parentral route of administration

1. Seminar presentation
pharmaceutical compounding
muhammad koksh sdiq
B.Sc. In pharmacy
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2. Topics :
*Parenteral products
*Parenteral drug Characteristics
*Parenteral Dosage Forms
*Kinds of Parenteral Drug Containers
*Labelling
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3. Parenteral Products
•administration by injection.
– i.v., i.m., s.c., i.d.
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4. Solution Formulation
– solvents must meet purity standards
– restricted number and kind of added substances
– no coloring agents permitted
– products are always sterilized
– products are pyrogen-free
– products prepared in environmentally controlled
areas under sanitary conditions
– volumes used are specific to application
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5. Components
•water
– water for injection
– sterile water for injection
•Surface active agent
– need to consider solubility
•anti-oxidants
– ex. ascorbic acid, sodium bisulfite
•buffers
– e.g. citric acid, sodium phosphate, sodium acetate, dipotassium
hydrogen phosphate
•chelating agents
– inactivate metals which catalyze degradation
•co-solvents
– e.g. ethanol, PEG, glycerin
•tonicity agents
– related to semi-permeable nature of cell membranes and osmotic
pressure of solution
•preservatives 5

6. Preservatives
•Criteria
– effective
– soluble
– sufficiently non-ionized in solution
– nonirritating, nonsensitizing, nontoxic
– chemically stable
– compatible with other ingredients
•Types
– antifungals
• benzoic acid, parabens, sodium benzoate, sodium propionate
– antimicrobials
• benzyl alcohol, phenol, chlorobutanol, acetylpryidinium chloride
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7. Parenteral drug Characteristics
• Formulation is limited to:
– solutions,
– suspensions, and
– Emulsions.
• Has to be STERILE (bacteria free).
• pH must match body fluid’s using buffer system.
• Limited volume should be used to avoid pain and
necrosis.
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8. Parenteral Dosage Forms
• Prepared in hospitals and home healthcare
pharmacies.
– Antibiotics
– Chemotherapy
– Nutrition
– Critical care medications
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9. Parenteral Routes of Administration
• Parenteral administration is an injection or infusion by
means of a needle or catheter inserted into the body.
• Parenteral forms deserve special attention.
– Complexity, widespread use, and potential for
therapeutic benefit and danger.
• The term parenteral comes from Greek words.
– para, meaning outside
– enteron, meaning the intestine.
• This route of administration bypasses the alimentary
canal.
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10. Parenteral Routes of Administration
Injection Independent
• ophthalmic
• intranasal
• inhalation
• dermal
• vaginal
• otic
Injection Dependent
• intravenous
• intramuscular
• intradermal
• subcutaneous
• epidural
• intrathecal
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11. Parenteral Route
• Disposable syringes and needles are used to
administer drugs by injection .
– Different sizes are available depending on the type
of mediation and injection needed .
Route of Administration Needle Gauge Needle Length
• Intravenous (IV) 16–20 1–1.5˝
• Intramuscular (IM) 19–22 1–1.5˝
• Subcutaneous (SC) 24–27 3/8–1˝
• Intradermal (ID) 25–26 3/8˝
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12. Parenteral Dosage Forms
• INTRA means INTO
– Intravenous into the vein
– Intradermal into the dermis (skin)
• Intramuscular (IM) injections
– Into a muscle
• Subcutaneous injections
– Under the skin
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13. 13

