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m 

   
m  

m
u m 
  
- various
Ê   &   


  Ê
  
 Ê

  



 Ê

Ê 

 Ê, and  Ê Ê


Ê  Ê.

u m  
- essential: in direct contact with
the internal body fluids/tissues, - infection
easily arises.
OO m
u O   
- sterile, pyrogen-free preparations intended to be
administered parenterally.
u À   
- injectable routes of administration.
- derived from the Greek words  (outside) and
  (intestine)
-   buffer, stabilizer, antibacterial
preservative, antioxidant
- packaged in hermetic containers
u ›
 
 fever-producing organic substances arising from
microbial contamination
- responsible for many of the febrile
reactions in patients following IV
injections.
O  m
OOmO 

     !    

  " !
u joints ½  
u joint fluid area ½ Ê  
u spinal column ½ Ê 
u spinal fluid ½ 
u arteries ½  
u heart ½  
u vein (intravenous, IV)
u muscle ½  Ê

u skin ½  

 Ê
u under the skin ½Ê Ê

Ê


 

O# m 
O# m 
u Ô     "  
- main hazard of IV infusion
-induced by intravenous needles/catheters
touching the wall of the vein and the possibility
of particulate matter in parenteral solutions.
u Ô  
- blood clot within the blood vessel or heart
- slowing of the circulation or an alteration of the
blood or vessel wall.
u a 
 clot circulates carried by the blood stream
£ blood vessel (obstruction and results in a
block or occlusion -   Ê 
u O   



- rapid action compared with other routes of
administration.
  

Ê achieved with accuracy
and immediacy not possible by other routes.
- lifesaving in emergencies, prompt action with
the direct placement of the drug to the circulation

Õ 

- once administered it cannot be retrieved.
- drug cannot be easily removed from the
circulation in Ê

 
O   

u part selected: veins of the     (in
front of the elbow)
- large, superficial, and easy to see and enter.

u m $ " 


Œinjectable solutions, syringes and needles,
and the point of entrance
- reduces the chance of carrying bacteria from
the skin into the blood via the needle.
u      "   "
- adjusted according to the needs of patient
- expressed in mL/hour and range from 42
to 150 mL/hour

u O   

- in aqueous solution
- must mix with the circulating blood and not
precipitate from solution: lead to   

 
Ê  and   



.

u O      
 use: source of calories and essential fatty
acids for patients requiring parenteral nutrition
for extended periods.
u ›    
 ›
- controls pain (surgical procedures, labor,
sickle cell crisis, and cancer), with less side
effects
- minimizes variations bet. suboptimal pain
relief & overuse of opioids

#%m
- provides constant & uniform analgesia
- prevents pharmacokinetic and
pharmacodynamic differences between patients
from interfering with the effectiveness of
analgesia
- permits patients to medicate themselves for
breakthrough pain
Om 
u O       "

& 
 '        
!
! ! 
- effects are less rapid but longer lasting than IV
administration.
- performed deep into the skeletal muscles

u O  '     


Œpoint at which the needle entered and where the
medication was deposited.
- injuries include:
Œparalysis resulting from neutral damage
Œabscess Œcyst Œembolism
Œhematoma Œsloughing of the skin
Œscarring
Om 
u "(  
&  
Œupper outer quadrant of the gluteus
maximus
&  "  
 !
Πdeltoid muscles of the upper arm/midlateral
muscles of the thigh
u volume of medication administered :
- 5 mL in the gluteal region
- 2 mL in the deltoid of the arm.
u ¦        O
- stain upper tissue by sealing medications in
the lower muscle
- creates a Z pattern that blocks infiltration of
medication into the subcutaneous tissue
- injection is 2 to 3 inches deep, and 20-gauge
and 22-gauge needle is used.
m m 
u se: for injection of small amounts of
medication.
u sual route for insulin injection
u Injection beneath the skin
- in the loose interstitial tissue of the outer,
upper arm, the anterior thigh, or the lower
abdomen.
u maximum amount of medication injected
- 1.3 mL,
Œgreater than 2 mL will most likely cause
painful pressure.
m m 
u m

