Pharmaceutics One Shot Notes with MCQs

Pharmaceutics One Shot Notes and MCQs: A Comprehensive Guide for Quick Revision

Pharmaceutics, the science of drug formulation, plays a crucial role in ensuring the safety, efficacy, and quality of medications. This one-shot pharmaceutics guide compiles key concepts, classifications, equipment, and processes involved in the preparation, manufacturing, and quality control of pharmaceuticals. Covering everything from tablet formulation defects, types of pharmaceutical water, mixing and drying equipment, to particle size separation methods, this guide serves as a quick and thorough reference for students and professionals alike.

In addition to clear, concise notes, a set of over 100 multiple-choice questions (MCQs) with answers is provided. These MCQs test your knowledge on various pharmaceutics topics such as tablet defects, drug dissolution, flow types, viscosity measurement, filtration equipment, drying techniques, and cleanroom classifications. This combination of notes and MCQs is designed for exam preparation, allowing you to quickly grasp critical information and test your understanding efficiently.

Whether you’re preparing for exams, interviews, or simply brushing up on your pharmaceutics knowledge, these one-shot notes and MCQs provide a fast, reliable, and comprehensive resource.

This Notes provides a brief yet thorough overview of essential pharmaceutics concepts with supporting MCQs to enhance learning and self-assessment. It is a perfect revision tool for students, pharmacists, and professionals seeking to master the basics and detailed aspects of drug formulation and manufacturing.

Pharmaceutics Notes One Shot

1. HEPA Filter Classifications

• Class 100 Area:
  • Particle count: No more than 100 particles per cubic foot (≥ 0.5 microns).
  • Example: Sterile and aseptic areas.
• Class 10,000 Area:
  • Particle count: No more than 10,000 particles per cubic foot (≥ 0.5 microns).
  • Example: Manufacturing areas.
• Class 100,000 Area:
  • Particle count: No more than 100,000 particles per cubic foot (≥ 0.5 microns).
  • Example: Packaging and storage areas.

2. Weight Variation According to USP Standards

• 130 mg or less: ± 10% variation allowed.
• 131 mg to 324 mg: ± 7.5% variation allowed.
• More than 324 mg: ± 5% variation allowed.

3. Types of Pharmaceutical Water

• Purified Water:
  • Prepared by distillation or ion exchange.
  • Not pyrogen-free; used as a pharmaceutical solvent.
• Water for Injection (WFI):
  • Produced by distillation or reverse osmosis.
  • Pyrogen-free but not sterile; must be used within 24 hours or stored at ≤ 5°C or ≥ 80°C.
• Sterile Water for Injection (Sterile WFI):
  • Same preparation as WFI but sterile.
  • Used for reconstitution of sterile solids and in single-dose containers.
• Bacteriostatic Water for Injection:
  • Prepared via distillation or reverse osmosis.
  • Sterile and used for both single and multi-dose containers.

4. Types of Flow

• Newtonian Flow:
  • Example: Water, glycerine, alcohol, and benzene.
• Plastic (Bingham Body):
  • Example: Suspension of ZnO in mineral oil, paint, printing inks, and firm jellies.
• Pseudoplastic Flow:
  • Example: Natural and synthetic gums (e.g., CMC, sodium alginate, gelatin).
• Dilatant Flow:
  • Example: De-flocculated suspensions with >50% solid content, such as concentrated titanium dioxide suspension.

5. Time-Dependent Viscosity

• Thixotropy (Gel-Sol Transformation):
  • Gel becomes sol upon agitation and reverts back to gel.
  • Example: Magma gels and petrolatum.
• Anti-Thixotropy (Rheopexy):
  • Sol forms a gel over time with rest or under specific conditions.

6. Tablet Coating Defects

• Blistering: Local detachment of the film from the tablet.
• Cratering: Volcanic-like craters exposing the tablet surface.
• Pitting: Formation of pits on the tablet core without disrupting the film.
• Blooming: Dull appearance of the coating due to temperature issues.
• Orange Peel/Roughness: Rough, non-glossy surface similar to an orange.

