Parenterals One Shot Notes with MCQs

Parenterals One Shot Notes

Looking to master the essentials of parenteral products in one go? This comprehensive guide covers everything you need to know – from routes of administration like intravenous and intramuscular to the formulation, classification, and quality control of sterile preparations. Learn about critical concepts such as pyrogen testing, sterility testing, packaging standards, and storage conditions.

To make your preparation even easier, we’ve included 50+ MCQs at the end of the notes, designed specifically for GPAT, Pharmacist Exams, Drug Inspector Tests, and other competitive exams. Whether you’re a pharmacy student or a healthcare professional, these Parenterals One-Shot Notes with MCQs will help you revise quickly and assess your understanding effectively.

Introduction to Parenterals

• Definition: The term “parenteral” is derived from two Greek words: ‘Para’ meaning outside and ‘Enterone’ meaning intestine. Parenteral preparations bypass the gastrointestinal tract and are administered directly into the body through various routes.
• Description:
  Parenterals are sterile solutions, suspensions, or emulsions containing drugs. They can be prepared in either aqueous or non-aqueous (oily) vehicles to:
  • Achieve rapid drug action.
  • Avoid first-pass metabolism.
  • Administer drugs that are poorly absorbed orally or are degraded by the gastrointestinal tract.

Routes of Parenteral Administration

1. Subcutaneous (SC):
   • Description: Injected into the subcutaneous tissue, usually in areas with fat like the abdomen, thigh, or upper arm.
   • Needle Details: 25–26 gauge, 3/8 to 5/8 inch length.
   • Injection Angle: 45 degrees.
   • Volume: Up to 1.5 mL to minimize discomfort by avoiding excessive pressure on sensory nerves.
2. Intramuscular (IM):
   • Description: Injected into deep muscle tissues to allow drug absorption over time.
   • Needle Details: 22–25 gauge, ½ to 1 inch.
   • Injection Angle: 90 degrees.
   • Volume: Limited to 3 mL per site to prevent pain.
3. Intravenous (IV): Injected directly into a vein for immediate drug action.
4. Intra-arterial: Injected into an artery, typically used in emergencies.
5. Intrathecal: Administered into the cerebrospinal fluid.
6. Intradermal: Injected into the dermis layer, primarily for allergy tests or vaccinations.
7. Intracardiac: Directly into the heart muscle, used in extreme emergencies.
8. Intra-articular: Injected into joints to treat inflammation or pain (e.g., corticosteroids).
9. Peridural: Injected into the space around the spinal cord for anesthesia.

Classification of Parenteral Products

1. Small Volume Parenterals (SVP):

• Definition: Injections packed in containers containing 100 mL or less.
• Purpose: Commonly used for:
  • Vaccines.
  • Pain management drugs.
  • Hormones (e.g., insulin).
• Preservatives: Often contain preservatives to prevent microbial growth for multi-dose containers.

2. Large Volume Parenterals (LVP):

• Definition: Packaged in volumes between 101 mL and 1000 mL.
• Purpose: Used to replace fluids, provide electrolytes, and supply calories (e.g., dextrose).
• Preservatives: Typically, preservatives are not used to avoid toxicity when large volumes are administered.
• Routes: Administered primarily by IV to maintain hydration or electrolyte balance.

Key Differences Between SVP and LVP:

Formulation of Parenteral Products

Parenteral preparations must meet several key requirements:

Key Characteristics:

1. Sterility: Absolutely free of microorganisms.
2. Stability: Must remain chemically stable over time.
3. Clarity: Should be free from visible particulate matter.
4. Pyrogen-Free: Must not contain fever-inducing substances.
5. Isotonicity: Should match body fluids to avoid tissue damage or pain.