- up to 3 mL capacities and 24-gauge to
26-gauge needles are.
u O 

  !  ! )
'  
- produce indurations, sloughing, or
abscess and may be painful
O 
u    into the corium, the more vascular
layer of the skin just beneath the epidermis.
u   
- various agents for diagnostic determinations,
desensitization, or immunization.
u  "      
-anterior forearm.
u  '
- short (three-eights of an inch) and narrow (23-
gauge to 26 gauge)
O 
OO*m OO m
u O  
-liquid preparations that are drug substances or
solutions
u YO  
-dry solids + suitable vehicles £ solutions
conforming to the requirements for   Ê
u O  a 
-liquid preparation of drug substance dissolved or
dispersed in a suitable emulsion medium
u O  À 
-liquid preparation of solid suspended in a suitable
liquid medium
u YO  mÀ 
-dry solid + suitable vehicle £ preparation
conforming to the requirements for 

ÊÊ Ê  Ê
Õ  

 
  


   
u m 

 
         
 
   
  
 
u 
 
    
 

   
      
  
 
u 

    
   
 
 

  
   
 

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Õ  

 
  


   
u a
 
 
 
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u     
      
       

 

    
    
  
  
 
u m


m

 
   
  
  
 
u m          
     
 

!  

!            
 
         
 

m #m#+Om OO m

u Î  O   m›


- most frequently used solvent in the large scale
manufacturer of injections
- '"   
 and meets the same standards for
presence of total solids
& manufacture of injectable products to be
sterilized after preparation.

u › Î m›


- not more than 1 mg/100 mL Î


  
u m Î  O   m›
- may contain slightly more total solids than
Î

  
because of the leaching of
solids from the glass-lined tanks during
sterilization
- use: solvent or diluent for already sterilized
and packaged injectable medication.

u    Î  O   m›


- sterile water for injection containing one or
more suitable antimicrobial agents.
- ³not intended for neonates´
- use: only in parenterals administered in small
volumes because of the presence of
antimicrobial agents
u m  O   m›
- sterile isotonic solution of NaCl in water for injection
- use: Œsterile vehicle in solutions or
suspensions of drugs for parenteral
administration
Π!      
 "",   
   '  
u   m  O  
- sterile isotonic solution of NaCl in water
for injection
- se: Œfor bacteriostatic water for
injection
Œcatheter or intravenous line flush
to maintain potency
u ÷
O   m›
- sterile solutions of NaCl, KCl, and $
in water for injection
- use: vehicle for other drugs/ alone as an
electrolyte replenisher and plasma volume
expander

u   ÷
O  
& contains NaCl, KCl, $ & Na lactate
- fluid and electrolyte replenisher
and a systemic alkalyzer
 - m#+Om
- use: when physical or chemical factors limit the
use of a wholly aqueous vehicle
Qualities:
& nonirritating, nontoxic, and not sensitizing
- must not exert a pharmacologic activity of its
own, nor affect the activity of the medicinal agent
- physical and chemical properties evaluated and
determined:
stability at various pH levels, viscosity,
fluidity, boiling point, miscibility with body
fluids, low vapor pressure and constant purity.
mmm    

u   permits addition of   


  ' ."".
/. 0 .  !
 

- to increase stability or usefulness (but not


interdicted in the individual monographs)
- harmless in the amounts administered
- do not interfere with the therapeutic efficacy of
the preparation or with specified assays and
tests.
+ m mOOO 
m   
 destruction of all living organisms and their spores
or their complete removal from the preparation.
u m  m  
& conducted in an autoclave and employs steam
under pressure
- microbial destruction is caused by denaturation &
coagulation of bacterial proteins by moist heat
-     ! '!: biological
indicator
- applicable to pharmaceutical preparations and
materials:
Œwithstand the required temperatures
Œpenetrated but not adversely affected by
moisture
u Õ m  
- carried out in ovens, heated by gas or electricity
and are generally thermostatically controlled
-   : biological indicator
- use: for substances not effectively sterilized by
moist heat

u m   Y  
- depends on the physical removal of
microorganisms by adsorption on the filter medium
or by a sieving mechanism
- use: for heat-sensitive solutions

À  
 thin plastic membrane of cellulosic esters with
millions of pores per square inch
a 
 


& aest suited for extemporaneous preparation of sterile
solution


- speed in the filtration of small quantities of solution
- ability to sterilize thermolabile materials
- relatively inexpensive equipment required
- development and proliferation of membrane filter
technology
- complete removal of living and dead microorganisms and
other particulate matter from the solution
 

- membrane tends to be fragile
- essential to determine that the assembly was properly
made (membrane not ruptured/flawed during assembly,
sterilization, or use).
u x m  
- requires specialized equipment resembling an
autoclave, and many combination steam
autoclaves and ethylene oxide sterilizers
- sterilizing heat resistant & moisture
resistant products

u m   O   ÷  
u - sterilization by gamma rays and by cathode
rays, but application of such techniques is
limited because of the highly specialized
equipment required and the effects of
irradiation on products and their containers
- biological indicator:  ' 
#OO  mOO*
& effectiveness of thermal sterilization quantified:
Œdetermination & calculation of F value to express
thermal death.

