LESSON PLAN SHRI.V.G.

JAMAKANDI SUBJECT: PHARMACEUTICAL TECHNOLOGY & BIOPHARMACEUTICS DEPARTMENT: PHARMACEUTICS CHAPTER: PHARMACEUTICAL EXCIPIENTS AND ADDITIVES Number of hours required as per RGUHS Syllabus: 05 Number of hours required as per lesson plan:05 Prerequisite: Student needs to understand the application of addition of excipients and additives in pharmaceutical formulation. Objective: a. To understand rationale behind using additives and excipients in the formulation b. To study their properties and their applications. c. To study in detail different pharmaceutical aids used in the manufacture of tablets, capsules, parenterals, liquids and semisolid formulations. Resources: a] Black board and chalk pieces. b] Over head projector. References: 1. 2. The theory and Practice of Industrial Pharmacy, Leon Lachmann, Pharmaceutics- Science of dosage forms design--- M.E. Aulton. Reprinted H.A.Lieberman, 3rd Edition. 1996. 3. Introduction to Pharmaceutical Dosage FormH.C.Ansel, 5th Edition. 4. Remingtons Pharmaceutical Sciences. 5. Indian Pharmacopiea- 1996. 6. British Pharmacopiea2000 7. United States Pharmacopieas- 21st Edition. 8. Hand book of excipients, Second Edition Published by Royal society Press. 9. Hand book of excipients, Fourth Edition, Raymond.C, Rowe.P., Sheskey.

10. Hand book of Drugs and Pharmaceuticals, Published by SPB board of consultants and engineers. Model Questions: 2 Marks 1. State the difference between excipients and additives. 2. List out various disintegrants used in the tablet formulations and its importance. 3. Antidusting agents are generally added in the capsule formulations Comment. 4. What nature of microcrystalline cellulose makes it directly compressible? 5 Marks 1. Write a note excipients and additives used in the capsule formulation. 2. Write a note on excipients used in tabletting technology. CHAPTER: A. TABLETS B. TABLET COATING Number of hours required as per RGUHS Syllabus:05 Number of hours required as per lesson plan:06 Prerequisite: tablet coating. Objective: a) To understand the concept of oral drug delivery by solid dosage tablets (conventional, enteric, prolonged and sustained release). b) To study the different techniques involved in formulations of tablets and coating technology. Student needs to understand technology involved and

formulations and the factors to be considered in formulation of tablets and

c) To study various quality assurance and quality control tests for coated and uncoated tablets as per Pharmacopoeial requirements. d) To illustrate equipments used in tabletting technology. e) To make a survey of various tablet formulation available in the market. Resources: a] Black board and chalk pieces. b] Over head projector. References: 1.The theory and Practice of Industrial Pharmacy, Leon Lachmann, H.A. Lieberman, 3rd Edition. 2.Pharmaceutics- Science of dosage forms design--- M.E. Aulton. Reprinted 1996. 3.Introduction to pharmaceutical dosage formH.C.Ansel, 5th Edition. 4.Remingtons Pharmaceutical Sciences. 5.Indian Pharmacopiea- 1996. 6.British Pharmacopiea2000 7.United States Pharmacopieas- 21st Edition. 8.Pharmaceutical Dosage forms Tablets Vol I,II, III--- Lieberman and Lachmann series. Model Questions: 2 Marks 1. List out the lubricants used in tablets. 2. Dissolution tests apparatus 3. Write a note on chewable tablets. 4. Disintegrants used in the tablet formulation. 5. Soluble tablets. 6. Manufacturing defects in the tablets. 7. Sweeteners used in tablets. 8. What do you mean by seal coat? 9. Types and application of coating.

10 Polymers used in film coating. 11. Enteric coating. 12. Mottling effect. 13. Rat holing effect- how it is rectifies. 14. Write a note on picking and sticking. 5 Marks 1. Explain the quality control tests of tablets. 2. List out the quality control tests for coated tablets with their limitations. 3. Classify various compressed tablets. 4. Fluidized bed drier for drying of the granules. 5. Basis for the formulation of sublingual tablets. 6. Write a note on film coating. 7. Write a note on dry granulation technique and its application in formulation of dosage form. 8. Write a note on the tablets manufactured by direct compression with relevant examples. 9. List out various glidants and lubricating agents used in the tabletting technology. Write their importance and in what concentration they are added in the formulations. 10 Equipments involved in coating. 10 Marks 1. Explain the advantages of granulation techniques. Classify granulation and explain the characters of each type 2. Give a detail account of the different excipients and their functions used in the tablets. 3. Explain different stages involved in sugar coating of a compressed tablets. 4. Explain different methods involved in coating technology and equipments used in coating. 5. Explain in detail Quality control tests for the coated and uncoated tablets with the specifications as stated in pharmacopeias.

