Butacaine MCQs With Answer

Butacaine MCQs With Answer

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Butacaine MCQs With Answer is a focused study resource for B.Pharm students covering butacaine (butamben), an ester local anesthetic commonly used in topical and infiltration formulations. This introduction emphasizes pharmacology, mechanism of action (voltage-gated sodium channel blockade), structure–activity relationships, formulation science, stability and compatibility, metabolism by plasma esterases, adverse effects including allergic reactions, analytical assay methods (HPLC/UV), quality control, and regulatory considerations. Questions are designed to probe both theoretical concepts and practical pharmaceutical aspects such as dosage form design, preservation, stability testing, and safety monitoring. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which molecular mechanism best explains Butacaine’s local anesthetic action?

  • Inhibition of acetylcholinesterase at the neuromuscular junction
  • Blockade of voltage-gated sodium channels in nerve membranes
  • Activation of GABA receptors in peripheral nerves
  • Antagonism of NMDA receptors on sensory neurons

Correct Answer: Blockade of voltage-gated sodium channels in nerve membranes

Q2. Butacaine belongs to which chemical class of local anesthetics?

  • Amide local anesthetic
  • Ester local anesthetic
  • Opioid analgesic class
  • Alpha-2 adrenergic agonist

Correct Answer: Ester local anesthetic

Q3. Which metabolic pathway is primarily responsible for the inactivation of Butacaine in plasma?

  • Hepatic CYP450-mediated oxidation
  • Plasma pseudocholinesterase-catalyzed hydrolysis
  • Glucuronidation in the liver
  • Renal tubular secretion unchanged

Correct Answer: Plasma pseudocholinesterase-catalyzed hydrolysis

Q4. The major allergenic metabolite associated with ester local anesthetics like Butacaine is derived from:

  • Acetylsalicylic acid
  • Para-aminobenzoic acid (PABA)
  • Glutathione conjugates
  • Benzoic acid esters

Correct Answer: Para-aminobenzoic acid (PABA)

Q5. Which formulation consideration improves the duration of local anesthetic effect of Butacaine in infiltration anesthesia?

  • Adding a nonionic surfactant to increase solubility
  • Co-administration with a vasoconstrictor such as epinephrine
  • Adjusting pH to strongly alkaline (>10)
  • Reducing lipid solubility to enhance diffusion

Correct Answer: Co-administration with a vasoconstrictor such as epinephrine

Q6. Which analytical technique is most appropriate for assay and impurity profiling of Butacaine in a topical formulation?

  • Gas chromatography with flame ionization detection (GC-FID)
  • High-performance liquid chromatography with UV detection (HPLC-UV)
  • Turbidimetric titration
  • Paper chromatography

Correct Answer: High-performance liquid chromatography with UV detection (HPLC-UV)

Q7. In formulation stability studies, which parameter is most critical for ester-type local anesthetics like Butacaine?

  • Photostability only
  • Hydrolytic stability in aqueous media
  • Oxidative stability at neutral pH only
  • Volatility under vacuum

Correct Answer: Hydrolytic stability in aqueous media

Q8. A key quality control test for Butacaine topical ointment would include which microbial test?

  • Total aerobic microbial count and absence of specified pathogens
  • Determination of endotoxin by LAL test only
  • Virucidal efficacy against influenza
  • Staining for mycobacteria

Correct Answer: Total aerobic microbial count and absence of specified pathogens

Q9. Which physicochemical property of Butacaine influences its onset of action?

  • Partition coefficient (lipid solubility)
  • Melting point
  • Optical rotation
  • Boiling point

Correct Answer: Partition coefficient (lipid solubility)

Q10. Why are ester local anesthetics like Butacaine more likely to cause allergic reactions than amide types?

  • They form stable glucuronide conjugates that are immunogenic
  • They are less protein bound, increasing antigenicity
  • They are metabolized to para-aminobenzoic acid (PABA), a common allergen
  • They contain sulfur moieties that directly activate mast cells

Correct Answer: They are metabolized to para-aminobenzoic acid (PABA), a common allergen

Q11. Which storage condition is generally recommended for preserving the stability of topical Butacaine formulations?

  • Store at high temperature (40°C) to maintain solubility
  • Store protected from light at controlled room temperature (15–25°C)
  • Freeze at –20°C to prevent hydrolysis
  • Store in direct sunlight to enhance drying

Correct Answer: Store protected from light at controlled room temperature (15–25°C)

Q12. A pharmacist needs to compound a Butacaine cream. Which preservative concern is most relevant for aqueous creams?

  • Preservative must be compatible with high ionic strength only
  • Preservative efficacy must be demonstrated in the presence of organic excipients and the drug
  • Preservative type is irrelevant for topical products
  • Only heat sterilization is required, no preservative needed

Correct Answer: Preservative efficacy must be demonstrated in the presence of organic excipients and the drug

Q13. Which adverse systemic effect is most characteristic of local anesthetic systemic toxicity (LAST)?

  • Hypersalivation and rhinorrhea
  • Central nervous system excitation followed by depression and cardiovascular depression
  • Profound hyperglycemia
  • Renal tubular necrosis

Correct Answer: Central nervous system excitation followed by depression and cardiovascular depression

Q14. For developmental formulation studies, which in vitro test helps predict Butacaine release from a topical semisolid?

  • Disk diffusion antimicrobial assay
  • In vitro release testing (IVRT) using diffusion cells
  • Spray pattern analysis
  • Pyrogenicity testing

Correct Answer: In vitro release testing (IVRT) using diffusion cells

Q15. Which stability-indicating attribute must be monitored to detect hydrolysis of Butacaine in solution?

