II B. PHARM SEMESTER III 1. 3.1 PHARMACEUTICS III (THEORY) TOTAL HOURS: 36 Sr. TOPICS NUMBER No.

OF HOURS 1 DESIGN AND DEVELOPMENT OF PHARMACEUTICALS 6 General considerations, Preformulation and formulation of dosage forms, general principles, excipients, detailed aspects and controlsIntroduction to Process and equipment validation. Procurement of Raw Materials - Manufacturers reliability, 2 Information Profile. TABLETS i) Introduction Types of tablets, their description, advantages and disadvantages of tablets in general.
a. Granulation technology: Tablet Formulation

Manufacturers Drug

components/excipients (binders, diluents, colorants, flavors, glidants, anti adherents, disintegrants, superdisintegrants etc.), review of solid-solid and solid-liquid mixing, drying of granules, mixing, granulation and drying equipments, advances in granulation technology and equipment, fluidization and fluidization equipment, pneumatic conveying, characterization of granules, in-process control.

Sr. No.

TOPICS

NUMBER OF HOURS

b. Tablet Compression: Tablet Machines (Single punch, single 5

and double rotary machines, dry cota compression machines), compression cycle, defects in compressed tablets, in-process control, prevention of cross contamination. Problems & trouble shooting in tablets. Tablet tooling, types & applications
c. Packaging of Tablets: Packaging materials (aluminium foil, 2

paper, plastic-PVC film, jars, labels etc.), packaging machines (blister, strip packaging, bulk pack), Cross contamination, product mix-up, product identification and relevant cGMP, in process control.
d. Quality Control standards: pharmacopoeial requirement,

Disintegration test, Disssolution test, hardness, friability, weight variation, content uniformity etc. ii) Coating of Tablets Need for coating, types (sugar, film, compression coating), materials used, coating equipments (different types of coating pans, fluid bed coating etc.), coating process, defects in coating, evaluation of coated tablets, safety considerations. iii) Manufacturing facilities and layout design of tablet dept. 3 POWDERS AND GRANULES Advantages, pretreatment to ingredients, processing techniques, mixing and equipment used for the same, pouches and bottle packing and equipments used for the same, environmental controls during manufacturing and packing of powders, effervescent products.

2 4

BOOKS RECOMMENDED:

1.

Ansels Pharmaceutical Dosage forms and Drug Delivery system (Wolter Kluwer, Lippincott William Wilkins)

2. Remingtons Pharmaceutical Sciences- Alfonso R. Gennaro ( Mack Publishing Co) 3. Bentleys T.B. of Pharmaceutics- Rawlins(ELBS) 4. The Theory and Practice of Industrial Pharmacy by Lachman, Lieberman and Kanig ( Lea and Febiger) 5. Modern Pharmaceutics- Dekker, Banker Rhodes 6. Groves- Parentral Products ( William Heinemann Medical Books Ltd.) 7. Hanlon- H.B.of packg. Engg.( Mc Graw Hill) 8. Swarbrick and Boyan- Encyclopedia of Pharmaceutical Technology (Marcel Dekker)

1. 3.1 PHARMACEUTICS - III (PRACTICALS) 3Hours/Week NOTE: Latest text books and pharmacopoeia should be referred.

1. Excipients : Evaluation of about three latest tablet excipients (atleast one multifunctional excipient) 2. Packaging: Evaluation of packaging materials. 3. Tablets i) Granulation, Compression including IPQC

Soluble aspirin tablets, Riboflavin tablets, Paracetamol tablets, Chewable tablets

Antihistaminic tablets ii) Evaluation of marketted Paracetamol tablets 4. Tablet Coating: demonstration 5. Powders Formulation & evaluation Oral-rehydration solution formulation Dry syrup formulation for reconstitution

Senna granules

Note: Incase of non-availability of raw materials/drugs for carrying out practical experiments covering similar principles can be carried out.

BOOKS RECOMMENDED:

1. Ansel, Introduction to Pharmaceutical Dosage Forms(Lea and Febiger)

2.

Sinko P., Martins Physical Pharmacy and Pharmaceutical Sciences, Lippincott/ Wolter Kluer. Remingtons Pharmaceutical Sciences (Mack) Mittal, Pharmaceutical Formulations.

3. 4.

5. Lachman, Industrial Pharmacy (Lea & Febiger) 6. Banker, Modern Pharmaceutics, Marcel Dekker.
7.

Official pharmacopoeia like I.P., B.P., U.S.P.