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Filling, finishing and special techniques of formulation of hard gelatin capsules
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manufacturing defects. In process and final product quality control tests for capsules
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Soft gelatin capsules: Nature of shell and capsule content, size of capsules
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Importance of base adsorption and minim/gram factors, production,
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in process and final product quality control tests
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Packing, storage and stability testing of soft gelatin capsules and their applications.
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Pellets: Introduction, formulation requirements, pelletization process, equipments for manufacture of pellets
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Parenteral Products,Ophthalmic Preparations:
a. Definition, types, advantages and limitations. Preformulation factors and essential requirements,
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vehicles, additives, importance of isotonicity
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Production procedure, production facilities and controls,
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aseptic processing c. Formulation of injections, sterile powders,
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large volume parenterals and lyophilized products.
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Containers and closures selection, filling and sealing of ampoules,
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vials and infusion fluids. Quality control tests of parenteral products.
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Ophthalmic Preparations: Introduction, formulation considerations; formulation of eye drops,
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Eye ointments and eye lotions;
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Labeling, containers; evaluation of ophthalmic preparations
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Cosmetics,Pharmaceutical Aerosols,Packaging Materials Science
Cosmetics: Formulation and preparation of lipsticks, shampoos, cold cream and vanishing cream,
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Tooth pastes, hair dyes and sunscreens
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Pharmaceutical Aerosols: Definition, propellants, containers, valves
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Types of aerosol systems; formulation and manufacture of aerosols;
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Evaluation of aerosols; Quality control and stability studies.
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Packaging Materials Science: Materials used for packaging of pharmaceutical products,
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Factors influencing choice of containers,
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Legal and official requirements for containers,
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stability aspects of packaging materials
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quality control tests.
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Exercise Files
CLASS24 (pdf)
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