7. Soluble Lubricants and Their Concentration Range

• Boric Acid: 1%
• Sodium Benzoate, Sodium Oleate, Sodium Acetate: 5%
• Sodium Lauryl Sulfate (SLS): 1-5%
• Magnesium Lauryl Sulfate (MLS): 1-2%

8. Semisolid Mixers

• Planetary Motion Mixer:
  • Features anchor-type paddles for pulling and kneading.
  • Used for ointments, tablet granulations, and viscous materials.
• Sigma Blade Mixer (Z-Blade/Double Cone Mixer):
  • Contains open troughs with kneading blades.
  • Suitable for pill mass, ointment, and granulation mixing.

9. Partition Coefficient

• Definition:
  • A measure of a drug’s lipophilicity and its ability to cross cell membranes.
  • Represented as the ratio of un-ionized drug in organic and aqueous phases at equilibrium.
• Formulas:
  • For Unionized Drugs: P=CorganicCaqueousP = \frac{C_{organic}}{C_{aqueous}}P=Caqueous​Corganic​​
  • For Ionizable Drugs: P=Corganic(1−α)×CaqueousP = \frac{C_{organic}}{(1 – \alpha) \times C_{aqueous}}P=(1−α)×Caqueous​Corganic​​, where α\alphaα is the degree of ionization.
• Drug Properties:
  • P>1P > 1P>1: Lipophilic drug.
  • P<1P < 1P<1: Hydrophilic drug.
• Common Solvents: Chloroform, ether, amyl acetate.
• Methods for Determination: Shake-flask method, HPLC, counter-current method.

10. Particle Size Separation Methods

• Sieving: 5–10,000 microns.
• Sedimentation:
  • Gravitational: 5–1,000 microns.
  • Centrifugal: 0.1–5 microns.
• Elutriation:
  • Gravitational (Water/Air): 10–500 microns.
  • Centrifugal: 0.5–50 microns.
• Cyclone Separation: 2–50 microns.

11. Mixing Equipment for Solids/Powders

• Ribbon Blender (Dry Mixer):
  • Uses convective mixing.
  • Suitable for free-flowing materials with uniform size and density.
• Tumbling Mixer:
  • Works through shear and diffusion mixing.
  • Operates at 30-100 RPM.
  • Examples: Twin-shape, double cone, cubic, and cylindrical tumblers.

12. Mixing Equipment for Liquids

• Propeller Mixer:
  • Used for low-viscosity liquids at < 8000 RPM.
  • Not suitable for viscous liquids like glycerin or castor oil.
• Turbine Mixer:
  • Contains an impeller; used for high-viscosity liquids such as glucose solutions.
  • Ideal for emulsification processes.
• Paddle Mixer:
  • Rotates at 100 RPM; used as an agitator for mixing liquids.

13. Methods of Viscosity Determination

• Newtonian Fluids:
  • Measured using Ostwald (capillary) or falling sphere viscometers.
• Non-Newtonian Fluids:
  • Measured using cup and bob or cone and plate viscometers.

14. Methods for Particle Size Determination

15. Mechanical Sterilization Methods

• Bacteria-Proof Filters (Cold Sterilization):
  • Ceramic Filters: Made from kieselguhr and unglazed porcelain.
  • Seitz Filters: Composed of asbestos and wood cellulose.
  • Sintered Glass Filters: Made from borosilicate glass.
  • Membrane Filters: Use cellulose acetate/nitrate or nylon; ideal for parenteral solutions.
  • HEPA Filters: Remove air particles larger than 0.3 microns.

16. Latin Terms for Drug Administration

17. Causes and Remedies of Tablet Lamination

• Cause:
  • Rapid relaxation of tablet’s peripheral regions upon ejection from the die.
• Remedies:
  • Use tapered dies (3-5° outward taper).
  • Include pre-compression steps.
  • Reduce turret speed and final compression pressure.

18. IVIVC (In Vitro-In Vivo Correlation) Levels and Parameters

• Level A: In vitro dissolution curve vs. absorption curve.
• Level B: Statistical moments like Mean Dissolution Time (MDT) and Mean Residence Time (MRT).
• Level C: Dissolution rate, Cmax, Tmax, and AUC.

