Material Science of Excipients and Additives

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Bhisma Narayan Ratha

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Core Courses

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Course: Material Science of Excipients and Additives

Code (Credit): CUTM1170 (2-0-1)

Course Objective

The student will be able to identify a range of excipients and additives. They will learn about their uses and suitability with different pharmaceutical formulations.

Learning Outcome

The student will be able to design necessary pre-formulation studies. Also will learn about appropriate excipients and additives required to achieve desired physical properties of the pre-formulation.

Course Syllabus

Module I: Pre-formulation Studies (4h + 3h)

  • Theory: Pre-formulation Studies - Introduction to pre-formulation, goals and objectives, study of physicochemical characteristics of drug substances. Physical properties: Physical form (crystal & amorphous), particle size, shape, flow properties, solubility profile (pKa, pH, partition coefficient), polymorphism. Chemical Properties - Hydrolysis, oxidation, reduction, racemization, polymerization BCS classification of drugs & its significant. Application of pre- formulation considerations in the development of solid, liquid oral and parenteral dosage forms and its impact on stability of dosage forms.
  • Project:
    1. Write a review report on a drug exhibiting polymorphism (drug of phytochemical origin).

Module II: Tablets (6h + 4h)

  • Theory: Introduction, ideal characteristics of tablets, classification of tablets. Excipients, Formulation of tablets, granulation methods, compression and processing problems. Equipment’s and tablet tooling. 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.
  • Project:
  1. Write a review report on recent development in tablet coating agents (citations used should not be older than 5 years).

Module III: Capsules (6h + 3h)

  • Theory: 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.
  • Project:
  1. Write a review report on key differences between hard gelatin and soft gelatin capsules (with reference to the materials used in preparation of hard/soft gelatin).

Module IV: Pellets (2h + 3h)

  • Theory: Introduction, formulation requirements, palletization process, equipment’s for manufacture of pellets. Parenteral definition, types, advantages and limitations. Pre-formulation factors and essential requirements, vehicles, additives, importance of isotonicity.
  • Project:

Write a review report on vehicles and additives for parenteral dosage forms.

Suggested Readings

    1. Liberman, H. A., Lachman, L., & Schwartz, J. B. (2005). Pharmaceutical dosage forms: Tablets volume-2. Marcel dekker, New York, 2.
    2. Banker, G. S., Siepmann, J., & Rhodes, C. (Eds.). (2002). Modern pharmaceutics. CRC Press.
    3. Remington, J. P. (2006). Remington: The science and practice of pharmacy (Vol. 1). Lippincott Williams & Wilkins.
    4. Allen, L., & Ansel, H. C. (2013). Ansel's pharmaceutical dosage forms and drug delivery systems. Lippincott Williams & Wilkins.

Session Plan

Session 1 (Theory)

Introduction to pre-formulation, goals and objectives, study of physicochemical characteristics of drug substances (Pre-formulation , Introduction to Pre-formulation).

Session 2 (Theory)

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

Session 3 (Theory)

Chemical Properties - Hydrolysis, oxidation, reduction, racemization, polymerization BCS classification of drugs & its significant (Redox Reaction, Chemical Properties)

Session 4 (Project)

Write a review report on a drug exhibiting polymorphism (drug of phytochemical origin). (Polymorphism, Drug Polymorphism PPT)

Session 5 (Theory)

Application of pre- formulation considerations in the development of solid, liquid oral and parenteral dosage forms and its impact on stability of dosage forms. (Drug Delivery System VIDEO, Drug stability PPT)

Session 6 (Theory)

Tablets - Introduction, ideal characteristics of tablets, classification of tablets. Excipients, Formulation of tablets. (Tablet VIDEO,  Tablet PPT)

Session 7 (Theory)

Granulation methods, compression and processing problems, Equipment’s and tablet tooling. (Tablet2 VIDEO, Tablet PPT)

Session 8 (Project)

Write a review report on recent development in granulation methods & tablet coating agents (citations used should not be older than 5 years). (Tablet 3 VIDEO, tablet-granulation PPT)

Session 9 (Theory)

Tablet coating - Types of coating, coating materials, formulation of coating composition, methods of coating. (Tablet coating VIDEOTablet coating PPT)

Session 10 (Theory)

Equipment employed and defects in coating. c. Quality control tests: In process and finished product tests. (QC VIDEO, Tablet QC PPT)

Session 11-12 (Project)

Write a review report on recent development in granulation methods & tablet coating agents (citations used should not be older than 5 years). (Tablet Coating VIDEO, QC for tablet PPT)

Session 13 (Theory)

Liquid orals - Formulation and manufacturing consideration of syrups and elixirs suspensions and emulsions. (Liquid dosage form (Emulsion) VIDEO, Suspensions & emulsions PPT)

Session 14 (Theory)

Filling and packaging - Evaluation of liquid orals official in pharmacopoeia (Evaluation of emulsion VIDEO, Oral liquid formulations PPT)

Session 15 (Theory)

Hard gelatin capsules - Introduction, Production of hard gelatin capsule shells. size of capsules. (Capsule Shell VIDEO, Capsules manufacturing PPT)

Session 16 (Theory)

Capsule filling, finishing and special techniques of formulation of hard gelatin capsules, manufacturing defects. (Capsule VIDEO,  Hard gelatin capsule PPT)

Session 17 (Theory)

In process and final product quality control tests for capsules. (QC testing VIDEO, Capsule QC PPT)

Session 18 (Theory)

Soft gelatin capsules - Nature of shell and capsule content, size of capsules (Soft Gelatin Capsul VIDEO, Soft Gelatin Capsul PPT)

Session 19 (Theory)

Importance of base adsorption and minim/gram factors, production, in process and final product quality control tests. (Softgel Encapsulation VIDEO, Softgelatin capsule QC PPT)

Session 20 (Theory)

Packing, storage and stability testing of soft gelatin capsules and their applications. (Softgel Encapsulation process VIDEO, Soft gelatin QC PPT)

Session 21 (Project)

Write a review report on key differences between hard gelatin and soft gelatin capsules (with reference to the materials used in preparation of hard/soft gelatin). (Soft gelatin Video, Capsule manufacturing PPT)

Session 22 & 23 (Theory)

Introduction, formulation requirements, palletization process, equipment’s for manufacture of pellets. (Pellet VIDEO, Pelletization technology review PDF)

Session 24 & 25 (Theory)

Parenteral dosage forms: Definition, types, advantages and limitations. Pre-formulation factors and essential requirements, vehicles, additives, importance of isotonicity. (Parenteral dosage VIDEO, Parentrals PPT)

Session 26 (Project)

Write a review report on vehicles and additives for parenteral dosage forms. (Particle inspection, analysis-of-parenteral-dosage-forms

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