4_m. ph pharmaceutical technology

5/20/2018 4_m. Ph Pharmaceutical Technology

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SYLLABUS REVISION

I - M.PHARM

PHARMACEUTICAL TECHNOLOGY

GOAL: To produce a competent Pharmaceutical technologist.

OBJECTIVE: Upon completion of the course, the candidate shall have:

An understanding of the concept and design of various pharmaceutical dosage forms

The ability to formulate and evaluate various dosage forms

The ability to work independently and as a member of the team

The ability to plan his / her work for efficient use of time and resources

The ability to identify the cause and to solve the problem

The ability to think and evaluate scientifically and critically

TEACHING/ LEARNING ACTIVITIES

. Journal Club: weekly, !ournal club meetings to be held to discuss the recent

development in the sub"ect published in the national and international "ournals.

#. S!"nar#: $eminars %&'( in a year) shall be arranged from e*perts in the field.

+. In$u#%r"al &"#"%#: isits to pharmaceutical industries to understand shop floor

activities.

-. Con'rn(# an$ !%"n)#: $taff and students are to be encouraged to

participate in seminars, workshops and conferences in the area of this sub"ect.

TITLE O* PAPERS

Pa+r I: Mo$rn P,ar!a(u%"(al Anal#"#

Pa+r II: A$&an($ P,ar!a(u%"(al T(,nolo)

Pa+r III: B"o+,ar!a(u%"(# an$ P,ar!a(o"n%"(#

Pa+r IV: A$&an(# "n ru) l"&r S#%!#


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A++n$"0 I: L"#% o' R1u"r$ E1u"+!n%#/In#%ru!n%#:

The following common and specialied euipments/instruments, and charts are to be

provided by the course conducting department/institution.

Co!!on E1u"+!n%#:

$ingle pan balances %analytical): 0#

$ingle pan balances %electronic/digital): 0#

1ot air oven: 0#

2agnetic stirrers: 03

2echanical stirrers %,#,& ltrs): 0-

4ouble pan balances %analytical): 0

Thermostatic digital water baths: 0#

4istillation assembly: & ltrs. capacity

1ot plates: 0-

5efrigerator: 0

T67 8it and plates

$ieves of different mesh sies %0, #, (, ##, --, (0, 30, #0): # each

S+("al E1u"+!n%#:

2onsanto 9 Pfier hardness testers: 0# each

4isintegration test apparatus: 0#

4issolution test apparatus %single "ar): 0-

4issolution test apparatus %(/3 !ars):0


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U'isible spectrophotometer %4ouble beam): 0

Tablet compression machine single station: 0

5otary tablet compression machine %&'0 station): 0

ath sonicator: 0

Table top centrifuge: 0

7apsule filling machine: 0

$tability chamber: 0

7oating 9 Polishing pan: 0

acuum pump with accessories: 0

Pocket / pen p1 meters: 0#

acuum filtration units: 0

5otary evaporator: 0

5otary shaker: 0

;iltration sets: 0#

rookefield iscometer : 0

#"rabl

1igh performance 6iuid 7hromatography %1P67): 0

7omputers with UP$ and a printer: 0-

;reee dryer: 0

Gla##2ar

7ommon laboratory glassware for regular e*periments: eakers, measuring cylinders,

conical flasks, 5 9 ; ;lasks %9 # lt. capacity), filtration unit, distillation unit,

thermometers 0 9 +(0 degree 7elsius etc..

C,!"(al# an$ Ra)n%#

7ommon pharma grade pure drug samples, polymers and other ad"uvants, solvents

etc. for the purpose of formulation reuired for the regular practicals.


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PAPER II -AVANCE PHARMACEUTICAL TECHNOLOGY

THEORY 34 Hour# 56 Hr#/ 78

9. PRE*ORMULATION STUIES

5Mar# allo%!n% : 93 8 5 Hr#.8

. CAPSULE TECHNOLOGY 5Mar# allo%!n% : 94 8 5> Hr#.8

2anufacturing euipment and machinery used in capsule technology. ;ormulation and

evaluation of hard gelatin capsules and soft gelatin capsules.

