Pharmaceutical Parenteral Practices Quiz

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Questions and Answers

What is the primary purpose of laminar flow hoods in production areas?

To visually inspect filled containers

To introduce new additives into parenteral products

To provide a working area for manufacturing drugs

To ensure filtered and directed airflow to reduce contamination (correct)

Which type of parenteral preparations contain only a single dose?

Multi-dose parenterals

Active dose parenterals

Single dose parenterals (correct)

Combined parenterals

What is the minimum particle size that can typically be detected through visual inspection using a light source?

10 μm

50 μm (correct)

25 μm

100 μm

What is one potential risk associated with infusing parenteral solutions containing particulate matter?

Inducing thrombi and vessel blockage (A) Signup and view all the answers

Which type of fabric is used for uniforms of personnel manufacturing parenterals to avoid contamination?

Monofilament fabrics (B) Signup and view all the answers

What is the primary advantage of intravenous (IV) drug administration?

Precise and immediate blood levels (C) Signup and view all the answers

Which veins are best suited for intravenous therapy?

Basilic and cephalic veins (C) Signup and view all the answers

What should be done before injecting medication through an IV?

Pull back the plunger to check for blood return (B) Signup and view all the answers

What is one of the disadvantages of intravenous drug administration?

Higher risk of extravasation (B) Signup and view all the answers

When performing venipuncture, which needle position is recommended for proper flow direction?

Bevel facing upward at the most acute angle (D) Signup and view all the answers

How are flow rates for intravenous fluids typically expressed?

Milliliters per hour (D) Signup and view all the answers

What measures should be taken to prevent infection during IV administration?

Disinfect the point of entrance (D) Signup and view all the answers

What is a common preparation method for a drug that is unstable in solution?

Preparing as a dry powder for reconstitution (D) Signup and view all the answers

If a drug is insoluble in water, which of the following formulations is NOT typically used?

Aqueous suspension (B) Signup and view all the answers

Which factor does NOT affect the onset and duration of action of a drug?

The type of packaging of the drug (D) Signup and view all the answers

What characterizes long-acting injections typically known as depot preparations?

They reduce the frequency of injections required. (B) Signup and view all the answers

What is a consideration when preparing solutions and suspensions for injections?

Solvents must meet special purity standards. (D) Signup and view all the answers

Which statement about drug solutions and suspensions is accurate?

Aqueous preparations are more miscible with body fluids. (D) Signup and view all the answers

Which solvent replacement is commonly used for a drug that is unstable in water?

A nonaqueous solvent (D) Signup and view all the answers

Why is the use of coloring agents prohibited in parenteral products?

They can lead to contamination and adverse reactions. (A) Signup and view all the answers

Which of the following formulations allows for a drug that is insoluble in water to be injected directly into the bloodstream?

Aqueous salt form of the drug (D) Signup and view all the answers

What is the primary use of sodium chloride injection, USP?

As a sterile vehicle for drug administration (D) Signup and view all the answers

What is the consequence of oils containing mineral oil or paraffin in injectable products?

They are not absorbed by body tissues. (B) Signup and view all the answers

Which statement accurately describes bacteriostatic sodium chloride injection, USP?

It contains one or more antimicrobial agents. (A) Signup and view all the answers

What does a high iodine number in an oil indicate about its fatty acid composition?

It is rich in unsaturated fatty acids. (B) Signup and view all the answers

Which of the following fixed oils is not commonly used in injections?

Coconut oil (B) Signup and view all the answers

Why is benzyl alcohol a concern when using bacteriostatic sodium chloride injection in neonates?

It may lead to accumulation of benzoic acid and unmetabolized benzyl alcohol. (C) Signup and view all the answers

What must be included on the label of parenteral products containing vegetable oils?

The specific oil used. (C) Signup and view all the answers

What quantity of sodium chloride injection is typically used to flush a catheter or IV line after each use?

