PARENTERAL DEVICES

Contents:
Definition of parenteral Types of parenterals

Needs of parenterals
Administration devices Packaging devices Summary References

Definition of parenterals=

para=beside and enterou=intestine It is the route of administration of drug across or through one or more layer of skin .
Essential note= High purity +Sterility

Types of parenterals=

=large volume parenterals =small volume parenterals

What are lvps????

according to USP ,lvps are an injection that are

packaged in containers labelled as containing 100 ml or more. According to FDA ,these are terminally sterilized aqueous drug product packaged in single dose container with capacity of 100ml/more to be administered in man.

What are svps????

According to USP, svps are injection that are packaged in containers labelled as containing 100ml or less.

Need of parenterals=
Needed bcause of following advantages-_

=immediate therapeutic responses =use full in non co-operative patient =accuracy of dose is achieved =therapeutic responses are more rapidly controlled. =immediate physiological action can be obtained. hence parenterals are needed.................

 Administration devices= For parenterals=these are as follows......

=filter needles =hypodermic needles =hypodermic syringes = inline filter =transfer needles =transfer sets.

Packaging devices of parenterals = Ampoules vials

prefilled syringes
Other devices = Pumps =

a}infusion pumps b}syringe pumps c}ambulatory pumps

 Disadvantages= =sterile conditions are necessary may produce complications. =physiological pain at the time of administration. =drug cant be withdrawn once administered. =risk of toxicity from local administration.
Parenteral routes of administration=

1}Intradermal 2}subcutaneous 3}intra muscular 4}Intracisternal

 Parenteral devices =
Definition of devices=

various items of equipment used to convey the product from its container into body of patient
According to official definition ..it excludes chemical

entities used in diagnosis of diseases as these are considered as

drugs
Devices include ..non chemical entities and articles

used in diagnosis or in prevention of diseases

Compatiblity between devices and product must be

evaluated.....

Material used in devices = Nylon, silicon ,rubber=for i.v.catheter Stainlessteel =for hypodermic needles.

Properties of devices=
Should be visibly clean
Plastic particles from molding must be eliminated.

What are needles????

it is the one which fits into syringe and used to inject or

withdraw fluid

Parts of needle =
a)shaft = long ,slender stem made of metal
b)hub = base attaches to syringe c)tip =end of needle furthest from hub d)lumen= hollow part of needle

Needles made up of stainlessteel or aluminium.

Packaged in plastic or paper overwrap.

Available in various sizes Size designated as length and gauge

Length depend on route of administration and body part

chosen.

what is gauge???
Diameter of opening use to designate size of lumen Ranges from 28 to 16 gauge larger the gauge smaller the opening

Types of system in needle gauge =

a}stub needle gauge
b}French catheter

Needles common in medical use =

7 to 33 where 7 largest and 33 smallest

Gauge no.

use
FOR DRAWING BIOOD SAMPLES FOR TESTING

21 G 17/ 16 G

FOR BLOOD DONATION

Consideration for needle selection = Viscosity of solution

Nature of rubber closure on parenteral container

larger lumen needle used for viscous solution smaller gauge needles used when rubber closure cored

easily.

Types of bevel =

= bevel is the slanted portion of needle a}standard bevel b}short bevel c}true short bevel

Administration devices =
a) Filter needles=

Definition =a needle with a filter molded into the hub designed for one time use to remove glass particles from a solution.

Its use was first recomended by

Katz,Borden,Hischer

Few common sizes are=

sizes
0.22 micron

uses
Remove bacteria and particulates

0.45 micron

Remove general particulates

1.2m micron

Remove fungi

micron

Coarse filter

For one time use only..

These are used to withdraw liquid from an ampule or to

inject after withdrawing from an ampule.

Figure = monoject filter needles These are hollow devices Some needleless injections are..Bioject,Advanta jet

 Available in wide variety of sizes ,shapes, lengths..

Different shapes are regular ,short, bevel and winged Needle sizes are called as gauge.

Fig: BD nooker filter needle BD filter needles has molded in filter membrane.

 Advantage =
It decreases entry of particulates larger than 5 micron

when withdraw medication from glass reservoir..

Filter straws =
Thin , flexible, sterile
straw used to withdraw a single dose of fluid from glass ampoule. Not used for injection.

Vented needles =
Used for powder medication

b)Hypodermic needles =

hypodermic means =beneath the skin

It is the one that fits into end of syringe

Used to inject specific amount of fluid out

of body.

Origin =
First invented by From greek word

FRENCH scientist PRAWAZ in 1851 ORPUA meaning skin and UTTO meaning
under

First well known attempt done to inject OPIUM into a dog in 1667

Product

description of hypodermic needles

Uses of hypodermic needles =

a}Non-specific uses in type one diabetics Asthma Severe allergies Multiple sclerosis

b}Industrial uses.
Needles with unbeveled blunt tip often used in

industry to apply precise amount of lubricant.

