Seminar presentation pharmaceutical compounding

muhammad koksh sdiqB.Sc. In pharmacy

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Topics :

*Parenteral products *Parenteral drug Characteristics*Parenteral Dosage Forms*Kinds of Parenteral Drug Containers*Labelling

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Parenteral Products

•administration by injection.

– i.v., i.m., s.c., i.d.

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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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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, dipotassiumhydrogen 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

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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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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Parenteral Dosage Forms

• Prepared in hospitals and home healthcare pharmacies.

– Antibiotics

– Chemotherapy

– Nutrition

– Critical care medications

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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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Parenteral Routes of Administration

Injection Independent

• ophthalmic

• intranasal

• inhalation

• dermal

• vaginal

• otic

Injection Dependent

• intravenous

• intramuscular

• intradermal

• subcutaneous

• epidural

• intrathecal

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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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Intradermal Injections

• Given into capillary-rich layer just below epidermis for:

– local anesthesia

– diagnostic tests

– immunizations

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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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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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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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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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Kinds of Parenteral Drug Containers

• Glass ampules

• Single and multidose vials

• Non constituted syringes

• Prefilled syringes

• Intravenous medication fluids

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AmpulesVials

Ampules and Vials

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Non constituted syringes

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Intravenous medication fluids

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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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• 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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LabellingEvery pharmaceutical preparation must comply with the labellingrequirements 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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Thank you

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