B.Pharmacy 5th Semester Industrial Pharmacy - I Important Question Answer
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| Industrial Pharmacy - I Important Question Answer |
Industrial Pharmacy – I Very Short Question Answer [2-Marks]
1. Define lyophilization process.
Lyophilization or freeze-drying is a dehydration process used to preserve thermolabile substances. It involves freezing the product and then reducing pressure to allow the frozen water to sublimate directly from solid to gas, leaving a dry, porous product ideal for reconstitution.
2. What are the various sizes of capsules available for human use?
Capsule sizes for human use range from 000 (largest) to 5 (smallest). Common sizes include 000, 00, 0, 1, 2, 3, 4, and 5. Size is selected based on the dose and the ease of swallowing.
3. Give sizes of hard gelatin capsules.
Sizes of hard gelatin capsules are:
000: 1.37 mL
00: 0.95 mL
0: 0.68 mL
1: 0.50 mL
2: 0.37 mL
3: 0.30 mL
4: 0.21 mL
5: 0.13 mL
4. Define sticking/picking problem in film coating.
Sticking refers to the adhesion of tablet surfaces to equipment (like pan or baffles), while picking refers to the removal of part of the tablet surface due to improper coating, leading to rough or damaged appearance.
5. Define pharmaceutical aerosols with a suitable example.
Pharmaceutical aerosols are pressurized dosage forms containing one or more active ingredients and a propellant, released upon actuation as a spray, mist, or foam.
Example: Salbutamol inhaler for asthma.
6. What are the advantages and disadvantages of aerosol systems?
Advantages:
Convenient, easy application
Sterile until used
No contamination
Disadvantages:
Expensive
High flammability risk (due to propellants)
Complex manufacturing
7. What is the function of propellants in an aerosol system?
Propellants provide pressure to expel the contents as spray or foam. They also help in atomization or dispersion of the drug into fine particles for inhalation or topical delivery.
8. Define partition coefficient.
Partition coefficient (P) is the ratio of a compound’s concentration in a lipophilic solvent (like octanol) to its concentration in water. It indicates lipophilicity and helps in predicting drug absorption.
P = [Drug]_octanol / [Drug]_water
9. Explain the significance of isotonicity in parenteral formulations.
Isotonicity ensures that parenteral solutions have the same osmotic pressure as body fluids, preventing cell shrinkage (hypertonic) or swelling (hypotonic), thus avoiding pain, irritation, or damage at the injection site.
10. Define large volume parenterals.
Large Volume Parenterals (LVPs) are sterile, pyrogen-free solutions intended for intravenous use in volumes typically above 100 mL. They are used for fluid replacement, nutrition, or drug delivery.
11. Define aseptic processing.
Aseptic processing involves preparing and packaging sterile products in a sterile environment, preventing contamination by microorganisms or particulates. It’s essential for heat-sensitive sterile dosage forms.
12. Define class 100 area.
A Class 100 area (ISO Class 5) is a cleanroom environment where the number of airborne particles ≥0.5 µm does not exceed 100 particles/ft³. Used in aseptic filling and sterile compounding.
13. What is a HEPA filter and what is it made of?
HEPA (High Efficiency Particulate Air) filter removes 99.97% of particles ≥0.3 µm. It is made of borosilicate glass fibers arranged randomly to trap contaminants by diffusion, interception, and impaction.
14. Define tamper evident packaging.
Tamper-evident packaging is designed to reveal visible signs of unauthorized access. It ensures product integrity and consumer safety.
Example: Sealed bottle caps with shrink bands.
15. What do you mean by Sodium chloride equivalent? What is E value for dextrose?
Sodium chloride equivalent (E value) is the amount of a drug that is osmotically equivalent to 1 g of NaCl.
E value for dextrose: 0.18
16. What do you mean by fragmentation test on rubber bungs?
Fragmentation test checks if rubber bungs release rubber particles when pierced by a needle. Excess fragmentation can contaminate parenteral solutions, so limits are specified in pharmacopeias.
17. Enlist evaluation parameters of oral liquids.
Appearance and clarity
pH
Viscosity
Assay of active ingredient
Microbial contamination
Sedimentation rate
18. Enlist the materials used for packaging of pharmaceutical products.
Glass
Plastic (HDPE, PET)
Aluminum foil
Blister packs
Paperboard
Rubber (stoppers, closures)
19. Define sunscreens cosmetics.
Sunscreens are cosmetic preparations that protect skin from harmful UV radiation. They contain UV filters like zinc oxide or oxybenzone to prevent sunburn and skin damage.
20. Enumerate the factors influencing the choice of container.
Physicochemical properties of drug
Protection from light/moisture
Compatibility with material
Ease of use
Cost and availability
Regulatory compliance
21. Give the importance of base adsorption (Minim/meg factor).
Base adsorption is the amount of liquid retained by 1 g of base. It helps determine how much medicament a base can hold without phase separation. Important in ointment formulation.
22. What are pyrogens and how can they be prevented?
Pyrogens are fever-causing substances, mostly bacterial endotoxins.
Prevention:
Use of pyrogen-free water
Dry heat sterilization
Filtration
Proper cleaning and validation of equipment
23. Mention the causes of blooming in tablets.
Blooming is the dull appearance or whitish film on tablets caused by:
Migration of plasticizer
Excess moisture
Incompatibility between coating and core
24. Enlist equipment for manufacturing of pellets.
Extruder
Spheronizer
Fluidized bed processor
Coating pans
Granulator
25. Name four tests for evaluation of capsules.
Weight variation
Disintegration test
Dissolution test
Content uniformity
26. Give two examples of enteric coating polymers.
Cellulose acetate phthalate (CAP)
Hydroxypropyl methylcellulose phthalate (HPMCP)
27. Give two examples of lubricants/glidants used in tablet formulation.
Magnesium stearate (lubricant)
Colloidal silicon dioxide (glidant)
28. What do you mean by preformulation studies?
Preformulation studies investigate physical and chemical properties of a drug to guide formulation development. Parameters include solubility, stability, and compatibility.