Hypodermic syringes =

= devices use to transfer liquid into and out of body . Also known as hypodermic needles.
Origin =
Hypodermic means under the skin and Syringe from Syrinx means tube.
Primary method for introduction of drug in body

Invented in mid 1800 by Alexander wood by modifying regular

syringe

 Parts of hypodermic syringe =

a}tip =point of attachment of needles b} barrel = part containing fluid to be injected or withdrawn c}plunger = for vacuum creation creation = to draw up fluid

Types of syringe tips =

I -Luer-Lok Tip ii- Luer-Slip Tip

iii- Eccentric Tip

iv- Catheter Tip

Catheter Tip

Eccentric Tip

Luer-Lok Tip

Luer-Slip Tip

 Syringe tips =
Syringe tip What is it ? use For needle fitting -----------For cleaning out tissue For filling body cavity Eccentric tip Wide syringe tip For oral application

Luer lock tip Syringe tip with screw Luer slip tip Syringe tip with slip needle Catheter tip Syringe tip with catheter

Sizes of hypodermic syringes vary from 1 to 60m

 Types of syringes =
type 1} tuberculin syringe description -narrow -total capacity 1 ml -volume measured 0.05 ml - 100 caliberations -capacity 1ml -Volume measured 1ml -Graduations as 40 ,80,100 u/ml -unit represent strength of insulin /ml use -newborn dosing -Pediatric dosing

2} insulin syringes

Made up of glass or plastic

d} filters =

device used to remove contamination such as fibers..

Types of filters = Depth filters = filter the solution being pulled/pushed in

syringes
Membrane filters = also called screen filters.

= filter the solution being expelled fm syringe

Membrane filters are commonly used..

Filter sizes =
5.0 micron = random path membrane filters 0.45 micron = inline filters for i.v suspension drugs 0.22 micron Transfer needles = to transfer medications

e} Transfer sets = transfer individual fluid from multiple supply..

also called iv administration sets
Sterilized before use by eto/radiation Sterile,pyrogen free disposable device

Plastic sets commonly used

Pvc sets also used Length is 6 inch extension up to 110 to

120 inch Std set lumen diameter is 0.28cm

 Common iv drop sets = 10 gtt/ml 15 gtt/ml }..for adults

20 gtt/ml
60 gtt/ml}for pediatrics

.c/as mini drop set

most iv set contain Y site /

injection port.

Parts of iv set =

a] spike

b] drip chamber
c] control clamp d] flexible tubing e] needle adapter f] clamps

SAFETY NOTES
PVC SETS SHOULD NOT BE USED FOR NITROGLYCERINE AS IT GET ABSORBED BY TUBING

 Packaging devices =

= the science ,art and technology of enclosing and protecting the products for use. a} ampoules b} vials and bottles c} prefilled syringes

 Ampoule =

= single dose container =made up glass container

* breaking of ampoule is challenging* *recently plastic ampoules for WFI available.

* How to open an ampoule?? 1} gently tap top of ampoule to bring medication to lower part of ampoule to bring medication to lower portion of ampoule

* clean the neck with swab of alcohol and grasp the

ampoule between thumb and index at neck

* forcefully snap the neck away

 Ampoule

fluid withdrawal =

tilt the ampoule ,place needle near opening and remove

fluid
Sealing of ampoule =

*Aim= to prevent contents from being contaminated Sealed by melting portion of glass neck
Types of sealing =

a}tip/bead seal b} pull seal

1} Tip seal=
melt enough glass tip of neck to form a bid and close the

opening Made in high temperature gas o2 flame

Precaution
adjust flame temperature

Adjust interval of heating

*incompletely sealed ampoule are LEAKERS

2}pull seal =
Heat the neck of ampoule below tip
Leave enough tip for grasping

Process of sealing

Rotate the ampoule in flame in single burner After softening of glass ,grasp the tip firmly and pulled

away from body of ampoule.

Advantages =

Slow process but tight sealing Seals powder ampoules

*wetting of neck gives fractured ampoule*

Disadvantage =
If product is organic lead to carbon deposition

b} Vials and Bottles =

Designed for single and multiple dose container with

preservative

Guidelines = Amount of air introduced should be equal to volume of fluid removed.

Withdrawal of medication = spray alcohol on top of vial allow to dry Puncture the rubber top Bring needle and syringe straight and penetrate Empty the air into vial

 Invert vial and draw required fluid Double chambered vial =

*for sterile powder with vehicle

 Prefilled

syringes=

For small dose parenterals

Diagnostic agents and vaccines

filled
Protein and peptide drugs also

packed eg ;=peptide drug product in DIAKYO CRYSTAL ZENITH

c} other devices =

pumps to deliver iv infusions

a} volumetric pumps eg: for antiasthma medication b} syringe pumps eg: for opiate in conc.form c}implantable pumps
eg: drugs placed under skin

d} Patient controlled analgesic pumps

eg: morphine {narcotics}

Implantable Morphine Pump for Pain...

e} Mobile infusion pumps/ambulatory

eg: for chemotherapy medications

* Catheters = for insertion into body cavity ,duct, vessels

*Types = Coronary Renal Infusion eg; butterfly catheter , balloon tip angiographic catheter *swan-ganz catheter placed in pulmonary artery's

Butterfly catheter

Ballon-tipped angiographic catheter

French catheter scale = used to measure outside

diameter of needle

D(mm)= F/3 OR F=D(mm)*3

References =

Pharmaceutical product development by N.K.JAIN Wikipedia

Lachman
Pharmaceutical product catalogue Pharmainfo .net