Components Used in Parenteral Formulation:

1. Active Drugs
2. Vehicles:
   • Aqueous Vehicle: Water for Injection (WFI) and Sterile Water for Injection.
     • WFI: Highly purified water with a pH of 5.0–7.0. Produced via distillation or reverse osmosis.
   • Water-Miscible Vehicles: Ethanol, propylene glycol, used to enhance drug solubility.
   • Non-Aqueous Vehicles: Fixed oils (e.g., sesame, peanut, and cottonseed oil) used to delay drug absorption.
3. Adjuvants:
   • Antioxidants: Prevent oxidation (e.g., ascorbic acid, tocopherol).
   • Solubilizing agents: (e.g. Tweens & polysorbates)
   • Chelating Agents: Remove trace metals that catalyze degradation (e.g., EDTA).
   • Buffering Agents: Maintain pH (e.g., citric acid, phosphate buffer).
   • Tonicity Agents: Ensure isotonicity (e.g., NaCl, dextrose).
   • Antibacterial Agents: Used for multi-dose containers (e.g., benzyl alcohol, phenol).
   • Suspending, emulsifying & wetting agents: (e.g. MC, CMC)

Evaluation of Parenteral Products

1. Sterility Testing:
   • Detects the presence of microorganisms.
   • Methods:
     • Membrane Filtration: Filter solutions and incubate the filter on culture media for bacterial or fungal growth.
     • Direct Inoculation: Product is directly introduced into the culture medium.
2. Leakage Testing:
   • Ensures the integrity of ampoules and vials.
   • Method:
     • Sealed ampoules are immersed in 1% methylene blue solution under vacuum.
     • If cracks are present, the colored solution enters the ampoule.
3. Clarity Testing:
   • Ensures the product is free of visible particles.
   • Methods:
     • Visual inspection, Coulter counter, or filtration.
4. Pyrogen Testing:
   • Detects fever-inducing substances (endotoxins).
   • Rabbit Test: Rabbits are injected with the sample and monitored for temperature changes.
   • LAL Test: Uses enzymes from horseshoe crabs to detect endotoxins by measuring gel formation.

Packaging and Storage of Parenteral Products

1. Glass Containers:
   • Type I: Borosilicate glass – chemically resistant.
   • Type II: Soda-lime glass treated for acidic solutions.
   • Type III: Regular soda-lime glass – used for powders and oils.
2. Rubber Closures: Ensure an airtight seal in multi-dose containers.
3. HEPA Filters:
   • Maintain sterile environments by filtering air with 99.97% efficiency for particles ≥0.3 microns.

Storage Conditions for Parenterals

• Cold Storage: 2–8°C (e.g., vaccines).
• Room Temperature: 20–25°C (e.g., IV fluids).
• Freezer Storage: -5 to -20°C (e.g., plasma products).

Important Competitive Exam Points

1. Local Anesthetic: Benzyl alcohol is used in some parenteral products.
2. Disposable Agents: Made from polypropylene.
3. Glass Resistance Testing: Measures alkali release into water.
4. Stabilizers for Ascorbic Acid Injections: Sodium bicarbonate or sodium carbonate is used.

MCQs on Parenteral Products

1. What does the term ‘Parenteral’ mean?
   • a) Inside the intestine
   • b) Outside the intestine
   • c) Through oral route
   • d) Sublingual administration
     Answer: b) Outside the intestine
2. Which of the following is NOT a parenteral route?
   • a) Intravenous
   • b) Intramuscular
   • c) Subcutaneous
   • d) Oral
     Answer: d) Oral
3. Why are parenterals preferred over oral dosage forms?
   • a) Faster absorption
   • b) Avoid first-pass metabolism
   • c) Suitable for poorly absorbed drugs
   • d) All of the above
     Answer: d) All of the above

4. What is the injection angle for subcutaneous administration?
   • a) 90°
   • b) 60°
   • c) 45°
   • d) 30°
     Answer: c) 45°
5. What is the preferred gauge size for intramuscular injections?
   • a) 18–20
   • b) 22–25
   • c) 25–27
   • d) 30–32
     Answer: b) 22–25
6. Which route involves injection into the cerebrospinal fluid?
   • a) Intrathecal
   • b) Intravenous
   • c) Intradermal
   • d) Intra-arterial
     Answer: a) Intrathecal
7. Intra-articular injections are administered into which of the following?
   • a) Muscles
   • b) Joints
   • c) Veins
   • d) Arteries
     Answer: b) Joints

8. What is the volume limit for small volume parenterals (SVP)?
   • a) 50 mL
   • b) 100 mL
   • c) 150 mL
   • d) 200 mL
     Answer: b) 100 mL
9. Large volume parenterals (LVP) are typically used for:
   • a) Local anesthesia
   • b) Electrolyte replenishment
   • c) Vaccines
   • d) Hormone therapy
     Answer: b) Electrolyte replenishment
10. Which of the following routes is most suitable for LVP administration?

