Pharmaceutics

Chapter Topics • History of the profession of Pharmacy in India in relation to Pharmacy education, industry, pharmacy practice, and various professional associations.

• Pharmacy as a career • Pharmacopoeia: Introduction to IP, BP, USP, NF and Extra Pharmacopoeia. Salient features of Indian Pharmacopoeia Packaging materials:

Types, selection criteria, advantages and disadvantages of glass, plastic, metal, rubber as packaging materials Pharmaceutical aids: Organoleptic (Colouring, flavouring, and sweetening) agents Preservatives: Definition, types with examples and uses Unit operations:

Definition, objectives/applications, principles, construction, and workings of:

Size reduction: hammer mill and ball mill Size separation: Classification of powders according to IP, Cyclone separator, Sieves and standards of sieves Mixing: Double cone blender, Turbine mixer, Triple roller mill and Silverson mixer homogenizer Filtration: Theory of filtration, membrane filter and sintered glass filter Drying: working of fluidized bed dryer and process of freeze drying Extraction:

Definition, Classification, method, and applications Tablets – coated and uncoated, various modified tablets (sustained release, extended-release, fast dissolving, multi- layered, etc.) Capsules - hard and soft gelatine capsules Liquid oral preparations - solution, syrup, elixir, emulsion, suspension, dry powder for reconstitution Topical preparations - ointments, creams, pastes, gels, liniments and lotions, suppositories, and pessaries Nasal preparations, Ear preparations Powders and granules - Insufflations, dusting powders, effervescent powders, and effervescent granules Sterile formulations – Injectables, eye drops and eye ointments Immunological products: Sera, vaccines, toxoids, and their manufacturing methods.

Basic structure, layout, sections, and activities of pharmaceutical manufacturing plants Quality control and quality assurance: Definition and concepts of quality control and quality assurance, current good manufacturing practice (cGMP), Introduction to the concept of calibration and validation Novel drug delivery systems: Introduction, Classification with examples, advantages, and challenges PHARMACEUTICS – PRACTICAL Course Code: ER20-11P 75 Hours (3 Hours/week) Scope: This course is designed to train the students in formulating and dispensing common pharmaceutical dosage forms.

Course Objectives: This course will discuss and train the following aspects of preparing and dispensing various pharmaceutical dosage forms

1. Calculation of working formula from the official master formula

2. Formulation of dosage forms based on working formula

3. Appropriate Packaging and labelling requirements

4. Methods of basic quality control tests Course Outcomes: Upon successful completion of this course, the students will be able to

1. Calculate the working formula from the given master formula

2. Formulate the dosage form and dispense in an appropriate container

3. Design the label with the necessary product and patient information

4. Perform the basic quality control tests for the common dosage forms Practicals

1. Handling and referring the official references: Pharmacopoeias, Formularies, etc.

for retrieving formulas, procedures, etc.

2. Formulation of the following dosage forms as per monograph standards and dispensing with appropriate packaging and labelling • Liquid Oral: Simple syrup, Piperazine citrate elixir, Aqueous Iodine solution • Emulsion: Castor oil emulsion, Cod liver oil emulsion • Suspension: Calamine lotion, Magnesium hydroxide mixture • Ointment: Simple ointment base, Sulphur ointment • Cream: Cetrimide cream • Gel: Sodium alginate gel • Liniment: Turpentine liniment, White liniment BPC • Dry powder: Effervescent powder granules, Dusting powder • Sterile Injection: Normal Saline, Calcium gluconate Injection • Hard Gelatine Capsule: Tetracycline capsules • Tablet: Paracetamol tablets

3. Formulation of at least five commonly used cosmetic preparations – e.g. cold cream, shampoo, lotion, toothpaste etc

4. Demonstration on various stages of tablet manufacturing processes

5. Appropriate methods of usage and storage of all dosage forms including special dosage such as different types of inhalers, spacers, insulin pens

6. Demonstration of quality control tests and evaluation of common dosage forms viz. tablets, capsules, emulsion, sterile injections as per the monographs Assignments The students shall be asked to submit written assignments on the following topics (One assignment per student per sessional period. i.e., a minimum of THREE assignments per student)

1. Various systems of measures commonly used in prescribing, compounding and dispensing practices

2. Market preparations (including Fixed Dose Combinations) of each type of dosage forms, their generic name, minimum three brand names and label contents of the dosage forms mentioned in theory/practical

3. Overview of various machines / equipments / instruments involved in the formulation and quality control of various dosage forms / pharmaceutical formulations.

4. Overview of extemporaneous preparations at community / hospital pharmacy vs. manufacturing of dosage forms at industrial level

5. Basic pharmaceutical calculations: ratios, conversion to percentage fraction, alligation, proof spirit, isotonicity Field Visit The students shall be taken for an industrial visit to pharmaceutical industries to witness and understand the various processes of manufacturing of any of the common dosage forms viz. tablets, capsules, liquid orals, injectables, etc. Individual reports from each student on their learning experience from the field visit shall be submitted.