Parenteral products are sterile preparations intended for administration through one or more layers of skin or mucous membranes. They include injections, infusions, powders for injection, and implants. Injections contain sterile solutions, while infusions are isotonic with blood. Single dose preparations are used once while multi-dose preparations contain preservatives. Parenterals must use suitable vehicles like water for injection, be isotonic to prevent hemolysis, and include necessary additives and buffers. They provide advantages of high bioavailability and no risk of missed doses over oral medications.

1. PARENTERAL PRODUCTS

2.  DEFINITION
 TYPES
 ADVANTAGES & DISADVANTAGES
 PREFORMULATION FACTORS
 ESSENTIAL REQUIREMENTS

3. INTRODUCTION
DEFINITION:
 The term parenteral has been derived from
greek word
 PARA ENTERON - outside the intestine
.
 Parenterals are sterile preparations intended for
administration under or through one or more layers
of skin or mucous memberane .

4. TYPES
 BASED ON FORMULATION
 INJECTIONS : It contains sterile solutions and
prepared by dissolving the active ingredient and
other substances in water for injection or other
suitable non aqueous base .
 INFUSIONS : These preparation are free from
bacterial endotoxins or pyrogens and are turned
isotonic with blood.

5.  POWDER FOR INJECTION :
These are solid compounds that are
distributed in their final volume when container or vital
are shaken to form a clear particle .
 CONCENTRATED SOLUTION FOR INJECTION:
These are diluted with water for injection
before injected through IV route .
 IMPLANTS :
The solid sterile preparations are implanted in
the tissue in order to release the active ingredient for
long periods .

6.  BASED ON DOSE
 SINGLE DOSE PREPARATIONS :
 These can be used only once .
 Contains sufficient quantity.
 Administration of volume specified on the
label
 MULTI DOSE PREPARATIONS :
 Multi dosing , chances of contamination is less
because it contains antimicrobial preservative
in appropriate conc.
 Preservative not exceed than 30ml .

7. ADVANTAGES
 They are free from pyrogens .
 Low toxicity as compared to solid dosage forms .
 100% Bioavailability .
 No chance of missing dose .
 Unconcious patients are also administered by
physician .

8. DISADVANTAGES
 High cost as compared to solid dosage form
.
 Requirement of trained person for
administration
 Highly risk if any mistakes happens at any
point.
 Real or physiological pain associated while
inject

16. Essential
requirement
s
vehicle
s
isotonicit
y

18. * VEHICLES
 AQUEOUS VEHICLE :
 Water for injection :
 Most commonly used solvent in large scale
manufacturing.
 Not sterilized and free from pyrogens .
 It is intended to be used within 24hrs after collection
.
 Total solid contents not more than 1mg/100ml .

19.  Sterile water for injection :
 It must be pyrogen free .
 Endotoxin level is not more than 0.25 USP .
 Single dose container not larger than 1 liter .
 Bacteriostatic water for injection :
 One or more suitable antimicrobial agents .
 It is packaged in prefilled syringes or in vials .
 Not more than 30 ml of water .

20. Non –Aqueous vehicle :
They should be .,
 Non-irritant .
 Non-toxic .
 Pharmacologically inert .
 Non-senstising .
 Metabolise easily .
 Less viscous to allow syringability .
eg: ethyl oleate , isopropyl myristate ,
benzyl benzoate , dimethylacetamide

21. ADDITIVES
 Solubilizing agents :
 Maintain the solubility of slightly soluble
drugs by increasing their solubility .
 ( EX ; polysorbates , PEG 40 , ethanol )
 Anti-oxidants :
 The substances that act against oxidants .
 (EX ; thiourea , ascorbic acid )

22.  Buffering agents :
 Formulations must be maintain the intended
Ph.
 (Eg; acetone ,citrate ,phosphate )
 Antimicrobial agents :
 Used for prevention of microbes in multiple
packaging .
 ( Eg; phenol or chlorobutanol )
 Chelating agents :
 Form complexes with the metal ion and
dissolve in the solvent , thus preventing the
metal ion from interferring in the manufacturing
process .
 (Eg; EDTA )

23. IMPORTANCE OF
ISOTONICITY
 It is important because if the solution is isotonic
with blood , the possibility of the product
penetrating the RBC’s and causing hemolysis is
reduced .
 In hypotonic solution ( 0.2% w/v of NaCl ),
water diffuses into the RBC’s causing swell and
burst i.e., hemolysis .
 In hypertonic solution ( 2 % w/v of NaCl),
water diffuses out of RBC’s causing them to
shrink .
 In isotonic solution ( 0.9 % w/v of NaCl
solution), that maintains their tonicity of RBC .

24. THANK
YOU