O  
          
  
& a characterized preparation of specific
microorganisms resistant to a particular
sterilization process
- use: to monitor a sterilization cycle and/or
periodically to revalidate the process
u Ô  Õ Ô 
- time required to kill a particular organism under
specified conditions
* %m

u    "'


 
- a lipopolysaccharide from the outer cell wall
of the bacteria and endotoxins.
- material is thermostable and water soluble
(remain in water even after sterilization by
autoclaving or by bacterial filtration).

u     " 
'
 
- by oxidizing: easily eliminate gases or
nonvolatile salts of any acidic compounds
present.

  .m

u ses: healthy rabbits properly maintained in


terms of environment and diet before the test
u Normal, or control, temperatures are taken for
each animal
- used as the base for the determination of any
temperature increase resulting from injection of
a test solution
- rabbits used: temperatures do not differ by
more than 1ºC from each other
0 '" 
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u à   
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u  !" 
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u !  
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u " 
Ê 
u #  
Ê
u $ 
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u %  
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u  
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u ' 
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m 
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u Ê 
u   
u ( 
  
u ) Ê 
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u   
u $ 
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u " 
 
u %  
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u * Ê 
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u %    
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u & #
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u *  *%%
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u &
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u , ()       
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u m        
 
u (      
   
    
  
4%O%.O%.
m % OO m
u m
  
- hermetic container for parenteral
administration as a single dose
- when opened, cannot be resealed with
assurance that sterility has been maintained

u  À  
- hermetic container that permits withdrawal of
successive portions of the contents without
changing the strength, quality, or purity of the
remaining portion
m+Om4#mmO OO  
+*&mO
 m
÷

5 
u m  
- room temperature and administered within
28 hours of preparation
- under refrigerator for 7 days or less before
complete administration over a period not to
exceed to 24 hours
u Frozen for 30 days or less before complete
administration
m+Om4#mmO OO  
+*&mO
 m

÷

6npreserved sterile products for administration


to one patient or batch-prepared products
- containing suitable preservatives for
administration to more than one patient

3. roducts prepared by closed-system aseptic


transfer of sterile nonpyrogenic finished
pharmaceutics obtained from licensed
manufacturer into sterile final containers
obtained from licensed manufacturer
m+Om4#mmO OO  
+*&mO m
÷

 
u stored beyond 7 days under refrigeration/stored
beyond 30 days frozen or administered beyond
28 hours after preparation and storage at room
temperature
u aatch-prepared without preservatives for use
by more than one patient.
u compounded by complex or numerous
manipulations of sterile ingredients obtained
from:
- licensed manufacturers in a sterile container
or reservoir obtained from a licensed
manufacturer by using closed-system aseptic
transfer
m+Om4#mmO OO  
+*&mO m

÷
 
u compounded from nonsterile ingredients or
compounded with nonsterile compounds with
nonsterile components, containers, or
equipment before terminal sterilization
u prepared by combining multiple ingredients by
using an open-system transfer or open reservoir
before terminal sterilization.
OOOOO%+
 7mO mOm+
m O m
(
u AÕ
!O  
- title for liquid preparations that are drug
substances or solutions thereof
u AÕ
!O  À 
- title for liquid preparations of solids suspended
in a suitable liquid medium
u AÕ
!O    
- title for liquid preparations of drug substances
dissolved or dispersed in suitable emulsion
medium
m
u AÕ
!Y  
- dry solids + suitable vehicles £ solutions
conforming in all respects to the requirements
for   Ê

u AÕ
!Y  À 
- dry solids that + suitable vehicles
£preparations conforming to the
requirements for Injectable uspensions
m&# m
u O  O   
 
-sterile aqueous solution of insulin: the only one
administered intravenously
- prepared from beef or pork pancreas or both
or through biosynthetic means
- problems encountered:
Œlipohypertrophy (buildup of fibrous
tissue) Œlipodystrophy
u  O 
- produced by using a special non-diseases-
forming laboratory strain of E. coli and
recombinant DNA technology
u ÀO  m 
- consists of zinc insulin lispro crystals dissolved in
a clear aqueous fluid
-  1!  !    '  
68 69  !  & !   

