Intrauterine drug delivery systems (IU-DDS) are specialized devices designed to provide localized, controlled drug release directly within the uterine cavity. This introduction covers key concepts such as device design, materials (biodegradable polymers like PLGA, PCL, and non-degradable materials), pharmacokinetics of local delivery, levonorgestrel-releasing IUS, copper IUDs, mechanisms of action, bioadhesion, release kinetics (zero-order, Higuchi, Korsmeyer–Peppas), safety, clinical indications, and regulatory considerations. Understanding uterine targeting, minimizing systemic exposure, and optimizing therapeutic index are central themes for B.Pharm students studying intrauterine drug delivery. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary advantage of intrauterine drug delivery systems compared to systemic therapy?
- Lower local drug concentration
- Increased systemic side effects
- Targeted uterine drug delivery with reduced systemic exposure
- Shorter duration of action
Correct Answer: Targeted uterine drug delivery with reduced systemic exposure
Q2. Which of the following is a commonly used steroid in levonorgestrel intrauterine systems?
- Estradiol
- Levonorgestrel
- Testosterone
- Medroxyprogesterone acetate
Correct Answer: Levonorgestrel
Q3. Which material is typically used for biodegradable intrauterine device matrices?
- Stainless steel
- Poly(lactic-co-glycolic acid) (PLGA)
- Copper
- Silicone rubber
Correct Answer: Poly(lactic-co-glycolic acid) (PLGA)
Q4. The Higuchi model is primarily used to describe which phenomenon in IU-DDS?
- Polymer degradation kinetics
- Drug release from a matrix by diffusion
- Systemic clearance of drug
- Device insertion force
Correct Answer: Drug release from a matrix by diffusion
Q5. Which intrauterine device acts mainly through a non-hormonal mechanism?
- Levonorgestrel IUS
- Copper IUD
- Progesterone-releasing IUS
- Estradiol-coated device
Correct Answer: Copper IUD
Q6. In the context of IU-DDS, what does “burst release” refer to?
- Gradual zero-order release over months
- Immediate high initial release of drug from the device
- Complete device biodegradation in 24 hours
- Delayed activation of drug after insertion
Correct Answer: Immediate high initial release of drug from the device
Q7. Which property of a polymer increases its hydrolytic degradation rate for biodegradable IU-DDS?
- Higher crystallinity
- Lower hydrophilicity
- Higher glycolic acid content in PLGA
- Addition of hydrophobic fillers
Correct Answer: Higher glycolic acid content in PLGA
Q8. Which release kinetic profile is most desirable for long-term contraception via IU-DDS?
- Rapid burst followed by no release
- Fluctuating pulsatile release
- Near zero-order sustained release
- Single immediate bolus release
Correct Answer: Near zero-order sustained release
Q9. Bioadhesive coatings on intrauterine devices are intended to primarily:
- Increase systemic absorption
- Improve retention and mucosal contact in the uterine cavity
- Accelerate device degradation
- Prevent insertion pain
Correct Answer: Improve retention and mucosal contact in the uterine cavity
Q10. Which in vitro test is commonly used to evaluate drug release from IU-DDS?
- Franz diffusion cell study
- Tail-flick analgesia test
- Hemolysis assay
- Patch-clamp recording
Correct Answer: Franz diffusion cell study
Q11. Korsmeyer–Peppas model is useful when the release mechanism is:
- Purely zero-order
- Complex or anomalous involving diffusion and erosion
- Irrelevant to IU-DDS
- Only governed by bulk degradation
Correct Answer: Complex or anomalous involving diffusion and erosion
Q12. Which factor does NOT directly affect intrauterine drug release rate?
- Polymer molecular weight
- Drug solubility in uterine fluids
- Operator’s clothing during insertion
- Surface area of the device
Correct Answer: Operator’s clothing during insertion
Q13. The levonorgestrel intrauterine system primarily exerts contraceptive effect by:
- Enhancing ovulation
- Thickening cervical mucus and suppressing endometrium
- Increasing systemic estrogen levels
- Acting as a mechanical barrier only
Correct Answer: Thickening cervical mucus and suppressing endometrium
Q14. Which sterilization method is commonly used for polymeric IU-DDS without significant polymer degradation?
- High-dose gamma radiation
- Autoclaving at 121°C
- Ethylene oxide (EtO) sterilization
- Dry heat at 200°C
Correct Answer: Ethylene oxide (EtO) sterilization
Q15. Which evaluation parameter assesses local tissue compatibility of an IU-DDS in preclinical studies?