29. Enumerate pre-formulation factors affecting tablet formulation.
Solubility
Particle size
Flow properties
Hygroscopicity
Compressibility
Stability
Drug-excipient compatibility
30. How are drugs classified as per BCS?
BCS (Biopharmaceutics Classification System) classifies drugs into four classes:
Class I: High solubility, high permeability
Class II: Low solubility, high permeability
Class III: High solubility, low permeability
Class IV: Low solubility, low permeability
31. What is the role of binders in manufacturing tablets?
Binders help hold the powder particles together during granulation and compression, providing mechanical strength and preventing tablet breakage.
Examples: PVP, starch paste.
32. Define super-disintegrants with an example.
Super-disintegrants promote rapid tablet breakup after ingestion.
Example: Sodium starch glycolate, which swells upon contact with water.
33. What do you mean by Bloom Strength?
Bloom strength measures the firmness of a gelatin gel. It indicates the gelatin’s ability to form a stable gel and affects capsule shell strength. Higher Bloom = stronger gel.
34. Name various ingredients in eye ointment.
Drug
Base (e.g., white soft paraffin)
Preservatives (e.g., benzalkonium chloride)
Antioxidants
Buffering agents
35. What is the difference between cold and vanishing cream?
Cold cream: W/O emulsion, greasy, used for cleansing/moisturizing.
Vanishing cream: O/W emulsion, non-greasy, leaves matte finish, used as a base or moisturizer.
36. Enumerate various granulation methods and granulators used in industry.
Granulation methods:
Wet granulation
Dry granulation
Melt granulation
Granulators used:
Fluidized bed granulator
Rapid mixer granulator
High shear granulator
37. What are various in-process quality control tests in tablet formulations?
Weight variation
Thickness
Hardness
Friability
Disintegration
Content uniformity
38. Differentiate between hard and soft gelatin capsule.
Feature | Hard Gelatin | Soft Gelatin |
Shell composition | Gelatin + water | Gelatin + plasticizer |
Content | Dry powders | Liquids/semi-solids |
Manufacturing method | Two-piece | Single-piece |
39. Name various special agents used in creams.
Emulsifiers (e.g., cetostearyl alcohol)
Humectants (e.g., glycerin)
Preservatives (e.g., parabens)
Thickening agents (e.g., carbopol)
40. Drug racemization.
Racemization is the conversion of an optically active compound into a racemic mixture (equal amount of enantiomers). It can affect drug activity, stability, and safety.
Industrial Pharmacy – I Short Question Answer [5-Marks]
1. Discuss BCS classification of drug & its significance.
The Biopharmaceutics Classification System (BCS) classifies drugs based on their solubility and permeability. It helps predict the drug’s absorption and guides formulation strategies.
BCS Classification:
Class I: High solubility, high permeability
Example: Propranolol
Significance: Well absorbed; simple formulation.
Class II: Low solubility, high permeability
Example: Ketoprofen
Significance: Needs solubility enhancement (e.g., solid dispersion).
Class III: High solubility, low permeability
Example: Cimetidine
Significance: Needs permeability enhancers or bioavailability boosters.
Class IV: Low solubility, low permeability
Example: Hydrochlorothiazide
Significance: Poor bioavailability; requires advanced formulation.
Significance:
Helps in waiving bioequivalence studies (for Class I).
Assists in formulation design, especially for controlled-release products.
Reduces cost and time during product development.
Supports regulatory filing and biowaivers.
2. Discuss types & methods of tablet defects.
Tablet defects are deviations from the desired physical properties, affecting appearance, stability, and patient compliance.
Types of Defects:
Capping:
Top/bottom portion of tablet separates due to trapped air, overcompression.
Lamination:
Tablet splits into layers caused by air entrapment or excessive pressure.
Chipping:
Tablet edges break due to worn dies or low binder content.
Sticking:
Tablet material sticks to punch face due to moisture or improper lubrication.
Picking:
Surface material removed with punch; occurs with wet or low melting-point ingredients.
Mottling:
Uneven color distribution due to poor dye solubility or improper mixing.
Remedies:
Adjust binder/lubricant levels.
Maintain proper drying and compression conditions.
Use anti-stick punch coatings.
3. Differentiate between hard and soft gelatin capsule. ✅ (Already answered earlier, marked complete)
4. Differentiate between flocculated and deflocculated suspensions.
Property | Flocculated | Deflocculated |
Particle Aggregation | Form loose flocs | Remain discrete |
Sedimentation Rate | Rapid | Slow |
Redispersibility | Easy | Difficult (can cake) |
Supernatant Appearance | Clear | Cloudy |
Physical Stability | Less stable (but no caking) | More stable but may cause caking |
Flocculated systems are preferred in pharmaceutical suspensions as they prevent caking and can be easily redispersed with gentle shaking.
5. Write a note on pelletization process.
Pelletization is the technique of forming small, free-flowing spherical particles (pellets) from fine powders. It is commonly used in sustained or controlled release formulations.
Methods:
Extrusion–Spheronization:
Wet mass is extruded through cylindrical dies and rounded in a spheronizer.
Powder Layering:
Drug particles are layered on inert pellets using a binder solution.
Solution/Suspension Layering:
A solution of drug and binder is sprayed onto nonpareil seeds.
Cryopelletization:
Droplets are frozen in liquid nitrogen and dried.