u  Ê
àÊ
- recombinant ultra-short acting insulin using
 Ê
 Ê 
½ +Ê
Ê as the
production organism
u OÀ O  mÀ  "›#   
À  
 O  
u  À   
- sterile suspension in aqueous vehicle buffered with
dibasic sodium phosphate to pH 7.1 to 7.4
u OÀ  O  mÀ   
O  O  
- premixed formation of isophane insulin
suspension and insulin suspension and insulin
injection
u  
$
- manufactured premixed insulin lispro and
neutral protamine lispro (NL) in fixed ratio
u O  ¦ mÀ 
u    À      
À À  À
    % 
 À   
  

- contains zinc chloride
u O  x 
 
- long-acting basal insulin preparation intended
for once daily subcutaneous administration at
bedtime in the treatment of type I diabetes
melitus in adults and children
- can also be used by adults with type II
diabetes who require long-acting insulin

u a$  O  ¦ mÀ 


- sterile suspension of zinc insulin crystals in an
aqueous solution medium buffered with sodium
acetate to pH 7.2 to 2.5
u O  O  › À
- patients achieve and maintain blood glucose
to nearly normal levels on a constant basis

OmOO m
- Expiration date is set after 24 months after
filling
- Amorphous form of zinc chloride added to
insulin prep. Has prompt action than the
crystals
- Freezing is avoided during storage
- reparations with neutral pH are more stable
than with acidic pH
m OO mm*4%"Õ
ÕO"OmÔa÷aÕO"m&'a
u  À  
- Antipsychotic drug with antiemetic
u    
- Histamine H2 antagonist
u Õ$    À À 
- Glucocorticoid
u Õ
$
- Carditonic
u ÕÀ    
- Ethaqnolamine, nonselective antihistamine
u Y 
- Loop diuretic
u ›    
- Anticonvulsant
u ›  À  x
- Anti-infective
u ›À 
- aeta-adrenergic receptor blocker for
hypertension
u & À 
- Calcium channel blocker
u À  
- Anticoagulant
u  À  
- Opioid analgesic
u   
- Cardiac depressant
u À 
- Opioid analgesic
u  À     
& %       
u À   
- Opioid analgesic
u '$ 
- Oxytocic
m   
 
m 
u - 

      "       
   
u . 
      

      

&   
 
& 
u - 

       

 
    
  
   
"            
m O# mO mO m
OOmO# m 5
 2  :O+ +
%m3
u    
- Fluid and nutrient replenisher
u Õ$ O   m›
- Fluid and nutrient replenisher
u Õ$  m  
O   m›
- Fluid, nutrient, electrolyte replenisher
u   O   m›
- Diagnostic aid in renal functions, diuretic, fluid
and nutrient replenisher
u ÷
O   m›
- Fluid and electrolyte replenisher
u   ÷
O   m›
- ystemic alkalinizer; fluid and electrolyte
replenisher
u m  O   m›
- Fluid and electrolyte replenisher; isotonic
vehicle
%&# m
u    Ô  À
u ÷À   Ô  À
u Î ÷ 
u a  ÷ 
u  ÷ 
u ›   "  
u (Ê
- odium
- otassium
- Magnesium
- Calcium
- Chloride
- Acetate
- hosphate
u a  "  
u O   O  Õ
mO mOO mmm O
:O++*
u  › 
u À   Õ

- Chlorpromazine HCl
- Diazepam
- Insulin
- Nitroglycerin
- romazine HCl
- romethazine HCl
- Thiopental sodium
- Thioridazine HCl
- Thrifluoperazine HCl
- Warfarin sodium
u  
 ÕÀ  
    À 
   
+O m
m Om
u  
 O ' 
& Norplant system
- set of 6 flexible closed capsules of a
dimethylsiloxane-methyl vinyl iloxane copolymer,
each containing 36 mg of the progestin
- excellent contraceptive
Zoladex implant
- Goserelin acetate implant, Zeneca harmaceuticals
± treatment of prostatic cancer
Crinone Gel ± assists in reproduction
Lacrisert ± for treatment of dry eyes
-
OO%O O*mOmm O m

-      !    


-  )
 #

u O
 m  
- intended to bathe or wash wounds, surgical
incisions, or body tissues

u Õ m  
- separations of substances from one another in
solution by taking advantage of their differing
diffusibility through membranes
;m OO%O m O m
u à 
à 
   
,%
u $ 
 
% "
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,%
u . +Ê
  
,%
u  
 
   
,%
u  
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