  • pH drift and appearance of PABA-related impurities by HPLC
  • Increase in refractive index only
  • Change in optical rotation exclusively
  • Decrease in viscosity only

Correct Answer: pH drift and appearance of PABA-related impurities by HPLC

Q16. Which excipient selection helps reduce skin irritation in a Butacaine topical formulation?

  • Use of high concentrations of alcohol as penetration enhancer
  • Inclusion of emollients and humectants to restore barrier function
  • Adding strong acidic buffers (pH <3)
  • Use of coarse abrasive particles for exfoliation

Correct Answer: Inclusion of emollients and humectants to restore barrier function

Q17. Which pharmacokinetic property describes the fraction of Butacaine that binds to plasma proteins?

  • Volume of distribution (Vd)
  • Protein binding percentage
  • Clearance rate (Cl)
  • Bioavailability (F)

Correct Answer: Protein binding percentage

Q18. During production of a Butacaine ointment, which test ensures uniform distribution of active drug?

  • Spectrophotometric identity test only
  • Content uniformity or assay of multiple samples from the batch
  • Viscosity measurement only
  • Disintegration test

Correct Answer: Content uniformity or assay of multiple samples from the batch

Q19. If a patient reports a history of severe ester anesthetic allergy, the best practice is to:

  • Proceed with Butacaine because topical use is always safe
  • Avoid ester-type local anesthetics and consider amide alternatives
  • Prescribe a higher dose to overcome allergy
  • Recommend oral antihistamines and proceed

Correct Answer: Avoid ester-type local anesthetics and consider amide alternatives

Q20. Which parameter is commonly specified in pharmacopeial monographs for topical anesthetic creams containing Butacaine?

  • Assay limits for active ingredient, pH range, and microbiological limits
  • Boiling point and flash point measurements
  • Animal efficacy studies only
  • Oral bioavailability percentage

Correct Answer: Assay limits for active ingredient, pH range, and microbiological limits

Q21. In case of accidental intravenous injection of a local anesthetic, which immediate measure is recommended?

  • Oral administration of activated charcoal
  • Stop injection, call for resuscitation, support airway/breathing and consider lipid emulsion therapy for severe toxicity
  • Induce vomiting to eliminate drug
  • Apply local heat to the injection site

Correct Answer: Stop injection, call for resuscitation, support airway/breathing and consider lipid emulsion therapy for severe toxicity

Q22. A compatibility concern when formulating Butacaine with other actives is:

  • Possible acid-base reaction leading to hydrolysis of the ester bond
  • Spontaneous polymerization with neutral excipients
  • Formation of insoluble salts with nonpolar oils only
  • Incompatibility is never a concern for topical products

Correct Answer: Possible acid-base reaction leading to hydrolysis of the ester bond

Q23. Which structural feature is most associated with the potency of local anesthetics like Butacaine?

  • Presence of a bulky aromatic lipophilic moiety linked to an intermediate chain and a tertiary amine
  • Single short-chain alcohol group
  • Polypeptide backbone
  • Presence of multiple sulfhydryl groups

Correct Answer: Presence of a bulky aromatic lipophilic moiety linked to an intermediate chain and a tertiary amine

Q24. For topical preparations, which in vivo test is often used to demonstrate the anesthetic effect of Butacaine?

  • Patch test for delayed hypersensitivity only
  • Human sensory testing such as standardized cutaneous pain or tactile threshold assessments
  • Systemic toxicity screening in rodents only
  • Oral absorption study

Correct Answer: Human sensory testing such as standardized cutaneous pain or tactile threshold assessments

Q25. Which impurity profile change would indicate oxidative degradation rather than hydrolysis of Butacaine?

  • Formation of PABA-related products
  • Appearance of new peaks consistent with N-oxide or hydroxylated species
  • Decrease in water content of the formulation
  • Increase in chloride ion concentration

Correct Answer: Appearance of new peaks consistent with N-oxide or hydroxylated species

Q26. During regulatory submission of a Butacaine topical product, which document is essential?

  • Certificate of analysis for raw materials and finished product stability data
  • Only a patent search report
  • Invoice copies for equipment purchase
  • Marketing plan with advertising samples only

Correct Answer: Certificate of analysis for raw materials and finished product stability data

Q27. Which laboratory parameter helps detect early contamination of a Butacaine cream batch during storage?

  • Regular pH monitoring and microbial count surveillance
  • Measuring melting point weekly
  • Checking color of external packaging only
  • Assessing odor by untrained personnel only

Correct Answer: Regular pH monitoring and microbial count surveillance

Q28. When designing pediatric topical dose recommendations for Butacaine, the most important consideration is:

  • Assume children tolerate higher doses than adults
  • Surface area and body weight ratio, and increased absorption risk through thin skin
  • Ignore systemic exposure because topical use is always safe
  • Only consider palatability

Correct Answer: Surface area and body weight ratio, and increased absorption risk through thin skin

Q29. Which excipient class can be used to enhance penetration of Butacaine through intact stratum corneum?

  • Occlusive agents and certain penetration enhancers like propylene glycol
  • Large particulate fillers to block absorption
  • Strong acids to denature skin proteins
  • High-molecular-weight polymers that reduce drug mobility

Correct Answer: Occlusive agents and certain penetration enhancers like propylene glycol

Q30. In designing an HPLC method for Butacaine assay, which mobile phase consideration helps separate the parent drug from PABA-related impurities?

  • Using pure water as mobile phase without organic modifier
  • Optimizing organic modifier percentage and pH to resolve polar impurities from the parent peak
  • Running at extremely high temperature only
  • Using no buffer and very low flow rate only

Correct Answer: Optimizing organic modifier percentage and pH to resolve polar impurities from the parent peak

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