19. Insoluble Lubricants and Their Properties

• Stearates (e.g., Magnesium Stearate): 0.25 – 1%
  • Widely used but reduces tablet strength and prolongs disintegration.
• Talc: 1 – 2%
  • Insoluble but not hydrophobic; moderately effective.
• Glyceryl Dibehenate (Compritol® 888): 1 – 5%
  • Functions as both lubricant and binder.
• Liquid Paraffin: Up to 5%
  • May cause dispersion issues; inferior to stearates.

20. ICH Stability Zones

21. Hygroscopicity

• Definition: The ability of a material to absorb moisture from the atmosphere and maintain equilibrium with atmospheric water.
• Types:
  • Deliquescent: Substances that absorb moisture to such an extent that they dissolve partially or completely into a solution.
  • Efflorescent: Substances that lose water and convert into a lower hydrate or become anhydrous.
• Examples:
  • Hygroscopic & Deliquescent: Ephedrine, Hyoscyamine, Phenobarbital, Pilocarpine, Physostigmine
  • Efflorescent: Atropine, Cocaine, Codeine, Scopolamine, Caffeine

22. Hausner’s Ratio

Used to indicate the flowability of powders:

• Less than 1.25: Good flow
• 1.25 to 1.5: Moderate flow
• More than 1.5: Poor flow

23. Types of Density

• True Density: Measured using a helium pycnometer (for porous solids) or liquid displacement (for non-porous solids).
• Granule Density: Determined using the mercury displacement method.
• Bulk Density: Measured by tapping powder in a graduated cylinder multiple times.

24. Granulation Issues and Remedies

Lamination Causes and Remedies

• Causes: Oily or waxy materials, excessive hydrophobic lubricant (e.g., magnesium stearate)
• Remedies: Modify the mixing process, add absorbents, reduce or change the lubricant.

Sticking Causes and Remedies

• Causes: Granules not dried properly, improper lubrication, excessive binder, or hygroscopic granules.
• Remedies:
  • Dry granules thoroughly and set moisture limits.
  • Increase lubrication or change lubricant type.
  • Reduce binder amount or change binder type.
  • Compress under controlled humidity to prevent sticking.

25. Powder Grades

• Coarse: 40% passes through a 44 sieve.
• Moderately Coarse: 40% passes through a 60 sieve.
• Moderately Fine: 40% passes through an 85 sieve.
• Fine: 40% passes through a 120 sieve.
• Micro Fine: 90% passes through a 350 mesh.
• Super Fine: 90% passes through a 10 µm sieve.

26. Forces of Attraction Between Particles

• Intermolecular Forces: Bind molecules (e.g., van der Waals forces).
• Intramolecular Forces: Bind atoms within molecules (ionic and covalent bonds).
• Ion-Dipole Interaction: Polar molecules interact with charged ions.
• Ion-Induced Dipole: Non-polar molecules become polarized in the presence of ions.

27. Filtration Equipment (Pressure Filters)

• Plate and Frame Filter Press: Used for surface filtration and sterile processes (e.g., antitoxin production).
• Metal Filter (Edge Filter): Made of stainless steel; used for syrup or insulin filtration.

28. Diffusion Layer Model/Film Theory

1. Solution Formation: A thin diffusion layer forms at the solid/liquid interface, saturated with the drug.
2. Diffusion Process: Solute diffuses from the layer into the solution. This is usually the rate-determining step.

29. Evaporator Equipment and Principles

• Evaporating Pan: Uses natural circulation for stable liquids.
• Vacuum Pan: For thermo-sensitive substances.
• Horizontal and Vertical Tube Evaporators: Common in sugar processing and non-viscous liquids.
• Climbing Film (Kestner Tube): Used for sugar, salts, and heavy solutions.