• a) IM
• b) IV
• c) SC
• d) Intradermal
  Answer: b) IV

11. Which of the following is used as a non-aqueous vehicle?

• a) Water for Injection
• b) Peanut oil
• c) Propylene glycol
• d) Ethanol
  Answer: b) Peanut oil

12. What is the pH range of water for injection (WFI)?

• a) 2.0–3.0
• b) 3.5–5.0
• c) 5.0–7.0
• d) 7.5–9.0
  Answer: c) 5.0–7.0

13. Which of the following acts as an antioxidant in parenteral preparations?

• a) Benzyl alcohol
• b) Ascorbic acid
• c) Sodium chloride
• d) Propylene glycol
  Answer: b) Ascorbic acid

14. What is the purpose of a chelating agent like EDTA?

• a) Maintain pH
• b) Remove trace metals
• c) Prevent microbial growth
• d) Act as a solvent
  Answer: b) Remove trace metals

15. Tonicity agents like sodium chloride are used to:

• a) Enhance solubility
• b) Maintain isotonicity
• c) Act as preservatives
• d) Provide calories
  Answer: b) Maintain isotonicity

16. Which of the following tests detects endotoxins?

• a) Clarity test
• b) LAL test
• c) Pyrogen test
• d) Leakage test
  Answer: b) LAL test

17. In the rabbit pyrogen test, the rise in body temperature indicates:

• a) Sterility
• b) Pyrogen contamination
• c) Drug efficacy
• d) Buffer concentration
  Answer: b) Pyrogen contamination

18. What is the incubation temperature for bacterial detection in the membrane filtration method?

• a) 25–30°C
• b) 30–35°C
• c) 37–42°C
• d) 45–50°C
  Answer: b) 30–35°C

19. Which test is used to check for cracks in ampoules?

• a) Leakage test
• b) Sterility test
• c) Pyrogen test
• d) Clarity test
  Answer: a) Leakage test

20. What is the minimum efficiency of HEPA filters?

• a) 95%
• b) 98%
• c) 99.97%
• d) 100%
  Answer: c) 99.97%

21. Which type of glass is used for storing highly sensitive drugs?

• a) Type I (Borosilicate)
• b) Type II (Soda-lime)
• c) Type III (General-purpose)
• d) Plastic containers
  Answer: a) Type I (Borosilicate)

22. Which of the following is NOT a packaging material for parenteral products?

• a) Rubber closures
• b) Soda-lime glass
• c) Aluminum foil
• d) HEPA filters
  Answer: d) HEPA filters

23. What is the recommended storage temperature for vaccines?

• a) -20°C
• b) 2–8°C
• c) 15–25°C
• d) 30–40°C
  Answer: b) 2–8°C

24. Parenteral products containing oil-based solvents are typically stored at:

• a) Room temperature
• b) Cold storage
• c) Freezer
• d) Warm storage
  Answer: a) Room temperature

25. Which local anesthetic is used in some parenteral products?

• a) Lidocaine
• b) Benzyl alcohol
• c) Procaine
• d) Xylocaine
  Answer: b) Benzyl alcohol

26. Which material is commonly used for disposable syringes?

• a) Polypropylene
• b) Polystyrene
• c) Borosilicate glass
• d) Rubber
  Answer: a) Polypropylene

27. Which method is used to maintain a sterile environment during parenteral preparation?

• a) Reverse osmosis
• b) HEPA filtration
• c) Ultrafiltration
• d) Lyophilization
  Answer: b) HEPA filtration

28. Which buffer is commonly used in parenteral products?

• a) Citric acid
• b) Acetate buffer
• c) Phosphate buffer
• d) All of the above
  Answer: d) All of the above

29. What does ‘pyro’ in the word ‘pyrogen’ mean?

• a) Fever
• b) Fire
• c) Pain
• d) Inflammation
  Answer: b) Fire

30. Which of the following is a pyrogen?

• a) Lipids
• b) Endotoxins
• c) Proteins
• d) Antioxidants
  Answer: b) Endotoxins

31. Which bacteria are known to produce endotoxins?

• a) Gram-positive bacteria
• b) Gram-negative bacteria
• c) All bacteria
• d) Fungi only
  Answer: b) Gram-negative bacteria