6. Explain in detail Technology used in manufacture of tablets and tablet coating. CHAPTER: CAPSULES: a. Hard Gelatin b. Soft Gelatin. Number of hours required as per RGUHS Syllabus: 08 Number of hours required as per lesson plan: 10 Prerequisite: Student needs to understand the concept and technology involved in manufacture of hard and soft gelatin capsules and the various quality control tests. Objective: a. To understand the concept of oral drug delivery by solid dosage capsules (conventional, enteric, prolonged and sustained release). b. To study the different techniques involved in formulations of hard and soft gelatin capsules. c. To study various quality assurance and quality control tests for hard and soft gelatin capsules as per Pharmacopoeial requirements. d. To illustrate equipments used in capsule technology. e. To make a survey of various hard and soft gelatin capsules formulation available in the market. Resources: a] Black board and chalk pieces. b] Over head projector. References: 1. The theory and Practice of Industrial Pharmacy, Leon Lachmann, H.A.Lieberman, 3rd Edition. 2. Pharmaceutics- Science of dosage forms design--- M.E. Aulton. Reprinted 1996. 3. Introduction to pharmaceutical dosage formH.C.Ansel, 5th Edition.

4. Remingtons Pharmaceutical Sciences. 5. Indian Pharmacopiea- 1996. 6. British Pharmacopiea2000 7. United States Pharmacopieas- 21st Edition. Model Questions: 2 Marks 1. Cleaning of capsules. 2. Give the storage conditions for the capsules. 3. What are the sizes of hard gelatin capsules? 4. Give the examples of four surfactants. 5. Special techniques in manufacture of capsules. 6. Importance base adsorption in soft gelatin capsules. 5 Marks 1. Explain quality control tests of capsules (both hard and soft gelatin capsules). 2. Explain the filling process of hard gelatin capsules. 3. Explain the formulation of capsule content in soft gelatin capsules. 4. Write a note on the sixes of hard and soft gelatin capsules. 5. Discuss the production of Soft elastic capsules. 6. Explain the manufacture of hard gelatin capsule shell. 7. What do you understand by accelerated stability study testing in capsules*** 8. Explain in detail extraction of gelatin. 9. What should be the nature of shell for manufacture of hard and soft gelatin capsules. 10. What do you understand by the term adsorption and minim/gram factors and importance of it filling of the soft gelatin capsule content? 11.Inprocess quality control tests in manufacture of soft gelatin capsule shell. 12. Calculation for base adsorption minim.

10 Marks 1. Discuss in detail the materials used in filling/finishing/sealing and formulation aspects of Hard gelatin capsules. Give the quality control tests for hard gelatin capsules. 2. Technology involved in the manufacture of the soft gelatin capsule shell and the quality control tests. CHAPTER: PARENTERAL PRODUCTS Number of hours required as per RGUHS Syllabus: 14 Number of hours required as per lesson plan:16 Prerequisite: Student needs to understand preformulation and formulation

factors to be considered parenteral technology, concept of aseptic technique and its importance in the parenterals manufacturing, storage of the parenterals and quality control tests for parenteral preparations. Objective: a. To study preformulation factors to be considered during formulations of small volume parenteral (SVPs) and large volume parenterals(LVPs). b. To study various Pharmacopeial requirements for manufacturing and storage of parenterals. c. To study different processes viz, prefilling techniques, washing of containers and closure, sealing of vials, ampoules and infusion bottles, involved in manufacturing. d. To illustrate different equipments used in manufacturing and aseptic technique in formulation. e. To study various quality control tests for parenterals. Resources: a] Black board and chalk pieces. b] Over head projector. References:

1.

The

Theory

and

Practice

of

Industrial

Pharmacy,

Leon

Lachmann,

H.A.Lieberman, 3rd Edition. 2. Pharmaceutics- Science of dosage forms design--- M.E. Aulton. 3. Introduction to pharmaceutical dosage formH.C.Ansel, 5th Edition. 4. Remingtons Pharmaceutical Sciences. 5. Indian Pharmacopiea- 1996. 6. British Pharmacopiea2000 7. United States Pharmacopieas- 21st Edition. 8. Pharmaceutical dosage forms: Parenterals medication Lachmann and Lieberman-2nd Edition. 9. Parenterals Vol I, Vol II Lachmann series. Model Questions: 2 Marks 1. Define LVP and SVP. 2. LAL test 3. Tests to determine pyrogens. 4. Isotonicity and its significance. 5. Lyophillization and its importance in the formulations. 6. Containers and closure in parenterals. 7. Give four examples for the non aqueous vehicles used in parenterals preparations. 5 Marks 1. Write a note on different routes of administration. 2. Significance of isotonocity and methods of adjustment. 3. What are paratonic solutions and what happens when they are administered into the body? 4. Write a note on formulations of small volume parenterals. 5. Write a note on formulations of large volume parenterals. 6. Write a note on containers and closures and selection. 7. Quality control tests for parenterals.