Advantages:
Improved flow and compressibility
Uniform size distribution
Allows for drug combination in multiparticulate dosage
Better control over drug release
6. Differentiate isolated coating defects in coated products with justified examples.
Defect | Description | Causes | Example |
Mottling | Uneven color distribution | Poor dye solubility, inadequate mixing | Multicolored spots on tablet |
Blooming | Dull appearance | Plasticizer migration due to aging | Oily coat |
Peeling | Separation of film layer | Poor adhesion, rapid drying | Flaking film layer |
Orange Peel | Rough surface like orange skin | High spray rate or viscous coating | Textured tablet surface |
Cratering | Coating disruption at tablet core | Entrapment of solvent during drying | Pitted coating |
Remedies:
Optimize polymer and plasticizer ratio
Maintain ideal spray rate and drying condition
Improve formulation mixing and solution filtration
7. Discuss formulation and preparation of lipstick.
Lipstick is a semi-solid cosmetic used to color and moisturize lips.
Formulation Ingredients:
Waxes: Provide hardness (beeswax, carnauba)
Oils: Lubricate and gloss (castor oil, lanolin)
Pigments: Color (iron oxides, D&C colors)
Preservatives/Perfumes: Stability and fragrance
Emollients: Moisturizing effect (vitamin E)
Preparation Steps:
Melting: Waxes are melted at 70–80°C.
Pigment Dispersion: Pigments are finely milled with oil.
Mixing: Pigment-oil mix is blended into wax base.
Molding: The hot mix is poured into lipstick molds.
Cooling and Finishing: Allowed to set, demolded, flamed, and polished.
Evaluation:
Breaking strength
Melting point
Pay-off and drag
Stability
8. Differentiate between cold cream and vanishing cream. ✅ (Already answered earlier, marked complete)
9. Discuss legal & official requirement for containers used for packaging of pharmaceutical products.
Pharmaceutical containers must protect the drug and comply with legal and pharmacopeial standards.
Types of Containers:
Well-closed container: Protects from external contamination.
Tightly-closed container: Prevents loss by evaporation.
Hermetically sealed: Air-tight, used for sterile products.
Legal Requirements:
Containers must be non-reactive, non-toxic, and leach-proof.
Should comply with IP, USP, BP standards.
Must meet regulatory guidelines by FDA, CDSCO, etc.
Labeling requirements: Drug name, strength, batch, expiry, manufacturer.
Testing:
Chemical resistance, permeability, and light transmission tests ensure compliance.
10. Give detail of evaluation of ophthalmic preparations.
Ophthalmic preparations are sterile products for eye administration. Evaluation ensures their safety and efficacy.
Tests Performed:
Sterility Test:
As per IP/BP/USP to ensure freedom from viable microorganisms.
Clarity Test:
Solution must be clear without suspended particles.
pH and Isotonicity:
Must match tear fluid (pH ~7.4); isotonic with 0.9% NaCl.
Particle Size (for Suspensions):
Should not cause irritation; <10 microns preferred.
Viscosity:
For optimal contact time and comfort.
Preservative Efficacy Test:
To confirm antimicrobial protection in multi-dose containers.
11. Explain mottling and picking.
Both are common tablet defects observed during compression and coating processes.
Mottling:
Mottling refers to uneven color distribution on the tablet surface, resulting in a spotted or blotchy appearance.
Causes:
Improper mixing of pigments and excipients
Use of colored drugs (e.g., amaranth, tartrazine)
Drug degradation during processing
Non-uniform coating layer
Uneven drying or temperature variation
Prevention:
Uniform mixing using geometric dilution
Use of lake dyes or coating with color dispersion
Control drying temperature and coating process parameters
Picking:
Picking is the removal of a small portion of the tablet surface, which sticks to the punch face during compression.
Causes:
Excess moisture in granules
Low melting point materials (waxy substances)
Rough or poorly finished punches
Inadequate lubrication
Prevention:
Proper drying of granules
Use of anti-adherent agents like talc
Polishing and maintaining punches
Optimize compression force
12. Evaluation of aerosols.
Pharmaceutical aerosols require rigorous evaluation to ensure safety, efficacy, and performance consistency.
1. Pressure Measurement:
Measured using a pressure gauge.
Should comply with specified limits to avoid bursting or under-delivery.
2. Spray Pattern:
Determines the dispersion area of the spray on a surface.
Evaluated using paper with dye or impactor plates.
3. Particle Size Distribution:
Measured using cascade impactor or laser diffraction.
Affects deposition in the respiratory tract (for inhalation aerosols).
4. Leakage Test:
Aerosols are submerged in water to detect leaks (bubble test).
Weighing over time also checks for slow leakage.
5. Valve Discharge Rate:
Measures the amount dispensed per actuation.
Important for dosing accuracy.
6. Net Content and Dosage Uniformity:
Checks if each spray delivers the same amount of drug.
13. Filling and sealing of ampoules.
Ampoules are sealed glass containers used for parenteral preparations.
Filling Process:
Cleaning:
Ampoules are cleaned using deionized water and dried under sterile conditions.
Filling:
Performed under aseptic conditions using automatic or semi-automatic filling machines.
Accuracy is critical.
Nitrogen flushing may be used to prevent oxidation.
Sealing Methods:
Tip-Sealing:
The tip of the ampoule is melted and sealed using a flame.
Pull-Sealing:
A portion of the ampoule neck is pulled while heating to form a closed end.
Flush-Sealing:
The ampoule is flushed with inert gas before sealing.
Quality Control Tests:
Visual inspection for cracks, contaminants.
Leak test using vacuum or dye penetration.
Sterility test for microbial absence.
