BO4102 Formulation of Pharmaceuticals Syllabus:
BO4102 Formulation of Pharmaceuticals Syllabus – Anna University PG Syllabus Regulation 2021
COURSE OBJECTIVES:
The course aims to,
Enable the students to acquire theoretical knowledge in pharmaceutical dosage forms
Understand the theoretical principles with application oriented problems.
UNIT I INTRODUCTION TO DOSAGE FORMS
History & Evolution; Definitions and Classification of Dosage forms and routes of administration (Oral, Parenteral, Topical, Rectal and Nasal), Pharmacokinetics/Pharmacodynamics parameters for Dosage form development
UNIT II PREFORMULATION AND STABILITY STUDIES
Physical properties of drugs – physical form, polymorphism, particle size, shape, density, wetting, dielectric constant, solubility, dissolution, organoleptic property and their effect on formulation, stability and bioavailability. Study of chemical properties of drugs – hydrolysis, oxidation, reduction, polymorphisms racemization, polymerization and their influence on formulation and stability of products. Stabilization and stability testing protocol for various pharmaceutical products.
UNIT III SOLID DOSAGE FORMS
Capsules: Materials for production of hard/Soft gelatin capsules, size of capsules and method of capsule filling. Soft gelatin Capsule Manufacturing and evaluation – Micro-encapsulation Classification, Methods of preparation and Evaluation of microcapsules. Tablets: Classification, tablet formulation excipients, Tablet Manufacturing methods: Wet granulation, dry granulation, direct compression methods. Tabletting machinery, processing problems and evaluation. Coating- Types, materials for coating, formulation, equipment, film defects and evaluation of coated tablets.
UNIT IV LIQUID, SEMI-SOLID AND AEROSOL DOSAGE FORMS
Liquid Dosage forms: Additives in formulations, vehicles, stabilizers, preservatives, suspending agents, emulsifying agents, solubilizer, colors, flavors, manufacturing, packaging and evaluation of clear liquids, suspensions and emulsions official in pharmacopoeia. Semisolid Dosage Forms: Mechanisms of drug penetration, factors influencing penetration, semisolid bases and their selection. General formulation of semisolids, clear gels, formulations of semisolids Cream, Gel, Paste; Suppositories, manufacturing procedure, evaluation and packaging. Aerosols: Types of propellants, general formulation, manufacturing, packaging methods, pharmaceutical applications and evaluation.
UNIT V PARENTERALS AND DRUG DELIVERY OF LARGE MOLECULES
Parenteral; Liquids, (Solutions, Suspensions and Emulsions); Nasal; Ophthalmic and Optic Preparations; Packaging dosage design & delivery. Delivery systems for Peptides and Proteins – Delivery of Nucleic acids, Antibodies and siRNA.
TOTAL : 45 PERIODS
COURSE OUTCOMES:
At the end of the course the student will be able to,
CO1 Have learnt Pharmacokinetics/Pharmacodynamics parameters for dosage form development.
CO2 Learn formulation of various dosage forms of drugs.
CO3 Learn evaluation of various dosage forms of drugs.
CO4 Have knowledge of technological advancements to improve formulations at the completion course.
REFERENCES:
1. Ansel, H.C. “Pharmaceutical Dosage Forms and Drug Delivery Systems”, 11th Edition, Lippincott Williams &Wilkins, 2018.
2. Misra, Ambikanandan, Shahiwala, Aliasgar “Novel Drug Delivery Technologies”, 1st Edition, Springer, 2019
3. Lieberman, H.A. “Pharmaceutical Dosage Forms: Tablets”. Vol.1-3, 2nd Edition, Marcel Dekker, 2005.
4. Lieberman, H.A. “Pharmaceutical Dosage Forms: Parenteral Medications”, Vol.1-3, 2nd Edition, Marcel Dekker, 2005.
5. Lieberman, H.A. “Pharmaceutical Dosage Forms: Disperse Systems”, Vol.1-3, 2nd Edition,Marcel Dekker, 2005.
6. Vyas S.P, Khar K.R. “ Targeted & Controlled Drug Delivery -Novel Carrier Systems”, 1st Edition, CBS Publishers, 2012.
7. Surendra Nimesh, Ramesh Chandra, Nidhi Gupta.”Nanotechnology for the Delivery of Therapeutic Nucleic Acids”. 1ST Edition, Woodhead Publishing, 2017.
8. Manfred Ogris, David Oupicky. “Nanotechnology for Nucleic Acid Delivery”.1st Edition Humana Press, 2013.