3. PARENTERALS TECHNOLOGY

5Mar# allo%!n% : 94 8 5 3 Hr#.8

2anufacturing of 6P, $P, $teriliation and sterility testing of parenterals, =2P 9

c =2P regulations of parenteral technology.

. STABILITY TESTING - RUGS AN OSAGE *ORMS


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5Mar# allo%!n% : 94 8 5> Hr#.8

$olid state drug stability, dosage form stability, accelerated stability testing, shelf life

calculations, strategies for prolonging shelf life. @ffect of packaging materials on dosage

form stability. asic principles of


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PRACTICALS

(6 hours/week)

) @ffect of surfactants on the solubility of drugs.

#) @ffect of co'solvents on the solubility of drugs.

+) Preparation and evaluation of solid dispersion.

-) Preparation and evaluation of inclusion comple*.

&) To study the effect of glidants and lubricants on flowability and compressibility of

granules.

() @ffect of different granulating agents and disintegrants on the properties of tablets.

G) Preparation and evaluation of aspirin effervescent tablets.

3) Preparation and evaluation of chewable antacid tablets.

H) Preparation and evaluation of coated tablets by pan coating.

0) ;ormulation and evaluation of capsules.

) ;ormulation and evaluation of small volume parentarals.

#) ;ormulation and evaluation of large volume parentarals.

+) @valuation of glass as a pharmaceutical packaging material.

-) @valuation of plastic as a pharmaceutical packaging material.

&)Accelerated stability testing, shelf'life determination and e*piration dating ofpharmaceuticals.

SCHEME OF EXAMINATION

. $ynopsis ' #0 marks

#. @*periment

2a"or @*periment ' +& marks

2inor @*periment ' #& marks

+. iva'voce ' #0 marks

To%al: 944 !ar#


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REFERENCE BOOKS

! "ieberman #$ and "achman ". %harmaceutical &osage Forms' (ablets. )ol. *, **

and ***, +arcel &ekker, e ork. "atest /dition.

0!. $vis 1/, "achman " and "ieberman #$, %harmaceutical &osage Forms'

%arenterals. )olume * and **, +arcel &ekker, e ork. "atest /dition.

2! 3obinson and "ee, Controlled drug delivery' Fundamentals and applications,

+arcel &ekker.

4! Carstensen, %harmaceutical principles o solid dosage orms, C3C.

5! 3ay and 6eller, #andbook o %harmaceutical /xcipients, %harmaceutical %ress.

7! %harmaceutical dosage orms' %arenteral, "achman, "ibermann, and $vis, )ol.

* 8 **

+arcel &ekker.

9! icholas %. Che:erision , %roduct design and testing polymeric materials.

;! %olymers in Controlled &rug &elivery 7 /d. "isbeth *lerm, Stanley &avis.


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Second /dition. 3evised and /xpanded.

9! $pplied production and operations management? @y /vans, $nderson,

Seeney and

6illiams.

JOURNALS

. 4rug 4evelopment and


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PAPER III - BIOPHARMACEUTICS AN PHARMACO@INETICS

Goal:To train the students in the area of biopharmaceutics and pharmacokinetics to work

efficiently in the 594 4ept of industry, to take part in clinical research %clinical trials)

ObF(%": Upon completion of the course, the candidate shall have the ability to:

7alculate Pharmacokinetics parameters from the given data.

Apply the principle of Pharmacokinetics in new drug development as well as in the

design of new formulations.

COURSE ESCRIPTION

THEORY 34 Hour# 5 T:6Hour#/78

9. ABSORPTION O* RUGS 5 Hr#.8

5Mar# allo%!n% : 64 8

$tructure of cell membrane, =astro'intestinal absorption of drugs, mechanisms of

drug absorption, ;actors affecting drug absorption: iological, Physiological,

Physico'chemical and Pharmaceutical. Absorption of drugs from non'per oral routes,

2ethods of determining absorption:In-vitro, in-situ and in-vivomethods.