32. What is the most common source of pyrogen contamination?

• a) Proteins
• b) Water
• c) Air
• d) Plastic containers
  Answer: b) Water

33. What is the incubation temperature for the LAL (Limulus Amebocyte Lysate) test?

• a) 20°C
• b) 25°C
• c) 37°C
• d) 42°C
  Answer: c) 37°C

34. What is the purpose of the gel-clot method in the LAL test?

• a) Measure pH
• b) Detect bacterial contamination
• c) Detect endotoxins through gel formation
• d) Maintain isotonicity
  Answer: c) Detect endotoxins through gel formation

35. What is the main purpose of aseptic conditions in parenteral preparation?

• a) Improve drug solubility
• b) Avoid microbial contamination
• c) Increase the pH
• d) Enhance drug absorption
  Answer: b) Avoid microbial contamination

36. Which sterilization method is used for glassware and metal equipment?

• a) Reverse osmosis
• b) Dry heat sterilization
• c) Steam sterilization
• d) Filtration
  Answer: b) Dry heat sterilization

37. At what temperature is dry heat sterilization typically performed?

• a) 100°C
• b) 180°C
• c) 250°C
• d) 650°C
  Answer: b) 180°C

38. Which of the following is used to sterilize heat-sensitive solutions?

• a) Dry heat
• b) Membrane filtration
• c) Autoclave
• d) Incineration
  Answer: b) Membrane filtration

39. What size filter is commonly used to sterilize parenteral products?

• a) 0.1 µm
• b) 0.22 µm
• c) 1.0 µm
• d) 5.0 µm
  Answer: b) 0.22 µm

40. What is the main drawback of using soda-lime glass for parenterals?

• a) Expensive
• b) High chemical resistance
• c) Alkali leaching
• d) Fragility
  Answer: c) Alkali leaching

41. Type I glass is also known as:

• a) Treated soda-lime glass
• b) Borosilicate glass
• c) Plastic glass
• d) Heat-resistant glass
  Answer: b) Borosilicate glass

42. Which of the following is used to seal multi-dose vials?

• a) Plastic caps
• b) Rubber closures
• c) Metal caps
• d) Heat-sealed lids
  Answer: b) Rubber closures

43. What is the maximum number of particles allowed in a Class 100 area?

• a) 10
• b) 100
• c) 1000
• d) 10000
  Answer: b) 100

44. What is the recommended storage condition for temperature-sensitive parenterals?

• a) Room temperature (20–25°C)
• b) Cold storage (2–8°C)
• c) Warm storage (30–40°C)
• d) Freezer storage (-5 to -20°C)
  Answer: b) Cold storage (2–8°C)

45. What happens if a parenteral solution is not isotonic?

• a) Reduces drug stability
• b) Causes pain and tissue damage
• c) Increases solubility
• d) Delays drug absorption
  Answer: b) Causes pain and tissue damage

46. Which of the following compounds is used as a bulking agent in freeze-dried formulations?

• a) Mannitol
• b) Sodium chloride
• c) Ascorbic acid
• d) Glycerin
  Answer: a) Mannitol

47. What is the purpose of using antioxidants in parenteral products?

• a) Increase viscosity
• b) Improve solubility
• c) Prevent oxidation
• d) Reduce isotonicity
  Answer: c) Prevent oxidation

48. Which material is used for manufacturing disposable syringes?

• a) Glass
• b) Polypropylene
• c) Rubber
• d) Polycarbonate
  Answer: b) Polypropylene

49. Which preservative is commonly used in multi-dose parenteral products?

• a) Benzyl alcohol
• b) Sodium chloride
• c) Citric acid
• d) Ethanol
  Answer: a) Benzyl alcohol

50. Which of the following is a local anesthetic used in parenterals?

• a) Lidocaine
• b) Benzyl alcohol
• c) Procaine
• d) Cocaine
  Answer: b) Benzyl alcohol

51. What test is used to detect endotoxins in parenteral preparations?

• a) Sterility test
• b) Pyrogen test
• c) LAL test
• d) Leakage test
  Answer: c) LAL test

52. Which of the following techniques is used to filter bacterial endotoxins?

• a) Reverse osmosis
• b) Ultrafiltration
• c) Membrane filtration
• d) Distillation
  Answer: b) Ultrafiltration

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