8aslcs of arenLeral uosage forms

W WhaL ls arenLeral/ln[ecLlon ?
arenLeral dosage forms are Lhose admlnlsLered dlrecLly
lnLo body Llssues raLher Lhan vla allmenLary canal (oLher Lhan
lnLesLlne)
lL ls uerlved from Creek ( Lo avold Lhe lnLesLlnes" )
ara 8eslde LnLeron lnLesLlne
1hree lmporLanL rouLe of admlnlsLraLlon
1 SC ( 2ML)
2 l/M ( 2ML 3ML)
3 l/v (Plgh)
ouLe of AdmlnlsLraLlon
n|story Cf arentera| 1herapy
1637 llrsL recorded ln[ecLlon ln anlmals Slr ChrlsLopher Wren
1833 llrsL subcuLaneous ln[ecLlons of drugs uslng hypodermlc needles
ur Alexander Wood
1920s roof of mlcroblal growLh resulLlng ln lnfecLlons
ur llorence SelberL
1933 AppllcaLlon of freeze drylng Lo cllnlcal maLerlals
1946 CrganlzaLlon of arenLeral drug AssoclaLlon
1961 uevelopmenL of lamlnar alr flow concepL
1980's Lmergence of Pome PealLh Care and aLlenL ConLrolled
Analgesla concepLs
1982 lnsulln and bloLechnology producLs
antages Cf arentera| |n|strat|on
lasLesL meLhod of drug dellvery (eg cardlac arresL asLhma shock)
vlable alLernaLlve Lo unsuccessful oral Lherapy
uncooperaLlve nauseous or unconsclous paLlenLs
Less paLlenL conLrol (le reLurn vlslLs)
Local effecL (eg denLlsLry anaesLheslology)
rolonged acLlon (eg lnLra arLlcular sLerolds lM penlclllln)
CorrecLlng serlous flulds and elecLrolyLe lmbalance
|saantages Cf arentera| |n|strat|on
AdmlnlsLered by Lralned personnel only uslng asepLlc procedures
aln on ln[ecLlon
ulfflculL Lo reverse an admlnlsLered drug's effecLs
ManufacLurlng and ackaglng requlremenLs
CosL
needle sLlcks
8aslcs of Mlcroblology
- WhaL ls Mlcroorganlsm ?
A mlcroorganlsm or mlcrobe ls an organlsm LhaL ls mlcroscoplc
(usually Loo small Lo be seen by Lhe naked human eye)
eg 8acLerla lungl eLc
8aslcs of Mlcroblology
acter|a
W 1hese are Lhe organlsms whlch have cell wall made of pepLldoglycan
W cannoL be seen wlLh naked eye
W 8acLerla are presenL everywhere
W 1he slze of bacLerla ls noL sLaLlc lL ls dlfferenL for every specles 1helr slze ranges
from |croeter to 7S |croeter
W 8acLerla are also classlfled on Lhe basls of Lhelr reacLlon Lo Crams sLaln
Cram poslLlve
Cram negaLlve
8acLerla
Some are useful and Some are Parmful
CerLaln bacLerla help break down lacLose ln
Lhe dlgesLlve LracL
bacLerla LacLobaclllus helps Lo reduce Lhe
dlarrhea for lnfanLs
CerLaln bacLerla acL as paLhogens and cause
LeLanus Lyphold fever pneumonla syphllls
cholera foodborne lllness and Luberculosls
Jhat are SCkLS
Why are Lhey a MA!C CPALLLnCL!!!!
Lndospores
MycobacLerlum
lungal Spores
Small nonenveloped vlruses (pollo roLavlrus
rables)
vegeLaLlve lungal Cells
Lnveloped vlruses (Perpes PepaLlLls 8
PepaLlLls C Plv)
vegeLaLlve 8acLerla
Most kes|stant
Least kes|stant
acter|a| Spores
W BaciIIus and CIostridium species
W SurvivaI mechanism, not reproduction.
1 ceII = 1 spore
W Resistant to environmentaI stresses and disinfectants.
Hardest to kiII.
ExampIe: the spores of Geobacillus. stearothermophilus
can survive for hours at 100+.
W mportant in EnvironmentaI monitoring program, it is the
reason we rotate a sporicidaI soIution in cIeaning program
8acLerlal cell wall
Lnotox|n a pyrogenlc (fever lnduclng)
subsLance (eg llpopolysaccharlde) presenL ln
Lhe bacLerlal cell wall LndoLoxln reacLlons
range from fever Lo deaLh
arentera|]In[ectab|e osage for st be
5tetlle
ltee ftom pytoqeo
ltee ftom vlslble pottlcolote mottets
lsotoolc
5toble
wbot ls 5tetlle ?
ltee ftom (mlctootqoolsm)8octetlo
now to qet stetlle ?
8y 5tetlllzotloo
wbot ls 5tetlllzotloo ?
wbot ls 5tetlllzotloo ?
ltocess tbot ellmlootes (temoves) ot kllls oll fotms of mlctoblol llfe
locloJloq looql 8octetlo ooJ vltoses (Ot)
5tetlllzotloo Jesttoys oll mlctootqoolsms locloJloq boctetlol
eoJospotes
now to stetlllze (1ypes of 5tetlllzotloo) ?
neot ury neot Moist neot
bemlcols tbyleoe OxlJe
lttoJlotloo Commo lttoJlotloo
li/trotion 8y 02 micron fi/ter
Ster|||zat|on by neat
1 MolsL PeaL SLeam AuLoclave
WhaL ls AuLoclave ?
121
o
C/30mln/12kg/cm
2
uty neot neotloq coll un5/1oooel stetlllzet

o
/Jmlo
wby less tempetotote wltb sbott tlme fot Aotoclove ?
lo o kltcbeo pototoes coo be cookeJ lo o few mlootes lo o steom ptessote
cooket wblle cookloq moy toke oo boot ot mote lo o botolt oveo eveo
tbooqb tbe oveo ls opetoteJ ot o mocb blqbet tempetotote 5teom especlolly
ooJet pressure cottles tbetmol eoetqy to tbe pototoes vety polckly wblle bot
olt Joes so vety slowly
PkOc55 lLOw cn4k1
aw maLerlals rlmary packlng maLerlals
Secondary packlng maLerlals
OullMN1 llOw
Inspect|on Labe||ng an ackag|ng of In[ectab|es
lospectloo
vlsual lnspecLlon wlLh manual handllng
AuLomaLed lnspecLlon
lobelloq ooJ lockoqloq
-CJ CUk I-LC1LLS
We have Lhree ln[ecLable faclllLles
1 l1C1
Ampoules (keLorol CseLron)
vlals (AnLl Cancer urugs)
2 l1C6
vlals (Cmez azo Lyophlllzed ln[ecLlon)
3 l1C7
vlals (AnLl Cancer urugs)
Porentero/ uosoqe form 1950 to 2011