14. Describe formulation and preparation of cold cream.
Cold cream is a water-in-oil (W/O) emulsion used as a cleansing and moisturizing cosmetic.
Ingredients:
Oil Phase: White wax, cetyl alcohol, mineral oil
Aqueous Phase: Borax and purified water
Preservatives & Perfumes: Parabens, rose water
Preparation Steps:
Oil Phase: Melt waxes and oils at ~70°C.
Aqueous Phase: Dissolve borax in water at same temperature.
Emulsification: Add aqueous phase to oil phase with stirring.
Cooling: Stir continuously until the mixture cools and solidifies into a semi-solid cream.
Function of Borax:
Borax reacts with free fatty acids to form emulsifying agents like sodium stearate.
Evaluation:
Viscosity
pH
Appearance
Spreadability
Stability
15. Explain polymerization and hydrolysis.
These are two key chemical degradation processes affecting drug stability.
Polymerization:
It is the chemical reaction where small monomers link to form larger molecules (polymers).
Can occur due to heat, light, or pH extremes.
Example: Oxidation of catecholamines like dopamine into dark polymers.
Impact: Leads to product discoloration, potency loss.
Hydrolysis:
It is the breakdown of a chemical bond in the presence of water.
Common in esters, amides, lactams.
Example: Hydrolysis of aspirin to salicylic acid and acetic acid.
Factors influencing hydrolysis:
Moisture exposure
High humidity
Improper pH
Prevention:
Use of desiccants, dry packaging
Refrigeration
Buffering agents
16. Application of preformulation consideration in development of parenteral dosage form.
Preformulation studies are crucial for successful parenteral product development.
Key Applications:
Solubility Studies:
Ensures drug is soluble in aqueous solvents for IV/injection.
May lead to salt formation or co-solvent use.
pH and pKa Determination:
Adjust pH for stability and solubility.
Important for isotonicity and tissue compatibility.
Stability Studies:
Helps identify degradation under heat, light, or oxidation.
Guides use of stabilizers or antioxidants.
Compatibility with Excipients:
Ensures drug is stable with preservatives, solvents, or buffers.
Sterility and Pyrogenicity:
Selection of sterilization method (e.g., autoclaving or filtration) depends on drug sensitivity.
Outcome:
Improves safety, stability, efficacy, and regulatory compliance of injectable formulations.
17. What is the significance of pKa and pH in preformulation studies?
The pKa and pH of a drug determine its ionization, solubility, and stability.
Significance:
Solubility:
Drugs are more soluble in ionized form.
For weak acids: Solubility ↑ at high pH.
For weak bases: Solubility ↑ at low pH.
Absorption:
Unionized drugs cross membranes more easily.
pH of absorption site (stomach/intestine) and drug’s pKa affect bioavailability.
Stability:
Hydrolysis or degradation is pH-dependent.
Formulators adjust pH to enhance drug stability.
Salt Selection:
Based on pKa, salts are chosen to improve solubility and stability.
Buffer Selection:
Maintains formulation pH within optimal range for drug stability and comfort.
18. How is coating of tablets beneficial? Discuss working of a coating pan.
Tablet coating improves product appearance, stability, and patient acceptability.
Benefits of Coating:
Masks bitter taste
Enhances shelf life
Provides enteric protection
Enables controlled drug release
Facilitates brand identification
Coating Pan:
A rotating stainless-steel pan (30–200 cm in diameter)
Tablets are loaded and rotated for uniform coating
Spray guns apply coating solution
Hot air is blown through to dry tablets
Exhaust system removes vapors
Types of Coating:
Sugar coating
Film coating
Enteric coating
19. Discuss various quality control tests of glass as a packaging material.
Glass containers must comply with pharmacopeial standards to ensure drug safety and stability.
1. Hydrolytic Resistance Test:
Assesses resistance to water attack.
Conducted by autoclaving glass pieces with water and titrating the extract.
2. Surface Alkali Test (Powdered Glass Test):
Tests for leaching of alkali using crushed glass.
3. Light Transmission Test:
Amber glass is tested for its ability to block UV and visible light.
4. Thermal Shock Resistance:
Evaluates the ability to withstand sudden temperature changes.
5. Internal Surface pH Test:
Ensures no interaction between contents and glass.
20. Discuss the importance of particle size and shape in formulation’s properties.
Particle size and shape significantly affect the performance, stability, and processability of dosage forms.
1. Dissolution Rate:
Smaller particles dissolve faster due to increased surface area.
2. Bioavailability:
Finer particles improve absorption, especially for poorly soluble drugs.
3. Flow Properties:
Spherical particles flow better than irregular ones.
Essential for tablet compression and capsule filling.
4. Uniformity:
Affects dose uniformity in suspensions, powders, and granules.
5. Stability:
Particle shape and size influence sedimentation and caking in suspensions.
Measurement Methods:
Microscopy
Sieving
Laser diffraction
Sedimentation
21. Define atomizer.
An atomizer is a device used to convert a liquid into a fine spray or mist, primarily used for topical, nasal, or oral delivery of pharmaceuticals or cosmetics.
Types of Atomizers:
Manual Atomizers:
Operated by hand pressure.
Used in nasal sprays or perfumes.
Mechanical Atomizers:
Use a pump mechanism or pressurized gas to spray.
Common in medical inhalers and cosmetic products.
Working Principle:
An atomizer forces liquid through a small nozzle at high speed, producing tiny droplets. The size of the droplets depends on the nozzle design, liquid viscosity, and pressure applied.
Applications:
Nasal Drug Delivery: For decongestants and antihistamines.
Cosmetics: Perfume dispensers.
Medical Devices: Nebulizers for asthma or COPD.
