Industrial applications of specific excipients are central to pharmaceutical manufacturing, affecting tablet strength, dissolution, stability and patient acceptability. For B.Pharm students, understanding functions and selection of excipients—binders, diluents, disintegrants, lubricants, glidants, film formers, plasticizers, wetting agents and stabilizers—is essential for robust formulation design and scale-up. Key topics include excipient compatibility, grade and impurity profiles, processing effects (granulation, compression, coating), analytical quality tests and regulatory requirements. Emphasis on common excipients such as microcrystalline cellulose, lactose, starch, povidone, HPMC, PEG and magnesium stearate links theory to industrial practice. This topic builds formulation intuition and problem-solving skills needed in R&D and manufacturing. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which excipient is most commonly used as a direct compression diluent with good compressibility and is widely applied in industrial tablet manufacture?
- Starch
- Microcrystalline cellulose (MCC)
- Lactose monohydrate
- Sodium starch glycolate
Correct Answer: Microcrystalline cellulose (MCC)
Q2. What is the primary industrial function of magnesium stearate in tablet production?
- Binder to improve tablet strength
- Superdisintegrant to accelerate breakup
- Lubricant to reduce die friction
- Glidant to improve powder flow
Correct Answer: Lubricant to reduce die friction
Q3. Which excipient is classified as a superdisintegrant commonly used to promote rapid tablet disintegration?
- Povidone (PVP)
- Croscarmellose sodium
- Mannitol
- Ethylcellulose
Correct Answer: Croscarmellose sodium
Q4. In wet granulation, which excipient is typically used as a water-soluble binder to form granules and improve cohesion?
- Hydroxypropyl methylcellulose (HPMC)
- Colloidal silicon dioxide
- Magnesium stearate
- Crospovidone
Correct Answer: Hydroxypropyl methylcellulose (HPMC)
Q5. Which excipient choice is most critical to prevent Maillard-type interactions in amine-containing active pharmaceuticals during industrial formulation?
- Mannitol
- Lactose
- Microcrystalline cellulose
- Sodium chloride
Correct Answer: Microcrystalline cellulose
Q6. For film coating to improve stability and mask taste, which excipient acts as a common film former in industrial processes?
- Polyethylene glycol (PEG)
- Hydroxypropyl methylcellulose (HPMC)
- Sorbitol
- Colloidal silicon dioxide
Correct Answer: Hydroxypropyl methylcellulose (HPMC)
Q7. Which test is commonly performed on excipients to ensure low residual moisture that could affect stability during industrial processing?
- Friability test
- Loss on drying (LOD)
- Disintegration test
- pH titration
Correct Answer: Loss on drying (LOD)
Q8. Which excipient is most suitable as an osmotic or effervescent granule component to enhance tablet dissolution and palatability?
- Magnesium stearate
- Mannitol
- Talc
- Hydrogenated vegetable oil
Correct Answer: Mannitol
Q9. What is the industrial concern when using high levels of magnesium stearate in tablet formulations?
- Increased wettability of API
- Enhanced tablet disintegration
- Hydrophobic film causing reduced dissolution
- Formation of reactive impurities
Correct Answer: Hydrophobic film causing reduced dissolution
Q10. Which excipient is used as a glidant to improve flow and reduce interparticle friction during large-scale powder handling?
- Colloidal silicon dioxide (Aerosil)
- Polyvinylpyrrolidone (PVP)
- Sodium starch glycolate
- Hydroxypropyl cellulose (HPC)
Correct Answer: Colloidal silicon dioxide (Aerosil)
Q11. When designing controlled-release tablets, which polymer is commonly used as a hydrophilic matrix former in industrial formulations?
- Ethylcellulose
- Hydroxypropyl methylcellulose (HPMC)
- Magnesium stearate
- Lactose
Correct Answer: Hydroxypropyl methylcellulose (HPMC)
Q12. Which excipient property is most important for selecting a lubricant compatible with direct compression at industrial scale?
- High solubility in water
- Low melting point
- Preferential adherence to punch surfaces and low concentration efficacy
- Strong acidic nature
Correct Answer: Preferential adherence to punch surfaces and low concentration efficacy
Q13. For parenteral formulations, which excipient selection criterion is essential compared with oral dosage forms?
- Taste masking potential
- Sterility and low endotoxin levels
- Compressibility for tablet making
- Ability to form films
Correct Answer: Sterility and low endotoxin levels
Q14. Which excipient is commonly used as a binder in aqueous granulation and also acts as a solubilizer for poorly soluble drugs?
- Povidone (PVP)
- Magnesium stearate
- Silicon dioxide
- Talc
Correct Answer: Povidone (PVP)
Q15. What is the principal industrial role of plasticizers like triethyl citrate or PEG in film coatings?