14. Intravenous Formulations
• Administered directly into a vein.
• Takes about 20 seconds to circulate throughout the
body.
• Aqueous solutions are the most common
formulations.
• Syringeability – the ease with which a suspension
can be drawn from container into a syringe.
• Injectablity is the ease of flow when a suspension is
injected into a patient.
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15. Intravenous Injections or Infusions
• Intravenous (IV) injections are injected directly
into veins and are administered at a 15- to 20-
degree angles.
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16. Intravenous Formulations Devices
• Syringes - come in a variety of sizes.
• Infusion
– Is the gradual intravenous injection of a volume of
fluid into a patient.
– Usually a large volume (500 ml to 1,000 ml).
– E.g. dextrose in water 5% (D5W), 0.45% sodium
chloride in water (½ NS).
– The solution bag has two ports: an administration
set port and a medication port.
• Infusion Pumps
– Ensures consistent and controlled delivery rate.
– Patient controlled analgesia are pumps for self
administration or pain medications.
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17. Advantages of the IV Route
• The IV injection route is the fastest method for delivering
systemic drugs.
– Preferred administration in an emergency situation.
• It can provide fluids, electrolytes, and nutrition.
– Patients who cannot take food or have serious problems
with the GI tract.
• It provides higher concentration of drug to bloodstream or
tissues.
– Advantageous in serious bacterial infection.
• IV infusion provides a continuous amount of needed
medication
– without fluctuation in blood levels of other routes
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18. Disadvantages of the IV Route
• Traumatic injury from the insertion of needle
• Potential for introducing:
– toxic agents
– microbes
– pyrogens
• Impossible to retrieve if adverse reaction occurs
– injected directly into the body
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19. Intravenous Formulation Complications
• Thrombus is a blood clot.
• Phlebitis is an inflammation of the vein.
• Air emboli occurs when air is introduced into the
vein.
• Particulate material can include small pieces of glass
that chip from the product’s vial or rubber pieces.
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20. Intramuscular Injections
• Care must be taken with deep IM injections to
avoid hitting a vein, artery, or nerve.
• In adults, IM injections are given into upper,
outer portion of the gluteus maximus.
–Large muscle on either side of the buttocks.
• For children and some adults, IM injections are
given into the deltoid muscles of the shoulders.
• Depot – the area in the muscle where the
formation is injected during an IM injection.
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21. Intramuscular Injections
• Typical needle is 19- to 22-
gauge 1 to 1.5 inch needle.
• Intramuscular (IM) injections
are administered at a 90-
degree angle
– Volume limited to less
than 3 mL
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22. Intramuscular Injections
• Used to administer
– antibiotics
– vitamins
– iron
– vaccines
• Absorption of drug by IM route is unpredictable
– not recommended for patients who are unconscious or in a
shocklike state
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23. Advantages and Disadvantages
of the IM Route
• Intramuscular (IM) and subcutaneous routes of
administration are convenient ways to deliver
medications
• Compared with the IV route:
– onset of response of the medication is slower
– duration of action is much longer
• Practical for use outside the hospital
• Used for drugs which are not active orally
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24. Advantages and Disadvantages
of the IM Route
• For intramuscular (IM) and subcutaneous routes of
administration, the injection site needs to be
“prepped”
– using alcohol wipe
• Correct syringe, needle, and technique must be used
• Rotation of injection sites with long-term use
– prevents scarring and other skin changes
– can influence drug absorption
Disadvantages :
Pain at injection sites for certain drugs.
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25. Subcutaneous Injections
• Administer medications below the skin into the
subcutaneous fat.
– Outside of the upper arm.
– Top of the thigh.
– Lower portion of each side of the abdomen.
– Not into grossly adipose, hardened, inflamed, or
swollen tissue.
• Often have a longer onset of action and a longer
duration of action.
– Compared with IM or IV injection.
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26. Subcutaneous Injections
• Given at a 45-degree
angle.
– 25- or 26-gauge
needle, short length.
• No more then 1.5 mL
should be injected into
the site.
– Avoids pressure on
sensory nerves causing
pain and discomfort.
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27. Subcutaneous Injections Insulin
• Given using 28- to 30-gauge short needles
– in special syringe that measures in UNITS.
• Keep insulin refrigerated.
• Check expiration dates frequently.
– Opened vials should be discarded after one month.
• A vial of insulin is agitated and warmed by rolling between the
hands and should never be shaken.
• The rubber stopper should be wiped with an alcohol wipe.
• DO NOT use SQ or SC abbreviations.
– Write out subcutaneous to minimize potential medication
errors.
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28. Subcutaneous Injections of insulin
• Insulin is administered following a plan for site
rotation
– to avoid or minimize local skin reactions
• Absorption may vary depending on
– site of administration
– activity level of the patient
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29. Subcutaneous Injections
• Medications administered by this route include:
– epinephrine (or adrenaline)
• for emergency asthmatic attacks or allergic reactions
– heparin or low molecular–weight heparins
• to prevent blood clots
– sumatriptan or Imitrex
• for migraines
– many vaccines
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30. Intradermal Injections
• Given into capillary-rich layer just below epidermis
for:
– local anesthesia
– diagnostic tests
– immunizations
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31. Advantages and Disadvantages
of the ID Route
• The intradermal (ID) route of administration is
used for diagnostic and allergy skin testing
– patient may experience a severe local reaction if
allergic or has prior exposure to a testing antigen
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32. Intradermal Injections
• Examples of ID injections include:
– Skin test for tuberculosis (TB)
• Typical site is the upper forearm, below the
area where IV injections are given.
– Allergy skin testing
• Small amounts of various allergens are
administered to detect allergies.
• Usually on the back.
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33. Intrathecal (into the spinal
canal) is most commonly used
for spinal anesthesia .
Intraperitoneal, (infusion or
injection into the peritoneum)
e.g. peritoneal dialysis in case of
renal insuffeciency.
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34. Parenteral Route Disadvantages
• Higher Cost.
• Require skilled personnel to administer them.
• Most difficult to remove once administered if there is
an adverse or toxic reaction.
• Requires a needle injection.
• Potential for infection or clot formation.
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35. Kinds of Parenteral
Drug Containers
• Glass ampules
• Single and multidose vials
• Non constituted syringes
• Prefilled syringes
• Intravenous medication fluids
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36. Ampules
Vials
Ampules and Vials
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37. Non constituted syringes
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39. Intravenous medication fluids
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40. Example
• Gramicine : ( gentamicine )
dosage form dose dosage
ampule (20, 40,80) mg 1x2 after meal
Used for : best in UTI , eye infection .
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41. • Ceftiaxone : ( nevakson )
dosage form dose dosage
vial ( 0.5 , 1 ) gm 1 x2 after meal
Used for : typhoid fever , malta fever , pneumonitis
meningitis , URTI , UTI , after surgery .
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42. Labelling
Every pharmaceutical preparation must comply with the labelling
requirements established under Good Manufacturing Practice.
The label should include:
(1) the name of the pharmaceutical product;
(2) the name(s) of the active ingredient(s);
(3) The percentage content of drug in a specified volume (in case
of dry preparation)
(4) the batch (lot) number assigned by the manufacturer;
(5) the expiry date and, when required, the date of manufacture;
(6) any special storage conditions or handling precautions that may
be necessary;
(7) directions for use, warnings, and precautions that may be
necessary; and
(8) the name and address of the manufacturer or the person
responsible for placing the product on the market.
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43. Thank you
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