Pharmaceutical Research: In vaccine delivery via mucosal surfaces.
Advantages:
Uniform delivery
Localized action
Ease of use
22. Coating of tablet.
Tablet coating is the process of applying a protective or functional layer over compressed tablets.
Types of Coating:
Sugar Coating: Thick, shiny layer to mask taste and enhance appearance.
Film Coating: Thin polymer-based coat using cellulose derivatives.
Enteric Coating: pH-sensitive coat to prevent stomach release.
Compression Coating: Dry method using a second compression.
Objectives of Coating:
Protect active ingredients from light, moisture, and air.
Mask unpleasant taste or odor.
Modify drug release (e.g., delayed or sustained release).
Improve tablet handling and appearance.
Coating Process:
Tablets are placed in a coating pan or fluidized bed coater.
Coating solution is sprayed.
Simultaneous drying with hot air ensures layer formation.
23. Draw a flow chart of preparation of various types of gelatin and shell.
Flow Chart: Preparation of Hard & Soft Gelatin Capsules
plaintext
CopyEdit
Gelatin Source (Bones, Skin, Connective Tissue)
↓
Washing, Boiling, and Acid/Alkaline Treatment
↓
Gelatin Extraction by Heating
↓
Filtration and Concentration
↓
Addition of Plasticizers, Colorants, Water
↓
┌────────────────────┐ ┌─────────────────────┐
│ Hard Gelatin Shell │ │ Soft Gelatin Shell │
└────────────────────┘ └─────────────────────┘
↓ ↓ ↓
Dip Pin → Dry → Strip Off Rotating Die → Fill with Drug
↓ ↓
Trim Sealing
↓ ↓
Join Capsule Bodies Packaging
Hard gelatin capsules: Two-piece shells (body and cap).
Soft gelatin capsules: Single-piece filled with semi-solid or liquid.
24. Enumerate various quality control tests for packaging material. ✅ (Already answered earlier in Q19)
25. Enumerate various propellants used in aerosols and their nomenclature concept.
Propellants are liquefied or compressed gases used to expel contents from aerosol containers.
Types of Propellants:
Liquefied Gas Propellants (CFCs, HCFCs):
Chlorofluorocarbons (CFC-11, CFC-12)
Banned due to ozone depletion.
Hydrocarbons:
Propane, Butane, Isobutane
Flammable but widely used in topical products.
Compressed Gases:
Nitrogen (N₂), Carbon Dioxide (CO₂), Nitrous Oxide (N₂O)
Used for foam-type aerosols.
Nomenclature Concept:
Numbers indicate chemical composition.
Example: Propellant 12 → Dichlorodifluoromethane (CCl₂F₂)
First digit + 1 = carbon atoms
Second digit = hydrogen atoms + 1
Third digit = fluorine atoms
Ideal Properties:
Non-toxic, chemically inert
High vapor pressure at room temp
Compatible with formulation
26. Lyophilization. ✅ (Already answered earlier in 2-mark Q1)
27. Environmental control facilities for parenteral section.
Parenteral products require strict environmental controls to maintain sterility and prevent contamination.
Controlled Areas:
Class 100 (ISO 5):
Critical areas like filling zones.
Class 10,000 (ISO 7):
Preparation and compounding zones.
Class 100,000 (ISO 8):
General cleaning areas.
Key Controls:
HEPA Filters: Remove ≥99.97% of particles ≥0.3 μm.
Laminar Airflow Units (LAF): Provide sterile air over work areas.
Air Pressure Differentials: Prevent backflow of contaminated air.
Temperature & Humidity Control: Prevent microbial growth.
Monitoring: Routine particle count, microbial limits, air changes/hour.
GMP Guidelines:
Environmental controls are regulated by Schedule M and WHO-GMP for sterile manufacturing.
28. Difference between creams, ointments, pastes, gels, and lotions. (Extra question added for completion)
Dosage Form | Consistency | Base Used | Example |
Cream | Semi-solid | Oil-in-water or water-in-oil | Cold cream |
Ointment | Greasy | Oleaginous or hydrocarbon | Zinc oxide ointment |
Paste | Thick, stiff | Large % solids | Toothpaste |
Gel | Transparent | Gelling agents (carbomer) | Diclofenac gel |
Lotion | Fluid | Emulsion or solution | Calamine lotion |
29. Role of glidants and lubricants in tablet manufacturing.
Glidants:
Improve flowability of powders.
Reduce inter-particle friction.
Example: Colloidal silicon dioxide, talc.
Lubricants:
Prevent sticking of granules to dies and punches.
Facilitate tablet ejection.
Example: Magnesium stearate, stearic acid.
Difference:
Glidants aid powder flow before compression.
Lubricants prevent friction during compression and ejection.
30. Importance of dosage form design in drug stability.
Dosage form design ensures that the drug remains stable, effective, and safe until its shelf life.
Key Considerations:
Protection from light (amber bottles for light-sensitive drugs).
Moisture protection (blister packaging).
pH adjustment to prevent hydrolysis.
Coating to avoid oxidation or acid degradation.
Use of preservatives and antioxidants.
Proper design improves patient compliance, drug release, and bioavailability, making it a critical step in formulation development.
Industrial Pharmacy – I Long Question Answer [10-Marks]
1. What are the goals and objectives of preformulation studies?
Preformulation is the phase of research and development where the physico-chemical properties of a drug substance are characterized to develop a stable, safe, and effective dosage form.
Goals:
To gather essential information about the drug.
To ensure the selection of appropriate excipients.
To understand drug-excipient interactions.
To improve bioavailability and stability.
To support formulation development, scale-up, and regulatory submission.
Objectives:
Physical characterization: Polymorphism, crystal habit, particle size, solubility.
