Parenteral Products

By: Howida Kamal, Ph.D

Parenteral Enteral Topical

Route of administration

INTO ONTO

Dosage forms

Dosage forms

Physical form

Solid Liquid Semi-solid

Powder

Granules

Tablets

Capsules

Suppository

Pessary

Solution

Suspension

Emulsion

Cream

Ointment

Paste

Gel

Inserts

Sponges

Microparticles

Nanoparticles

Liposomes

Films

Microemulsion

Nanoemulsion

Nanosuspension

In-situ gels

Dosage forms

Sterile Non-sterile

Free from all forms of

microbial life

(vegetative & sporing) Extent of total

bioburden

Free from

pathogens

Sterility

Injections (parentrals)

Ophthalmic

Products

The 1st Official injection in PB: morphine, 1867.

The second “cocaine” was added 1898 after sterilization

was attempted.

Sterile Products

Parenteral Products Ophthalmic Products

"para enteron “= to avoid the intestines

Parenteral Products

1. Sterility

Parenteral Products must meet a number

of special criteria such as:

2. Pyrogen free

4. Buffered

5. Osmotic pressure (Isotonic, hypotonic, hypertonic)

pH

Buffer capacity

6. Packaging Product protection

Ease of use

3. Free from foreign particles

Primary Specialized

Routes of Parenteral Administration

Intravenous

(I.V.)

Subcutaneous

(s.c.) Intramuscular

(I.M.)

Made into a vein

(introduced directly

into the blood

stream)

Made into the striated

muscle fibers that lie

beneath the

subcutaneous layer

Made under the skin,

into the subcutaneous

tissue

Intravenous

(I.V.)

Subcutaneous

(s.c.) Intramuscular

(I.M.)

Routes of Parenteral Administration

Intravenous injections

Injected or infused directly into a vein.

Peripheral line Central line

Site of injection

Peripheral veins

•Hand veins

•Arm veins

•Leg veins

•Femoral veins

•Dorsal foot veins

•Scalp veins (In small children )

Deep central veins

•Chest veins

•Neck veins

Intravenous injections

Peripheral line Central line

Plastic indwelling catheters

(PVC, Teflon or polyethylene)

Small volume injections

1.5 in length

22 gauge needle

Intravenous infusion

1-2-in. long, beveled

18 - 22 gauge needle

Method of injection

Intravenous injections

Smaller gauge numbers indicate larger outer diameters

-Thoroughly clean the skin-insertion site using alcohol

swab for 30 seconds and then allowed to dry

-Prepare the injection aseptically.

-Aspirate before injection to ensure that the drug will be

administered intravenously.

Intravenous injections

Method of injection

Intravenous injections

Solution Emulsion

Drug form

aqueous hydroalcoholic

(O/W)

Small volume Large volume

Volume

1 to >1000 ml

Indications

Intravenous injections

a. To achieve an immediate pharmacologic effect,

especially in emergencies, such as arrythmias or

seizures.

b. To treat serious, life-threatening infections

c. To guarantee delivery and distribution when hypotension

or shock exists.

d. To restore rapidly electrolyte and fluid balance.

e. To provide continuous nutrition (hyperalimentation)

when patients are unable to be fed by mouth.

f. To administer drugs which would be too irritating or

caustic to be given by other parenteral routes (due to

the rapid dilution in the circulating blood and the

general insensitivity of the venous wall to pain).

Precautions (complications)

Intravenous injections

a. Uncontrolled or excessive administration of

drugs or fluids cannot be counteracted.

b. Injection of microorganisms, toxins, particulate

matter, or air.

c. Thrombosis at the site of injection or infusion.

d. Extravasation of injections or infusions at the

site of administration.

e. The occurrence of physical or chemical

incompatibilities between agents prior to or at

the time of injection.

Gluteal site Vastus lateralis site

Site of injection

Deltoid site

Ventrogluteal Dorsogluteal

Intramuscular injections

Method of injection

Intramuscular injections

-Aspirate before injection to ensure that the

drug will NOT be administered intravenously.

-Thoroughly clean the skin-insertion site

using alcohol swab for 30 seconds and then

allowed to dry

--Prepare the injection aseptically.

-insert the needle into the patient skin at a

90˚angle until approximately 1cm of the

needle is left showing-

Drug form

Intramuscular injections

Solution Emulsion

Aqueous Oily O/W W/O

Suspension

Aqueous Oily Colloidal

Most liquid pharmaceutical forms can be given

intramusculary

Volume

1-5 ml for adults

Much smaller volumes are acceptable in children

Intramuscular injections

Indications

Intramuscular injections

1. For a reasonably rapid systemic uptake of the drug (15-20

min). (I.M. route is second only to the I.V. route in rapidity of

onset of systemic action) .

2. For relatively prolonged action (1 to 2h up to several months)

this is called de-Pot.

3. To inject concentrated and irritant drugs that could damage

subcutaneous tissue. (I M injections are less painful when

administered correctly because skeletal muscles have fewer

pain-sensing nerves

4. To inject relatively larger volumes than S.C. route (larger

volumes can be absorbed because of the rapid uptake of the

drug into the blood stream via the muscle fiber)

Precautions (complications) Precautions (complications)

1. Avoid entering a blood vessel (especially an artery), which might

lead to:

• Infusion of a toxic agent or a toxic vehicle directly to an organ or tissue.

• Introducing a particulate matter from a suspension to a blood vessel which

lead to clot formation.

2. The accidental striking of or injection into a peripheral nerve may

result in a peripheral sensory damage.

3. If a large bolus of drug is injected, local damage or muscle infarction

may result, leading to:

•A sterile abscess

•Elevation of serum levels of muscle enzymes. This may present confusing

diagnostic problems, especially in patients under suspicion of having a

myocardial infarction or hepatitis.

4. Septic abscesses may result if m.o. from the skin flora punched in by

the needle at the time of injection .

5. The intramuscular route should never be employed in patients with

significant heart failure or shock.

Intramuscular injections

Subcutaneous injections

Site of injection

side of the arm front of the thigh

back of the arm. abdomen

Subcutaneous injections

Method of injection

Beveled, 24 to 25 gauge, 1/4 to 5/8-in. long needle

Subcutaneous injections

-Thoroughly clean the skin-insertion

site using alcohol swab for 30 seconds

and then allowed to dry

-Prepare the injection aseptically.

- insert the needle into the patient skin at

a 45o or 90˚angle

Method of injection

-Aspirate before injection to ensure that the

drug will NOT be administered intravenously.

- Press or rub the site for a few seconds.

Subcutaneous injections

Drug form

Solution Fine particles low viscosity

suspensions

Volume

0.5-1.5 ml

Subcutaneous injections

Indications

For drugs which cannot be administered orally because of

lack of absorption from or inactivation by the contents of

the gastrointestinal tract (insulin, vaccines and narcotics)

Subcutaneous injections

Limitations

a. Absorption is slower and less predictable than by the

intramuscular route.(due to little blood flow to fatty tissue)

b. If heart failure, shock, or vascular collapse exists, this

route should not be depended upon.

c. Medications that are highly acidic, alkaline, or irritating,

should not be administered by this route as they cause

the production of pain, inflammation and necrosis of

tissues.

d. Subcutaneous injections are not given if the skin is

burned, hardened, inflamed, swollen, or damaged by a

previous injection