6. BIOAVAILABILITY 5? Hr#.8

5Mar# allo%!n% : 93 8?b"ectives and consideration in bioavailability studies, 7oncept of euivalence,

2easurement of bioavailability, 4etermination of the rate of absorption,

ioeuivalence protocol and its importance, ioeuivalence studies.

=. ISSOLUTION 5= Hr#.8

5Mar# allo%!n% : 94 8

7$ 7lassification, Eoyes'hitneyCs dissolutions rate law, $tudy of various

approaches to improve dissolution of poorly soluble drug,In-vitrodissolution testing

models, In-vitro release kinetic models, similarity and dissimilarity factors,

biowaivers,In-vitro- In vivocorrelation.


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>. PHARMACO@INETICS 594 Hr#.8

5Mar# allo%!n% : 638

asic considerations, Pharmacokinetic models, 7ompartment modeling: ?necompartment model '


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#. 4 Mar#

=. Cal(ula%"on - 64 Mar#

>. V"&a-&o( - 64 Mar#

To%al - 944 Mar#

RE*ERENCE BOO@S

. iopharmaceutics and 7linical Pharmacokinetics by 2ilo =ibaldi, -th edition,

Philadephia, 6ea and ;ebiger, HH.

#. io pharmaceutics and Pharmacokinetics'A Treatise, y 4. 2. rahmankar and $unil

.!aiswal, allabh Prakashan Pitampura, 4elhi

+. Applied iopharmaceutics and Pharmacokinetics by $hargel. 6 and Iu A7, #nd

edition, 7onnecticut, Appleton 7entury 7rofts, H3&.


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-. Te*tbook of iopharmaceutics and Pharmacokinetics, 4r. $hobha 5ani 5. 1iremath,

Prism ooks Pvt 6td, angalore, #000

&. iopharmaceutics and 7linical Pharmacokinetics by 2ilo =ibaldi, #ndedition, 2arcel

4ekker


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-. http://www#.courses.vcu.edu/pt*ed/m#/powerpoint/download/6ambL#04rug

L#04istribution.pdf

&. http://physiologie.envt.fr/spip/


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>. MUCO AHESIVE RUG ELIVERY SYSTEMS 5 Hr#. 8

5Mar# allo%!n% : 93 8

7oncepts, advantages and disadvantages, structure of oral mucosa, transmucosal

permeability, theories of muco adhesion and muco adhesive polymers, mucosal membranemodels, permeability enhancers. 4evelopment and evaluation of buccal, nasal, pulmonary,

rectal, vaginal and ocular drug delivery systems and their applications.

3.TRANSERMAL RUG ELIVERY SYSTEMS 5? Hr#.8

5Mar# allo%!n% : 93 8

5ationale behind transdermal drug delivery, Permeation through skin, factors affectingpermeation, basic components of T44$, formulation approaches used in development of

T44$ and their evaluation, permeation enhancers.


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PRACTICALS 5T:Hour#/78

. 7omparative evaluation of marketed sustained release tablets and data treatment.

#. Preparation and evaluation of matri* tablets using natural polymers.

+. Preparation and evaluation of matri* tablets using synthetic polymers.

-. Preparation and evaluation of microspheres by solvent evaporation.

&. Preparation and evaluation of muco' adhesive microspheres by ionic gelation method.

(. Preparation and evaluation of microspheres by temperature change method.

G. Preparation and evaluation of microcapsules by wa* embedded method.

3. Preparation and evaluation of buccal patches.

H. Preparation and evaluation of buccal tablets.0. Preparation and evaluation of transdermal films.

. @valuation of the effect of various permeation enhancers on transdermal drug delivery.

#. Preparation and evaluation of hydrodynamically balanced tablets.

+. Preparation and evaluation of ocular insitugel.

SCHEME O* E;AMINATION

. $ynopsis ' #0 marks

#. @*periment

a) ;ormulation ' +& marks

b) @valuation ' #& marks

+. iva'voce ' #0 marks

To%al: 944 !ar#


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RE*ERENCES

. 7hien I., Eovel drug delivery systems, #nd edition, revised and e*panded, 2arcel4ecker,


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4_m. ph pharmaceutical technology

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