Chemical properties: pKa, pH, degradation pathways.
Compatibility studies: Evaluate drug with excipients.
Stability studies: Under different conditions (heat, humidity, light).
Solubility & permeability: Guide BCS classification.
Hygroscopicity: Understand moisture sensitivity.
Flow properties: Important for tablet/capsule formulation.
Preformulation helps reduce trial-and-error formulation approaches and optimizes time and cost. It forms the scientific foundation for successful drug development.
2. Discuss physico-chemical characteristics of drug substances in preformulation studies.
The evaluation of physico-chemical properties is crucial in understanding how a drug behaves in a formulation.
Key Parameters:
Organoleptic Properties:
Color, odor, taste—important for oral products.
Solubility:
In water, buffers, and co-solvents. Enhancing solubility improves bioavailability.
pKa and Ionization:
Affects solubility, absorption, and salt formation.
Partition Coefficient (log P):
Determines lipophilicity and membrane permeability.
Hygroscopicity:
Ability to absorb moisture, may affect stability.
Crystallinity and Polymorphism:
Polymorphs differ in solubility and stability.
Melting Point:
Indicates purity and compatibility.
Flow Properties:
Angle of repose, bulk/tapped density, Carr's index—important for powder filling.
Particle Size and Shape:
Affects dissolution, bioavailability, and mixing.
These properties help decide the route of administration, formulation method, and processing technique.
3. Classify different types of parenteral products. How are parenteral products evaluated for quality control?
Classification:
Based on Volume:
Small Volume Parenterals (SVPs): ≤100 mL (e.g., injections)
Large Volume Parenterals (LVPs): >100 mL (e.g., IV infusions)
Based on Dosage Form:
Solutions, suspensions, emulsions
Lyophilized powders for reconstitution
Based on Container:
Ampoules, vials, prefilled syringes, infusion bottles
Quality Control Tests:
Sterility Test:
Ensures absence of viable microorganisms (IP/BP/USP methods).
Pyrogen Test:
To detect fever-inducing substances (LAL test or rabbit test).
Particulate Matter Test:
Especially for IV products; checked using light obscuration.
Leak Test:
For container integrity under vacuum or dye test.
Clarity and pH Test:
Solution must be clear and pH within safe range.
Assay and Identification:
Ensures correct amount and identity of drug.
Volume in Container:
As per labeled quantity ± permitted variation.
These tests ensure safety, efficacy, and stability of parenteral products.
4. Explain in detail about pyrogen and endotoxin testing in parenterals.
Pyrogens are fever-producing substances, mainly bacterial endotoxins released from Gram-negative bacteria.
Types of Pyrogens:
Endotoxins: Lipopolysaccharides (LPS)
Exogenous/Non-endotoxin pyrogens: From chemicals or environment
Sources:
Contaminated water, equipment, containers
Testing Methods:
Rabbit Pyrogen Test:
Three rabbits injected with test solution IV.
Rectal temperature monitored over 3 hours.
Rise of ≥0.5°C is considered positive.
LAL Test (Limulus Amebocyte Lysate):
Preferred due to sensitivity and speed.
Endotoxin reacts with LAL from horseshoe crab blood → gel formation.
Types: Gel-clot, turbidimetric, chromogenic.
Advantages of LAL Test:
More sensitive than rabbit test.
Less time-consuming.
Detects only endotoxins.
Control Measures:
Use of Water for Injection (WFI)
Depyrogenation at 250°C
Cleanroom and HEPA-filtered environment
Testing ensures pyrogen-free and safe parenteral administration.
5. Discuss method of preparation and evaluation parameters of ophthalmic products.
Ophthalmic products include eye drops, eye ointments, and eye suspensions, used for local action on the eye.
Preparation:
Solution Form:
Drug dissolved in sterile solvent (WFI).
Adjust pH and tonicity.
Add preservatives (e.g., benzalkonium chloride).
Suspensions:
Finely divided drug dispersed.
Requires good suspending agents.
Ointments:
Drug mixed with sterile ointment base under aseptic conditions.
Sterilization:
Autoclaving (121°C for 20 min) or filtration through 0.22 µm filter.
Packaging:
In sterilized plastic or glass dropper bottles.
Evaluation Parameters:
Sterility test (per IP/USP)
Clarity test
pH (6.5–7.5) and isotonicity
Particle size (for suspensions): <10 µm
Viscosity
Preservative effectiveness test
Maintaining sterility and isotonicity ensures safety and comfort to the eye.
6. Define propellants and classify containers.
Propellants:
Propellants are compressed or liquefied gases used in aerosol systems to expel the product from the container and aid in its dispersion as a fine mist or spray.
Functions:
Create pressure inside the container.
Dispense product in desired form (spray, foam, mist).
Sometimes serve as solvent or carrier.
Types of Propellants:
Liquefied Gas Propellants:
Chlorofluorocarbons (CFCs) – Now banned due to ozone depletion.
Hydrofluoroalkanes (HFAs): Environmentally safe alternatives.
Hydrocarbons: Propane, butane, isobutane – Used in topical aerosols.
Compressed Gas Propellants:
Nitrogen (N₂), Carbon dioxide (CO₂), Nitrous oxide (N₂O)
Common in foam or food products.
Classification of Containers:
Tin-Plated Steel Containers:
Economical, used with hydrocarbon propellants.
Aluminum Containers:
Lightweight, corrosion-resistant, used in pharmaceutical aerosols.
Glass Containers:
Chemically inert, allows visual inspection but fragile.
Plastic-Coated Glass:
Combines transparency and improved strength.
Plastic Containers:
Limited use due to permeability and compatibility issues.