30. Eutectic Mixture

• Definition: A combination of two or more substances that inhibit each other’s crystallization, resulting in a lower melting point than either component individually.
• Applications: Can be formed between active pharmaceutical ingredients (APIs), APIs with excipients, or between excipients.
• Key Factors:
  • Components must be miscible in liquid but immiscible in solid state.
  • Intimate contact is necessary for melting point depression.
  • Components may interact via physical bonds like hydrogen bonding.
• Examples: Menthol, thymol, camphor, phenol, salol

31. Electrokinetic Phenomena

1. Electrophoresis:
   • Movement of dispersed charged particles through a liquid under the influence of an electric field.
   • Zeta potential formula:
     ζ=VE×4πμk×9×104 volts\zeta = \frac{V}{E} \times \frac{4\pi\mu}{k} \times 9 \times 10^4 \text{ volts}ζ=EV​×k4πμ​×9×104 volts
2. Electro-osmosis:
   • Movement of liquid relative to a stationary solid under the influence of an electric field.
3. Streaming Potential:
   • Potential difference generated when a liquid flows through a fixed solid. This is the opposite of electro-osmosis.
4. Sedimentation Potential:
   • Occurs when a potential difference is set up due to the movement of suspended particles, opposite to electrophoresis.

32. Dryer Equipment Based on Use

• For Solids (Granules):
  • Tray Dryer (Batch process)
  • Fluidized Bed Dryer (FBD) (Batch process)
  • Rotary Dryer (Continuous process)
  • Turbo Dryer (Continuous process)
  • Tunnel/Belt/Conveyor Dryer (Continuous process)
  • Freeze Dryer (Batch process)
  • Vacuum Dryer (Batch process)
• For Solutions:
  • Rotary Dryer, Spray Dryer, Drum Dryer, Pan Dryer
• For Paste or Sludges:
  • Vacuum Dryer, Agitator Dryer

33. Characteristics of Specific Dryers

1. Tray Dryer (Shelf Dryer):
   • Suitable for chemical powders, crude drugs, and tablet granules.
   • Only supports batch processing.
2. Fluidized Bed Dryer (FBD):
   • Short drying time (~30 minutes).
   • Used for tablet granules, plastic materials, coal, and inorganic salts.
3. Tunnel Dryer (Belt/Conveyor Dryer):
   • Continuous process for drying paraffin wax, gelatin, and soap.
4. Rotary Dryer (Modified Tunnel):
   • Used for powders and granular solids.

34. Disintegration Time for Tablets and Capsules

1. Uncoated Tablet: 15 minutes
2. Film/Sugar Coated Tablet: 60 minutes
3. Enteric Coated Tablet: 3 hours
4. Hard Gelatin Capsule: 30 minutes
5. Soft Gelatin Capsule: 60 minutes

35. Disintegrants Used in Tablets

36. Liniment vs. Lotion

37. Causes and Remedies of Chipping in Tablets (Machine Issues)

38. Causes and Remedies of Picking in Tablets

39. Classification of Centrifuges

40. Classification of Binders

1. Sugars:
   • Sucrose, Liquid Glucose
2. Natural Binders:
   • Acacia, Tragacanth, Gelatin, Starch Paste, Pregelatinized Starch, Alginic Acid, Cellulose
3. Synthetic/Semisynthetic Polymers:
   • Methyl Cellulose, Ethyl Cellulose, Hydroxypropyl Methyl Cellulose (HPMC), Hydroxypropyl Cellulose, Sodium Carboxymethyl Cellulose
   • Polyvinyl Pyrrolidone (PVP), Polyethylene Glycol (PEG), Polyvinyl Alcohol, Polymethacrylates

41. Cowling’s, Fried’s, and Bastedo’s Formulas

These formulas help in calculating pediatric doses based on a child’s age.

• Cowling’s Formula:
  Child Dose=Age in years+124×Adult Dose\text{Child Dose} = \frac{\text{Age in years} + 1}{24} \times \text{Adult Dose}Child Dose=24Age in years+1​×Adult Dose
• Fried’s Formula:
  Child Dose=Age in months150×Adult Dose\text{Child Dose} = \frac{\text{Age in months}}{150} \times \text{Adult Dose}Child Dose=150Age in months​×Adult Dose
• Bastedo’s Formula:
  Child Dose=Age in years+330×Adult Dose\text{Child Dose} = \frac{\text{Age in years} + 3}{30} \times \text{Adult Dose}Child Dose=30Age in years+3​×Adult Dose

42. Causes and Remedies of Capping (Machine Issues)

43. Biopharmaceutical Classification System (BCS)

44. Aseptic Preparation – Environmental Grades

45. Angle of Repose – Powder Flow

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