in process and final product quality control tests - Raghu College Of Pharmacy

INDUSTRIAL PHARMACY I in process and final product quality control tests

INDUSTRIAL PHARMACY I

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Preformulation Studies

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

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

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:

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;

Labeling, containers; evaluation of ophthalmic preparations

Cosmetics,Pharmaceutical Aerosols,Packaging Materials Science

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.

Announcements Reviews Course Info

Exercise Files

CLASS23 (pdf)

523.96 KB

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