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Industrial Pharmacy-I (Theory)

Industrial Pharmacy-I (Theory)

Teacher

Mr Himansu Bhusan Samal

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Core Courses

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Course Name : Industrial Pharmacy-I

Code(Credit) : CUTM1577 (4-0-0)

Course Objectives 

To Understand and appreciate the influence of  Pharmaceutical additives and various Pharmaceutical dosage forms on the performance of the drug product.

Learning Outcomes

  • To understand various Pharmaceutical Dosage forms and their manufacturing techniques
  • To Know various considerations in development of pharmaceutical dosage forms
  • To formulate and evaluate solid, liquid and semisolid dosage forms
  • To correlate the theoretical knowledge with professional and practical need of Pharmaceutical industry.
  • Able to Select the appropriate packaging materials for various pharmaceutical dosages form.

Course Syllabus:

MODULE-I
Preformulation Studies: Introduction to preformulation, goals and objectives, study of physicochemical characteristics of drug substances.
a. Physical properties: Physical form (crystal & amorphous), particle size, shape, flow properties, solubility profile (pKa, pH, partition coefficient), polymorphism
b. 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.

MODULE-II
Tablets:
a. Introduction, ideal characteristics of tablets, classification of tablets. Excipients, Formulation of tablets, granulation methods, compression and processing problems. Equipments and tablet tooling.
b. Tablet coating: Types of coating, coating materials, formulation of coating
composition, methods of coating, equipment employed and defects in coating.
c. Quality control tests: In process and finished product tests

Liquid orals: Formulation and manufacturing consideration of syrups and elixirs suspensions and emulsions; Filling and packaging; evaluation of liquid orals official in pharmacopoeia

MODULE-III
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.
b. 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

MODULE-IV
Parenteral Products:
a. Definition, types, advantages and limitations. Preformulation factors and essential requirements, vehicles, additives, importance of isotonicity
b. Production procedure, production facilities and controls,
aseptic processing
c. Formulation of injections, sterile powders, large volume parenterals and
lyophilized products.
d. 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

MODULE-V
Cosmetics: Formulation and preparation of the following cosmetic preparations: 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.

Reference :

1.

Session Plan

Session 1

Introduction to preformulation, goals and objectives, study of physicochemical characteristics of drug substances

Pre-Formulation

Session 2

Physical properties: Physical form (crystal & amorphous), particle size, shape, flow properties, solubility profile (pKa, pH, partition coefficient), polymorphism

Preformulation

Session 3

Chemical Properties: Hydrolysis, oxidation, reduction, racemisation, polymerization

Stability-converted

Session 4

BCS classification of drugs & its significant

BCS

Session 5

Application of preformulation considerations in the development of solid, liquid oral and parenteral dosage forms and its impact on stability of dosage forms.

SIGNIFICANCE OF PREFORMULATION STUDIES

Session 6

Tablet-Introduction, ideal characteristics of tablets, classification of tablets

Tablet

Session 7

Excipients used in Tablet

Tablet Excipients

Session 8

Formulation of tablets, granulation methods, compression

Tablet Manufacturing Process

Tablet Manufacturing

Session 9

Processing problems, Equipment and tablet tooling.

Tablet Defects

Tablet Tooling

Session 10

Tablet coating: Types of coating, coating materials, formulation of coating composition, methods of coating, equipment employed and defects in coating

Tablet Coating

Session 11

Quality control tests: In process and finished product tests

QC of Tablet

Session 12

Formulation and manufacturing consideration of syrups and elixirs

Liquid Oral (Syrup & Elixirs)

Session 13

Formulation and manufacturing consideration of suspensions and emulsions

Suspension

Emulsion

Session 14

Filling and packaging; evaluation of liquid orals official in pharmacopoeia

Session 15

Hard gelatin capsules: Introduction, Production of hard gelatin capsule shells. size of capsules

Capsule

Session 16

Filling, finishing and special techniques of formulation of hard gelatin capsules, manufacturing defects. In process and final product quality control tests for capsules.

Capsule Evaluation

Session 17

Soft gelatin capsules: Nature of shell and capsule content, size of capsules,importance of base adsorption and minim/gram factors

Soft Gelatin Capsule

Session 18

Production, in process and final product quality control tests. Packing, storage and stability testing of soft gelatin capsules and their applications.

Capsule

Session 19

Pellets: Introduction, formulation requirements, pelletization process

Pellets

Pellets

Session 20

Equipment for manufacture of pellets

Pellets Manufacturing Equipment

Session 21

Definition, types, advantages and limitations of Parenterals. Preformulation factors and essential requirements

Parenterals

Session 22

Vehicles & additives in Parenterals, importance of isotonicity

Session 23

Production procedure, production facilities and controls, aseptic processing

Session 24

Formulation of injections, sterile powders, large volume parenterals and lyophilized products.

Session 25

Containers and closures selection, filling and sealing of ampoules, vials and infusion fluids

Session 26

Quality control tests of parenteral products

QC of Parenterals

Session 27

Ophthalmic Preparations: Introduction, formulation considerations

Opthalmic Preparation

Session 28

Formulation of eye drops, eye ointments and eye lotions

Session 29

Methods of preparation; labeling, containers; evaluation of ophthalmic preparations

Session 30

Cosmetics: Formulation and preparation of the following cosmetic preparations: lipsticks, shampoos, cold cream and vanishing cream, tooth pastes, hair dyes and sunscreens.

Cosmetics

Session 31

Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol systems

Aerosol

Session 32

Formulation and manufacture of aerosols; Evaluation of aerosols; Quality control and stability studies.

Session 33

Packaging Materials Science: Materials used for packaging of pharmaceutical products, factors influencing choice of containers, legal and official requirements for containers

Packaging

Session 34

Stability aspects of packaging materials, quality control tests of packaging materials

Case Studies

Case Studies

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