2 mL (C) Signup and view all the answers

What type of substances does the USP permit to be added to injections?

Substances that increase the product's stability. (A) Signup and view all the answers

Under what condition can medications preserved with benzyl alcohol still be used in neonates?

If no preservative-free formulation is available and clinical judgment deems it appropriate. (B) Signup and view all the answers

What is Ringer’s injection, USP composed of?

Sodium chloride, potassium chloride, and calcium chloride (A) Signup and view all the answers

What is the purpose of using antibacterial preservatives in multiple-dose injectable products?

To ensure sterility throughout its use. (B) Signup and view all the answers

Why should care be taken when using bacteriostatic sodium chloride injection as a vehicle for medications?

Compatibility with preservatives and sodium chloride must be ensured. (B) Signup and view all the answers

Which of the following agents is prohibited in parenteral products?

Coloring agents (A) Signup and view all the answers

What criteria must additives meet when included in parenteral products?

They must not interfere with specified tests. (B) Signup and view all the answers

What is a key distinction between sodium chloride injection, USP and bacteriostatic sodium chloride injection, USP?

The absence of antimicrobial agents in sodium chloride injection. (D) Signup and view all the answers

What is the primary reason oils used in injections must remain clear when cooled to 10°C?

To ensure the stability and clarity of the injectable product. (D) Signup and view all the answers

For what reason is sodium chloride injection frequently used as a catheter or IV line flush?

To maintain patency of the line. (A) Signup and view all the answers

What does the saponification number measure in oils?

The average molecular weight of fatty acids. (D) Signup and view all the answers

What is the primary concern regarding the use of bacteriostatic sodium chloride injection for flushing umbilical catheters in neonates?

It carries the risk of using benzyl alcohol. (B) Signup and view all the answers

Study Notes

Parenterals

Parenteral refers to injectable routes for drug administration, excluding oral routes.
Sterility is essential in all parenteral preparations due to direct contact with internal body fluids
Injectable preparations include small-volume injectable preparations, large-volume injectable preparations, irrigation fluids, and biologic preparations (vaccines, toxoids, antitoxins)
Ophthalmic preparations are other examples of sterile dosage forms

Injections

Injections are sterile, pyrogen-limited preparations administered parenterally.
Pyrogens (bacterial endotoxins) are organic metabolic products from Gram-negative bacteria causing fever and hypotension when present in excessive amounts in intravenous injections.
The term parenteral derives from Greek words "para" (outside) and "enteron" (intestine) and describes routes other than oral administration.
Injections are primarily used in emergencies, noncompliance, or when other routes are ineffective (i.e., insulin).
Injections are commonly administered in hospitals, extended care facilities, or clinics, and less frequently at home.

Parenteral Routes of Administration

Drugs can be injected into various body organs and areas, including joints (intraarticular), joint fluid area (intrasynovial), spinal column (intraspinal), spinal fluid (intrathecal), arteries (intra-arterial), heart (intracardiac - emergencies), veins (intravenous - common route), muscle (intramuscular - IM), skin (intradermal), under the skin (subcutaneous - SC, sub-Q).

Intravenous Route

Advantages: rapid onset of action, direct entry into the systemic circulation, bypassing absorption, and achieving precise and immediate optimum blood levels.
Disadvantages: irreversible delivery, potential for thrombi and embolus, and increased risk of overdose and side effects compared to oral medications.
Suitable veins: Basilic and cephalic veins (on the back of the hand and dorsal forearm).
Antecubital vein is less preferred for IV therapy as it is a point of flexion and has a high risk of extravasation.

Parenteral Administration Techniques

Strict aseptic precautions are mandatory to prevent infection.
Injectable solutions, syringes, and needles must be sterile.
The injection site must be disinfected to minimize the risk of introducing skin bacteria into the bloodstream.
Before injection, aspirate (withdraw) the plunger of the syringe or squeeze the special bulb on IV sets to confirm proper needle placement.
A backflow of blood into the administration set indicates proper needle placement.
Large and small volume drug solutions are intravenously administered.
Common use of a 1000mL solution containers for IV infusions within hospitals.