- Systemic blood pressure monitoring
- Histopathology of endometrium
- Renal clearance measurement
- Electrocardiogram
Correct Answer: Histopathology of endometrium
Q16. A reservoir-type intrauterine device is characterized by:
- Drug uniformly dispersed in a solid polymer matrix
- Drug contained in a central core surrounded by rate-controlling membrane
- Drug only on the surface with immediate release
- Drug chemically bonded to metal surface
Correct Answer: Drug contained in a central core surrounded by rate-controlling membrane
Q17. Which polymer is known for mucoadhesive properties and is used in localized uterine formulations?
- Polyethylene glycol (PEG)
- Chitosan
- Polytetrafluoroethylene (PTFE)
- Polyvinylidene fluoride (PVDF)
Correct Answer: Chitosan
Q18. What is the main clinical concern associated with copper IUDs?
- Hyperprolactinemia
- Increased menstrual bleeding and cramping
- Permanent infertility in all users
- Systemic hormone-related side effects
Correct Answer: Increased menstrual bleeding and cramping
Q19. Which parameter best describes the initial slope of cumulative drug release versus square root of time according to Higuchi?
- Partition coefficient
- Diffusion coefficient and drug loading
- Melting point of polymer
- Device tensile strength
Correct Answer: Diffusion coefficient and drug loading
Q20. Which regulatory documentation is most critical for approval of an IU-DDS?
- Clinical performance data, biocompatibility and stability studies
- Only animal study summaries
- Marketing strategy documents
- Employee training manuals
Correct Answer: Clinical performance data, biocompatibility and stability studies
Q21. Which design feature helps minimize expulsion of an intrauterine device?
- Large rigid external frame extending beyond cervix
- Optimized shape and flexible arms tailored to uterine cavity
- Heavier weight to stay in place
- Surface roughness to promote rapid degradation
Correct Answer: Optimized shape and flexible arms tailored to uterine cavity
Q22. In IU-DDS, “uterine targeting” primarily aims to:
- Increase systemic distribution of drug
- Deliver the therapeutic agent to the endometrium with minimal systemic exposure
- Promote oral absorption
- Bypass local uterine tissues completely
Correct Answer: Deliver the therapeutic agent to the endometrium with minimal systemic exposure
Q23. Which in vivo model is commonly used for preclinical assessment of intrauterine devices?
- Rabbit or macaque uterine models
- Drosophila melanogaster
- Zebrafish embryo only
- Plant tissue cultures
Correct Answer: Rabbit or macaque uterine models
Q24. Which measurement indicates a successful local pharmacokinetic profile for an IU-DDS?
- High systemic Cmax with low uterine levels
- Stable therapeutic uterine concentration with low systemic levels
- No drug detectable anywhere
- Rapid systemic clearance but no uterine retention
Correct Answer: Stable therapeutic uterine concentration with low systemic levels
Q25. What role does surface area-to-volume ratio play in drug release from IU-DDS?
- No effect on release kinetics
- Higher ratio typically accelerates release due to increased surface for diffusion
- Higher ratio always prevents drug diffusion
- It only affects mechanical strength, not release
Correct Answer: Higher ratio typically accelerates release due to increased surface for diffusion
Q26. Which adverse event necessitates immediate removal of an intrauterine device?
- Asymptomatic amenorrhea
- Suspected or confirmed pelvic infection/sepsis
- Minor spotting after insertion
- Normal cramping for a few days
Correct Answer: Suspected or confirmed pelvic infection/sepsis
Q27. Which technique is used to measure polymer molecular weight changes during degradation studies?
- Gel permeation chromatography (GPC)
- Infrared spectroscopy for pH only
- Visual inspection
- Pulse oximetry
Correct Answer: Gel permeation chromatography (GPC)
Q28. Which factor is most important when selecting a drug candidate for IU-DDS?
- Extremely high systemic toxicity irrespective of local dose
- High potency and efficacy at low local concentrations with limited systemic effects
- Requirement for frequent systemic dosing
- Complete insolubility in uterine fluids
Correct Answer: High potency and efficacy at low local concentrations with limited systemic effects
Q29. How does copper in copper IUDs provide contraceptive effect?
- By releasing progesterone
- By generating a local inflammatory reaction toxic to sperm and preventing implantation
- By increasing systemic estrogen levels
- By acting as a physical barrier only
Correct Answer: By generating a local inflammatory reaction toxic to sperm and preventing implantation
Q30. Which analytical assay is essential for quantifying drug content in IU-DDS stability studies?
- High-performance liquid chromatography (HPLC)
- Stethoscope auscultation
- Urine dipstick only
- Standard pH paper
Correct Answer: High-performance liquid chromatography (HPLC)
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
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