BO4111 Formulation and Quality Control Methods for Pharmaceuticals Laboratory Syllabus:

BO4111 Formulation and Quality Control Methods for Pharmaceuticals Laboratory Syllabus – Anna University PG Syllabus Regulation 2021

COURSE OBJECTIVES:

The course aims to
> Provide hands on experience on different forms of drug formulation
> Learn the quality control methods available for evaluation of pharmaceuticals.

PART I: FORMULATION EXPERIMENTS

1. Preparation of Nano Emulsions.
2. Preparation of Lyophilised powder
3. Preparation of solid dosage forms (Eg. Granules, Tablets, Capsules)
4. Preparation of liquid dosage forms (Eg. True Solutions, mixtures, Elixirs)
5. Preparation of biphasic dosage forms (Eg. Emulsion, Suspension)
6. Preparation of semisolid dosage forms (Eg. Ointments, Creams, Gels, lotions
7. Preparation of Parenteral and ophthalmic formulations
8. Preparation of specialized dosage forms (Eg. Suppositories, Patches)

PART II: QUALITY CONTROL METHODS FOR PHARMACEUTICALS

1. Disintegration test, weight variation.
2. Particulate matter, Transmittance of light, Viscosity, Extractables and leachable, Freeze-Thaw test.
3. pH, Dissolution, Sedimentation volume, Rheological method, Zeta potential measurement,
4. Particle size distribution, In-vitro release testing,
5. Leakage test, Pyrogen test, Sterility, Particulate matter, Preservative efficacy test.
6. Sprays & Inhalations – Valve discharge rate, Spray pattern & Plume geometry, Dosage with metered valves, Foam stability.
7. Net content and Weight loss, pH, Osmolality.
8. Stability testing for all dosage forms.

EQUIPMENTS REQUIRED

1. Mortar and Pestle
2. Sieves of all sizes
3. Granulator
4. Punching machine
5. Capsule filler
6. Disintegration, dissolution and friability testing apparatus
7. Formulation reagents (surface acting agents, glidants, diluents etc,)
8. pH meter, physical balances

TOTAL: 60 PERIODS

COURSE OUTCOMES:

At the end of the course the student will be able to,
CO1 Develop of different dosage forms of drugs.
CO2 Learn the evaluation of various dosage forms of drugs.
CO3 Get knowledge of developing new formulation.
CO4 Find out the stability of the dosage forms
CO5 Have hands on experience in dosage form formulation and pursue a career in industry.

REFERENCES:

1. Ansel, H.C. “Pharmaceutical Dosage Forms and Drug Delivery Systems”, 11th Edition, Lippincott Williams & Wilkins, 2018.
2. Lieberman, H.A. “Pharmaceutical Dosage Forms: Tablets”. Vol.1-3, 2nd Edition, Marcel Dekker, 2005.
3. Lieberman, H.A. “Pharmaceutical Dosage Forms: Parenteral Medications”, Vol.1-3, 2nd Edition, Marcel Dekker, 2005.
4. Lieberman, H.A. “Pharmaceutical Dosage Forms: Disperse Systems”, Vol.1-3, 2nd Edition, Marcel Dekker, 2005.
5. Lachman, Leon “The Theory And Practice of Industrial Pharmacy”, 4th Edition, Varghese Publishing House, 2013.
6. USP NF, guidelines: http://www.usp.org, https://www.uspnf.com, & http://www.fda.gov.