IV Infusion Hazards

Thrombus formation (blood clot) may occur if the needle or catheter touches the vein wall, or if the solution is irritating to biologic tissues.
The clot can circulate and cause embolus formation (obstruction of the blood vessel).
This can be harmful to the patient, depending on location and severity.

IV Drugs and Emulsions

Parenteral drugs are usually aqueous solutions to properly mix with blood and avoid precipitation.
Precipitation can cause pulmonary microcapillary occlusion and blood flow blockage.
Fat emulsions are used for extended parenteral nutrition, typically containing soy oil emulsified in egg yolk phospholipids in a glycerin-in-water vehicle.

Automated IV Delivery Systems

Patient-controlled analgesia (PCA) systems are commercially available for intermittent self-administration of analgesics in surgical procedures, labor, or cancer treatment.

Intramuscular Injections

Administered deep into skeletal muscles, aiming for areas distant from major nerves and blood vessels.
Suitable injection sites: upper outer quadrant of the gluteus maximus (adults), deltoid muscle (adults), midlateral muscles of the thigh (infants and young children), and deltoid muscles of the upper arm (infants and young children).
Injection volumes: 5mL in gluteal region, 2mL in deltoid.
Potential for injury related to injection point, potential for paralysis from neural damage, abscess, embolism, cysts, hematoma, and sloughing of the skin/scarring.
Should vary injection site during repeated injections.
It is imperative to check for blood entry in the syringes.
Certain medications (like iron dextran) may stain the tissue, so Z-track technique is used to minimize subcutaneous tissue staining; skin is displaced laterally prior to injection, the needle is then inserted, and the syringe is aspirated. Needle is then slowly withdrawn and skin released.

Subcutaneous Injections

Medication in small volumes (0-1.3mL).
Injection site: outer upper arm, anterior thigh, or lower abdomen.
Rotating injection sites for frequent injections is crucial to avoid potential damage and/or complications.
The site should be thoroughly cleaned before each injection.
Syringe volumes up to 3mL and 24-26 gauge needles used.

Intradermal Injections

Used for small volumes of medications suitable for diagnostic tests, desensitization, and immunization.
Injection site: anterior forearm.
Short and narrow needle (23-26 gauge) is inserted horizontally into the skin with a bevel facing up; the injection is made with the bevel just disappearing into the corium.

Specialized Access

Central venous catheters are used for repeated injections over a period.
They are used in situations like cancer chemotherapy, long-term antibiotic therapy, and total parenteral nutrition (TPN).

Official Types of Injections

Injections are separated into five types (Injection, for injection, injectable emulsion, injectable suspension, For injectable suspension) based on physical states.

Solvents and Vehicles for Injections

Water for injection (USP) is the most common solvent for injections.
It is prepared by distillation or reverse osmosis, non-sterile, pyrogen free.
Some formulations contain bacteriostatic agents whereas others do not need these.
It is intended to be a solvent, vehicle, or diluent for already sterilized and packaged injectable medications.

Sterile Water for Injection

Packaged in single-dose containers not larger than 1 L and should be pyrogen free.
It can not contain antimicrobial agents.

Bacteriostatic Water for Injection

Sterile water for injection containing one or more suitable antimicrobial agents.
Usually packaged in vials containing a maximum of 30mL.

Sodium Chloride Injection

Sterile, isotonic sodium chloride solutions in water injection.
Usually contains no antimicrobial agents.
Can be used as a sterile vehicle in solutions or suspensions of other drugs for parenteral administration; Sodium chloride injection is frequently used for maintaining catheter or IV line patency and usually 2mL is used for flushing the IV line after each use.