8. Write a note on the importance of the aseptic technique and laminar air flow services used during manufacturing of parenterals. 9. Write a note on the sources of contamination during manufacturing of the parenterals and methods to prevent. 10. Standards for water for injections. 11. Pyrogen testing in manufacturing of the parenterals. 12. Principle involved in lyophilization technique for preservation.

10 Marks 1. Write a note on the pretreatment and manufacturing of water for injection. Add a note on the standards for WFI. 2. Write in detail the quality control tests for parenterals. 3. Write in detail Manufacturing of Large volume parenterals (LVP) and small volume parenterals(SVP). CHAPTER: OPHTHALMIC FORMULATIONS Number of hours required as per RGUHS Syllabus: 04 Number of hours required as per lesson plan:04 Prerequisite: Student needs to understand the concept of ophthalmic drug delivery the ideal requirements of ophthalmic formulations. Objective: a. To study the ideal characteristic of ophthalmic formulations. b. To illustrate the formulation details and storage conditions. c. To study evaluations parameters of ophthalmic formulations. Resources: a] Black board and chalk pieces. b] Over head projector. References:

1.

The Theory and Practice of Industrial Pharmacy, Leon Lachmann,

H.A.Lieberman, 3rd Edition. 2. Pharmaceutics- Science of dosage forms design--- M.E. Aulton. 3. Introduction to Pharmaceutical dosage formH.C.Ansel, 5th Edition. 4. Remingtons Pharmaceutical Sciences. 5. Indian Pharmacopiea- 1996. 6. British Pharmacopiea2000 7. United States Pharmacopieas- 21st Edition. 8. Dispensing Pharmacy by Cooper and Gunns5 Edition. Model Questions: 2 Marks 1. Importance of isotonicity in manufacturing of ophthalmic formulation. 2. Comment on the statement Hydrogen ion concentration is very important in formulation of ophthalmic solutions. 3. Give examples for the buffers used in the ophthalmic preparations. 4. Give examples for the viscosity enhancers used in the formulation used for the eyes. 5 Marks 1. State the requirements of ophthalmic formulations. 2. Write a note on container and closure used in packaging of ophthalmic formulations. 3. How are ophthalmic formulations evaluated. 10 Marks 1. State the requirements, formulations and evaluations of formulations in detail. CHAPTER: LIQUID ORALS Number of hours required as per RGUHS Syllabus: 05 Number of hours required as per lesson plan:05 ophthalmic

Prerequisite: Student needs to understand formulation of liquid orals. Objective: a. To study the ideal characteristic of formulations taken orally. b. To illustrate the formulation details and storage conditions. c. To study the different process i.e. manufacturing, filling and packaging of liquid orals. Resources: a] Black board and chalk pieces. b] Over head projector. References: 1.The Theory and Practice of Industrial Pharmacy, Leon Lachmann, H.A.Lieberman, 3rd Edition. 2. Pharmaceutics- Science of dosage forms design--- M.E. Aulton. 3. Introduction to Pharmaceutical dosage formH.C.Ansel, 5th Edition. 4. Remingtons Pharmaceutical Sciences. 5. Indian Pharmacopiea- 1996. 6. British Pharmacopiea2000 7. United States Pharmacopieas- 21st Edition. 8. Dispensing Pharmacy by Cooper and Gunns5 Edition. 9. Formulation Manual By Kohli and Shah. Model Questions: 2 Marks 1. Explain steps involved in filling of liquid orals. 2. Preservatives added in liquid oral. 5 Marks 1. State the formulation details of liquid orals. 2. Write a note on filling and packaging of liquid orals. 10 Marks 1. State the requirements, manufacturing, filling and packaging of liquid orals.