- Increase coating brittleness
- Lower glass transition temperature to increase film flexibility
- Enhance tablet disintegration
- Act as primary binders in core formulation
Correct Answer: Lower glass transition temperature to increase film flexibility
Q16. Which excipient class helps prevent oxidative degradation of APIs during manufacturing and storage?
- Antioxidants (e.g., ascorbic acid, BHT)
- Disintegrants
- Glidants
- Film formers
Correct Answer: Antioxidants (e.g., ascorbic acid, BHT)
Q17. In taste-masked orally disintegrating tablets, which excipient combination is often used industrially to enhance mouthfeel and palatability?
- Lactose and talc
- Sorbitol and mannitol
- Ethylcellulose and magnesium stearate
- Colloidal silicon dioxide and PVP
Correct Answer: Sorbitol and mannitol
Q18. Which analytical parameter of excipients is most relevant to predict flow behavior during high-speed tablet compression?
- Viscosity at 25°C
- Angle of repose and bulk/tapped density
- Melting point
- UV absorbance
Correct Answer: Angle of repose and bulk/tapped density
Q19. Which excipient is preferable when aiming for rapid aqueous wettability and improved dissolution of hydrophobic APIs?
- Hydrophobic lubricants
- Surfactants such as sodium lauryl sulfate
- Nonporous fillers
- Lipid-based binders
Correct Answer: Surfactants such as sodium lauryl sulfate
Q20. What is a common regulatory quality test for industrial excipients to ensure safety for oral products?
- Microbial limits testing
- Tablet hardness testing
- Compressibility index
- Coating thickness
Correct Answer: Microbial limits testing
Q21. Which excipient is chosen to reduce dust generation and improve blend uniformity in large-scale mixing?
- Colloidal silicon dioxide to enhance flow and reduce dusting
- Magnesium stearate to increase dusting
- Starch to reduce flowability
- Ethylcellulose as superdisintegrant
Correct Answer: Colloidal silicon dioxide to enhance flow and reduce dusting
Q22. For chewable tablets, which diluent is preferred industrially for pleasant mouthfeel and non-hygroscopic nature?
- Lactose monohydrate
- Mannitol
- Microcrystalline cellulose
- Magnesium stearate
Correct Answer: Mannitol
Q23. When scaling up from lab to industrial production, why is excipient grade and source control important?
- They do not influence final product properties
- Variation can alter flow, compressibility and stability leading to manufacturing failures
- They only affect color and are not critical
- Higher cost always gives better performance
Correct Answer: Variation can alter flow, compressibility and stability leading to manufacturing failures
Q24. Which excipient is used as a chelating agent in formulations to improve oxidative stability by sequestering metal ions?
- EDTA (ethylenediaminetetraacetic acid)
- Povidone (PVP)
- HPMC
- Colloidal silicon dioxide
Correct Answer: EDTA (ethylenediaminetetraacetic acid)
Q25. Which property of lactose must be considered for heat-and-moisture-sensitive APIs during industrial processing?
- Its ability to act as a plasticizer
- Lactose can undergo Maillard reaction with primary amines
- High lubricity causing tablet sticking
- It is a potent surfactant
Correct Answer: Lactose can undergo Maillard reaction with primary amines
Q26. In spray drying of excipient systems, which excipient characteristic is crucial to form stable particles and prevent stickiness?
- High hygroscopicity
- Glass transition temperature and low residual moisture
- Strong basicity
- High degree of crystallinity only
Correct Answer: Glass transition temperature and low residual moisture
Q27. Which excipient is commonly used industrially as a tablet disintegrant that swells by water uptake and disrupts the tablet matrix?
- Croscarmellose sodium
- Magnesium stearate
- Ethylcellulose
- Talc
Correct Answer: Croscarmellose sodium
Q28. Which excipient class is essential in parenteral formulations to maintain isotonicity and patient safety?
- Diluents/tonicity agents such as sodium chloride or mannitol
- Glidants such as silicon dioxide
- Film formers
- Superdisintegrants
Correct Answer: Diluents/tonicity agents such as sodium chloride or mannitol
Q29. What is the primary industrial role of colloidal silicon dioxide when added at low concentrations to powder blends?
- Act as a primary binder
- Increase tablet hardness dramatically
- Improve flow by reducing interparticle cohesion (glidant)
- Serve as a superdisintegrant
Correct Answer: Improve flow by reducing interparticle cohesion (glidant)
Q30. When selecting excipients for moisture-sensitive APIs, which industrial strategy is most appropriate?
- Use hygroscopic excipients to absorb moisture
- Choose low-hygroscopicity excipients and include desiccants or protective coatings
- Increase processing humidity to protect API
- Rely solely on refrigeration without formulation changes
Correct Answer: Choose low-hygroscopicity excipients and include desiccants or protective coatings
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.
Mail- Sachin@pharmacyfreak.com