Ringer's Injection and Lactated Ringer's Injection

Sterile solutions of sodium chloride, potassium chloride, and calcium chloride (Ringer's Injection, USP) in water for injection.
Used as vehicles for other drugs or as electrolyte replenisher and plasma volume expander.
Lactated Ringer's Injection contains sodium lactate, acting as both a fluid and electrolyte replenisher and a systemic alkalizer.

Nonaqueous Vehicles

The use of non-aqueous solvents may be necessary given limited water solubility or hydrolysis susceptibility of the medication.
Nonaqueous solvents must be non-irritating, non-toxic, non-sensitizing, not influence the medicinal agent's activity.

Methods of Sterilization

Common methods for sterilizing pharmaceutical preparations include steam, dry heat, filtration, gas, and ionizing radiation.
Steam sterilization (autoclaving) is often preferred for heat-stable products, but may be damaging to some products.
Dry heat sterilization requires higher temperatures and longer exposure times.
Filtration is suitable for heat-sensitive solutions.
Gas sterilization (ethylene oxide) is useful for heat-sensitive and moisture-sensitive materials.
Ionizing radiation sterilization is highly effective but requires specialized equipment.

Preparation of Parenteral Solutions

The preparation of parenteral solutions involves dissolving ingredients according to Good Manufacturing Practices (GMPs), and then filtering the resulting solutions until clear. Solutions are then transferred quickly into proper containers for sterilization and final quality checks for sterility and pyrogens.

Packaging, Labeling, and Storage of Injections

Injection containers should not interact physically or chemically with the medication.
Glass containers for injections should be clear or light amber to permit inspection of contents.
Single-dose containers (e.g., ampoules, vials) are used for single-use injections and are not resealable. Multiple-dose containers, with rubber closures, can be used repeatedly without loss of sterility.
Specific labeling and storage requirements are determined by the individual monograph.

Small Volume Parenterals

Small-volume injections, typically at or below 100mL.
Common uses for this dosage form include medication for children and animals.

Insulin

Among the most commonly used injectable medications
Concerned with carbohydrate metabolism but also influences protein and fat metabolism.
Facilitates glucose uptake in liver, muscle, and adipose tissue. Increases amino acid uptake and inhibits fat breakdown/ketone production.

Insulin Uses

Administrated to patients with absent or abnormal pancreatic beta cell function to improve glucose, fat, protein metabolism.
Used to treat diabetes that can not be controlled via diet or other oral anti-diabetic drug.
Can be used to improve appetite and increase weight in non-diabetic malnutrition cases.

Insulin Administration

Needle, pen devices, and infusion pumps are often used; nasal administration was initially available but later discontinued.

Insulin Strengths

Originally available in strengths U-40 (40 U/mL) and U-80 (80 U/mL), with U-80 discontinued
The preferred strength is now U-100 (100 U/mL). Some specific needs may still require alternative strengths or diluting fluid for handling, storage, or administration.

Insulin Types

Basal insulins (intermediate-acting or long-acting) mimic continuous basal insulin secretion from the pancreas, helping suppress hepatic glucose production between meals and overnight.
Bolus insulins (rapid or short-acting) mimic the postprandial rise in blood glucose levels.
There is no ceiling dose in terms of insulin, but dosages are often in the range of 5-100 U per day.

Insulin Preparations

Regular, Lispro (Humalog), Aspart (Novalog), Glulisine (Apidra), Isophane (NPH - or intermediate), Insulin Zinc Suspensions (or lente - or extended), Insulin Glargine (Lantus)

Insulin Considerations

Labeling features the strength (U/mL) of the product. Should always be inspected for clarity and contamination. Proper labeling and storage are both imperative for safety and efficacy.

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Description

Test your knowledge on key concepts regarding parenteral preparations, laminar flow hoods, and safety measures in pharmaceutical production. This quiz covers important industry standards and practices that ensure sterile manufacturing. Prepare to answer questions about contamination risks and inspection criteria.