2. Explain the requirements, formulations, manufacture and containers used for eye ointments. CHAPTER: SEMI-SOLID DOSAGE FORMS Number of hours required as per RGUHS Syllabus: 04 Number of hours required as per lesson plan:06 Prerequisite: Student needs to understand the concept of semisolid dosage forms and its absorption and technology involved in manufacturing. Objective: a. To study the ideal characteristic of semisolid formulations. b. To study the mechanism of drug penetration and factors influencing penetration of the dosage. c. To illustrate different semisolid bases and bases for selection. d. To study techniques for the preparation Suppositories and methods to evaluate them. e. To study general formulations of semisolid and methods to evaluate them. Resources: a] Black board and chalk pieces. b] Over head projector. References: 1. 2. The Theory and Practice of Industrial Pharmacy, Leon Lachmann, H.A.Lieberman, 3rd Edition. Pharmaceutics- Science of dosage forms design--- M.E. Aulton. Reprinted 1996. 3. Introduction to Pharmaceutical dosage formH.C.Ansel, 5th Edition. 4. Remingtons Pharmaceutical Sciences. 5. Indian Pharmacopiea- 1996. 6. British Pharmacopiea2000 7. United States Pharmacopiea- 21st Edition. 8. Dispensing Pharmacy by Cooper and Gunns5 Edition.

9. Formulation Manual- By Kohli and Shah. Model Questions: 2 Marks 1. Suppositories bases. 2. Medicated jellies 3. Ointments bases. 5 Marks 1. State various quality control tests for ointments. 2. Preparations of the gels 3. What are jellies? How do they differ from ointments? Mention their uses. 4. Explain the term displacement value and its importance in formulation of suppositories. 5. Classify Semisolid dosage. Explain in detail formulations of gels. 6. State the difference between Gels and jellies. 7. Write a note on semisolid bases and their selection. 8. Evaluation of semisolid dosage as per pharmacopeial standards 10 Marks 1. Give various types of ointment bases. How are ointments formulated and quality control tests performed? 2. Explain how rectal suppositories are formulated, packed and stored. What are pessaries, how are they formulated. Write a note on medicaments used in them. 3. Classify semisolid dosage? Mechanism of drug penetration and factors influencing the drug absorption from semisolid. CHAPTER: PHARMACEUTICAL AEROSOLS Number of hours required as per RGUHS Syllabus: 06 Number of hours required as per lesson plan:08 Prerequisite: Student needs to understand the concept behind usage, its formulation, packaging and storage of pharmaceutical aerosols.

Objective: a. To study the importance of aerosol formulations in drug targeting and effective drug utilization. b. To illustrate the technology involved in manufacturing of aerosols and its packaging. c. To study the parameters used for the evaluation of aerosols. Resources: a] Black board and chalk pieces. b] Over head projector.

References: 1. The Theory and Practice of Industrial Pharmacy, Leon Lachmann, H.A.Lieberman, 3rd Edition. 2. Pharmaceutics- Science of dosage forms design--- M.E. Aulton. 3. Introduction to Pharmaceutical dosage formH.C.Ansel, 5th Edition. 4. Remingtons Pharmaceutical Sciences. 5. Indian Pharmacopiea- 1996. 6. British Pharmacopiea2000 7. United States Pharmacopieas- 21st Edition. 8. Dispensing Pharmacy by Cooper and Gunns5 Edition. 9. Formulation Manual- By Kohli and Shah. Model Questions: 2 Marks 1. Propellants used in aerosols. 2. Conatiners used in aerosols. 3. Spray tests in aerosols. 4. Drug content tests for aerosols. 5. Metals used in packaging of aerosols. 5 Marks 1. Write a note propellants used in manufacture of aerosols.

2. Quality control tests in aerosols. 3. Formulation of aerosols. 4. Write a note on stability studies of aerosols. 10 Marks 1. Explain the term aerosols. State the requirements for the formulations of stable aerosols. Classify aerosols; add a note on containers and closure used for packaging. 2. Write in detail quality control tests of aerosols and how are the stability studies of aerosol formulations carried out.

CHAPTER: RADIOPHARMACEUTICAL Number of hours required as per RGUHS Syllabus: 03 Number of hours required as per lesson plan: 05 Prerequisite: Student needs to understand uses of Radiopharmaceuticals, diagnosis and safety precautions. Objective: a. To study different types of radiopharmaceuticals and their uses. b. To classify different types of radiopharmaceuticals, uses in diagnosis and treatment. c. To study the method of preparation handling. d. To study the safety precaution involved in radiopharmaceuticals. Resources: a] Black board and chalk pieces. b] Over head projector. References: 1. The Theory and Practice of Industrial Pharmacy, Leon Lachmann, H.A.Lieberman, 3rd Edition. 2. Pharmaceutics- Science of dosage forms design--- M.E. Aulton.