Proper container selection ensures compatibility, strength, inertness, and propellant containment.
7. Discuss formulation and evaluation of pharmaceutical aerosols.
Formulation of Aerosols:
Active Ingredient:
Drug substance to be delivered (e.g., salbutamol).
Propellants:
Liquefied gases or compressed gases to expel the contents.
Solvents:
Ethanol or other co-solvents to dissolve drug and propellant.
Valve and Actuator:
Controls dose and spray pattern.
Container:
Must withstand pressure and be compatible with formulation.
Types of Pharmaceutical Aerosols:
Inhalation aerosols: For asthma or COPD.
Topical aerosols: Local application to skin or wounds.
Nasal aerosols: For decongestants.
Evaluation Parameters:
Leak Test:
Ensures container integrity.
Spray Pattern and Particle Size:
Assessed using impactor or imaging.
Valve Discharge Rate:
Determines dose delivered per actuation.
Net Content:
Must conform to labeled amount.
Pressure Measurement:
Done using pressure gauges.
Drug Content Uniformity:
Ensures consistent dose with each actuation.
Proper formulation and testing ensure therapeutic efficacy, safety, and patient acceptability.
8. Explain in detail on cold filling and pressure filling methods for aerosols.
Aerosols are filled using either cold filling or pressure filling methods, depending on the nature of the propellant and product.
Cold Filling Method:
Product concentrate is chilled to around -30 to -40°C in a cold box.
Liquefied propellant is added and allowed to mix with the concentrate.
The mixture is filled into pre-cooled containers and sealed.
Advantages:
Simple and economical.
Suitable for non-aqueous systems.
Disadvantages:
Not suitable for moisture-sensitive or aqueous-based products.
Risk of propellant loss due to evaporation.
Pressure Filling Method:
Product concentrate is filled into the container first.
Propellant is introduced under pressure through the valve system.
Equipment includes a pressure burette or crimping machine.
Advantages:
Suitable for all types of systems (aqueous or non-aqueous).
More accurate and less product loss.
Disadvantages:
Requires expensive and pressurized equipment.
Needs safety precautions for handling propellants.
Comparison:
Feature | Cold Filling | Pressure Filling |
Accuracy | Moderate | High |
Product Loss | Higher | Lower |
Suitable for | Non-aqueous systems | All systems |
Equipment Cost | Lower | Higher |
Pressure filling is preferred in pharmaceutical industry due to its accuracy and broader applicability.
9. Describe various official and non-official tests conducted on film-coated tablets. Mention the official limits.
Film-coated tablets must meet specific standards to ensure uniformity, efficacy, and stability.
Official Tests (as per IP/USP/BP):
Weight Variation Test:
20 tablets weighed individually and average calculated.
Limit: ±5% deviation for tablets >250 mg.
Disintegration Test:
Should disintegrate within 30 minutes unless specified otherwise.
Dissolution Test:
Performed using paddle or basket apparatus.
Drug release profile should meet pharmacopeial specifications.
Hardness and Friability:
Friability should be ≤1% weight loss.
Hardness must be sufficient to withstand handling.
Assay and Content Uniformity:
Active ingredient should be within 90–110% of label claim.
Non-official Tests:
Color Uniformity:
Visual inspection under uniform lighting.
Surface Texture and Appearance:
No cracks, peeling, or rough spots.
Coating Thickness:
Measured using micrometer or weight gain method.
Moisture Content:
Checked using Karl Fischer titration or LOD method.
These tests help maintain quality, consistency, and therapeutic equivalence.
10. Explain various defects encountered in tablet compression and coating and their remedies.
Tablet manufacturing often encounters defects due to formulation or process-related issues.
Defects in Compression:
Capping:
Top/bottom layer separates.
Remedy: Improve granule lubrication, adjust pressure.
Lamination:
Tablet splits into layers.
Remedy: Reduce air entrapment, modify binder concentration.
Chipping:
Edge of tablet breaks off.
Remedy: Check tooling, increase binder.
Sticking:
Material sticks to punch.
Remedy: Use anti-adherents like talc or improve drying.
Picking:
Tablet surface lifts with punch.
Remedy: Modify formulation, use polished punches.
Defects in Coating:
Mottling:
Uneven color distribution.
Remedy: Uniform mixing, use soluble colorants.
Blooming:
Dull appearance.
Remedy: Optimize plasticizer levels and curing time.
Peeling/Flaking:
Separation of coating.
Remedy: Improve polymer adhesion.
Orange Peel Effect:
Rough surface like orange skin.
Remedy: Reduce spray rate or viscosity.
By identifying the root causes and taking corrective actions, such defects can be minimized, leading to high-quality tablets.
11. Discuss in detail about various tests which are generally done to maintain the quality control of tablets.
Quality control (QC) ensures that tablets meet required specifications for identity, strength, purity, and performance.
Official Tests (Pharmacopeial):
Weight Variation Test:
Ensures uniformity in drug content.
Limits: ±5% for tablets >250 mg.
Hardness Test:
Measures mechanical strength (in kg/cm²).
Acceptable range: 4–10 kg/cm² depending on tablet type.
Friability Test:
Assesses ability to withstand mechanical shocks.
Test: 100 rotations at 25 rpm in friabilator.
Limit: ≤1% weight loss.
Disintegration Test:
Time required to disintegrate in specified fluid.
For uncoated tablets: ≤15 minutes (IP/USP).
Dissolution Test:
Determines drug release rate using USP Apparatus I or II.
Must meet drug-specific release profile.
Content Uniformity:
Assures consistent dosage in each unit.
85–115% of label claim is acceptable for most drugs.
Non-Official Tests:
Thickness and Diameter:
Checked using vernier calipers or micrometer.