3. Introduction to Pharmaceutical dosage formH.C.Ansel, 5th Edition. 4. Remingtons Pharmaceutical Sciences. 5. Indian Pharmacopiea- 1996. 6. British Pharmacopiea2000 7. United States Pharmacopieas- 21st Edition. 8. Dispensing Pharmacy by Cooper and Gunns5 Edition.

Model Questions: 2 Marks 1. Classify types of radiopharmaceuticals used in diagnosis. 2. Classify different radiopharmaceuticals. 3. Comment safety measures involved in radiopharmaceuticals. 4. Methods of handling radiopharmaceuticals. 5 Marks 1. Write in detail about radiopharmaceuticals. 2. Illustrate radiopharmaceuticals safety precautions. 3. Methods of preparation handling of radiopharmaceuticals. 10 Marks 1. Write in detail radiopharmaceuticals used in diagnosis and treatment, methods of preparation handling and safety precautions.

CHAPTER: COSMETICS Number of hours required as per RGUHS Syllabus: 13 Number of hours required as per lesson plan: 13 Prerequisite: Student needs to understand formulation of cosmetics. Objective: a. To study different types of cosmetic formulations and ideal characteristics of each formulations. b. To study different types of herbal cosmetics. Resources:

a] Black board and chalk pieces. b] Over head projector. References: 1. Drug manufacturing manual- By Kohli and Shah. 2. Harry cosmetology 3. Introduction to Pharmaceutical dosage formH.C.Ansel, 5th Edition. 4. Remingtons Pharmaceutical Sciences. 5. Technology for the preparation and distribution of drugs and cosmetics- by Shiv Narayan Sahu. Model Questions: 2 Marks 1. Ingredients of lipstick. 2. Formulation of tooth powder. 3. Cold cream 4. Vanishing cream 5 Marks 1. Formulation details of cold cream and vanishing cream. 2. Write a note on tooth paste and tooth powder. 3. Write a note on herbal cosmetics used in the cosmetics. 4. Formulations of clear liquid shampoo. CHAPTER: BIOPHARMACEUTICS Number of hours required as per RGUHS Syllabus: 08 Number of hours required as per lesson plan: 10 Prerequisite: Student needs to understand in design and development of dosage forms. Objective: a. To understand the concept of biopharmaceutics, bioavailability, bioequivalence of dosage forms for therapeutic use. b. To study different processes involved and factors effecting absorption. application of biopharmaceutics

c. To

illustrate

different

parameters

used

for

determination

of

bioavailability. d. To study different blood level curves. e. To compare in-vitro and in-vivo bioavailability (in-vivo and in-vitro correlation). f. To compare bioavailability and bioequivalence studies. Resources: a] Black board and chalk pieces. b] Over head projector. References: 1. The Theory and Practice of Industrial Pharmacy, Leon Lachmann, H.A.Lieberman, 3rd Edition. 2. Pharmaceutics- Science of dosage forms design--- M.E. Aulton. 3. Introduction to Pharmaceutical dosage formH.C.Ansel, 5th Edition. 4. Remingtons Pharmaceutical Sciences. 5. United States Pharmacopeia- 21st Edition. 6. Biopharmaceutics and Pharmacokinetics- By Bramanakar 7. Biopharmaceutics and Pharmacokinetics- By P.L. MAdan. 8. Dissolution and Bioavailability-Abdou. Model Questions: 2 Marks 1. Passive absorption. 2. Facilitated diffusion. 3. Active transport. 4. Define bioavailability and bioequivalence. 5. Absolute and relative bioavailability. 6. In-vitro and In-vivo correlation. 7. Enhancement of bioavailability. 8. Partition coefficient and absorption.

9. Pinocytosis and phygocytosis. 10. Endocytosis. 5 Marks 1. Define drug absorption and write in detail pharmaceutical factors effecting drug absorption. 2. Write a note on physiochemical factors effecting drug absorption. 3. Bioavailability and methods to determine bioavailability. 4. Bioequivalence and techniques for bioequivalence studies from a single dose. 5. Explain term in-vitro in-vivo correlation with relevant examples. 6. Mechanism of drug absorption. 7. Official techniques for the determination of bioavailability (dissolution factor). 8. Absolute bioavailability and absolute bioavailability. 9. Determination of absorption coefficient by back residual method. 10 Marks 1. Write a note on absorption, mechanism of drug absorption and factors affecting. 2. Define bioavailability, classify bioavailability, write in detail factors effecting bioavailability. 3. Write in physicochemical and pharmaceutical factors effecting absorption. 4. Define the term bioavailability and bioequivalence and classify them with examples. Write a note on in -vitro in-vivo correlation.