Moisture Content:
Checked by Karl Fischer method or LOD technique.
Appearance and Color Uniformity:
Visual inspection to check for mottling, cracks, or chips.
Tablet Porosity and Density:
Affects dissolution and stability.
These tests ensure consistent efficacy, stability, and patient safety.
12. Highlight the difference in nature of capsule shells of hard and soft gelatin capsules. What is the pharmacopeial disintegration limit for these types?
Capsules are solid dosage forms with a gelatin shell that encloses drug substances.
Hard Gelatin Capsules (HGC):
Structure: Two-piece capsule – cap and body.
Gelatin Type: High Bloom strength (Type B gelatin).
Moisture Content: 13–16%.
Filling: Dry powders, granules, pellets, mini-tablets.
Use: Mostly for oral solid drugs.
Soft Gelatin Capsules (SGC):
Structure: Single, sealed capsule.
Gelatin Type: Plasticized gelatin (with glycerin/sorbitol).
Moisture Content: 20–30%.
Filling: Liquids, semi-solids, suspensions.
Use: For oily, non-aqueous liquids, vitamins, and nutraceuticals.
Pharmacopeial Disintegration Limits:
Hard Gelatin Capsules: Should disintegrate within 30 minutes in water at 37°C (unless otherwise stated).
Soft Gelatin Capsules: Same limit of 30 minutes, provided the shell softens and ruptures within the time frame.
These parameters ensure rapid drug release and absorption post ingestion.
13. What are the advantages of capsules as a dosage form?
Capsules offer multiple pharmaceutical and patient-centric benefits:
1. Improved Patient Compliance:
Tasteless and odorless shell masks unpleasant taste.
Easier to swallow compared to tablets.
2. Versatility in Formulation:
Suitable for solids (HGC) and liquids (SGC).
Can encapsulate drugs that are sensitive to light or moisture.
3. Enhanced Drug Stability:
Shell protects active ingredients from air and light.
4. Ease of Manufacturing and Filling:
HGC filling is simple and does not involve compression.
Ideal for dose titration in clinical trials.
5. Better Bioavailability:
SGC provides faster dissolution and absorption, especially for lipophilic drugs.
6. Aesthetic and Branding Advantages:
Different colored caps and bodies enable product differentiation.
Despite their costlier production than tablets, capsules are favored for flexibility, speed to market, and user acceptability.
14. Discuss in detail about various mechanisms of filling powders in hard gelatin capsules.
Powder filling in hard gelatin capsules is performed using several mechanical methods, each designed to ensure accurate dosing.
1. Auger Filling:
Powder is fed into a hopper with an auger (screw).
Auger rotation controls powder flow into capsules.
Suitable for fine, free-flowing powders.
2. Vibratory Filling:
Capsules are partially filled with powder and subjected to vibration.
Powder settles due to gravity and vibration.
Ensures compact and uniform fill.
3. Piston-Tamp Filling (Dosing Disc Mechanism):
Most commonly used in high-speed capsule fillers.
Powder is compressed into slugs using tamping pins.
Slugs are ejected into the capsule body.
4. Dosator System:
A tube (dosator) enters the powder bed and picks up a fixed amount by vacuum or spring pressure.
Powder is then transferred to the capsule body.
Factors Affecting Filling:
Powder flowability
Particle size and density
Moisture content
Uniformity and compressibility
Proper selection of filling mechanism ensures dose uniformity and capsule integrity.
15. Discuss the factors influencing the choice of containers for packaging liquid products.
The container must protect the product’s quality, safety, and efficacy during its shelf life.
1. Physicochemical Properties of the Product:
pH: Acidic or alkaline liquids may react with certain plastics or metals.
Solvent nature: Alcohols or oils can leach plasticizers from plastic containers.
Light sensitivity: Requires amber or opaque packaging.
2. Type of Dosage Form:
Oral liquids: Bottles with measuring cups/spoons.
Injectables: Glass ampoules or vials.
Ophthalmic preparations: Dropper bottles with sterility protection.
3. Container Material:
Glass: Inert, impermeable, chemically resistant.
Plastic (HDPE, PET, LDPE): Lightweight, unbreakable, but permeable to moisture/gases.
4. Barrier Properties:
Resistance to oxygen, light, and moisture.
5. Regulatory and Safety Requirements:
Tamper-evident seals.
Child-resistant closures.
6. Cost and Availability:
Impacts large-scale production.
Proper container selection ensures product stability, user convenience, and regulatory compliance.
16. Enumerate the tests conducted for evaluating the suitability of low-density polyethylene (LDPE) as a packaging material.
LDPE is widely used in packaging of ophthalmics, parenterals, and oral liquids, especially squeeze-type containers.
Tests for LDPE Evaluation:
Physicochemical Test:
No release of toxic substances.
Checked for color, odor, and clarity.
Water Vapor Transmission Rate (WVTR):
Measures permeability to moisture.
LDPE is semi-permeable; lower WVTR indicates better moisture barrier.
Extractables and Leachables:
Heated with solvents and analyzed for migrated substances (UV or GC/MS).
Light Transmission Test:
For colored LDPE, checks ability to block light.
Mechanical Strength:
Tests for tensile strength, elongation, and impact resistance.
Chemical Resistance Test:
Exposure to acids, alkalis, alcohols to ensure container stability.
Biological Reactivity Test:
As per USP Class VI; checks for tissue reactivity when used in injectables.
LDPE’s evaluation confirms it is safe, compatible, and protective, ensuring drug product quality.
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B.Pharmacy 5th Semester Industrial Pharmacy - I Important Question Answer
B.Pharmacy 5th Semester All Subject Important Question Answer
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